A.S.K.-PrEP Program (Assistance Services Knowledge-PrEP)

Abstract: The A.S.K.-PrEP (Assistance Services Knowledge-PrEP) program works with extremely high-risk HIV-negative trans women and men who have sex with men to link participants into PrEP medical services. A.S.K.-PrEP consists of individualized, client-centered PrEP navigation sessions to assess PrEP readiness, assess barriers to PrEP initiation and/or adherence, assess readiness for adherence, and to plan for PrEP persistence. Additionally, through the five-session A.S.K.-PrEP intervention, the PrEP navigator works with each participant to remove structural barriers to PrEP initiation/adherence (mental health, substance use [including injection drug use], intimate partner violence, STDs, housing, hormones, sex work), insurance enrollment/patient assistance), link participants into needed ancillary services, all with the ultimate goal of linkage to PrEP and persistent daily PrEP adherence. Discussions of PrEP readiness and individual and structural barriers to PrEP linkage and adherence occur throughout the five sessions. Throughout the duration of the project, participants can opt-in/opt-out of receiving culturally competent, theory-based PrEP adherence support text messages. Each text message has a theoretical conceptual foundation based on Social Support Theory (to provide informational, emotional or instrumental PrEP support), Health Belief Model (to identify or reduce HIV risks) or Social Cognitive Theory (to increase self-regulation skills and self-efficacy for PrEP persistence). A.S.K.-PrEP partners with three local clinics to provide culturally appropriate PrEP medical services.

HPTN 085: The AMP Study

The AMP Study (also known as HVTN 704/HPTN 085) tests an experimental antibody against HIV. AMP stands for Antibody Mediated Prevention. This is the idea of giving people antibodies that fight HIV to see if they will protect people from becoming HIV infected.

The AMP study tests an antibody called VRC01, a manufactured antibody against HIV. This is a new idea for HIV prevention that is related to what has been done in HIV vaccine research. In traditional HIV vaccine studies, people get a vaccine and researchers wait to see if their bodies will make antibodies against HIV in response to the vaccine. In this study, we will skip that step, and give people the antibodies directly.

VRC01 will be given using intravenous infusions. This is more commonly known as getting an IV, or getting a drip. The IV is given to the study participant every eight weeks for 30-60 minutes. To get an IV, a sterile needle is used to place a small plastic tube into a vein in the participant’s arm. A bag of fluid is hung from a pole and connected to a pump, which controls how quickly the contents of the bag flow through the tube into the participant’s arm.

There will be 3 different groups in this study. One third of study participants will get a higher dose of the antibody in their IV. One third will get a lower dose of the antibody in their IV. One third will get an infusion of sterile salt water without any antibody in it. This is called a placebo. Participants will be enrolled in the study for about two years.

