Selectively willing and conditionally able: HIV vaccine trial participation among women at "high risk" of HIV infection

Efficacy studies of investigational HIV vaccines require enrollment of individuals at ‘high risk’ for HIV. This paper examines participation in HIV vaccine trials among women at ‘high risk’ for HIV acquisition. In-depth interviews were conducted with 17 African-American women who use crack cocaine and/or exchange sex for money/drugs to elicit attitudes toward medical research and motivators and deterrents to HIV vaccine trial participation. Interviews were digitally recorded and transcribed; data were coded and compiled into themes. Most women expressed favorable attitudes toward medical research in general. Motivators for trial participation included compensation; personal benefits including information, social services, and the possibility that the trial vaccine could prevent HIV; and altruism. Deterrents included: dislike of needles; distrust; concern about future consequences of participating. In addition, contingencies, care-giving responsibilities, and convenience issues constituted barriers which could impede participation. Respondents described varied, complex perspectives, and individual cases illustrate how these themes played out as women contemplated trial participation. Understanding factors which influence vaccine research participation among women at ‘high risk’ can aid sites to tailor recruitment procedures to local contexts. Concerns about future reactions can be addressed through sustained community education. Convenience barriers can be ameliorated by providing rides to study visits when necessary, and/or conducting study visits in accessible neighborhood locations. Women in this sample thought carefully about enrolling in HIV vaccine trials given the structural constraints within which they lived. Further research is needed regarding structural factors which influence personal agency and individuals’ thinking about research participation.     

