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.

Text Me, Girl! – Text Messaging to Improve Linkage, Retention and Health Outcomes among HIV-positive Young Transgender Women

Abstract: Young trans women experience a number of psychosocial challenges including discrimination, prejudice, stigmatization, and social/economic marginalization, which stand as obstacles to linkage and retention in HIV care and ART medication adherence. Due to these challenges, and their often transient nature, a text-messaging HIV intervention that is easily accessible, culturally competent, private and portable is a particularly salient method for engaging and retaining young trans women in HIV care. This project utilizes a text-messaging intervention to improve engagement, retention, and health outcomes along the HIV Care Continuum, with the desired outcome of viroligical suppression, among HIV-positive young trans women, aged 18-34, who are not linked to care, or not retained in care, or not prescribed ART, or nonadherent to ART, or not virologically suppressed. Over the course of the 90-day intervention, participants receive 270 theory-based text messages that are targeted, tailored, and personalized specifically for HIV-positive young trans women; participants receive three messages per day in real-time within a 10-hour graduated and automated delivery system. The text-message content is pre-written along the HIV Care Continuum (i.e., HIV positivity/physical and emotional health, linkage/retention in care, ART adherence/viral load suppression) and is based on three proven theories of behavior change (i.e., Social Support Theory, Social Cognitive Theory, and Health Belief Model). Following screening for eligibility, informed consent, and baseline assessment, participants are randomized into one of two conditions: Group A: Immediate Text Message Intervention Delivery (ID, n=60); or, Group B: Delayed Text Message Intervention (DD, n=60) whereby participants are delivered the text-messaging intervention after a delayed 90-day period. Participants in both groups receive the exact same 90-day text-messaging intervention. Following the 90-day theory-based, trans-specific text-messaging intervention, participants may opt in/opt out of continued weekly post-intervention messages for ongoing retention and engagement support derived from the HRSA-funded UCARE4LIFE library. The randomized two-group repeated measures design assesses participants at 3-, 6-, 12-, and 18-months post-randomization to determine observed intervention effects and longitudinal intervention effects.

The Alexis Project

Abstract: Trans women of color experience a number of psychosocial challenges including discrimination, prejudice, stigmatization, and social/economic marginalization, which stand as obstacles to HIV care and other needed services. The Alexis Project* employs a multi-tiered, comprehensive approach, which includes network, individual and structural components to identify, recruit, test, link, treat and retain trans women of color into quality HIV care. The Alexis Project incorporates three proven models, Social Network Recruitment (network), Peer Health Navigation (individual) and Contingency Management (structural), into one multi-leveled project to optimize HIV health outcomes for trans women of color. Through Social Network Recruitment, local trans women recruit trans women of color from their social, sexual and drug-using networks into the project for either testing (HIV unknown status) or (for those who are aware of their HIV infection but not in care) to the combined Peer Health Navigation and Contingency Management intervention. Over the five-year study, 139 trans women of color will enroll in the combined Peer Health Navigation and Contingency Management intervention.  The project goals are: 1) to identify trans women of color who are unaware of their HIV-positive status and identify trans women of color who are already aware of their HIV infection but have never been engaged in care or have refused a referral to care or have dropped out of care; 2) to directly link HIV-infected trans women of color to a Peer Health Navigator; 3) to link HIV-infected trans women of color to quality HIV care; 4) to work with HIV-infected trans women of color to address the barriers in their life that limits or impedes their access to HIV care; and, 5) to retain HIV-infected trans gender women of color in HIV care to reach and sustain HIV milestones. Peer Health Navigators work with participants to identify HIV care services and other needed services, develop a specific client-centered treatment plans, remove barriers to those services and access those services. Contingency Management provides increasing valuable incentives for attending HIV medical visits and reaching and sustaining HIV milestones.

Hours: Weekdays, 10:30 a.m. to 7:00 p.m.

Contact: 323-793-4645 or 323-512-7014

Funding Source: This project is funded by the Health Resources and Services Administration (HRSA) and sponsored by Friends Research Institute, Inc.

https://www.friendscommunitycenter.org/alexis-project

*The Alexis Project is named after Alexis Rivera who died on March 28, 2012, at the age of 34, from complications related to HIV. Alexis was a proud Latina trans woman; a community activist, a peer advocate and a gatekeeper.

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.

HPTN-083

Abstract: Cabotegravir LA (CAB LA) is a long-acting injectable integrase inhibitor, also known as GSK 1265744 LA or 744 LA. This is a Phase 2b/3 study designed to establish the efficacy of CAB LA for pre-exposure prophylaxis (PrEP) in HIV-uninfected men who have sex with men (MSM) and in transgender women (TGW). Small single-dose and multiple-dose studies and Phase 2a safety/tolerability studies have been performed for CAB LA. This PrEP efficacy study is the next developmental investigation of CAB LA in healthy, HIV-uninfected MSM and TGW. CAB LA is the first antiretroviral (ARV) drug being studied as an intervention for HIV prevention prior to regulatory approval of the drug for HIV treatment. A parallel development program for use of cabotegravir (oral and injectable) for treatment of HIV-infected individuals is currently in Phase 2b studies with a salutary safety and efficacy profile to date.