Engaging Seronegative Youth to Optimize HIV Prevention Continuum

Abstract: Young people at highest risk for HIV in the U.S. will be gay, bisexual transgender youth (GBTY) and homeless youth (HY) in communities with high HIV incidence and overwhelmingly Black and Latino. Focusing on Los Angeles and New Orleans, seronegative youth at highest risk for HIV will be screened in homeless shelters and gay-identified community-based organizations (CBO). A cohort of 1500 seronegative youth will be recruited that is 82% male (79% GBTY), 66% Black, 16% Latino, and 18% white, non-Hispanic. About 27% will be 12-17 and 73% between 18-24 years old. All youth will be followed longitudinally over 24 months at four month intervals and tested for HIV, STI, serious substance abuse, health care utilization, and comorbid conditions – a Prototypical Retention/Prevention (R/P) Strategy. Over 24 months, acutely HIV infected youth will be triaged to Study 1. This Prototypical R/P Strategy operationalizes the CDC’s recommendations for the engagement of GBTY in repeat HIV testing, linkage to care, and options for combination prevention (PrEP, PEP – with behavioral interventions). Building on this team’s extensive experience with behavioral and mobile/social media interventions, a randomized controlled trial (RCT) will be conducted with four intervention conditions: 1) an Automated Messaging and Monitoring Intervention (AMMI), which will use texts to diffuse prevention messages daily and to monitor risk behaviors weekly (n=900); 2) a Peer Support intervention on a social media platform (i.e., Facebook) in which young people will post messages and stories about their experiences preventing HIV, plus the AMMI (n=200); 3) an eNavigator intervention in which a B.A.-level staff supports youth, primarily through texting and social media, but also in-person meetings, to provide support in crisis situations, refer to treatment, and assist in gaining access to health care and other services, plus Peer Support and AMMI (n=200); and, 4) a combined intervention of eNavigator, Peer Support, and AMMI (n=200). A single outcome will be composed of six key behaviors (access to medical care, accessing and adherence to PrEP or PEP, treatment of all STI, and 100% condom use). In addition to evaluating the added benefit of increasing levels of intervention, the brief 7- item weekly text-messaging monitoring surveys will provide approximately 100,000 weekly reports of indicators of primary and secondary outcomes that can inform our understandings about the relationships between risk and comorbid states. This study will have policy implications for the allocation of resources to HIV testing resources in local communities, the uptake and scalability of text and social media interventions, and the models for diffusing evidence-based interventions (EBI) globally (without requiring replication with fidelity to a manual).

Project Number: 5U19HD089886-02

Resiliency Education to Reduce Depression Disparities

Abstract: Depression is the leading cause of adult disability and common among lesbian, gay, bisexual (LGB) adults. Primary care depression quality improvement (QI) programs can improve outcomes for minorities more significantly than for nonminorities, but they are seldom available in safety-net systems. We build on findings from Community Partners in Care (CPIC) and Building Resiliency and Increasing Community Hope (B-RICH). CPIC compared depression QI approaches across healthcare and social /community services in communities of color. CPIC included healthcare and “community-trusted” programs (e.g., homeless, faithbased) to work as a network to address depression, compared to individual-program technical assistance. In CPIC, both conditions improved mental wellness, mental health quality of life, and depression over 12 months. B-RICH, a randomized study, evaluated lay delivery of a seven-session, CBTinformed resiliency education class versus case management on patients’ depressive symptoms over three months, in unpublished but completed analyses. The proposed demonstration supplements the resiliency class with a mobile/interactive voice response case management tool to reinforce class content and depression care reminders (BRICH+).

 

Natural History of AIDS in Homosexual Men

Abstract: The UCLA Center of the Multicenter AIDS Cohort Study proposes to continue to document clinical, immunologic, physiologic, behavioral, virologic, genetic and psychosocial changes in HIV-infected and -uninfected men-who-have-sex-with-men (MSM). This includes proposed studies to document these changes in MSM recruited 1983-4 and 2001-2, as well as plans to recruit new untreated and recently treated HIV-infected MSM (primarily African- and Hispanic- Americans), to maintain the cohort. The UCLA MACS will provide leadership and participation in the working groups, MACS-wide and local studies and research publications, and collaborative multi-cohort studies, as it has since the inception of the MACS 30 years ago. The UCLA MACS has recruited a large team of young and established co-investigators from a wide range of disciplines. These investigators have developed, and are continuing to develop, innovative proposals to advance our understanding of the pathophysiology, immunology, genetics and biobehavioral characteristics of treated and untreated HIV infection. The breadth, youth, experience and innovation of the UCLA MACS investigators, combined with the experience and commitment of the long-term staff, and our leadership of quality control procedures for immunologic and virologic measures and specimen processing, will continue to play an invaluable role in the success of the MACS over the next five years.