Bridging the Divide: HIV Prevention Research and Black Men Who Have Sex With Men

Objectives. We obtained contextual information regarding documented barriers to HIV clinical trial participation among Black men who have sex with men (MSM), and explored current preventive HIV clinical trial attitudes, beliefs, and perceptions among Black MSM leaders in the United States.Methods. We conducted 2 focus groups with Black MSM leaders attending an annual African American MSM Leadership Conference on HIV/AIDS. Focus group questions explored biomedical research perceptions and attitudes, barriers to participation in biomedical prevention research, and steps that need to be taken to address these barriers. A feedback and member checking (participants presented with final themes to provide feedback and guidance) session was also held at the 2012 conference.Results. Three distinct themes emerged regarding Black MSM engagement and participation in HIV vaccine research: (1) community-based organizations as true partners, (2) investment in the Black gay community, and (3) true efforts to inform and educate the community.Conclusions. A key focus for improving efforts to engage the Black MSM community in preventive HIV clinical trials is building and maintaining equitable and reciprocal partnerships among research institutions, Black-led AIDS service organizations and community-based organizations, and community members.Black men who have sex with men (MSM) represent 1 in 500 US citizens and 9% of all MSM in the United States,1 yet they accounted for 38% of new HIV infections among MSM and 70% of new HIV infections among Black males in 2010.2 Nationally, MSM represent about 4% of the male population, yet they account for 52% of all people living with HIV.3 HIV prevalence among Black MSM is roughly double the prevalence among White MSM.2 The impact of HIV on the Black MSM community has dramatically increased over time. From 2006 to 2009 the annual number of new HIV infections among MSM rose by 20% and new infections among young MSM (aged 13 to 29 years) during this same period increased dramatically (48%).4 For Black MSM the HIV disease burden is experienced throughout the lifetime. Among young men (aged 13–24 years), Black MSM are 14 times more likely to test HIV-positive than are White MSM.5 As a result, many Black MSM are infected with HIV as they enter adulthood. Like other racial and ethnic groups, Black MSM are more likely to date other Black MSM.6,7 This practice, known as assortative mixing, combined with higher HIV prevalence within Black MSM communities, may contribute to the dramatic increase in the odds of becoming infected for Black MSM as they age. By the time Black MSM reach age 25 years, 1 in 4 are already infected with HIV and by age 40, 60% are living with HIV.8Published data regarding HIV trial participation has focused on the larger Black community and has shown that overall US Blacks take part in HIV vaccine trials at the same rate as Whites.9,10 From 1988 to 2002, Black individuals represented 10% of the volunteers enrolled in US preventive HIV vaccine trials.11 Unpublished data through March 2013 indicate that 22% of all HIV vaccine trial participants identified as Black or African American and, of these participants, 8% identified as Black MSM (e-mail communication from Alicia Sato, Statistical Center for HIV/AIDS Research and Prevention, March 27, 2013). Although there has been a marked increase in the proportion of racial/ethnic minority participants in the United States in phase I and phase II preventive HIV vaccine trials across National Institute of Allergy and Infectious Diseases (NIAID)-funded networks, these numbers do not reflect the HIV epidemic’s impact on Black MSM in the United States.The inclusion of Black MSM in HIV vaccine research is necessary for 2 main reasons. First, it is plausible that a vaccine may have variable efficacy in different racial/ethnic groups12,13 and underrepresentation may have implications for generalizability of clinical trials results in these populations. Insufficient numbers of participants of color in the first HIV vaccine efficacy trial14 made it difficult to interpret subgroup analyses of minority populations. This is of particular interest because there were fewer infections among Black and Asian vaccinees compared with Black and Asian placebo recipients in that trial, but the numbers of Black and Asian participants were so small that it was impossible to know whether this was an actual sign of vaccine efficacy or a result of random chance. Second, participation in HIV vaccine clinical trials may help ensure increased acceptability when a licensed vaccine becomes available.In general, major medical, clinical, and behavioral research studies have limited numbers of Black individuals involved as research participants. Much of the literature on the relative absence of Blacks in research points to the mistrust of researchers for many reasons including historical and current racial discriminatory practices directed at African Americans.15–17 Several studies have explored barriers to participation specific to HIV vaccine trials experienced by the larger African American community. The most commonly cited causes of poor participation by Blacks in HIV vaccine trials are mistrust or fear, stigma, and misinformation.18,19 Survey data have found that many Black individuals believe that a cure for AIDS exists and is being withheld from the poor20 or kept a secret.21 For many Black people, the term “medical research” is associated with being lied to, used, and treated like guinea pigs.22 Additional barriers to participation include lack of information and understanding as well as limited knowledge of the nature of research.22–25Few studies have explored the barriers to HIV vaccine research participation faced by Black MSM. Social stigmatization of HIV and AIDS is a persistent concern for Black individuals in the United States.26 Black MSM often experience being labeled as “high risk” in the larger gay community and the fear of strengthening this stereotype may prevent participation in an HIV vaccine trial. In one study of MSM, participants identified the stigma of trial enrollment and the fear of being viewed by intimate partners as high risk or promiscuous as a significant barrier to enrollment.27Recent efforts by the HIV Vaccine Trials Network (HVTN) and other NIAID-funded networks to improve preventive HIV clinical trial participation among Black, Latino(a), and MSM communities have focused on partnering with community and faith-based organizations to increase awareness of the need for an HIV vaccine, and to improve public knowledge and attitudes about HIV vaccine research. These efforts have included developing research-based HIV vaccine–related messages; identifying, establishing, and sustaining partnerships with organizations and key opinion leaders who are part of the priority audiences and who would disseminate the key messages; and identifying other effective communication channels and strategies for stakeholder engagement and dissemination of HIV vaccine research–related information.We report the findings of a focus group study of Black MSM key opinion leaders examining attitudes and perceptions of HIV prevention research and the NIAID HIV Vaccine Research Education Initiative (NHVREI) in the Black MSM community. The objectives were to (1) obtain important contextual information regarding documented barriers to HIV clinical trial participation among Black MSM, and (2) explore current HIV vaccine clinical trial attitudes, beliefs, and perceptions among Black MSM in the United States who had been involved in NHVREI to ascertain if exposure to NHVREI made a difference in the way Black MSM key opinion leaders viewed biomedical interventions. NHVREI’s logic model focused on including community leaders to reach key populations. As such, the researchers hypothesized that those MSM leaders with a history of involvement with NHVREI activities would indicate more support for MSM participation in preventive HIV vaccine trials specifically and biomedical research generally.     

