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date: 22 August 2017

The ACT2 Program and Eliminating Racial and Ethnic Disparities in HIV and AIDS Clinical Trials: A Case Study in Health and Risk Messaging

Summary and Keywords

It is well documented that African American/Black and Hispanic individuals are underrepresented in biomedical research in the United States (U.S.), and leaders in the field have called for the proportional representation of varied populations in biomedical studies as a matter of social justice, economics, and science. Yet achieving appropriate representation is particularly challenging for health conditions that are highly stigmatized such as HIV/AIDS. African American/Black, and Hispanic individuals, referred to here as “people of color,” are greatly overrepresented among the 1.2 million persons living with HIV/AIDS in the United States. Despite this, people of color are substantially underrepresented in AIDS clinical trials. AIDS clinical trials are research studies to evaluate the safety and effectiveness of promising new treatments for HIV and AIDS and for the complications of HIV/AIDS, among human volunteers. As such, AIDS clinical trials are critical to the development of new medications and treatment regimens. The underrepresentation of people of color in AIDS clinical trials has been criticized on a number of levels. Of primary concern, underrepresentation may limit the generalizability of research findings to the populations most affected by HIV/AIDS. This has led to serious concerns about the precision of estimates of clinical efficacy and adverse effects of many treatments for HIV/AIDS among these populations. The reasons for the underrepresentation of people of color are complex and multifaceted. First, people of color experience serious emotional and attitudinal barriers to AIDS clinical trials such as fear and distrust of medical research. These experiences of fear and distrust are grounded largely in the well-known history of abuse of individuals of color by medical research institutions, and are complicated by current experiences of exclusion and discrimination in health care settings and the larger society, often referred to as structural racism or structural violence. In addition, people of color experience barriers to AIDS clinical trials at the level of social networks, such as social norms that do not support engagement in medical research and preferences for alternative therapies. People of color living with HIV/AIDS experience a number of structural barriers to clinical trials, such as difficulty accessing and navigating the trials system, which is often unfamiliar and daunting. Further, most health care providers are not well positioned to help people of color overcome these serious barriers to AIDS clinical trials in the context of a short medical appointment, and therefore are less likely to refer them to trials compared to their White peers. Last, some studies suggest that the trials’ inclusion and exclusion criteria exclude a greater proportion of people of color than White participants. Social/behavioral interventions that directly address the historical and contextual factors underlying the underrepresentation of people of color in AIDS clinical trials, build motivation and capability to access trials, and offer repeated access to screening for trials, hold promise for eliminating this racial/ethnic disparity. Further, modifications to study inclusion criteria will be needed to increase the proportion of people of color who enroll in AIDS clinical trials.

Keywords: AIDS clinical trials, HIV, medical research studies, racial/ethnic disparities, health equity, African American, Black, Hispanic, behavioral intervention, peer-driven intervention

Racial/Ethnic Disparities in HIV/AIDS Clinical Trials in the United States

AIDS clinical trials (ACTs) are research studies to evaluate promising new medical approaches for the treatment of HIV and AIDS and its complications. ACTs are diverse in nature and include studies that evaluate the efficacy of new medications, combinations of medications, and dosing schedules, such as once-a-day regimens and those designed to produce fewer side effects, as well as studies of therapeutic vaccines; therapies to prevent and treat the opportunistic infections, co-infections (including Hepatitis C virus), complications of therapies, and other comorbidities associated with HIV/AIDS; treatments to reconstitute HIV-damaged immune systems; evaluations of alternative therapies to treat the consequences of HIV; biomedical investigations of the progression and consequences of HIV disease, including observational studies in which no treatments are provided; and studies to develop a cure for HIV (National Institute of Allergy and Infectious Diseases (NIAID), 2013).

HIV is a disease of social disadvantage (Pellowski, Kalichman, Matthews, & Adler, 2013). In this third decade of the HIV epidemic in the United States (U.S.), African Americans/Blacks and Hispanics, mainly those from lower socioeconomic status backgrounds, are overrepresented among people living with HIV (PLWH) compared to Whites. In fact, African Americans/Blacks and Hispanics, referred to in this paper as “people of color,” make up 65% of all HIV/AIDS cases reported in the United States, yet represent only 25% of the general population (Centers for Disease Control and Prevention, 2012). Almost all women living with HIV are African American/Black or Hispanic (> 80%; Centers for Disease Control and Prevention, 2012). Racial/ethnic disparities in rates of treatment for and progression of HIV disease are pronounced. African American/Black and Hispanic PLWH are more likely to suffer the ill effects of HIV/AIDS, to die from HIV/AIDS, and to die earlier, compared to their White peers (Siddiqi, Hu, & Hall, 2015). Despite the availability of HIV care and treatment in the United States, these racial/ethnic and gender disparities in HIV/AIDS incidence and morbidity/mortality have not decreased, including in the past decade (Siddiqi et al., 2015). Further, a large proportion of PLWH of color are men who have sex with men (MSM), followed by heterosexuals and persons who inject drugs (Centers for Disease Control and Prevention, 2012)—highlighting the intersecting role of “multiple stigmas” in risk for HIV and its effect on communities of color.

PLWH of color have long been underrepresented in ACTs. Over the past decade fewer than half of those enrolled in ACTs nationally have been African American/Black or Hispanic (44%) (NIAID). Yet insufficient attention has been paid to the specific recruitment of people of color into ACTs (King, 2002). PLWH enter ACTs through a screening process in which the patient’s medical history and medical status are used to determine his/her eligibility for open trials. There are at least two stages where PLWH of color experience barriers to entry. First, PLWH of color are referred to and/or present for ACT screening at disproportionately low rates, and they do not have the opportunity to enroll into ACTs as a result (Gwadz et al., 2010b). Second, for those who are screened for ACTs, evidence suggests they are less likely to be found eligible for ACTs compared to their White peers (Gandhi et al., 2005).

Because ACTs are critical to the development of new treatment regimens, the failure to include appropriate numbers of PLWH of color into ACTs has been criticized on a number of levels. First, and most importantly, insufficient involvement of people of color, including women, limits the generalizability of research findings to these populations most affected by HIV/AIDS (Cargill & Stone, 2005; Parada, 2000). This lack of proportional representation has led to serious concerns about the precision of estimates of the clinical efficacy and adverse effects of many treatments for HIV/AIDS and related complications among these populations (Pollack & Altman, 2003). Second, excluding PLWH of color from ACTs denies them the opportunity to contribute to the science of HIV treatment, an altruistic act that many PLWH find meaningful. Moreover, although ACTs are not intended to provide individual benefit to participants, participating in ACTs may provide access to a high level of attention and care that may not otherwise be available to PLWH. In fact, participants in trials often evidence better health and quality of life than their peers in clinic settings, a phenomenon referred to as the “trials effect” (Gifford et al., 2002; King, Wong, Shapiro, Landon, & Cunningham, 2004). For some patients, ACTs may represent their best access to state-of-the-art life-extending, therapies, particularly for individuals with poor access to services (Parada, 2000). Increasing the number of people, including women, of color in ACTs will therefore advance scientific knowledge and improve clinical treatments and outcomes for these populations (Parada, 2000). Further, some have argued for an ethical mandate to reduce barriers to ACTs for these groups and to increase equitable access to ACTs. Despite the attention paid to this public health concern over the past few decades, recent data indicate that racial/ethnic disparities in ACT persist (Castillo-Mancilla et al., 2014; Gwadz et al., 2010a; Menezes et al., 2011).

The Larger Context of Barriers to ACTs for PLWH of Color

Barriers to ACTs for PLWH of color are grounded in a historical and cultural context. The United States has a long and sorrowful history of mistreating and exploiting vulnerable populations such as people of color in medical research studies (Washington, 2007). These historical events, which are numerous, have profoundly affected norms regarding and attitudes toward medical research among people of color. The Tuskegee Syphilis Study is perhaps the most notorious example of these abuses. This study was conducted between 1932 and 1972 by the U.S. Public Health Service. It involved rural African American/Black men infected with syphilis, who were studied without their consent under the pretense of receiving free health care from the U.S. government (Thomas & Quinn, 1991). Over a period of 40 years, none of the men were told they had the disease, and none were provided with treatment for the disease, even after penicillin was established as an effective treatment for syphilis. Ultimately, numerous study participants died of syphilis, 40 of their wives contracted the disease, and 19 children were born with congenital syphilis (Thomas & Quinn, 1991). This infamous study along with numerous other examples of exploitation and maltreatment by the medical research establishment contribute to fear and distrust not only of ACTs and other types of medical research, but of the HIV care system, health care providers, and other larger societal structures including the government (Beer et al., 2012). Although the U.S. medical research system was reformed in the 1970s when the Tuskegee Syphilis Study came to light, the study continues to serve as a powerful example of the dangers of medical research and untrustworthiness of researchers to the population at large, and people of color in particular. The effects of the Tuskegee Syphilis Study persist, perhaps in part, because this type of historical maltreatment resonates with present-day exclusion, discrimination, and structural racism/structural violence (Ford & Airhihenbuwa, 2010; Thomas & Quinn, 1991).