Project Number: 5U01SI035040-25

STI Screening as a Combined HIV Prevention Platform for MSM in Peru

Abstract: Periodic counseling, testing, and treatment for rectal sexually transmitted infections (STIs) provides a multi- dimensional platform to integrate behavioral and biological HIV prevention strategies for men who have sex with men (MSM) in Peru. Rectal STIs like gonorrhea and chlamydia are key risk factors for HIV acquisition among MSM, both as indirect behavioral markers of recent unprotected receptive anal intercourse (URAI), and as inflammatory factors that increase cellular risk for HIV co-transmission. However, there have been no prospective studies of interventions addressing the specific behavioral and biological risk factors associated with rectal STI transmission or the potential impact on HIV transmission risk of integrating rectal GC/CT screening with other prevention services. We will use nucleic acid testing to screen 750 behaviorally high-risk MSM for rectal gonorrheal and/or chlamydial (GC/CT) infection. GC/CT-positive subjects will receive single-dose antibiotic treatment and either single-session Personal Cognitive Counseling (PCC) (n=50) or standard post-test counseling (n=50). A GC/CT-negative control group (n=50) will also be enrolled to compare biological outcomes including changes in levels of inflammatory cytokines following rectal STI. Aim 1: To adapt a Personalized Cognitive Counseling (PCC) model for use with MSM in Peru. Aim 2: To adapt and pre-test the SJEI and behavioral assessment instruments for use with MSM in Peru. Aim 3: To pilot a combined HIV prevention intervention based on rectal STI counseling, testing, and treatment for MSM in Peru. Estimates of feasibility/acceptability of the intervention, GC/CT prevalence/re-infection rate and the effect on behavioral and biological mediators of HIV infection will be used to plan an R01 evaluation of rectal STI surveillance as HIV prevention for MSM in Peru.

Project Number: 5R01MH105272-03

Assessing Willingness to Test for HIV among Men who have Sex with Men using Conjoint Analysis

Project Name: Assessing Willingness to Test for HIV among Men who have Sex with Men using Conjoint Analysis: Implications for Testing and Treatment for Prevention of HIV Transmission

Brief overview: Various HIV testing methods currently available all have advantages and drawbacks.  In order to increase consumers’ HIV testing uptake, identifying key attributes influencing willingness to test for HIV is critical. MSM have significantly lower rates of HIV testing than the rest of the US population, despite reporting similar rates of risk behaviors. This study used conjoint analysis to provide an empirical basis for determining strategies to increase HIV testing uptake among MSM in Los Angeles, thus contributing to the feasibility of the “test and treat” initiative in Los Angeles. PrEP

Targeted Risk Group: Men who have sex with men (MSM)

Geographical Location: Los Angeles, CA

Intervention Model:  Cross-sectional study assessing willingness to test for HIV using conjoint analysis

Research methods: From June 2011 to September 2011, 75 MSM aged 18 and over were recruited from the Los Angeles Gay and Lesbian Center (LAGLC) to participate in a one-time conjoint analysis exercise to gather information around their HIV testing preferences.  Each hypothetical HIV testing scenario (conjoint) consisted of specific combination of seven dichotomous attributes.  We found a broad range of willingness to test (WTT) for HIV scores across the eight hypothetical HIV testing scenarios (range: 32.33 – 80.33).  The HIV testing scenarios with the highest WTT score had the following attribute profile: test given at home, free, blood collection, results available immediately, anonymous, results can be given by phone, and counseling given in-person by a counselor.  The HIV testing scenario with the lowest WTT score had the following attribute profile: test given at home, costs $50, blood collection, result available in 1-2 weeks, anonymous, results given in person, and counseling information on a brochure with an option to call.  Three attributes had a significant impact on influencing MSM’s decision to get tested for HIV.  Price had the biggest impact (impact score=31.42), followed by timeliness of results (Impact score=13.91) and location (Impact score=10.25).  Impacts of other four attributes on WTT score were not statistically significant.

Local Significance: This pilot study provided a vital first step in providing population-specific data on willingness to test for HIV among MSM in Los Angeles.  The findings will be valuable in informing HIV testing research and policy communities on 1) consumer reactions to different attributes of HIV testing, 2) the design of social marketing campaigns to facilitate HIV testing uptake, and 3) the design of new HIV testing methods to ensure uptake.