"Once I begin to participate, people will run away from me": understanding stigma as a barrier to HIV vaccine research participation in Kenya

Purpose

Participation of volunteers in clinical research is essential to the development of effective HIV prevention methods, including an HIV vaccine. This study expands current knowledge of stigma and discrimination related to participation in HIV vaccine research in sub-Saharan Africa by exploring the perception of stigma and discrimination as a barrier to participation in HIV vaccine research in Kenya.

Methods

Eighteen focus groups with a total of 133 participants and 82 individual interviews were conducted with a range of respondents at two centers in Nairobi, Kenya: a preventive AIDS vaccine trial center; and a preparatory clinical and epidemiological study center. Respondents included peer leaders, community advisory board members, former and current volunteers in clinical research, study staff, community leaders and community members. Data were analyzed using an iterative coding process.

Results

Four prominent stigma-related barriers to participation emerged among all respondent groups, across both centers: (1) volunteers are often assumed by family and community members to be HIV positive because of their participation in vaccine research; (2) HIV-related stigma is perceived as pervasive and damaging in the communities where volunteers live, thus they fear consequent stigma if people believe them to be HIV positive; (3) potential volunteers fear being tested for HIV, a prerequisite for participation, because of possible disclosure of HIV status in communities with high perceived HIV-related stigma; and (4) volunteers must carefully manage information about their participation because of misperceptions and assumptions about vaccine research volunteers.

Conclusions

HIV-related stigma and discrimination influence people's decisions to join HIV-vaccine related research. Findings underscore a need for integration of stigma-reduction programming into education and outreach activities for volunteers, and the communities in which they live. This is particularly critical for trials recruiting individuals with higher HIV risk, who are often already highly stigmatized.     

Community preparedness for HIV vaccine trials in the Democratic Republic of Congo

This paper reports on an assessment of community preparedness for HIV vaccine trials in the Democratic Republic of Congo. Formative research was conducted in the capital city of Kinshasa during the period October 2003 to March 2004 to answer questions pertinent to planning trials of a preventive HIV vaccine and to identify related issues. Twenty-seven in-depth interviews and two focus groups were held with potential trial participants and community leaders. Data was collected on the subjects of vaccines, HIV/AIDS and sexual behaviour, and an HIV vaccine. The study also sought to identify factors that motivate a person to volunteer for a vaccine trial or which are disincentives to participation, along with preparedness of the larger community for trials. Personal concerns for health and for the impact of the epidemic on families and country were common motivations for participation. The danger of an experimental vaccine and the stigma of a positive HIV antibody test as the result of vaccination are major concerns and disincentives. The health, educational, and local non-governmental sectors are identified as having important roles to play in assuring preparedness for trials, although significant challenges exist to achieving community preparedness.     

A descriptive analysis of transgender participants in phase 1-2a trials of the HIV Vaccine Trials Network (HVTN) in the United States and Peru

BackgroundHIV disproportionately impacts transgender populations globally, creating challenges to inclusion in trials requiring low HIV risk profiles (LHRP) for acquisition. Our knowledge of transgender individuals with LHRP is limited. We conducted an analysis of transgender and cisgender individuals in HVTN trials enrolling individuals with LHRP.MethodsWe analyzed data from 694 participants enrolled in the phase 1-2a HVTN trials in the US and Peru from 2009 to 2014 that included individuals who reported gender identity (GI) differing from assigned birth sex (transgender [TG]), and compared them with those who reported a congruent GI (cisgender [CG]).Results681 participants (98%) were CG and 13 (2%) were TG. Mean age was 25 years. 16% were Hispanic and most (69%) were White. Reasons for enrolling included to help find an effective vaccine (TG 100%; CG 98%) and help their community (TG 100%; CG 96%). Significant differences by GI were observed in reported pre-existing conditions (p = 0.004); however, approximately 10% of pre-existing conditions reported by TG were GI-related (e.g., gender dysphoria). Significant differences were observed in hormone therapy use (p < 0.001) and mental health medications (p = 0.007). Retention was excellent with 2.1% missed visits and no discontinuations of vaccination for TG and 3% missed visits and 7.1% discontinuations among CG. There was no statistically significant difference in HIV incidence.ConclusionsPrimary reasons for participation were altruistic for all participants. Comparable to CG counterparts, TG participants maintained LHRP, followed trial procedures, and had high retention, facilitating meaningful early phase HIV preventive vaccine trial contributions.     