Similarly, counternarratives (also called “conspiracy theories” by some) play an important role in influencing the attitudes of PLWH of color regarding ACTs and medical research. Theories about HIV, such as a theory that the U.S. government created HIV as a plot to eliminate African American/Black individuals and that the U.S. government has developed a cure for HIV/AIDS but is withholding it from people of color, emerge from an entrenched distrust of the government (Heller, 2015). Heller (2015) attributes these beliefs to the long history of disenfranchisement experienced by African Americans/Black throughout American history, beginning with the horrors of slavery and continuing through the ongoing struggle for civil rights. A body of research has shown that Hispanic populations similarly encounter and endorse such counternarratives (Ross, Essien, & Torres, 2006; Westergaard, Beach, Saha, & Jacobs, 2014). Thus when asked about ACTs, African American/Black and Hispanic PLWH will commonly state they neither wish to be a “guinea pig” nor trust in medical research.

Despite the history of abuses of populations of color by medical institutions and the continued resonance of this history, medical distrust does not necessarily preclude willingness to participate in medical research (Gwadz et al., 2006; Westergaard et al., 2014). Other research has shown that knowledge of the Tuskegee Syphilis Study does not directly cause individuals to decline to participate in medical research (Katz et al., 2006). These findings taken together suggest interventions are needed to acknowledge the past maltreatment of PLWH of color in medical research, highlight research participants’ rights and protections, allow PLWH to consider the factors that might make them willing or unwilling to participate in ACTs, help them navigate an unfamiliar and sometimes overwhelming system, and make a personal decision about participating in ACTs.

Barriers to and Facilitators of ACT Participation for PLWH of Color

In this historical context, the empirical literature indicates that barriers to ACTs for PLWH of color are complex and multifaceted and operate at the levels of individual PLWH, their social networks, organizations that serve PLWH, and the larger environment, referred to as structural barriers (Gwadz et al., 2010a; Gwadz et al., 2010b; Gwadz et al., 2006). These barriers interact with each other across multiple levels of influence to create potent impediments to ACTs for PLWH of color. We conceptualize the barriers that people of color face to ACTs using the theory of triadic influence (TTI) (Flay & Petraitis, 1994). The TTI is an integrative model that identifies three “streams of influence” on health behavior: individual/attitudinal, social, and structural levels. Theoretically, barriers at these three levels of influence combine synergistically to reduce both patients’ access to ACTs and their motivation to enroll in biomedical studies (see Table 1).

The structural level of influence includes aspects of health care settings and the providers who work within those settings, and the structural-level factors interact with individual/attitudinal and social factors. PLWH must, of course, be made aware of ACTs in order to be able to participate in screening for medical studies. Generally, PLWH are informed about trials directly by clinical trial researchers or through their health care providers who may refer them to studies. Yet it is well documented that PLWH of color are much less likely to be recruited for or referred to ACTs than their White counterparts (DeFreitas, 2010; Sullivan, McNaghten, Begley, Hutchinson, & Cargill, 2007). It has been suggested that inadequate or ineffective outreach efforts to these groups and the additional cost of developing and implementing appropriate recruitment strategies, hamper the efforts of clinical trials research units to insure more inclusive samples (Shavers-Hornaday, Lynch, Burmeister, & Torner, 1997).

Further, health care providers’ and researchers’ beliefs and assumptions about PLWH of color appear to play a major role in the disproportionately low participation of people of color in ACTs. Research has shown that HIV care providers, who serve as one critical gateway to ACTs by referring their patients to screening for ACTs, tend to assume PLWH of color are less interested in and willing to participate in ACTs than White individuals and thus are less likely to refer PLWH to ACTs (Cargill & Stone, 2005; Stone, Mauch, & Steger, 1998). In fact, PLWH of color may indeed have mixed feelings about ACTs but may be willing to explore them if encouraged to do so (Gwadz et al., 2010b; Gwadz et al., 2006).

Another barrier to participation of PLWH of color in ACTs centers around the fact that ACTs often involve invasive procedures or multiple study visits over extended periods of time. It is essential that research subjects complete protocols with perfect or near perfect adherence. In light of these demands, providers report being less likely to refer PLWH of color to ACTs out of concerns about their abilities to adhere adequately to study protocols (Cotton, Finkelstein, He, & Feinberg, 1993; Murphy, 1991). Yet PLWH of color have been shown to adhere well to ACTs and complete trials with appropriate support (Andersen, Fass, & van der Horst, 2007).

The nature of the health care encounter is another organizational-level barrier. Health care providers are not well positioned to help PLWH of color overcome barriers to ACTs in the context of a short health care encounter. Indeed, health care providers are charged with treating a complex health condition in a challenging population, meaning that explaining and pre-screening PLWH of color for ACTs may be, understandably, a low priority. Thus interventions are needed in clinic settings to complement health care encounters and provide information to PLWH of color about ACTs, and to address other types of barriers to ACTs.

PLWH of color who are recruited for or referred to ACTs may be less likely to participate due to personal barriers as well—an important individual/attitudinal factor. For those who are aware of or even recruited for ACTs, PLWH of color are more likely than White individuals to decline participation (Sullivan et al., 2007). Ongoing or even past substance use may prevent some PLWH from engaging in ACTs. ACTs have historically had restrictive criteria for substance users, including persons who inject drugs (Parada, 2000). Although these restrictions have eased somewhat in recent years, PLWH who have a history of substance abuse (but not active substance use) may not be aware of these changes and thus may not explore ACTs based on the assumption they will not be found eligible, even if they are not currently using substances. Women who use substances, even if not heavily, may fear that discovery of their drug use by medical professionals will threaten child custody (Greenberger, 1998). Practical barriers and life circumstances may also interfere with ACT enrollment, given the perceived or real-time commitment required. Such practical barriers include a lack of access to transportation, lack of childcare, and other pressing life problems related to poverty (Parada, 2000). Over half of HIV-infected women have minor-age children; family responsibilities and childcare may be experienced as greater priorities than ACTs (Brown-Peterside, Chiasson, Ren, & Koblin, 2000). Undocumented immigrants may avoid the ACT system, fearing exposure of their immigration status to authorities or assuming that ACTs are not available to them as a result (Gany, Herrera, Avallone, & Changrani, 2006). Yet these types of barriers to ACTs are not insurmountable.

Social-level influences can serve as barriers to participation in ACTs for PLWH of color. An extensive literature has demonstrated the powerful effects that peer norms, social comparisons, modeling and reinforcement, and social interactions can have on individuals’ behaviors, particularly HIV risk behaviors (Flay & Petraitis, 1994; Latkin, 1998). In particular, misinformation and negative or ambivalent beliefs about ACTs are common in the social networks of PLWH of color (Gwadz et al., 2010b; Gwadz et al., 2006). This lack of social network support to pursue ACTs and fear of experiencing social stigma related to ACT participation impedes engagement in ACTs.

The design of trials, that is, their specific inclusion and exclusion criteria, may create additional impediments to ACTs for PLWH of color. The National Institute of Allergy and Infectious Diseases (NIAID) has demonstrated a long-standing interest in developing ACTs for people of color and women (NIAID, 2008). Yet some data suggest that PLWH of color may be less likely to be found eligible for ACTs compared to Whites (Marshak et al., 2007). Thus restrictive eligibility criteria of ACTs has been cited as one factor contributing to lower eligibility rates of PLWH of color compared to Whites. For example, in one study, among a sample of mostly non-White PLWH, only 13% were found eligible for ACTs largely because of clinical factors that precluded their participation (e.g., CD4 and viral load levels, medical histories) (Marshak et al., 2007). Yet little research has examined the contribution of the practices of ACTs themselves to low enrollment rates among PLWH of color (Gandhi et al., 2005).

