Effects of Behavioral Intervention Components for African American/Black and Latino Persons Living with HIV with Non-suppressed Viral Load Levels: Results of an Optimization Trial.

There is an urgent need for efficient behavioral interventions to increase rates of HIV viral suppression for populations with serious barriers to engagement along the HIV care continuum. We carried out an optimization trial to test the effects of five behavioral intervention components designed to address barriers to HIV care continuum engagement for African American/Black and Latino persons living with HIV (PLWH) with non-suppressed HIV viral load levels: motivational interviewing sessions (MI), focused support groups (SG), peer mentorship (PM), pre-adherence skill building (SB), and navigation with two levels, short (NS) and long (NL). The primary outcome was HIV viral suppression (VS) and absolute viral load (VL) and health-related quality of life were secondary outcomes. Participants were 512 African American/Black and Latino PLWH poorly engaged in HIV care and with detectable HIV viral load levels in New York City, recruited mainly through peer referral. Overall, VS increased to 37%, or 45% in a sensitivity analysis. MI and SG seemed to have antagonistic effects on VS (z = - 1.90; p = 0.057); the probability of VS was highest when either MI or SG was assigned, but not both. MI (Mean Difference = 0.030; 95% CI 0.007-0.053; t(440) = 2.60; p = 0.010) and SB (Mean Difference = 0.030; 95% CI 0.007-0.053; t(439) = 2.54; p = 0.012) improved health-related quality of life. This is the first optimization trial in the field of HIV treatment. The study yields a number of insights into approaches to improve HIV viral suppression in PLWH with serious barriers to engagement along the HIV care continuum, including chronic poverty, and underscores challenges inherent in doing so.

Exploring behavioral intervention components for African American/Black and Latino persons living with HIV with non-suppressed HIV viral load in the United States: a qualitative study.

BACKGROUND: The persistence of racial/ethnic inequities in rates of engagement along the HIV care continuum signals the need for novel approaches. We developed six behavioral intervention components for use in an optimization trial, grounded in a model that integrates critical race theory, harm reduction, and self-determination theory, designed to address various barriers that African American/Black and Latino persons living with HIV (PLWH) experience to the HIV care continuum. The components were: health education, motivational interviewing sessions, pre-adherence skill building, peer mentorship, focused support groups, and navigation. The present qualitative exploratory study describes participants' perspectives on the components' acceptability, feasibility, and impact. METHODS: Participants were African American/Black and Latino PLWH poorly engaged in HIV care and with non-suppressed HIV viral load in New York City. From a larger trial, we randomly selected 46 participants for in-depth semi-structured interviews. Interviews were audio-recorded and transcribed verbatim, and data were analyzed using directed content analysis. Quantitative data on sociodemographic and background characteristics and components' acceptability and feasibility were also collected. RESULTS: On average, participants were 49 years old and had lived with HIV for 19 years. Most were cisgender-male and African American/Black. Participants reported a constellation of serious social and structural challenges to HIV management including chronic poverty, unstable housing, and stigma. Across components, a non-judgmental and pressure-free approach and attention to structural and cultural factors were seen as vital to high levels of engagement, but lacking in most medical/social service settings. Prominent aspects of individual components included establishing trust (health education); developing intrinsic motivation, goals, and self-reflection (motivational interviewing sessions); learning/practicing adherence strategies and habits (pre-adherence skill building); reducing social isolation via peer role models (peer mentorship); reflecting on salient goals and common challenges with peers without stigma (focused support groups); and circumventing structural barriers to HIV management with support (navigation). Components were found acceptable and feasible. Findings suggested ways components could be improved. CONCLUSIONS: The present study advances research on interventions for African American/Black and Latino PLWH, who experience complex barriers to engagement along the HIV care continuum. Future study of the components is warranted to address racial/ethnic health inequities in HIV.

Advancing behavioral interventions for African American/Black and Latino persons living with HIV using a new conceptual model that integrates critical race theory, harm reduction, and self-determination theory: a qualitative exploratory study.