To enroll in HPTN-083, click here for more information.

Project Number: 5um1ai068619-11

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

Hep-Safe Hollywood

Homeless, stimulant-using gay/bisexual men and transgender women are at high risk for hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV infection due to high rates of injection drug use and high-risk sexual behaviors. Thus, use of stimulants threatens to intensify homeless persons’ risk of exposure to hepatitis B, C viruses and HIV; therefore, research focused on this group is critical. A contingency management (CM) intervention may be particularly well suited for this high-risk population. CM is an intervention that attempts to modify a targeted behavior by providing incentives for changing that behavior (in simple terms, positive reinforcement). CM interventions have been successfully implemented among stimulant-using gay and bisexual men to reduce drug use and concomitant sexual risk behaviors.

The Hep-Safe Hollywood study will implement a CM intervention to increase successful HAV/HBV vaccination completion programs among homeless, stimulant-using gay/bisexual men and transgender in Hollywood. This randomized, control trial will assign 500 homeless, stimulant-using gay and bisexual men to either an enhanced nurse case managed program, which includes specialized education and CM, or a standard program, which includes brief education and CM. This study is innovative in that it will allow us to look at the effect of an enhanced nurse case management and CM program versus a standard brief education and CM program. The study will evaluate the effectiveness of homeless, stimulant-using gay/bisexual men and transgender women on completion of the HAV/HBV vaccine and, secondarily, on reduction of risk for hepatitis and HIV. Additionally, the study will assess the relative cost of these programs in terms of completion of the vaccine series. The study combines best strategies to approach, engage and intervene with this hidden and high-risk population and to assess the feasibility and efficacy of interventions that may prove beneficial in preventing hepatitis A, B, C and HIV infections.

This study is a collaboration between UCLA School of Nursing and Friends Research Institute, with Dr. Adeline Nyamathi, as the principal investigator.

 

The TransAction Program

Many male-to-female transgender women are at high-risk of HIV infection as a result of several socio-cultural conditions, such as low income, high unemployment, lower levels of education, and unstable housing. Economic necessity, as a result of severe unemployment and housing discrimination, results in a reliance on sex work to secure food, shelter, and money.

The TransAction Program provides culturally appropriate, evidence based HIV prevention services that address both individual and socio-cultural risk factors. The program offers a multi-tier health education and risk reduction (HE/RR) intervention – utilizing both individual and group-delivered interventions – designed to reduce high-risk sexual and drug behaviors among transgender women. Most specifically the intervention target risk behaviors that are specific to the socio-cultural circumstances of high-risk transgenders, particularly exchange sex, hormone misuse, injection and non-injection drug risks. The program consists of a comprehensive, culturally appropriate, continuum of services that includes outreach encounters, individual-delivered interventions (IDI), skills building group-delivered interventions (GDI) and support groups.

Follow-up IDI assessments are conducted at 30, 60 and 90 days. Face-to-face street outreach is conducted in identified high-risk areas of Hollywood, West Hollywood and downtown Los Angeles and in the natural settings where high-risk transgender women congregate. The skills building GDI component of the intervention serves to increase knowledge and awareness of HIV risk behaviors and develop skills to decrease HIV risk behaviors. Concurrently, the support GDI component of the intervention serves to increase social support and self-esteem. Both the skills building GDI and support GDI – working concomitantly with the outreach encounters and IDI – motivate ongoing and maintained HIV risk reductions and gear participants’ towards HIV testing to identify their HIV status and, finally, develop skills for disclosing HIV status.

The TransAction Skills Building Groups

HIV Counseling & Texting Program

The HIV Counseling and Texting (HCT) program utilizes social networks testing methodology, specifically designed to work with HIV infected and high-risk gay and bisexual men of color and transgender women. HIV infected or high-risk negative participants who either come to the Friends Community Center site for services or are contacted through street outreach and meet eligibility are invited to serve as recruiters. The engagement of new recruiters will be an active and ongoing part of the program. Potential recruiters attend a group orientation, which explains the social network methodology and informs potential recruiters that they will be requested to recruit individuals from their social, sexual or drug-using networks whom they believe to be at high-risk of HIV infection. Following the training period (brief identification, group orientation, individual interview), the recruiter begins to locate network associates to be referred to our testing site. Confirmatory HIV tests and STI testing (syphilis, Chlamydia, gonorrhea) are also available at the Friends Community Center site. Participants (both those who test HIV negative and positive) are then linked to appropriate medical, social, psychological, CRCS and other needed services. Network associates who wish to become recruiters are be assessed for eligibility and appropriateness.

This program is funded by the Los Angeles County, Department of Health Services, Office of AIDS Programs and Policy (OAPP).