What can HIV vaccine trials teach us about future HIV vaccine dissemination?

This investigation explored commonalities and differences in barriers and motivators to HIV vaccine trial participation and acceptability of future U.S. Food and Drug Administration (FDA)-approved HIV vaccines in order to identify implications of clinical trials for future HIV vaccine dissemination. Fifteen focus groups were conducted with 157 predominately ethnic minority and low income participants recruited using venue-based sampling in Los Angeles. Data were analyzed using narrative thematic analysis. Barriers and motivators in common across willingness to participate (WTP) in HIV vaccine trials and future HIV vaccine acceptability (e.g., concerns about vaccine-induced infection, false-positives, side effects, efficacy, mistrust and stigma) suggest clinical trials present significant opportunities to develop and evaluate empirically based interventions to support future HIV vaccine dissemination. Barriers specific to HIV vaccine acceptability (e.g., concerns about duration of protection, cross-clade protection, cost and access) also indicate the need for formative research focused specifically on future dissemination. Protection motivation, common to WTP and acceptability, highlights the need to provide and evaluate prevention counseling and education in clinical trials, which may form the basis of evidence-informed preventive interventions to be launched in tandem with dissemination of partial efficacy HIV vaccines.     

HIV vaccine-induced sero-reactivity: A challenge for trial participants,researchers, and physicians

Antibody-inducing vaccines are a major focus in the preventive HIV vaccine field. Because the most common tests for HIV infection rely on detecting antibodies to HIV, they may also detect antibodies induced by a candidate HIV vaccine. The detection of vaccine-induced antibodies to HIV by serological tests is most commonly referred to as vaccine-induced sero-reactivity (VISR). VISR can be misinterpreted as a sign of HIV infection in a healthy study participant. In a participant who has developed vaccine-induced antibodies, accurate diagnosis of HIV infection (or lack thereof) may require specialized tests and algorithms (differential testing) that are usually not available in community settings. Organizations sponsoring clinical testing of preventive HIV vaccine candidates have an ethical obligation not only to inform healthy volunteers about the potential problems associated with participating in a clinical trial but also to help manage any resulting issues. This article explores the scope of VISR-related issues that become increasingly prevalent as the search for an effective HIV vaccine continues and will be paramount once a preventive vaccine is deployed. We also describe ways in which organizations conducting HIV vaccine trials have addressed these issues and outline areas where more work is needed.     

'It's really a hard life': love, gender and HIV risk among male-to-female transgender persons

Scientific studies demonstrate high rates of HIV infection among male-to-female (MTF) transgender individuals and that stigma and discrimination place MTFs at increased risk for infection. However, there is little research examining how gender roles contribute to HIV risk. This paper reports on in-depth interviews with 20 MTFs attending a community clinic. Data reveal that stigma and discrimination create a heightened need for MTFs to feel safe and loved by a male companion and that in turn places them at a higher risk for acquiring HIV. Male-to-female transgender individuals appear to turn to men to feel loved and affirmed as women; their main HIV risk stems from their willingness to engage with sexual partners who provide a sense of love and acceptance but who also may also request unsafe sexual behaviours. A model illustrating how HIV risk is generated from stigma and discrimination is presented.     

‘It's really a hard life’: Love,gender and HIV risk among male‐to‐female transgender persons

Scientific studies demonstrate high rates of HIV infection among male‐to‐female (MTF) transgender individuals and that stigma and discrimination place MTFs at increased risk for infection. However, there is little research examining how gender roles contribute to HIV risk. This paper reports on in‐depth interviews with 20 MTFs attending a community clinic. Data reveal that stigma and discrimination create a heightened need for MTFs to feel safe and loved by a male companion and that in turn places them at a higher risk for acquiring HIV. Male‐to‐female transgender individuals appear to turn to men to feel loved and affirmed as women; their main HIV risk stems from their willingness to engage with sexual partners who provide a sense of love and acceptance but who also may also request unsafe sexual behaviours. A model illustrating how HIV risk is generated from stigma and discrimination is presented.     

Social impact of preventive HIV vaccine clinical trial participation: a model of prevention, assessment and intervention

Preventive HIV vaccine trial participants may experience problems related to trial participation, including difficulties with personal relationships, employment, education, health care, housing, health insurance, disability insurance, life insurance, travel or immigration. During the 19 years that the U.S.-based National Institute of Allergy and Infectious Diseases (NIAID) has conducted preventive HIV vaccine trials, we have developed a model to prevent and resolve social impact related to study participation and assist study participants who report such events. Key elements of the model include: informing potential volunteers of risks prior to enrollment; standardizing data collection methods on social impact events; reviewing and following-up on reported social impact events; assisting participants, including provision of free HIV testing to differentiate HIV infection from vaccine-induced HIV antibody; implementing broad-based and targeted community education programs for achieving community support; communicating with scientific and health care communities; and working with government agencies, non-government agencies and industry on mechanisms to address SI. This approach, established in collaboration with NIAID-funded clinical trial groups, serves as a model for prevention, assessment, monitoring, and intervention for social impact related to preventive HIV vaccine clinical trial participation. Although further research is necessary, this model could be adapted for use in different clinical trials.     

Representation of Latinos and Blacks in screening for and enrollment into preventive HIV vaccine trials in New York City

IntroductionIn the United States, Latinos and Blacks are disproportionately affected by HIV/AIDS, but have been underrepresented in HIV vaccine trials. We assessed screening and enrollment of Blacks and Latinos for preventive HIV vaccine trials conducted in New York City, 2009–2012.MethodsA retrospective analysis was conducted among 18–50 year old men and transgender women screening for four preventive phase 1 and 2 HIV vaccine trials. Demographic, recruitment, and behavioral/medical eligibility data and outcome of screening were examined. To determine factors associated with enrollment, a multivariable logistic regression analysis was performed.ResultsAmong 6077 individuals who provided contact information, 2536 completed a phone pre-screen. 96 (1.6% of recruitment contacts) enrolled. Latinos were 35.7% of recruitment contacts, but 17.7% of those enrolled, whereas Blacks were 22.5% and 32.3%, respectively. Among all Latinos, nearly one third were excluded for being uncircumcised, an eligibility criterion for several studies. In multivariable analysis among potentially eligible potential participants, controlling for age and recruitment method, Latinos were less likely than Whites to enroll in a preventive HIV vaccine trial (aOR 0.52, 95% CI 0.28–0.95) whereas Blacks were as likely as Whites (aOR 0.99, 95% CI 0.59–1.67). Individuals recruited through print advertisements, social media/internet, referral, and other modes were more likely to enroll compared to those recruited through in-person outreach, controlling for age and race/ethnicity.ConclusionsTargeted outreach has led to substantial inclusion of Latinos and Blacks, with Blacks comprising almost a third of those enrolled in these preventive HIV vaccine trials. Latinos, however, were less likely to enroll compared to Whites. Circumcision status as an eligibility criterion partly accounts for this, but further studies are warranted to address the reasons Latinos decide not to participate in preventive HIV vaccine trials.     

Conceptual framework for behavioral and social science in HIV vaccine clinical research

HIV vaccine clinical research occurs within a context where biomedical science and social issues are interlinked. Previous HIV vaccine research has considered behavioral and social issues, but often treated them as independent of clinical research processes. Systematic attention to the intersection of behavioral and social issues within a defined clinical research framework is needed to address gaps, such as those related to participation in trials, completion of trials, and the overall research experience. Rigorous attention to these issues at project inception can inform trial design and conduct by matching research approaches to the context in which trials are to be conducted. Conducting behavioral and social sciences research concurrent with vaccine clinical research is important because it can help identify potential barriers to trial implementation, as well as ultimate acceptance and dissemination of trial results. We therefore propose a conceptual framework for behavioral and social science in HIV vaccine clinical research and use examples from the behavioral and social science literature to demonstrate how the model can facilitate identification of significant areas meriting additional exploration. Standardized use of the conceptual framework could improve HIV vaccine clinical research efficiency and relevance.     

Perceived Risks and Benefits of Sex Work among Transgender Women of Color in San Francisco

Prior research has shown that male-to-female (MTF) transgender women of color in the United States have a high rate of HIV infection and often engage in sex work for economic survival. With the exception of studies on HIV prevalence and behavioral risk, little research exists to elucidate the social context and determinants of sex work and related health risks among these women. Through a qualitative analysis of seven focus groups with 48 transgender women of color, we examined why and how participants became involved in sex work, documented risks associated with sex work, and explored what motivated participants to remain in sex work. Participants reported on how social networks and cultural norms, immigration issues, and experiences of racism, sexism, and transphobia influenced their decisions to enter and the risks encountered in sex work. Findings revealed that transgender women of color who engage in sex work have unique needs and experiences that must be addressed through structural and social network-based interventions to minimize their vulnerability to social and public health harms.     

At the intersection of trust and mistrust: A qualitative analysis of motivators and barriers to research participation at a safety-net hospital

Introduction

The underrepresentation of Black, Indigenous, and People of Color (BIPOC) individuals in healthcare research limits generalizability and contributes to healthcare inequities. Existing barriers and attitudes toward research participation must be addressed to increase the representation of safety net and other underserved populations.

Methods

We conducted semi-structured qualitative interviews with patients at an urban safety net hospital, focusing on facilitators, barriers, motivators, and preferences for research participation. We conducted direct content analysis guided by an implementation framework and used rapid analysis methods to generate final themes.

Results

We completed 38 interviews and identified six major themes related to preferences for engagement in research participation: (1) wide variation in research recruitment preferences; (2) logistical complexity negatively impacts willingness to participate; (3) risk contributes to hesitation toward research participation; (4) personal/community benefit, interest in study topic, and compensation serve as motivators for research participation; (5) continued participation despite reported shortcomings of informed consent process; and (6) mistrust could be overcome by relationship or credibility of information sources.

Conclusion

Despite barriers to participation in research studies among safety-net populations, there are also facilitators that can be implemented to increase knowledge and comprehension, ease of participation, and willingness to join research studies. Study teams should vary recruitment and participation methods to ensure equal access to research opportunities.

Patient/Public Contribution

Our analysis methods and study progress were presented to individuals within the Boston Medical Center healthcare system. Through this process community engagement specialists, clinical experts, research directors, and others with significant experience working with safety-net populations supported data interpretation and provided recommendations for action following the dissemination of data.     

Life Skills: Evaluation of a Theory-Driven Behavioral HIV Prevention Intervention for Young Transgender Women

Young transgender women are at increased risk for HIV infection due to factors related to stigma/marginalization and participation in risky sexual behaviors. To date, no HIV prevention interventions have been developed or proven successful with young transgender women. To address this gap, we developed and pilot tested a homegrown intervention “Life Skills,” addressing the unique HIV prevention needs of young transgender women aged 16–24 years. Study aims included assessing the feasibility of a small group-based intervention with the study population and examining participant’s engagement in HIV-related risk behaviors pre- and 3-months-post-intervention. Fifty-one (N = 51) young transgender women enrolled in the study. Our overall attendance and retention rates demonstrate that small group-based HIV prevention programs for young transgender women are both feasible and acceptable. Trends in outcome measures suggest that participation in the intervention may reduce HIV-related risk behaviors. Further testing of the intervention with a control group is warranted.     

Adapting Effective Narrative-Based HIV-Prevention Interventions to Increase Minorities' Engagement in HIV/AIDS Services

Disparities related to barriers to caring for HIV-positive and at-risk minorities continue to be a major public health problem. Adaptation of efficacious HIV-prevention interventions for use as health communication innovations is a promising approach for increasing minorities' utilization of HIV health and ancillary services. Role-model stories, a widely-used HIV-prevention strategy, employ culturally tailored narratives to depict experiences of an individual modeling health-risk reduction behaviors. This article describes the careful development of a contextually appropriate role model story focused on increasing minorities' engagement in HIV/AIDS health and related services. Findings from interviews with community members and focus groups with HIV-positive minorities indicated several barriers and facilitators related to engagement in HIV health care and disease management (e.g., patient–provider relationships) and guided the development of role-model story narratives.     

A qualitative exploration of barriers to HIV prevention,treatment and support: Perspectives of transgender women and service providers

Transgender (trans) women experience barriers to access to HIV care, which result in their lower engagement in HIV prevention, treatment and support relative to cisgender people living with HIV. Studies of trans women's barriers to HIV care have predominantly focused on perspectives of trans women, while barriers are most often described at provider, organisation and/or systems levels. Comparing perspectives of trans women and service providers may promote a shared vision for achieving health equity. Thus, this qualitative study utilised focus groups and semi-structured interviews conducted 2018–2019 to understand barriers and facilitators to HIV care from the perspectives of trans women (n = 26) and service providers (n = 10). Barriers endorsed by both groups included: (a) anticipated and enacted stigma and discrimination in the provision of direct care, (b) lack of provider knowledge of HIV care needs for trans women, (c) absence of trans-specific services/organisations and (d) cisnormativity in sexual healthcare. Facilitators included: (a) provision of trans-positive trauma-informed care, (b) autonomy and choice for trans women in selecting sexual health services and (c) models for trans-affirming systems change. Each theme had significant overlap, yet nuanced perspective, between trans women and service providers. Specific recommendations to improve HIV care access for trans women are discussed. These recommendations can be used by administrators and service providers alike to work collaboratively with trans women to reduce barriers and facilitators to HIV care and ultimately to achieve health equity for trans women.     

HIV prevention for Black women: structural barriers and opportunities

Black women bear a disproportionate burden of HIV/AIDS in North America. The purpose of this investigation was to explore Black Canadian women's perspectives on HIV risk and prevention. Four 90-minute focus groups (n=26) and six key informant interviews were conducted in Toronto with Black women of African and Caribbean descent and low socioeconomic status. Data analysis revealed a number of potent barriers to existing HIV preventive interventions: stigma, cultural disconnections, lack of engagement of Black religious institutions, and multiple intersecting forms of discrimination. Recommended HIV prevention opportunities included the Black church, mainstreaming, health care providers, and ethno-specific agencies. HIV prevention strategies for North American Black women, rather than focusing on HIV and individual risk behaviors, may benefit from a primary focus on social and structural factors (e.g., promoting gender equality, economic opportunity, women-controlled prevention technologies and combating racism in health care) thereby integrating HIV prevention into the larger context of community health and survival.     

An Extended Model of Reasoned Action to Understand the Influence of Individual- and Network-Level Factors on African Americans’ Participation in HIV Vaccine Research

In the United States, the number and proportion of HIV/AIDS cases among black/African Americans continue to highlight the need for new biomedical prevention interventions, including an HIV vaccine, microbicide, or new antiretroviral (ARV) prevention strategies such as pre-exposure prophylaxis (PrEP) to complement existing condom usage, harm reduction methods, and behavioral change strategies to stem the HIV epidemic. Although black/African Americans are disproportionately impacted by HIV/AIDS, their participation in HIV clinical research continues to have unique challenges. We theorize that interaction among multilevel factors creates ideal alignment for minority participation in HIV clinical studies. Thus, we initially set out to test an extended model of reasoned action with 362 participants to understand the interplay of sociopsychological and network-level considerations influencing minority participation in HIV prevention research efforts. In this study, we linked the intrapersonal dimensions of attitudes, beliefs, and normative concerns to community-level components, appraisal of involvement with the clinical research organization, an entity which operates within a networked structure of community partner agencies, and identification with coalition advocacy aims. Various participatory outcomes were explored including involvement in future HIV vaccine community functions, participation in community promotion of HIV vaccine research, and community mobilization. Three-stage least squares estimates indicated similar findings across three models. Significant effects demonstrate the importance of positive attitudes toward HIV vaccine research, favorable health research beliefs, perceived social support for participation, HIV/AIDS issue engagement, and perceived relevance of the clinical research site’s mission and values. Identification of these nuanced pathway effects provides implications for tailored community program development.