Another structural-level barrier to ACT participation among PLWH of color is the clinical trial setting itself. The settings where ACTs are conducted have historically not been located in clinics where patients receive regular care, and clinical trial research units may have policies and procedures that differ from clinic settings, making it difficult for PLWH to navigate this unfamiliar setting (El-Sadr & Capps, 1992a). The unfamiliar and sometimes academic nature of the clinical trials setting in terms of location, atmosphere, procedures, and expectations of patients contributes to their fear and mistrust of medical research (Andersen, Fass, & van der Horst, 2007; Gifford et al., 2002). Clinical trial research units have traditionally been located in settings separate from usual care; recent guidelines have recommended moving such activities into the community

Table 1. Summary of primary barriers to and facilitators of ACTs for PLWH of color using the theory of triadic influence

Individual/attitudinal

Low levels of awareness and knowledge of ACTs

Distrust of medical research

Fears of medical research

Tendency to decline trials if offered the opportunity

Beliefs they will be excluded from trials because of actual or presumed substance use

Practical barriers and life circumstances

“Competing priorities” complicated by poverty

Desire to give back to community (altruism)

Desire for good health, new opportunities

Willingness to explore medical research

Social

Norms unsupportive of participation in medical research

Lack of role models who participate in ACTs

Stigma

Structural—aspects of the clinical trial and health care setting

Trial settings are unfamiliar environments for many PLWH of color

Trial settings may be located in settings separate from usual care; may be inconveniently located

Insufficient outreach and recruitment efforts directed to populations of color

Lack of culturally based recruitment strategies

Lack of support to help PLWH of color to navigate trial settings

Providers’ assumptions about the negative attitudes of PLWH of color toward ACTs, and their lack of interest

Short health care encounters cannot overcome serious barriers

Structural—aspects of ACTs and the ACT system

Design of trials may exclude PLWH of color

Interventions to Address Disparities in ACTs

Racial/ethnic disparities in ACTs and the factors underlying these disparities have been fairly well described. Yet the science of interventions to address the barriers to ACT participation and reduce disparities among PLWH of color, whether structural, organizational, or social/behavioral interventions, is scant. In fact, only a small number of interventions have been developed to address this problem, and rarely have they been tested in rigorous, controlled trials. Nonetheless, these past interventions shed light on potential strategies to increase enrollment of PLWH of color. Freedberg and colleagues (2001) tested a brief and relatively straightforward intervention in an urban hospital-based HIV clinic, in which culturally tailored information about ACTs was provided to all PLWH in the clinic, regardless of their patient characteristics, at their first clinic visit (Freedberg et al., 2001). This intervention, which, in effect, reduces the need for providers to pre-screen patients and therefore make judgments about their abilities to potentially adhere to protocols, was successful in reducing race, gender and risk behavior-related disparities in ACTs, although disparities were not eliminated. El-Sadr and Capps (1992b) describe a second program aimed at increasing participation of PLWH of color and women in medical studies at a hospital-based clinic. The program targeted barriers at multiple levels of influence, including fear and mistrust (El-Sadr & Capps, 1992a). The intervention, which was not formally evaluated to our knowledge, provided transportation to study visits, peer groups to support adherence to study protocols, home visits, outreach specialists, case management, referrals to ancillary services, and culturally tailored materials to inform participants about ACTs. A third intervention, which aimed to increase the participation of women in ACTs, focused on the preparation stage of trials to ensure greater success at enrolling women (Falcon et al., 2011; Grewe, Ma, Gilbertson, Rennie, & Tucker, 2016). To ensure that a representative sample of women would be enrolled, the Gender, Race, and Clinical Experience (GRACE) intervention eased study exclusion criteria, instituted enrollment quotas for women, engaged physicians and community advisors during the development phase, chose study sites successful at nurturing provider-patient relationships, and provided sites with resources to adjust to the needs of female patients. The GRACE study was successful in some respects; however, a greater proportion of women (32.8%) discontinued compared to men (23.2%), highlighting the complexity of the problems of underrepresentation and indicating that a further focus on factors that influence retention is warranted (Falcon et al., 2011). This body of research highlights the importance of non-medical staff such as outreach and retention specialists, among others, to complement the efforts of medical personnel, and suggests the need for multilevel behavioral interventions that can be implemented in clinic and community settings to address the complex barriers that PLWH of color face to ACT screening and enrollment.

The ACT2 Program to Reduce Barriers to ACTs for PLWH of Color

The ACT2 program is a peer-driven social/behavioral intervention designed to increase participation in ACT screening and enrollment among African American/Black and Hispanic PLWH, found highly efficacious in a rigorous randomized controlled trial (Gwadz et al., 2014; Gwadz et al., 2013; Gwadz et al., 2011). The ACT2 program is a culturally based intervention, in that it addresses the barriers to ACT's most salient to PLWH of color. In keeping with the complexity of the barriers to ACTs that PLWH of color experience, the ACT2 intervention targets barriers to ACTs at multiple levels of influence: individual/attitudinal-level barriers, such as limited knowledge and distrust of ACTs; social-level barriers, such as peer norms discouraging participation in medical research and the need to bring the health care provider into ACT decisions; and structural-level barriers, such as PLWH’s unfamiliarity with and difficulties negotiating the clinical trials research unit setting. The overall goal of the ACT2 program is to foster PLWH’s decisions about screening for ACTs, the main gateway for enrollment into trials. In addition to potentially gaining access to ACTs, through screening PLWH learn about the ACT system, may gain information about their own health and treatment options, and also implicitly challenge the notion that people of color are not interested in ACTs. Thus presenting for screening can be, in part, an altruistic act that promotes health equality. Despite these potential direct and indirect benefits of screening, PLWH of color present for screening at very low rates (Gwadz et al., 2010b). Thus screening is a low-risk/potentially high reward activity.

Moreover, the ACT2 intervention focuses on screening for ACTs, and not mainly on the decision to enroll, because eligibility rates for trials are low. In fact, rates of eligibility for ACTs tend to be low for all racial/ethnic groups (10–50%) due to strict inclusion/exclusion criteria, and, as noted above, eligibility may be lower for populations of color than for White individuals (Gandhi et al., 2005). PLWH are informed about these low eligibility rates before they screen during the ACT2 program, and weigh the pros and cons of screening for ACTs in this context. In short, the ACT2 program is based on the assumption that screening is appropriate and potentially useful for all PLWH, whether or not they are found eligible for a trial, and enrollment in ACTs may be appropriate for PLWH, depending on their wishes, medical status, and life circumstances. This approach of increasing motivation for a low-risk activity, namely, screening, which leads to a more challenging decision, enrollment, is consistent with commitment theory, which articulates how an individual’s initial smaller decisions and actions promote more substantial engagement later on (Burger, 1999).

The ACT2 program was grounded in the anti-racist stance to foreground how structural racism, which often manifests as exclusion, stress, discrimination, and poor access to health care resources, limits equitable clinical trials participation (Shavers & Shavers, 2006). In light of the barriers to ACTs that PLWH of color experience, the intervention was designed to challenge the behavioral and cultural analyses commonly used to explain underrepresentation of people of color in research, such as that they are not interested, do not understand protocols, will not adhere to protocols, have substance use problems that will interfere with participation, and/or will drop out of studies (Andersen et al., 2007; Rivers, August, Sehovic, Green, & Quinn, 2013; Stone et al., 1998). In fact, there is substantial evidence that PLWH of color are interested in trials (while at the same time distrustful), can understand them, and can adhere to them with appropriate supports (Andersen et al., 2007; Freedberg et al., 2001; Gwadz et al., 2006).

In practice, the anti-racist stance informed the overall purpose of the intervention components, in that they were designed to articulate the potential impact of past abuses by medical research of people of color and “unpack” the historical and present-day individual-, social-, and structural-level factors that cause disproportionality in ACTs; as well as explain the role of the ACT2 program in reducing barriers to ACTs. In theory, the process of highlighting the legitimate reasons why people of color do not enter clinical trials in high numbers, while at the same time providing information about and access to trials, will allow PLWH of color the freedom to make personal decisions about ACT screening participation and, later, if the screen and are found eligible, about enrollment.

Relevant to the ACT2 program, the multifaceted barriers to ACTs reduce not only motivation to participate in ACTs, but also behavioral skills to manage the ACT systems and access to ACTs (Leonard et al., 2013). In keeping with the emphasis on multilevel barriers to ACTs, the specific intervention content was guided by the TTI (Flay & Petraitis, 1994), a theoretical integrative model that individual-, attitudinal-, and social/structural levels of influence on health behavior. The TTI integrates constructs from previous theories, including social cognitive theory and the health belief model (Janz & Becker, 1984). The TTI also goes beyond these theories to include social factors and influences in the broader cultural or macroenvironment (Mermelstein, 1997).