Doxycycline Prophylaxis or Incentive Payments to Reduce Syphilis among HIV-infected Men Who Have Sex with Men

This pilot study will investigate the feasibility of conducting a large, randomized trial comparing a structural intervention to contingency management to reduce incident syphilis infections in an especially high risk group: HIV+ men who have sex with men (MSM) who have had syphilis twice or more since their HIV diagnosis. Subjects will be randomized to receive either QD doxycycline as syphilis prophylaxis or a financial incentive to remain STI free.

We will : 1) measure adherence to study visits in both arms; 2) measure adherence to the prophylaxis regimen; 3) measure any changes in risk behaviors among study participants and 4) to the extent possible in a small pilot study of short duration, compare effectiveness of doxycycline with that of a monetary incentive for remaining STI free.

Targeted Risk Group

 HIV+ men who have sex with men (MSM) who have had syphilis twice or more since their HIV diagnosis.

Intervention Model

Subjects will be randomized to receive either 1) Doxycycline, 100 mg. to be taken once daily or 2) an incentive for remaining STI free.

Local Significance 

Results of this study can be used to inform public health policy and programs to reduce risk of STI and HIV transmission among HIV+ “core transmitters,” and can also be easily extended to HIV negative MSM with repeated STIs. With the preliminary data from this study we hope to apply for further funding to support a larger, multisite definitive study incorporating one or both of the current interventions.

 

 

Comunidades Positivas “Positive Communities”

Also known as Prevention For Positives (P4P), this is a five-year, NIMH-funded study that tests two interventions  — one behavioral and one biomedical — to prevent HIV and STI (sexually transmitted infection) transmission among HIV- and/or STI-positive men who have sex with men in Lima, Peru.

This study evaluates two interventions carried-out simultaneously – one which is community-based and focuses on behavioral modification, and the other to improve access and service coverage for contacts of index cases for various sexually transmitted infections (STIs) – in order to prevent the transmission of HIV and STIs in Peru. Comunidades Positivas, the behavioral intervention, is designed to reduce the frequency of unprotected sex with non-primary partners. The biomedical intervention is designed to evaluate the effectiveness of enhanced partner therapy for incident STIs with the goal of reducing re-infection rates and therefore, incident STIs.

 

Assessing Sexual Social Networks of Black and Hispanic MSM/Ws in Los Angeles County

Nationally and locally Blacks and Latinos have the highest incidences of HIV/AIDS. When stratifying incidence by gender, Blacks and Latino women have higher rates of HIV infection compared to their White counterparts. A recent “mainstream” hypothesis for the rise in numbers among minority women is that Black and Latino men in concurrent secret sexual relationships with men and Black and Latina women are the “bridgers” of infection between the homosexual (MSM) community and the heterosexual community. Currently no scientific evidence of transmission trends supporting this hypothesis has been documented. Although inferences from surveys such as the Young Men’s Study have been proffered as proof, such studies do not show direct causation. Further, few scientific studies have analyzed the societal and cultural factors that could impact the decision of Black and Latino men to disclose their sexual practices or HIV seropositivity.

The research project involved a two phase mixed methods study (qualitative and quantitative) focusing on cultural, spiritual, racial and gender related factors that facilitate or impede the disclosure of Black and Latino men who have sex with men and women (MSM/W) of their sexual preference or HIV serostatus.

Phase 1 consisted of 9 focus groups with 4 participants each (n=36) and 12 focused interviews (n= 12). All interviewees completed a short survey after the focus group or interview. A racially concordant facilitator conducted each research session. Phase 2 utilized findings from Phase I to construct an ethnographic interview guide. Forty ethnographic interviews (10 African-American MSM/W, 10 Hispanic MSM/W and 20 of their adjacent or peripheral female sexual partners) were conducted.