BACKGROUND: Rates of participation in HIV care, medication uptake, and viral suppression are improving among persons living with HIV (PLWH) in the United States. Yet, disparities among African American/Black and Latino PLWH are persistent, signaling the need for new conceptual approaches. To address gaps in services and research (e.g., insufficient attention to structural/systemic factors, inadequate harm reduction services and autonomy support) and improve behavioral interventions, we integrated critical race theory, harm reduction, and self-determination theory into a new conceptual model, then used the model to develop a set of six intervention components which were tested in a larger study. The present qualitative study explores participants' perspectives on the study's acceptability, feasibility, and impact, and the conceptual model's contribution to these experiences. METHODS: Participants in the larger study were African American/Black and Latino PLWH poorly engaged in HIV care and with non-suppressed HIV viral load in New York City (N = 512). We randomly selected N = 46 for in-depth semi-structured interviews on their experiences with and perspectives on the study. Interviews were audio-recorded and professionally transcribed verbatim, and data were analyzed using directed qualitative content analysis. RESULTS: On average, participants were 49 years old (SD = 9) and had lived with HIV for 19 years (SD = 7). Most were male (78%) and African American/Black (76%). All had taken HIV medication previously. Challenging life contexts were the norm, including poverty, poor quality/unstable housing, trauma histories exacerbated by current trauma, health comorbidities, and substance use. Participants found the study highly acceptable. We organized results into four themes focused on participants' experiences of: 1) being understood as a whole person and in their structural/systemic context; 2) trustworthiness and trust; 3) opportunities for self-reflection; and 4) support of personal autonomy. The salience of nonjudgment was prominent in each theme. Themes reflected grounding in the conceptual model. Participants reported these characteristics were lacking in HIV care settings. CONCLUSIONS: The new conceptual model emphasizes the salience of systemic/structural and social factors that drive health behavior and the resultant interventions foster trust, self-reflection, engagement, and behavior change. The model has potential to enhance intervention acceptability, feasibility, and effectiveness with African American/Black and Latino PLWH.

African American/Black and Latino Adults with Detectable HIV Viral Load Evidence Substantial Risk for Polysubstance Substance Use and Co-occurring Problems: A Latent Class Analysis.

Substance use problems are highly prevalent among persons living with (PLWH) in the United States and serve as serious barriers to engagement in HIV care. Yet, in contrast to studies of single substances, little is known about patterns of polysubstance use in this population. Moreover, other risk factors (e.g., financial hardship, incarceration, homelessness, and mental health distress) are also prevalent and complicate HIV management. The present study drew on a cross-sectional survey with African American/Black and Latino (AABL) adult PLWH from low socioeconomic status backgrounds in New York City who were insufficiently engaged in HIV care and evidenced detectable HIV viral load (N = 512). We used latent class analysis (LCA) to explore patterns of polysubstance use and their relationships to financial hardship, incarceration, homelessness, and mental health. LCA yielded three substance use classes: Class 1, a high polysubstance use/high-risk substance use class (9%); Class 2, a polysubstance use/moderate substance use risk class (18%); and Class 3, a moderate polysubstance use/moderate-to-low-risk substance use class (74%). Mental health symptoms were prevalent in all classes, but Class 1 had greater mental health distress than the other two classes. Current homelessness was more prevalent in Classes 1 and 2. We cannot end the HIV epidemic without engaging and treating AABL PLWH who have serious barriers to engagement along the HIV care continuum, and who evidence polysubstance use along with co-occurring risk factors. Clinical settings can develop outreach and engagement approaches to bring this subpopulation of PLWH into care settings, and further, specialized services are needed to successfully screen, treat, and retain them.

Black and Latino Persons Living with HIV Evidence Risk and Resilience in the Context of COVID-19: A Mixed-Methods Study of the Early Phase of the Pandemic.