The main counseling approach used in the ACT2 program was motivational interviewing (Hettema, Steele, & Miller, 2005; Miller & Rollnick, 2012). This behavior change approach is congruent with the TTI and also has demonstrated efficacy or effectiveness in a large number of intervention studies (Hettema et al., 2005). Motivational interviewing is a flexible, collaborative counseling method that actively engages, focuses, and guides participants in order to elicit and strengthen durable, high-quality intrinsic motivation for behavior change. Because motivational interviewing is designed to operate without applying pressure or judgment on participants, the approach is a good fit for interventions with populations who may be wary, fearful, and/or distrusting, such as PLWH of color who are asked to entertain the notion of ACT participation (Hettema et al., 2005).

Further, as part of the strategy to address social barriers to ACTs, the ACT2 program is a peer-driven intervention (PDI). The PDI model was developed by Broadhead and Heckathorn (Broadhead et al., 1998). It uses peer-to-peer education experiences as the primary mechanism of behavior change. PDI is a successful, culturally appropriate, and low-cost intervention methodology that taps into six critical elements of behavior change: knowledge, skill building, motivation, peer pressure, social norms, and repetition (Broadhead et al., 1998; Heckathorn, 1990, 1993). PDIs include core messages that form the basis of peer education, and participants are trained to educate their peers on these core messages. Thus PDI capitalizes on the social influence processes that exist among social networks. In comparison to interventions that attempt to alter individuals’ preferences regarding their own behavior, interventions based on network-mediated control attempt to alter an individuals’ preference of how peers in their social network behave by providing secondary incentives based on their peers’ performance. When individuals suggest or urge peers in their network to act in a certain way, their own commitment to the desired behavior is strengthened for two reasons: First, the act of urging peers is a public affirmation of the desired behavior; and second, retreating from the desired behavior would make the individual look hypocritical and opportunistic. Through successive waves of peer education, as peers educate their peers, network social norms may be altered (Heckathorn, Broadhead, Anthony, & Weakliem, 1999). Moreover, providing all participants the opportunity to both receive and deliver education to peers increases individuals’ self-efficacy and mastery (Broadhead et al., 1998).

PDI has been used successfully with PLWH to increase medication adherence (Broadhead et al., 2002). Similar to HIV-prevention or adherence knowledge, ACT-related information can be spread through social and geographic networks, and these networks can facilitate a change of normative beliefs about ACTs. Additionally, the use of a PDI with PLWH takes advantage of the personal transformative and community-focused changes that often occur among HIV-infected individuals. PDI is based on the theory of normative regulation. This theory posits that the behaviors of individuals are amplified through their social groups (Heckathorn, 1997).

Components of the ACT2 Social/Behavioral Intervention

The ACT2 intervention consists of six hours of structured group and individual sessions, the opportunity for participants to provide education on core messages about ACTs to 1–3 of their peers (each of which serves as an additional “dose” of intervention), and navigation through the screening process to resolve barriers that might arise (Leonard et al., 2013). The core messages for ACT2, presented in Table 2, were designed to be clear and simple and to target the specific barriers to ACTs experienced by PLWH of color. In addition to being used by participants to educate peers, the core messages are also integrated into and repeated throughout the intervention sessions. Indeed, because we found in our preliminary studies that PLWH of color find the topic of ACTs to be confusing, complex, and emotionally laden, the intervention includes a substantial amount of repetition of its core messages and themes. The program is guided by a detailed manual. In the next section we provide a detailed description of the intervention components.

Table 2. Core Intervention Messages

AIDS clinical trials study the newest treatments available.

Screening is a discussion to see if an AIDS clinical trial is right for you.

Screening does not mean joining a trial.

AIDS clinical trials can treat other health problems such as Hepatitis C.

People who use drugs or alcohol can participate in AIDS clinical trials.

Even if you never took anti-HIV medications, AIDS clinical trials can still help you.

People who feel good still get screened for AIDS clinical trials.

You don’t have to change your current treatment to participate in AIDS clinical trials.

Every year, thousands of women and people of color join clinical trials.

More women and people of color are needed in AIDS clinical trials.

Participants first learn about the ACT2 program from a peer who has been trained to conduct peer education on the core messages (e.g., screening is discussion to see if an AIDS clinical trial is right for you). This peer education is intended, at minimum, to pique the potential new participant’s interest in and enhance his/her motivation to explore the topic of ACTs. This peer contact is critical, as the topic of ACTs is generally so onerous and fear-inducing that some PLWH of color will not even consider discussing it. Yet because peers have credibility, peer education can overcome that initial barrier in many cases.

Participants brought into the project by peers then engage in three small group sessions (60–90 minutes each) with 6 to 9 other PLWH. Group sessions are designed to address the individual, attitudinal, and social barriers to ACTs described above. The sessions are made up of interactive exercises and video presentations, and include pre-printed posters and handouts. As such, the intervention is not didactic, but instead is designed to facilitate the exploration of the salient issues from the perspective of the group members. The limit on the number of participants in each group to less than 10 is intended to allow participants time to discuss and process the intervention material, which is typically unfamiliar to them and can be emotionally laden.

In the first group session, the main goals are to build knowledge about ACTs and develop motivation to screen. To accomplish the session’s goals, the intervention facilitator explains what ACTs are designed to do, as many participants will not be familiar with ACTs or will have misconceptions about ACTs. One common misconception held by PLWH of color is that ACTs are comprised solely of Phase I trials, which test the safety of new medications. (In fact, ACTs study a wide range of biomedical research questions and most ACTs are not Phase I safety trials.) A second common misconception is that participants might be placed on a regimen that has no active ingredients, that is, a placebo. (Some trials include a placebo, but these generally are studies that seek to test a new medication that supplements a standard ART regimen; thus participants will receive at least the standard of care in addition to the new medication or the placebo, depending on which arm of the study they are randomized to).

The heart of the first session is a facilitated discussion of the problem of underrepresentation of people of color in ACTs and the reasons why PLWH of color are underrepresented, including structural, social, and individual-level factors. Through these exercises, both negative and positive attitudes toward clinical trials and the barriers to ACTs that PLWH of color experience are discussed. This is typically an emotional session, where the topics of exclusion, discrimination, racism, classism, conspiracy theories, and structural violence are raised and explored by the group. This aspect of the ACT2 program is one of its most innovative and powerful elements. Theoretically, examining the pros and cons of screening, in the context of a better understanding of ACTs and the importance of participation in ACTs by PLWH of color as an altruistic behavior that can reduce racial/ethnic disparities, will foster motivation for engaging in screening.

The main theme of the second group session is developing a better understanding of the ACT screening process and examining one’s personal readiness for screening. In this session, participants first review and demonstrate knowledge of core concepts learned during the first group session, including the purposes and types of ACTs, historical and current barriers to getting screened, and the problem of too few people of color in ACTs. This repetition of core concepts helps participants retain the materials and also process their meaning at an emotional level. In subsequent exercises, participants gain skills to talk to their health care providers about ACTs and involve their family and friends in their decisions about screening and, if found eligible, enrollment. As described above, the focus of participants’ decisions is kept on screening, a low-risk activity, and the decision regarding enrollment is deferred until the actual screening process, when the participant will learn if he/she is found eligible for a trial. Throughout the intervention, including this session, the participant’s autonomy and personal decisions about ACT screening participation are respected, consistent with the motivational interviewing approach. In fact, some participants will never screen for ACTs, and may hold very negative views on ACTs. Motivational interviewing allows those with no interest in ACTs to stay engaged in the intervention and to contribute to the group process. Theoretically, the lack of pressure to screen for ACTs on the part of the interventionist also fosters participants’ personal decision-making process, and allows them to entertain the idea of screening for ACTs, which they may never have considered before. At the end of the session, participants conduct an exercise to weigh the “pros and cons” of screening for ACTs, individually and as a group, to inform their future personal decisions.

In the third and final group session, called “Spreading the Word,” exercises are designed to build motivation among participants both to conduct peer education and, through repetition of the core messages, to participate in screening for ACTs. Facilitators teach behavioral skills necessary for successful peer education. Participants work in dyads to practice specific skills, such as different methods for approaching peers and taking steps to manage confidentiality. At the conclusion of this session, participants receive a wallet card listing the 10 core messages to be conveyed and discussed with peers, if they so choose.

Following this third session, the peer education phase begins. Over four weeks, participants are encouraged to share and explain the 10 core messages about ACTs with peers. Participants can continue in the intervention if they decline to educate peers. Theoretically, conducting peer education is considered a “dose” of intervention that is delivered without the interventionist’s supervision.

At the end of the peer education phase, whether or not they educate peers, participants engage in a short individual intervention session (approximately 30 minutes) conducted at a clinical trials research unit. This session is intended to help participants overcome personal and structural barriers to ACTs and allow the participant to physically locate and visit an ACT site and meet the clinical trial staff, with the goal of increasing their comfort level with participating in screening. Participants also finalize their personal decision about being screened for open trials at the clinical trials research unit. Locating the session at a clinical trials research unit is an important aspect of the intervention, because PLWH of color are often fearful of even the idea of visiting a clinical trials research unit, which in itself may bring up concerns about coercion and feelings of distrust. Thus visiting the unit and meeting with the intervention facilitator, with whom the participant has built a relationship by this point, allays concerns. Further, the clinical trials research units are often unfamiliar settings and can be challenging to locate in the hospital complex, and therefore encouraging participants to locate the unit in this structured fashion is useful. Participants who elect to be screened are provided with the contact information for the individual conducting the first, pre-screening, visit, who is located on this same clinical trials research unit. Thus providing easy access to screening is considered a component of the ACT2 program.

The intervention concludes with the patient navigation phase, during which participants who decide to be screened receive individualized support, mainly by phone, to overcome barriers to participation in screening and in the trials themselves. Navigation is an efficacious intervention approach first designed to reduce disparities in cancer care for low-income women of color (Ell, Vourlekis, Lee, & Xie, 2007; Freeman, 2006). Navigation focuses on identifying and overcoming individual and structural barriers that individuals encounter at various steps during the course of accessing services (Christie et al., 2008). Importantly, navigation is individualized based on participant need. It is a strengths-based approach and includes the motivational interviewing approach to assist participants in accessing needed services (Christie et al., 2008; Ell et al., 2007; Ferrante, Rovi, Das, & Kim, 2007; Freeman, 2006; Psooy, Schreuer, Borgaonkar, & Caines, 2004). Over a three- to six-month period, facilitators follow up with participants who express interest in participating in screening. This support may include assisting with decision making and logistical challenges (such as finding childcare arrangements or transportation) and serving as a liaison among participants; their primary care providers; and the trial site to resolve barriers to screening and enrollment, such as transportation or obtaining necessary health records (most individuals typically require only one to three phone contacts to complete screening). Participants who defer or decline to be screened also receive periodic phone calls so that facilitators can offer assistance should the participants change their minds. During the screening process participants will learn whether they are found eligible for one or more trials or other biomedical studies, and will then make a decision regarding enrollment, generally in conjunction with their primary care providers and social support networks. In some cases, participants were provided with navigation through the enrollment process as well (Leonard et al., 2013).

The Efficacy of the ACT2 Program and Its “Active Ingredients”

The ACT2 program was tested in a research study using a cluster randomized controlled trial design. Participants were 540 adult African American/Black and Hispanic PLWH in New York City, recruited through peers. Most participants had been living with HIV/AIDS for over 10 years but very few had access to ACTs in the past. The study compared how well the intervention worked compared to a typical health education program of the same length. Participants in the intervention group were more than 30 times more likely to go through the screening and eligibility process for ACTs than those who did not receive the intervention. About half of those who went through the screening process were found eligible for studies (48.6%), mainly observational medical studies, but less commonly treatment studies. Almost all of those found eligible for a study joined the study, resulting in a total of 44.4% of those screened deciding to join a study. In fact, 9 out of 10 of those found eligible for a medical study joined a study. Thus the ACT2 program had a powerful effect on rates of screening for and enrollment into ACTs compared to treatment as usual (Gwadz et al., 2014; Gwadz et al., 2013; Gwadz et al., 2011). Yet the study also suggests the need for changes in the ways ACT eligibility criteria are defined and operationalized to bring more PLWH of color into therapeutic trials as well as biomedical observational studies (Gandhi et al., 2005).

In a qualitative study of the ACT2 program, the components of the program that were most successful in influencing ACT screening decisions, and how those intervention components appear to have operated, were explored with ACT2 participants (Ritchie et al., 2017). This study found the core messages emphasizing autonomy, namely, participating in ACTs is a choice and screening for ACTs is not a commitment to enroll, were important aspects of the intervention program. The extent to which participants feared ACTs and feared losing their autonomy if they became involved in ACT screening cannot be overemphasized. The fear of being used as a “guinea pig,” that is, having something done to one without consent, was nearly universal among participants in the larger ACT2 study. Thus intervention content served to alter some misconceptions about, and therefore reduce fears of, ACTs. In particular, participants responded to messages that challenged the commonly held belief that taking part in an ACT screening session would automatically result in an individual being enrolled into a clinical trial against his or her will. Further, participants found it useful to understand the specific steps in the process of enrolling into ACTs. This effort to disentangle screening from enrollment had the effect of alleviating worries that the ACT system could in effect transform participants’ curiosity about ACTs into an opportunity for researchers to coerce them into a study.

Addressing distrust of the medical research establishment was a second active ingredient of the ACT2 program. Overall, participants entered the intervention fearing ACTs and distrustful of the clinical trials research units, but, as we discuss above, also expressed substantial willingness to explore ACTs. The intervention was designed to tackle this duality. Exercises to discuss past grievous ethical violations perpetrated on people of color by medical researchers, such as those in the Tuskegee Syphilis Study, among other examples, had a positive impact on participants’ trust in the ACT2 program and willingness to entertain the idea of ACT screening. Indeed, participants reported that these intervention elements resonated powerfully with their own experiences and understandings of racism and other forms of structural inequality, including unequal and inaccessible health care.

The ACT2 program also drew attention to participants’ rights of consent and voluntariness in contemporary medical research. Thus, consistent with the motivational interviewing approach, the ACT2 intervention sought to validate the relevance of past abuses of people of color in research, as well as progress made in the numerous protections that have been put in place since the 1970s (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978; U.S. Department of Health and Human Services 2009), while not implying that ethical violations are impossible in contemporary America. Participants’ distrust of ACTs and of medical research more generally did not necessarily dissipate in response to the intervention, but talking about distrust and acknowledging the legitimate reasons for distrust appeared to increase participants’ motivation to explore ACT screening, even in the context of distrust. Thus, distrust and willingness to explore ACTs can co-occur.

The qualitative study found that the motivational interviewing approach and small group format were a good fit for this public health problem. As we have described, participants typically entered the study distrustful of ACTs and, by association, wary of the ACT2 intervention as well. Yet their very attendance in the intervention suggested curiosity about ACTs. Motivational interviewing is specifically designed to foster personal decision making about behavior change in the context of ambivalence, without putting pressure on participants to choose one option or another. Participants reported experiencing interventionists as non-judgmental and non-pressuring and as lacking ulterior motives such as a desire to “trick” participants into entering trials. This climate of non-judgment and open acceptance of diverse views affected participants in a number of ways. First, it fostered participants’ abilities to process new information about ACTs, and also increased the degree to which they felt they could trust both the information and the messengers. Further, the ACT2 intervention messages appeared to trigger a commitment to helping the larger community of PLWH of color, which boosted motivation to screen for ACTs. For many participants, understanding the extent of disproportionality in ACTs, where PLWH of color are overrepresented in HIV/AIDS rates but underrepresented in ACTs, triggered a desire to participate in ACT screening in part as a means of helping their communities and “those who came after them.” In some cases, participation in screening was viewed as a potential means of sparking change in the current ACT system, because the ACT system might change if more PLWH of color gained access. The fact that participants experienced the ACT2 intervention with other peers seemed to contribute to this emergent desire to contribute to the community; together group participants developed a shared awareness and understanding of HIV and racial/ethnic disparities, and this was in turn a powerful motivator of action.

Components to help participants overcome structural barriers to ACTs did not resonate with participants as strongly as other components, with one exception: The brief intervention session on the clinical trials research unit, a means of helping participants to locate and increase their comfort with the clinical trials research unit, emerged as a useful element. Participants reported being pleasantly surprised that the clinical trials research unit looked like a “regular” medical office. Further, participants commonly reported they were pleased to find the staff to be pleasant and supportive, and were glad clinical trials research unit staff did not “snatch anyone up and inject them with something,” as participants, perhaps somewhat facetiously, sometimes feared.