The COVID-19 pandemic has great potential to disrupt the lives of persons living with HIV (PLWH). The present convergent parallel design mixed-methods study explored the early effects of COVID-19 on African American/Black or Latino (AABL) long-term survivors of HIV in a pandemic epicenter, New York City. A total of 96 AABL PLWH were recruited from a larger study of PLWH with non-suppressed HIV viral load. They engaged in structured assessments focused on knowledge, testing, trust in information sources, and potential emotional, social, and behavioral impacts. Twenty-six of these participants were randomly selected for in-depth semi-structured interviews. Participants were mostly men (64%), African American/Black (75%), and had lived with HIV for 17 years, on average (SD=9 years). Quantitative results revealed high levels of concern about and the adoption of recommended COVID-19 prevention recommendations. HIV care visits were commonly canceled but, overall, engagement in HIV care and antiretroviral therapy use were not seriously disrupted. Trust in local sources of information was higher than trust in various federal sources. Qualitative findings complemented and enriched quantitative results and provided a multifaceted description of both risk factors (e.g., phones/internet access were inadequate for some forms of telehealth) and resilience (e.g., "hustling" for food supplies). Participants drew a direct line between structural racism and the disproportional adverse effects of COVID-19 on communities of color, and their knowledge gleaned from the HIV pandemic was applied to COVID-19. Implications for future crisis preparedness are provided, including how the National HIV/AIDS Strategy can serve as a model to prevent COVID-19 from becoming another pandemic of the poor.

Stopping, starting, and sustaining HIV antiretroviral therapy: a mixed-methods exploration among African American/Black and Latino long-term survivors of HIV in an urban context.

BACKGROUND: Although periods of HIV antiretroviral therapy (ART) discontinuation have deleterious health effects, ART is not always sustained. Yet, little is known about factors that contribute to such ART non-persistence among long-term HIV survivors. The present study applied a convergent parallel mixed-methods design to explore the phenomena of stopping/starting and sustaining ART, focusing on low-socioeconomic status African American or Black and Latino persons living with HIV (PLWH) who face the greatest challenges. METHODS: Participants (N = 512) had poor engagement in HIV care and detectable HIV viral load. All received structured assessments and N = 48 were randomly selected for in-depth interviews. Quantitative analysis using negative binomial regression uncovered associations among multi-level factors and the number of times ART was stopped/started and the longest duration of sustained ART. Qualitative data were analyzed using a directed content analysis approach and results were integrated. RESULTS: Participants were diagnosed 18.2 years ago on average (SD = 8.6), started ART a median five times (Q1 = 3, Q3 = 10), and the median longest duration of sustained ART was 18 months (Q1 = 6, Q3 = 36). Factors associated with higher rates of stops/starts were male sex, transgender identity, cannabis use at moderate-to-high-risk levels, and ART- and care-related stigma. Factors associated with lower rates of stops/starts were older age, more years since diagnosis, motivation for care, and lifetime injection drug use (IDU). Factors associated with longer durations of sustained ART were Latino/Hispanic ethnicity, motivation for ART and care, and recent IDU. Factors associated with a shorter duration were African American/Black race, alcohol use at moderate-to-high-risk levels, and social support. Qualitative results uncovered a convergence of intersecting risk factors for stopping/starting ART and challenges inherent in managing HIV over decades in the context of poverty. These included unstable housing, which contributed to social isolation, mental health distress, and substance use concerns, the latter prompting selling ("diverting") ART. Primarily complementary quantitative and qualitative findings described mechanisms by which risk/protective factors operated and ways PLWH successfully restart and/or sustain ART. CONCLUSIONS: The field focuses substantially on ART adherence, but greater attention to reducing the frequency of ART non-persistence is needed, along with creating social/structural conditions favorable for sustained ART.

Understanding long-term HIV survivorship among African American/Black and Latinx persons living with HIV in the United States: a qualitative exploration through the lens of symbolic violence.

BACKGROUND: Persons living with HIV (PLWH) are living longer, although racial/ethnic and socioeconomic status (SES) disparities persist. Yet, little is known about the experience of living with and managing HIV over decades. The present study took a qualitative approach and used the lens of symbolic violence, a type of internalized, non-physical violence manifested in the power differential between social groups. We focused on adult African American/Black and Latinx (AABL) PLWH from low-SES backgrounds. METHODS: Data were drawn from two studies with AABL PLWH in New York City (N = 59). After providing signed informed consent, participants engaged in in-depth semi-structured interviews on aspects of HIV management. Interviews were audio-recorded and professionally transcribed verbatim, and data were analyzed using directed qualitative content analysis. RESULTS: Participants in the two studies were comparable on sociodemographic and background characteristics. They had lived with HIV for 20 years, on average (range 3-33 years). All were from low-SES backgrounds and most were African American/Black and men. Participants experienced a convergence of multiple social exclusions, harms, and stigmas, consistent with symbolic violence, which contributed to disengagement from HIV care and discontinuation of HIV medications. We organized results into five sub-themes: (1) participants were "ground down" over time by material, social, and emotional challenges and this diminished self-worth and, at times, the will to live; (2) social isolation and self-isolation, based in part on feeling devalued and dehumanized, served as stigma-avoidance strategies and mechanisms of social exclusion; (3) stigmatizing aspects of patient-provider interactions, both experienced and anticipated, along with (4) restricted autonomy in HIV care and other settings (e.g., parole) reduced engagement; and (5) poor HIV management was internalized as a personal failure. Importantly, resilience was evident throughout the five sub-themes. CONCLUSIONS: Symbolic violence is a useful framework for understanding long-term HIV management and survivorship among AABL PLWH from low-SES backgrounds. Indeed, forms of symbolic violence are internalized over time (e.g., experiencing devaluation, dehumanization, loss of self-worth, and anticipated stigma), thereby impeding successful HIV management, in part because avoiding HIV care and discontinuing HIV medications are primary coping strategies. Results have implications for interventions in community and health care settings.

Engagement in the Hepatitis C care continuum among people who use drugs.

Despite high rates of Hepatitis C virus (HCV) infection among people who use drugs (PWUDs), access to the HCV care continuum combined with the receipt of medications for addiction treatment in primary care settings remains suboptimal. A qualitative study was conducted among adults admitted for inpatient detoxification for opioid use disorder (OUD) in New York City (n=23) to assess barriers and facilitators with HCV prevention, screening, treatment, interactions with primary care providers, and experiences with integrated care approaches. Study findings yielded six major themes related to HCV care. Major gaps persist in knowledge regarding HCV harm reduction strategies, voluntary HCV testing services, and eligibility for HCV treatment. Treatment coordination challenges reinforce the importance of enhancing linkages to HCV care in key access-points utilized by PWUDs (e.g., emergency rooms, specialty addiction treatment settings). Peer networks combined with frequent patient-physician communication were elicited as important factors in facilitating linkage to HCV care. Additional care coordination needs in primary care settings included access to integrated treatment of HCV and OUD, and administrative support for enrollment in Medicaid, subsidized housing, and access to transportation vouchers.

"Like I Have No Choice": A Qualitative Exploration of HIV Diagnosis and Medical Care Experiences While Incarcerated and Their Effects.

It is estimated that one in six Black and Latino adult persons living with HIV (PLWH) spend time in correctional institutions each year. Yet after release, PLWH of color evidence poor HIV health outcomes across the HIV care continuum. This study, guided by an ecological approach and Critical Race Theory, sought to understand the lived experiences of socioeconomically disadvantaged PLWH of color who received an HIV diagnosis and/or medical care while incarcerated, and the ways in which those experiences influenced engagement in medical care after release. Drawn from a larger study in Brooklyn, NY, in 2013-2016, a subset of 28 participants who received in-depth qualitative interviews were purposively sampled for a secondary analysis of participants who received an HIV diagnosis and/or medical care while incarcerated. Using an Interpretive Phenomenological Analysis, we found participant's experiences were shaped by longstanding mistrust of the medical establishment. While incarcerated, lack of autonomy, substandard medical care, and poor social support exacerbated medical mistrust and avoidance of HIV medical care long after release. Engagement in HIV medical care and treatment were also impacted by a dynamic interplay of factors including substance use, prolonged periods of denial, poverty, and repeated bouts of incarceration. Given that experiences of HIV diagnosis and medical care while incarcerated have long-ranging, adverse effects, we argue that a better understanding of the ways in which PLWH of color experience HIV diagnosis and medical care while incarcerated may serve to inform intervention efforts within correctional institutions to improve HIV health outcomes.

THE IOWA GAMBLING TASK IN VIOLENT AND NONVIOLENT INCARCERATED MALE ADOLESCENTS.

Previous studies have found impaired affective decision-making, as measured by the Iowa Gambling Task (IGT), in various antisocial populations. This is the first study to compare the IGT in violent and nonviolent incarcerated American youth. The IGT was administered to 185 incarcerated adolescent male offenders charged with either nonviolent (38.4%) or violent (61.6%) crimes. General linear mixed models and t tests were used to assess differences between the groups. The full sample performed worse than if they had selected from the decks at random. The violent offenders performed more poorly than the nonviolent offenders overall, primarily because they preferred "disadvantageous" Deck B to a greater degree; however, they did demonstrate some degree of learning by the final block of the task. Adolescent offenders demonstrate impaired affective decision-making. Behavior suggested preferential attention to frequency of loss and amount of gain and inattention to amount of loss.

Doing battle with "the monster:" how high-risk heterosexuals experience and successfully manage HIV stigma as a barrier to HIV testing.

BACKGROUND: Annual HIV testing is recommended for populations at-risk for HIV in the United States, including heterosexuals geographically connected to urban high-risk areas (HRA) with elevated rates of HIV prevalence and poverty, who are primarily African American/Black or Hispanic. Yet this subpopulation of "individuals residing in HRA" (IR-HRA) evidence low rates of regular HIV testing. HIV stigma is a recognized primary barrier to testing, in part due to its interaction with other stigmatized social identities. Guided by social-cognitive and intersectionality theories, this qualitative descriptive study explored stigma as a barrier to HIV testing and identified ways IR-HRA manage stigma. METHODS: In 2012-2014, we conducted in-depth qualitative interviews with 31 adult IR-HRA (74% male, 84% African American/Black) with unknown or negative HIV status, purposively sampled from a larger study for maximum variation on HIV testing experiences. Interviews were audio-recorded and professionally transcribed verbatim. Data were analyzed using a systematic content analysis approach that was both theory-driven and inductive. RESULTS: Stigma was a primary barrier to HIV testing among IR-HRA. In the context of an under-resourced community, HIV stigma was experienced as emerging from, and being perpetuated by, health care organizations and educational institutions, as well as community members. Participants noted it was "better not to know" one's HIV status, to avoid experiencing HIV-related stigma, which could interact with other stigmatized social identities and threaten vital social relationships, life chances, and resources. Yet most had tested for HIV previously. Factors facilitating testing included health education to boost knowledge of effective treatments for HIV; understanding HIV does not necessitate ending social relationships; and tapping into altruism. CONCLUSIONS: In the context of economic and social inequality, HIV stigma operates on multiple, intersecting layers. IR-HRA struggle with an aversion to HIV testing, because adopting another stigmatized status is dangerous. They also find ways to manage stigma to engage in testing, even if not at recommended levels. Findings highlight strategies to reduce HIV stigma at the levels of communities, institutions, and individuals to improve rates of annual HIV testing necessary to eliminate HIV transmission and reduce HIV-related racial and ethnic health disparities among IR-HRA.

Cognitive Decline as a Result of Incarceration and the Effects of a CBT/MT Intervention: A Cluster-Randomized Controlled Trial.

This study primarily tests whether incarceration negatively affects cognitive functioning; namely emotion regulation, cognitive control, and emotion recognition. As a secondary interest, we test protective effects of a Cognitive Behavioral Therapy/Mindfulness Training (CBT/MT) intervention. Dormitories containing 197 incarcerated males aged 16-18 were randomly assigned to either a CBT/MT program or an active control condition. A cognitive task was administered pre-treatment and again four months later, upon treatment completion. Performance on all outcome variables was significantly worse at follow-up compared to baseline. There were marginally significant group by time interactions. While the control group performance significantly declined in both cognitive control and emotion regulation, the CBT/MT group showed no significant decline in either outcome. This is the first study to probe the effects of incarceration on these three processes. Findings suggest that incarceration worsens a known risk factor for crime (cognitive functioning), and that a CBT/MT intervention may help buffer against declines.

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.

BACKGROUND: African American/Black and Hispanic persons living with HIV (AABH-PLWH) in the U.S. evidence insufficient engagement in HIV care and low uptake of HIV antiretroviral therapy, leading to suboptimal clinical outcomes. The present qualitative study used critical race theory, and incorporated intersectionality theory, to understand AABH-PLWH's perspectives on the mechanisms by which structural racism; that is, the macro-level systems that reinforce inequities among racial/ethnic groups, influence health decisions and behaviors. METHODS: Participants were adult AABH-PLWH in New York City who were not taking antiretroviral therapy nor well engaged in HIV care (N = 37). Participants were purposively sampled for maximum variation from a larger study, and engaged in semi-structured in-depth interviews that were audio-recorded and professionally transcribed verbatim. Data were analyzed using a systematic content analysis approach. RESULTS: We found AABH-PLWH experienced HIV care and medication decisions through a historical and cultural lens incorporating knowledge of past and present structural racism. This contextual knowledge included awareness of past maltreatment of people of color in medical research. Further, these understandings were linked to the history of HIV antiretroviral therapy itself, including awareness of the first HIV antiretroviral regimen; namely, AZT (zidovudine) mono-therapy, which was initially prescribed in unacceptably high doses, causing serious side effects, but with only modest efficacy. In this historical/cultural context, aspects of structural racism negatively influenced health care decisions and behavior in four main ways: 1) via the extent to which healthcare settings were experienced as overly institutionalized and, therefore, dehumanizing; 2) distrust of medical institutions and healthcare providers, which led AABH-PLWH to feel pressured to take HIV antiretroviral therapy when it was offered; 3) perceptions that patients are excluded from the health decision-making process; and 4) an over-emphasis on antiretroviral therapy compared to other non-HIV related priorities. We found that although participants were located at the intersection of multiple social categories (e.g., gender, social class, AABH race/ethnicity), race/ethnicity and social class were described as primary factors. CONCLUSIONS: Critical race theory proved useful in uncovering how macro-level structural racism affects individual-level health decisions and behaviors. HIV clinical settings can counter-balance the effects of structural racism by building "structural competency," and interventions fostering core self-determination needs including autonomy may prove culturally appropriate and beneficial for AABH-PLWH.

Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations: a study protocol.

BACKGROUND: More than half of persons living with HIV (PLWH) in the United States are insufficiently engaged in HIV primary care and not taking antiretroviral therapy (ART), mainly African Americans/Blacks and Hispanics. In the proposed project, a potent and innovative research methodology, the multiphase optimization strategy (MOST), will be employed to develop a highly efficacious, efficient, scalable, and cost-effective intervention to increase engagement along the HIV care continuum. Whereas randomized controlled trials are valuable for evaluating the efficacy of multi-component interventions as a package, they are not designed to evaluate which specific components contribute to efficacy. MOST, a pioneering, engineering-inspired framework, addresses this problem through highly efficient randomized experimentation to assess the performance of individual intervention components and their interactions. We propose to use MOST to engineer an intervention to increase engagement along the HIV care continuum for African American/Black and Hispanic PLWH not well engaged in care and not taking ART. Further, the intervention will be optimized for cost-effectiveness. A similar set of multi-level factors impede both HIV care and ART initiation for African American/Black and Hispanic PLWH, primary among them individual- (e.g., substance use, distrust, fear), social- (e.g., stigma), and structural-level barriers (e.g., difficulties accessing ancillary services). Guided by a multi-level social cognitive theory, and using the motivational interviewing approach, the study will evaluate five distinct culturally based intervention components (i.e., counseling sessions, pre-adherence preparation, support groups, peer mentorship, and patient navigation), each designed to address a specific barrier to HIV care and ART initiation. These components are well-grounded in the empirical literature and were found acceptable, feasible, and promising with respect to efficacy in a preliminary study. METHODS/DESIGN: Study aims are: 1) using a highly efficient fractional factorial experimental design, identify which of five intervention components contribute meaningfully to improvement in HIV viral suppression, and secondary outcomes of ART adherence and engagement in HIV primary care; 2) identify mediators and moderators of intervention component efficacy; and 3) using a mathematical modeling approach, build the most cost-effective and efficient intervention package from the efficacious components. A heterogeneous sample of African American/Black and Hispanic PLWH (with respect to age, substance use, and sexual minority status) will be recruited with a proven hybrid sampling method using targeted sampling in community settings and peer recruitment (N = 512). DISCUSSION: This is the first study to apply the MOST framework in the field of HIV prevention and treatment. This innovative study will produce a culturally based HIV care continuum intervention for the nation's most vulnerable PLWH, optimized for cost-effectiveness, and with exceptional levels of efficacy, efficiency, and scalability. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02801747 , Registered June 8, 2016.

Behavioral intervention improves treatment outcomes among HIV-infected individuals who have delayed, declined, or discontinued antiretroviral therapy: a randomized controlled trial of a novel intervention.

Nationally up to 60 % of persons living with HIV are neither taking antiretroviral therapy (ART) nor well engaged in HIV care, mainly racial/ethnic minorities. This study examined a new culturally targeted multi-component intervention to address emotional, attitudinal, and social/structural barriers to ART initiation and HIV care. Participants (N = 95) were African American/Black and Latino adults with CD4 < 500 cells/mm(3) not taking ART, randomized 1:1 to intervention or control arms, the latter receiving treatment as usual. Primary endpoints were adherence, evaluated via ART concentrations in hair samples, and HIV viral load suppression. The intervention was feasible and acceptable. Eight months post-baseline, intervention participants tended to be more likely to evidence "good" (that is, 7 days/week) adherence (60 vs. 26.7 %; p = 0.087; OR = 3.95), and had lower viral load levels than controls (t(22) = 2.29, p = 0.032; OR = 5.20), both large effect sizes. This highly promising intervention merits further study.

Hybrid STTR intervention for heterosexuals using anonymous HIV testing and confidential linkage to care: a single arm exploratory trial using respondent-driven sampling.

BACKGROUND: An estimated 14 % of the 1.2 million individuals living with HIV in the U.S. are unaware of their status. Yet this modest proportion of individuals with undiagnosed HIV is linked to 44-66 % of all new infections. Thus innovative intervention approaches are needed to seek out and test those with undiagnosed HIV, and link them to HIV treatment with high retention, an approach referred to as "Seek, Test, Treat, and Retain" (STTR). The present protocol describes a creative "hybrid" STTR approach that uses anonymous HIV testing followed by confidential care linkage, focused on heterosexuals at high risk (HHR) for HIV, who do not test as frequently as, and are diagnosed later, than other risk groups. METHODS/DESIGN: This is a single-arm exploratory intervention efficacy trial. The study has two phases: one to seek out and test HHR, and another to link those found infected to HIV treatment in a timely fashion, with high retention. We will recruit African American/Black and Latino adult HHR who reside in urban locations with high poverty and HIV prevalence. Participants will be recruited with respondent-driven sampling, a peer recruitment method. The "Seek and Test" phase is comprised of a brief, convenient, single-session, anonymous HIV counseling and testing session. The "Treat and Retain" component will engage those newly diagnosed with HIV into a confidential research phase and use a set of procedures called care navigation to link them to HIV primary care. Participants will be followed for 6 months with objective assessment of outcomes (using medical records and biomarkers). DISCUSSION: Undiagnosed HIV infection is a major public health problem. While anonymous HIV testing is an important part of the HIV testing portfolio, it does not typically include linkage to care. The present study has potential to produce an innovative, brief, cost-effective, and replicable STTR intervention, and thereby reduce racial/ethnic disparities in HIV/AIDS. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02421159 , Registered April 15, 2015.

Strategies to uncover undiagnosed HIV infection among heterosexuals at high risk and link them to HIV care with high retention: a "seek, test, treat, and retain" study.

BACKGROUND: Over 50,000 individuals become infected with HIV annually in the U.S., and over a quarter of HIV infected individuals are heterosexuals. Undiagnosed HIV infection, as well as a lack of retention in care among those diagnosed, are both primary factors contributing to ongoing HIV incidence. Further, there are racial/ethnic disparities in undiagnosed HIV and engagement in care, with African Americans/Blacks and Latinos remaining undiagnosed longer and less engaged in care than Whites, signaling the need for culturally targeted intervention approaches to seek and test those with undiagnosed HIV infection, and link them to care with high retention. METHODS/DESIGN: The study has two components: one to seek out and test heterosexuals at high risk for HIV infection, and another to link those found infected to HIV care with high retention. We will recruit sexually active African American/Black and Latino adults who have opposite sex partners, negative or unknown HIV status, and reside in locations with high poverty and HIV prevalence. The "Seek and Test" component will compare the efficacy and cost effectiveness of two strategies to uncover undiagnosed HIV infection: venue-based sampling and respondent-driven sampling (RDS). Among those recruited by RDS and found to have HIV infection, a "Treat and Retain" component will assess the efficacy of a peer-driven intervention compared to a control arm with respect to time to an HIV care appointment and health indicators using a cluster randomized controlled trial design to minimize contamination. RDS initial seeds will be randomly assigned to the intervention or control arm at a 1:1 ratio and all recruits will be assigned to the same arm as the recruiter. Participants will be followed for 12 months with outcomes assessed using medical records and biomarkers, such as HIV viral load. DISCUSSION: Heterosexuals do not test for HIV as frequently as and are diagnosed later than other risk groups. The study has the potential to contribute an efficient, innovative, and sustainable multi-level recruitment approach and intervention to the HIV prevention portfolio. Because the majority of heterosexuals at high risk are African American/Black or Latino, the study has great potential to reduce racial/ethnic disparities in HIV/AIDS. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01607541, Registered May 23, 2012.

ACT2 peer-driven intervention increases enrollment into HIV/AIDS medical studies among African Americans/Blacks and Hispanics: A cluster randomized controlled trial.

African American/Black and Hispanic persons living with HIV/AIDS ("AABH-PLHA") are under-represented in HIV/AIDS medical studies (HAMS). This paper evaluates the efficacy of a social/behavioral intervention to increase rates of screening for and enrollment into HAMS in these populations. Participants (N = 540) were enrolled into a cluster randomized controlled trial of an intervention designed to overcome multi-level barriers to HAMS. Primary endpoints were rates of screening for and enrollment into therapeutic/treatment-oriented and observational studies. Intervention arm participants were 30 times more likely to be screened than controls (49.3 % vs. 3.7 %; p < .001). Half (55.5 %) of those screened were eligible for HAMS, primarily observational studies. Nine out of ten found eligible enrolled (91.7 %), almost all into observational studies (95.2 %), compared to no enrollments among controls. Achieving appropriate representation of AABH-PLHA in HAMS necessitates modification of study inclusion criteria to increase the proportion found eligible for therapeutic HAMS, in addition to social/behavioral interventions.

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.

African-American and Latino/Hispanic persons living with HIV/AIDS are underrepresented in AIDS clinical trials (ACTs). The aim of this paper was to uncover factors, either unmodifiable or not directly targeted for change, that predicted screening for ACTs during an efficacious peer-driven intervention (N = 540 total; N = 351 in an intervention arm, N = 189 control). This paper focused on participants assigned to an intervention arm, 56 % of whom were screened for ACTs. We found a decreased odds of screening was associated with closer proximity to the screening site, gay/lesbian orientation, lower mental health symptoms, current injection drug use, more recent HIV diagnosis, lack of prior screening experience, and failure to attend all intervention sessions, but there were no gender or racial/ethnic differences. Efforts to reduce racial/ethnic disparities in ACTs can be enhanced by attending to these specific factors, which may interfere with programmatic efforts to increase African-American and Latino/Hispanic representation in ACTs.