Social/Behavioral Interventions Are Needed to Reduce Disparities in Trials

The low rates of enrollment of people of color in medical research is a national problem that affects clinical trials of the vast majority of, if not all, diseases and conditions, including the very large number of cancer clinical trials (Rivers et al., 2013). HIV clinics and health care providers are sorely challenged to treat HIV infection, a complex medical condition, and barriers to ACTs for PLWH of color are not easy to address. The ACT2 intervention was the first social/behavioral intervention shown in a randomized clinical trial to increase rates of screening for and enrollment into ACTs among African American/Black and Hispanic PLWH. Thus, clinical trials research units can begin to eliminate racial/ethnic disparities in ACTs by implementing multicomponent interventions such as ACT2 to build motivation and capability to access trials, offering repeated access to screening, and centralizing screening efforts where appropriate. Further, modifications to study inclusion criteria will be needed to increase the proportion of people of color who enroll in AIDS clinical trials. Findings from the ACT2 project may have applications for trials of conditions other than HIV.

Discussion of the Literature

A substantial body of research has documented the low rates of enrollment in ACTs among PLWH of color, as well as the factors that drive this disparity. In the past, the ACT research literature has been criticized for not documenting the race/ethnicity and sex of research participants, a problem that may not yet be resolved (Johnston & Heitzeg, 2015). For example, Johnston and Heitzeg (2015) conducted a systematic review to determine the extent to which adult subjects representing sex (female), race (non-White), and age (>50 years) categories are included in clinical studies of HIV curative interventions. They found that only 23% studies reported full demographic data of enrollees, and only 6% reported conducting efficacy analyses by demographic categories. This gap in the literature warrants attention. Recently, barriers at the level of health care providers and clinical trials research units have received attention (Andersen et al., 2007; King, 2002), which has perhaps taken the focus off PLWH themselves as the primary locus of the problem of underrepresentation. Nonetheless, a number of other gaps in the literature hamper the study of this topic. First, there are little, if any, national data published on a regular basis on the rates of enrollment of PLWH of color in ACTs, including women, making it challenging to determine whether these disparities are decreasing, increasing, or remaining stable, or whether they vary geographically. However, there is no indication that these disparities have decreased substantially (Castillo-Mancilla et al., 2014). Further, in comparison to studies documenting the problem and its causes, significantly less attention has been paid to strategies to increase the proportions of PLWH of color in trials. The Gender, Race, and Clinical Experience (GRACE) study attended to the numerous barriers that women experience to ACTs and successfully enrolled and retained a sample of women representative of the racial/ethnic demographics of females with HIV/AIDS in the United States (Grewe et al., 2016). Yet a greater proportion of women discontinued compared to men, highlighting the complexity of the problem of underrepresentation of PLWH of color, including women. Thus study highlights the need for future research on factors that influence study discontinuation (Falcon et al., 2011). Thus innovative, multilevel intervention strategies focused on this problem are needed. The ACT2 program is promising, and implementation science approaches can inform the processes by which efficacious interventions such as ACT2 can be integrated into medical settings (El-Sadr, Philip, & Justman, 2014).

Further Reading

Adeyemi, O. F., Evans, A. T., & Bahk, M. (2009). HIV-infected adults from minority ethnic groups are willing to participate in research if asked. AIDS Patient Care and STDS, 23(10), 859–865.Find this resource:

Andersen, J. W., Fass, R., & van der Horst, C. (2007). Factors associated with early study discontinuation in AACTG studies, DACS 200. Contemporary Clinical Trials, 28(5), 583–592.Find this resource:

Freedberg, K. A., Sullivan, L., Georgakis, A., Savetsky, J., Stone, V., & Samet, J. H. (2001). Improving participation in HIV clinical trials: impact of a brief intervention. HIV Clinical Trials, 2(3), 205–212.Find this resource:

Freeman, R., Gwadz, M., Silverman, E., Kutnick, A., Leonard, N., Ritchie, A., … Martinez, B. (2017). Critical race theory as a tool for understanding poor engagement along the HIV care continuum among African American/Black and Hispanic persons living with HIV in the United States: A qualitative exploration. International Journal for Equity in Health, 16(1), 54.Find this resource:

Gandhi, M., Ameli, N., Bacchetti, P., Sharp, G. B., French, A. L., Young, M., … Greenblatt, R. M. (2005). Eligibility criteria for HIV clinical trials and generalizability of results: The gap between published reports and study protocols. AIDS, 19(16), 1885–1896.Find this resource:

Gifford, A. L., Cunningham, W. E., Heslin, K. C., Andersen, R. M., Nakazono, T., Lieu, D. K., … Bozzette, S. A. (2002). Participation in research and access to experimental treatments by HIV-infected patients. New England Journal of Medicine, 346(18), 1373–1382.Find this resource:

Gwadz, M. V., Cleland, C. M., Belkin, M., Ritchie, A., Leonard, N., Riedel, M., … A. C. T. Collaborative Research Team. (2014). ACT2 peer-driven intervention increases enrollment into HIV/AIDS medical studies among African Americans/Blacks and Hispanics: A cluster randomized controlled trial. AIDS and Behavior, 18(12), 2409–2422.Find this resource:

Gwadz, M. V., Cleland, C. M., Leonard, N. R., Ritchie, A. S., Banfield, A., Riedel, M., … Mildvan, D. (2013). Predictors of screening for AIDS clinical trials among African-Americans and Latino/Hispanics enrolled in an efficacious peer-driven intervention: Uncovering socio-demographic, health, and substance use-related factors that promote or impede screening. AIDS and Behavior, 17(2), 801–812.Find this resource:

Gwadz, M. V., Colon, P., Ritchie, A. S., Leonard, N. R., Cleland, C. M., Riedel, M., … Mildvan, D. (2010). Increasing and supporting the participation of persons of color living with HIV/AIDS in AIDS clinical trials. Current HIV/AIDS Reports, 7(4), 194–200.Find this resource:

Gwadz, M. V., Leonard, N. R., Cleland, C. M., Riedel, M., Banfield, A., Mildvan, D., & ACT2 Project Collaborative Research Team. (2011). The effect of peer-driven intervention on rates of screening for AIDS clinical trials among African Americans and Hispanics. American Journal of Public Health, 101(6), 1096–1102.Find this resource:

King, W. D., DeFreitas, D., Smith, K., Andersen, J., Perry, L. P., Adeyemi, T., … Mildvan, D. (2007). Attitudes and perceptions of AIDS clinical trials group site coordinators on HIV clinical trial recruitment and retention: A descriptive study. AIDS Patient Care and STDS, 21(8), 551–563.Find this resource:

Leonard, N. R., Banfield, A., Riedel, M., Ritchie, A. S., Mildvan, D., Arredondo, G., … Gwadz, M. V. (2013). Description of an efficacious behavioral peer-driven intervention to reduce racial/ethnic disparities in AIDS clinical trials. Health Education Research, 28(4), 574–590.Find this resource:

Ritchie A, Gwadz, M. V., Perlman, D., De Guzman, R., Leonard N. R. (2017). Eliminating racial/ethnic disparities in AIDS clinical trials in the United States: A qualitative exploration of an efficacious social/behavioral intervention. Journal of AIDS and Clinical Research, 8, 648.Find this resource:

Stone, V. E., Mauch, M. Y., Steger, K., Janas, S. F., & Craven, D. E. (1997). Race, gender, drug use, and participation in AIDS clinical trials. Lessons from a municipal hospital cohort. Journal of General Internal Medicine, 12(3), 150–157.Find this resource:

Sullivan, P. S., McNaghten, A. D., Begley, E., Hutchinson, A., & Cargill, V. A. (2007). Enrollment of racial/ethnic minorities and women with HIV in clinical research studies of HIV medicines. Journal of the National Medical Association, 99(3), 242–250.Find this resource:

Volkmann, E. R., Claiborne, D., & Currier, J. S. (2009). Determinants of participation in HIV clinical trials: The importance of patients’ trust in their provider. HIV Clinical Trials, 10(2), 104–109.Find this resource:

References

Andersen, J. W., Fass, R., & van der Horst, C. (2007). Factors associated with early study discontinuation in AACTG studies, DACS 200. Contemporary Clinical Trials, 28(5), 583–592.Find this resource:

Beer, L., Fagan, J. L., Garland, P., Valverde, E. E., Bolden, B., Brady, K. A., … Project Never In Care. (2012). Medication-related barriers to entering HIV care. AIDS Patient Care and STDS, 26(4), 214–221.Find this resource:

Broadhead, R. S., Heckathorn, D. D., Altice, F. L., van Hulst, Y., Carbone, M., Friedland, G. H., … Selwyn, P. A. (2002). Increasing drug users’ adherence to HIV treatment: Results of a peer-driven intervention feasibility study. Social Science & Medicine, 55(2), 235–246.Find this resource:

Broadhead, R. S., Heckathorn, D. D., Weakliem, D. L., Anthony, D. L., Madray, H., Mills, R. J., & Hughes, J. (1998). Harnessing peer education networks as an instrument for AIDS prevention. Public Health Reports, 113(Suppl. 1), 42–57.Find this resource:

Brown-Peterside, P., Chiasson, M. A., Ren, L., & Koblin, B. A. (2000). Involving women in HIV vaccine efficacy trials: Lessons learned from a vaccine preparedness study in New York City. Journal of Urban Health, 77(3), 425–437.Find this resource:

Burger, J. M. (1999). The foot-in-the-door compliance procedure: A multiple-process analysis and review. Personality and Social Psychology Review, 3(4), 303–325.Find this resource:

Cargill, V. A., & Stone, V. E. (2005). HIV/AIDS: A minority health issue. The Medical Clinics of North America, 89(4), 895–912.Find this resource:

Castillo-Mancilla, J. R., Cohn, S. E., Krishnan, S., Cespedes, M., Floris-Moore, M., Schulte, G., … ACTG Underrepresented Populations Survey Group. (2014). Minorities remain underrepresented in HIV/AIDS research despite access to clinical trials. HIV Clinical Trials, 15(1), 14–26.Find this resource:

Centers for Disease Control and Prevention. (2012). New HIV infections in the United States. Retrieved from http://www.cdc.gov/nchhstp/newsroom/docs/2012/HIV-Infections-2007-2010.pdf.

Christie, J., Itzkowitz, S., Lihau-Nkanza, I., Castillo, A., Redd, W., & Jandorf, L. (2008). A randomized controlled trial using patient navigation to increase colonoscopy screening among low-income minorities. Journal of the National Medical Association, 100(3), 278–284.Find this resource:

Cotton, D. J., Finkelstein, D. M., He, W., & Feinberg, J. (1993). Determinants of accrual of women to a large, multicenter clinical trials program of human immunodeficiency virus infection. The AIDS Clinical Trials Group. Journal of Acquired Immune Deficiency Syndromes, 6(12), 1322–1328.Find this resource:

DeFreitas, D. (2010). Race and HIV clinical trial participation. Journal of the National Medical Association, 102(6), 493–499.Find this resource:

Ell, K., Vourlekis, B., Lee, P. J., & Xie, B. (2007). Patient navigation and case management following an abnormal mammogram: A randomized clinical trial. Preventive Medicine, 44(1), 26–33.Find this resource:

El-Sadr, W., & Capps, L. (1992a). The challenge of minority recruitment in clinical trials for AIDS. Journal of the American Medical Association, 267(7), 954–957.Find this resource:

El-Sadr, W., & Capps, L. (1992b). The challenge of minority recruitment in clinical trials for AIDS. Journal of the American Medical Association, 267(7), 954–957.Find this resource:

El-Sadr, W. M., Philip, N. M., & Justman, J. (2014). Letting HIV transform academia—embracing implementation science. New England Journal of Medicine, 370(18), 1679–1681.Find this resource:

Falcon, R., Bridge, D. A., Currier, J., Squires, K., Hagins, D., Schaible, D., … Group, G. S. (2011). Recruitment and retention of diverse populations in antiretroviral clinical trials: Practical applications from the gender, race and clinical experience study. Journal of Women’s Health, 20(7), 1043–1050.Find this resource:

Ferrante, J. M., Rovi, S., Das, K., & Kim, S. (2007). Family physicians expedite diagnosis of breast disease in urban minority women. Journal of the American Board of Family Medicine, 20(1), 52–59.Find this resource:

Flay, B. R., & Petraitis, J. (1994). The theory of triadic influence: A new theory of health behavior with implications for preventive interventions. In G. L. Albrecht (Ed.), Advances in medical sociology: Volume IV. A reconsideration of models of health behavior change (pp. 19–44). Greenwich, CT: JAI.Find this resource:

Ford, C. L., & Airhihenbuwa, C. O. (2010). Critical Race Theory, race equity, and public health: Toward antiracism praxis. American Journal of Public Health, 100(Suppl. 1), S30–S35.Find this resource:

Freedberg, K. A., Sullivan, L., Georgakis, A., Savetsky, J., Stone, V., & Samet, J. H. (2001). Improving participation in HIV clinical trials: Impact of a brief intervention. HIV Clinical Trials, 2(3), 205–212.Find this resource:

Freeman, H. P. (2006). Patient navigation: A community based strategy to reduce cancer disparities. Journal of Urban Health, 83(2), 139–141.Find this resource:

Gandhi, M., Ameli, N., Bacchetti, P., Sharp, G. B., French, A. L., Young, M., … Greenblatt, R. M. (2005). Eligibility criteria for HIV clinical trials and generalizability of results: The gap between published reports and study protocols. AIDS, 19(16), 1885–1896.Find this resource:

Gany, F. M., Herrera, A. P., Avallone, M., & Changrani, J. (2006). Attitudes, knowledge, and health-seeking behaviors of five immigrant minority communities in the prevention and screening of cancer: A focus group approach. Ethnicity & Health, 11(1), 19–39.Find this resource:

Gifford, A. L., Cunningham, W. E., Heslin, K. C., Andersen, R. M., Nakazono, T., Lieu, D. K., … Bozzette, S. A. (2002). Participation in research and access to experimental treatments by HIV-infected patients. New England Journal of Medicine, 346(18), 1373–1382.Find this resource:

Gorelick, P. B., Harris, Y., Burnett, B., & Bonecutter, F. J. (1998). The recruitment triangle: Reasons why African Americans enroll, refuse to enroll, or voluntarily withdraw from a clinical trial. An interim report from the African-American Antiplatelet Stroke Prevention Study (AAASPS). Journal of the National Medical Association, 90(3), 141–145.Find this resource:

Greenberger, P. (1998). News from the Society for the Advancement of Women’s Health Research. Targeting mental illness and substance abuse among women. Journal of Women’s Health, 7(4), 407–410.Find this resource:

Grewe, M. E., Ma, Y., Gilbertson, A., Rennie, S., & Tucker, J. D. (2016). Women in HIV cure research: Multilevel interventions to improve sex equity in recruitment. Journal of Virus Eradication, 2, 49–51.Find this resource:

Gwadz, M. V., Cleland, C. M., Belkin, M., Ritchie, A., Leonard, N., Riedel, M., … A. C. T. Collaborative Research Team. (2014). ACT2 peer-driven intervention increases enrollment into HIV/AIDS medical studies among African Americans/Blacks and Hispanics: A cluster randomized controlled trial. AIDS Behavior, 18(12), 2409–2422.Find this resource:

Gwadz, M. V., Cleland, C. M., Leonard, N. R., Ritchie, A. S., Banfield, A., Riedel, M., … Mildvan, D. (2013). Predictors of screening for AIDS clinical trials among African-Americans and Latino/Hispanics enrolled in an efficacious peer-driven intervention: Uncovering socio-demographic, health, and substance use-related factors that promote or impede screening. AIDS and Behavior, 17(2), 801–812.Find this resource:

Gwadz, M. V., Colon, P., Ritchie, A. S., Leonard, N. R., Cleland, C. M., Riedel, M., … Mildvan, D. (2010a). Increasing and supporting the participation of persons of color living with HIV/AIDS in AIDS clinical trials. Current HIV/AIDS Reports, 7(4), 194–200.Find this resource:

Gwadz, M. V., Cylar, K., Leonard, N. R., Riedel, M., Herzog, N., Arredondo, G. N., … A. C. T. Collaborative Study Team Project. (2010b). An exploratory behavioral intervention trial to improve rates of screening for AIDS clinical trials among racial/ethnic minority and female persons living with HIV/AIDS. AIDS and Behavior, 14(3), 639–648.Find this resource:

Gwadz, M. V., Leonard, N. R., Cleland, C. M., Riedel, M., Banfield, A., Mildvan, D., & ACT2 Project Collaborative Research Team. (2011). The effect of peer-driven intervention on rates of screening for AIDS clinical trials among African Americans and Hispanics. American Journal of Public Health, 101(6), 1096–1102.Find this resource:

Gwadz, M. V., Leonard, N. R., Riedel, M., Arredondo, G., Nakagawa, A., Cylar, K., … the Project ACT Collaborative Research Team. (2006, August). Project ACT: A pilot intervention to increase screening for AIDS clinical trials among racial/ethnic minorities and women in New York City. Paper presented at the XVI International AIDS Conference, Toronto, Canada.Find this resource:

Heckathorn, D. D. (1990). Collective sanctions and compliance norms: A formal theory of group-mediated social control. American Sociological Review, 55(3), 366–384.Find this resource:

Heckathorn, D. D. (1993). Collective action and group heterogeneity: Voluntary provision versus selective incentives. American Sociological Review, 58(3), 329–350.Find this resource:

Heckathorn, D. D. (1997). Respondent-driven sampling: A new approach to the study of hidden populations. Social Problems, 44(2), 174–199.Find this resource:

Heckathorn, D. D., Broadhead, R. S., Anthony, D. L., & Weakliem, D. L. (1999). AIDS and social networks: HIV prevention through network mobilization. Sociological Focus, 32, 159–179.Find this resource:

Heller, J. (2015). Rumors and realities: Making sense of HIV/AIDS conspiracy narratives and contemporary legends. American Journal of Public Health, 105(1), e43–e50.Find this resource:

Hettema, J., Steele, J., & Miller, W. R. (2005). Motivational interviewing. Annual Review of Clinical Psychology, 1, 91–111.Find this resource:

Janz, N., & Becker, M. (1984). The health belief model: A decade later. Health Education Quarterly, 11(1), 1–47.Find this resource:

Johnston, R. E., & Heitzeg, M. M. (2015). Sex, age, race and intervention type in clinical studies of HIV cure: A systematic review. AIDS Research and Human Retroviruses, 31(1), 85–97.Find this resource:

Katz, R. V., Kegeles, S. S., Kressin, N. R., Green, B. L., Wang, M. Q., James, S. A., … Claudio, C. (2006). The Tuskegee Legacy Project: Willingness of minorities to participate in biomedical research. Journal of Health Care for the Poor and Underserved, 17(4), 698–715.Find this resource:

King, T. E. (2002). Racial disparities in clinical trials. New England Journal of Medicine, 346(18), 1400–1402.Find this resource:

King, W. D., Wong, M. D., Shapiro, M. F., Landon, B. E., & Cunningham, W. E. (2004). Does racial concordance between HIV-positive patients and their physicians affect the time to receipt of protease inhibitors? Journal of General Internal Medicine, 19(11), 1146–1153.Find this resource:

Latkin, C. A. (1998). Outreach in natural settings: The use of peer leaders for HIV prevention among injecting drug users’ networks. Public Health Report, 113(Suppl. 1), 151–159.Find this resource:

Leonard, N. R., Banfield, A., Riedel, M., Ritchie, A. S., Mildvan, D., Arredondo, G., … Gwadz, M. V. (2013). Description of an efficacious behavioral peer-driven intervention to reduce racial/ethnic disparities in AIDS clinical trials. Health Education Research, 28(4), 574–590.Find this resource:

Marshak, A., Costantini, G., Middleton, S., Barnett, S., Garmon, D., Gwadz, M., … ACT2 Collaborative Research Team. (2007). Screening for AIDS clinical trials in the project ACT cohort of racial/ethnic minorities and women in New York City: Substantial interest but low eligibility. Paper presented at the 4th International AIDS Society Conference, Sydney, Australia.Find this resource:

Menezes, P., Eron, J. J., Jr., Leone, P. A., Adimora, A. A., Wohl, D. A., & Miller, W. C. (2011). Recruitment of HIV/AIDS treatment-naive patients to clinical trials in the highly active antiretroviral therapy era: influence of gender, sexual orientation and race. HIV Medicine, 12(3), 183–191.Find this resource:

Mermelstein, R. (1997). Individual interventions: Stages of change and other health behavior models—the example of smoking cessation. In S. Gallant, G. Keita, & R. Royak-Shaler (Eds.), Health care for women: Psychological, social, and behavioral influences. Washington, DC: American Psychological Association.Find this resource:

Miller, W. R., & Rollnick, S. (2012). Motivational interviewing: Helping people change (3d ed.). New York: Guilford Press.Find this resource:

Murphy, T. F. (1991). Women and drug users: The changing faces of HIV clinical drug trials. QRB Quality Review Bulletin, 17(1), 26–32.Find this resource:

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1978). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Bethesda: US Government Printing Office.Find this resource:

National Institute of Allergy and Infectious Diseases (NIAID). Strategic plan for addressing health disparities: Fiscal years 2002–2006. Retrieved from http://www.niaid.nih.gov/about/whoweare/documents/niaid_hd_plan_final.pdf.

National Institute of Allergy and Infectious Diseases (NIAID). (2008). HIV infection in minority populations. Retrieved from http://www.niaid.nih.gov/topics/HIVAIDS/Understanding/Population%20Specific%20Information/Pages/minorityPopulations.aspx.Find this resource:

National Institute of Allergy and Infectious Diseases (NIAID). (2013). NIAID strategic plan 2013. Retrieved from https://www.niaid.nih.gov/about/whoweare/planningpriorities/Pages/default.aspx.Find this resource:

Oh, S. S., Galanter, J., Thakur, N., Pino-Yanes, M., Barcelo, N. E., White, M. J., … Wu, A. H. (2015). Diversity in clinical and biomedical research: A promise yet to be fulfilled. PLoS Med, 12(12), e1001918.Find this resource:

Parada, J. (2000). The changing face of AIDS. Minority Health Today, 1(5), 9–17.Find this resource:

Pellowski, J. A., Kalichman, S. C., Matthews, K. A., & Adler, N. (2013). A pandemic of the poor: Social disadvantage and the U.S. HIV epidemic. The American Psychologist, 68(4), 197–209.Find this resource:

Pollack, A., & Altman, L. (2003, February 24). Large trial finds AIDS vaccine fails to stop infection. New York Times, sec. A1, col. 1.Find this resource:

Psooy, B. J., Schreuer, D., Borgaonkar, J., & Caines, J. S. (2004). Patient navigation: Improving timeliness in the diagnosis of breast abnormalities. Canadian Association of Radiologists Journal, 55(3), 145–150.Find this resource:

Ritchie, A., Gwadz, M.V., Perlman, D., De Guzman, R., Leonard, N. R., et al. (2017). Eliminating racial/ethnic disparities in AIDS clinical trials in the United States: A qualitative exploration of an efficacious social/behavioral intervention. Journal of AIDS and Clinical Research, 8, 648.Find this resource:

Rivers, D., August, E. M., Sehovic, I., Green, B. L., & Quinn, G. P. (2013). A systematic review of the factors influencing African Americans’ participation in cancer clinical trials. Contemporary Clinical Trials, 35(2), 13–32.Find this resource:

Ross, M. W., Essien, E. J., & Torres, I. (2006). Conspiracy beliefs about the origin of HIV/AIDS in four racial/ethnic groups. Journal of Acquired Immune Deficiency Syndromes, 41(3), 342–344.Find this resource:

Shavers, V. L., & Shavers, B. S. (2006). Racism and health inequity among Americans. Journal of the National Medical Association, 98(3), 386.Find this resource:

Shavers-Hornaday, V. L., Lynch, C. F., Burmeister, L. F., & Torner, J. C. (1997). Why are African Americans under-represented in medical research studies? Impediments to participation. Ethnicity & Health, 2(1–2), 31–45.Find this resource:

Siddiqi, A. E. A., Hu, X. H., & Hall, H. I. (2015). Mortality among Blacks or African Americans with HIV infection—United States, 2008–2012. Morbidity and Mortality Weekly Report, 64(4), 81–86.Find this resource:

Stone, V. E., Mauch, M. Y., & Steger, K. A. (1998). Provider attitudes regarding participation of women and persons of color in AIDS clinical trials. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology, 19(3), 245–253.Find this resource:

Sullivan, P. S., McNaghten, A. D., Begley, E., Hutchinson, A., & Cargill, V. A. (2007). Enrollment of racial/ethnic minorities and women with HIV in clinical research studies of HIV medicines. Journal of the National Medical Association, 99(3), 242–250.Find this resource:

Thomas, S. B., & Quinn, S. C. (1991). The Tuskegee Syphilis study, 1932 to 1972: Implications for HIV education and AIDS risk education programs in the Black community. American Journal of Public Health, 81(11), 1498–1505.Find this resource:

U.S. Department of Health and Human Services (2009). Protection of Human Subjects Title 45 Code of Federal Regulations Part 46. Retrieved from http://www.hhs.gov/ohrp/humansubjects/regbook2013.pdf.pdf.

Washington, H. A. (2007). “Medical Apartheid” (Harriet A. Washington). New York Times Book Review, 6.Find this resource:

Westergaard, R. P., Beach, M. C., Saha, S., & Jacobs, E. A. (2014). Racial/ethnic differences in trust in health care: HIV conspiracy beliefs and vaccine research participation. Journal of General Internal Medicine, 29(1), 140–146.Find this resource: