Posts classified under: Biomedical

Battling Stigma for Service Engagement among Women with HIV in Vietnam

Abstract:Women living with HIV/AIDS (WLHA) bear a higher level of stigma because of their socio-cultural vulnerabilities. Women are more likely to internalize social stigma and produce a sense of shame and loss of self-worth, which results in a delay in health service seeking and compromised health outcomes. In Vietnam, stigma towards WLHA is exacerbated by the deeply rooted female inferiority culture. However, research targeting WLHA is generally lacking. We propose this study to address stigma among WLHA and explore the use of virtual support system in WLHA’s service engagement in Vietnam. The 2-year study will proceed in two phases in Hanoi, Vietnam. Phase 1 will be formative studies, including in-depth interviews with 30 WLHA and focus groups with 20 service providers and community stakeholders. This phase aims to investigate the cultural and contextual background of HIV and gender roles in Vietnam and to identify effective strategies to support and engage WLHA in healthcare. These formative findings will inform the development of an intervention to be pilot tested in the next phase. Phase 2 will be a 6-month intervention pilot with 90 WLHA using an online/offline hybrid approach. During Month 1 of the pilot, WLHA will participate in an in-person section to form mutual support groups and prepare for the following online components. During Month 2-4 of the pilot, study investigators will teach WLHA a series of empowerment strategies to cope with stigma and utilize social support to seek healthcare services. These skills will be taught via interactive online group activities. During Month 4-6, WLHA will self-administer the online groups without the intervention of study investigators. WLHA’s multidimensional stigma measures, mental health burdens, and service use self- efficacy will be assessed at baseline, month 4, and month 6. Progress data of the intervention will be documented to inform the feasibility and sustainability of the online support approach. Acceptability data and feedback will be collected from the WLHA participants upon completion of the 6-month pilot period.

Project Number: 1R21TW012018-01

https://reporter.nih.gov/search/9c5dRBJyvkGOpSB3l9HRSw/project-details/10302007

 

Contact PI/ Project Leader

LIN, CHUNQING,  (lincq@ucla.edu)

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

PUBLIC HEALTH RELEVANCE: HIV stigma and discrimination have enormous negative impacts on women, and reducing internalized stigma has significant implications for the effort to engage women in HIV prevention and care. This proposed study will devise strategies to empower women living with HIV in Vietnam to combat HIV and gender intersectional stigma. This study will lead to implementable and scalable approaches to promote women living with HIV’s mental health and service seeking not only in Vietnam but also globally.

 

 

Project Start Date: 17-September-2021

Project End Date: 31-May-2023

Budget Start Date: 17-September-2021

Budget End Date: 31-May-2022

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF DRUG ABUSE + FOGARTY INTERNATIONAL CENTER / FY Total Cost by IC: $219,421

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.

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

HPTN-077

Abstract: To evaluate the safety, tolerability, pharmacokinetics and acceptability of the injectable agent, GSK1265744 long-acting injectable (744LA), in healthy, HIV-uninfected men and women. It is a multi-site, double-blind, two-arm, randomized, placebo-controlled trial of the safety, tolerability, and acceptability of 744LA. HPTN-077 will study HIV-uninfected men and women at low to minimal risk for acquiring HIV infection, ages 18 to 65. of approximately 176 men and women, randomized 3:1, with 132 in the active drug arm, and 44 in the placebo arm. It is anticipated that approximately 60% of the enrolled participants will be women. Participants will be randomized to receive daily oral GSK1265744 (30 mg tablets) or daily oral placebo for 4 weeks, followed by a one-week washout, to assess safety and tolerability before they receive injections. After safety and tolerability assessments from the oral phase have been completed (if no concerns are identified), participants will enter the injection phase of the study and will receive two intra-muscular (IM) gluteal injections of 744LA (800 mg, administered as two 400 mg injections) or placebo (matching vehicle control) at three study visits performed at 12-week intervals.

Project Number: 5UM1AI068619-11

Multimodal Interventions to Improve Adherence to Oral Tenofovir/Emtricitabine as Pre-Exposure Prophylaxis in Women in Southern California

Abstract: Daily oral pre-exposure prophylaxis (PrEP) with tenofovir/emtricitabine (TDF/FTC) as part of a combination prevention package has been shown to be effective for HIV prevention in randomized control trials of MSM and heterosexual men and women at risk for HIV infection; however, some studies in African women have shown lack of efficacy that is believed to be in large part due to inadequate PrEP adherence. In addition, pharmacokinetic studies in women suggest that near-perfect adherence for TDF/FTC oral dosing may be more critical for protection against vaginal compared to rectal exposures. Taken together, these results imply that women may require substantially greater levels of adherence to oral TDF/FTC to effectively decrease HIV acquisition. Therefore, interventions to optimize adherence are particularly vital to maximizing the protective efficacy of PrEP for women. Although current FDA approval and CDC clinical guidelines for oral TDF/FTC as PrEP include at-risk women as candidates for use, limited clinical data exists on the use of PrEP in US women. Further research is needed to advance effective implementation, particularly taking into account the known challenges to achieving and maintaining high levels of adherence for women. In this demonstration project, we will evaluate adherence to, and acceptability of once-daily oral TDF/FTC as PrEP among HIV-uninfected women in Southern California who are at increased risk of HIV acquisition. Los Angeles and San Diego represent two of the top three counties in California of number of reported HIV/AIDS cases. In combination, they total over half of the number of HIV cases in the state supporting the need for ongoing prevention efforts in all at-risk populations (1). Working in tandem, the LAC PATH and CCTG partnership provides a unique opportunity to further collaborative research that has been fostered within the CHRP funding structure, capitalizing on the strengths of existing individual projects in MSM and transgender women.

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.

 

Friends Care I

The majority of new HIV infections across Los Angeles County continue to be found among men who have sex with other men (MSM).  Within MSM, stimulant abuse, particularly methamphetamine abuse, is the major factor in driving new infections, primarily via behavioral disinhibition contributing MSM methamphetamine users to engage in extremely high-risk sexual transmission behaviors.

Friends Care combines the biomedical intervention of Post-exposure Prophylaxis (PEP) for HIV prevention with the behavioral intervention Contingency Management (CM), which targets reduction of methamphetamine use as a way of reducing concomitant high-risk sexual behaviors for HIV-negative, methamphetamine-using MSM.

Friends Care will enroll 49 HIV-negative, methamphetamine-using MSM into the CM component of the dual intervention.  Participants receive a baseline assessment including urine analysis for the presence of methamphetamine metabolites, a rapid oral HIV antibody test, a physical examination including a comprehensive metabolic panel and complete blood count, HIV/STI prevention information, and medication adherence information.  Following baseline assessments, participants begin an 8-week, 3x/week, CM intervention and are given a 4-day starter pack of tenofivir with emtricitabine (i.e., Truvada).  Participants earn vouchers for methamphetamine metabolite-free urine samples, which are redeemable for goods and services.

In the event of an unexpected high-risk sexual exposure to HIV, i.e., unprotected anal intercourse with an HIV-positive or status unknown partner, participants are instructed to immediately call the clinic and begin the 4-dose starter pack of Truvada. An appointment with the physician is scheduled within 96 hours of the participant’s first dose of Truvada; participants then receive a second rapid oral HIV antibody test and are given the additional 24-day pack of Truvada. Participants return to the clinic at 3-months post baseline for a follow-up evaluation and a third rapid oral HIV antibody test.

In combining these two interventions in this unique program, Friends Care aims to reduce methamphetamine use and concomitant high-risk sexual behaviors, while reducing potential seroconversions.

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P-QUAD Study

PQUAD is a pilot project to evaluate the acceptability, safety, and feasibility of delivering community-based HIV post-exposure prophylaxis in diverse Los Angeles County communities. It is a joint venture of UCLA, the Los Angeles Office of AIDS Programs and Policy (OAPP), the Department of Public Health Sexually Transmitted Disease Program, AIDS Project Los Angeles (APLA), and pharmaceutical industry partners.

Originally conceived in December, 2007, P-QUAD is now operational at 2 sites in epicenters of the HIV epidemic in Los Angeles: The Los Angeles Gay and Lesbian Center (opened March 2, 2010 in the Hollywood/West Hollywood area of Los Angeles with a largely MSM catchment), and The OASIS Clinic (opened April 15, 2010 in the south central area of Los Angeles with a largely lower socioeconomic status, at risk African-American and Latino catchment). The study provides dual or triple-agent ART for 28 days as post-exposure prophylaxis for HIV infection to individuals exposed sexually or via injection-drug works sharing, when presenting within 72 hours of an appropriately high-risk exposure. Additionally, substance use, mental health, and behavioral risk reduction referrals/linkages are provided as appropriate. Efficacy, safety, adherence, tolerability and behavioral outcomes are being collected. In the event of seroconversions, longitudinal specimens are stored for virologic analyses.

The program currently is providing Truvada (tenofovir + emtricitabine), or Combivir (zidovudine + lamivudine) with or without Kaletra (ritonavir + lopinavir). An upcoming amendment will offer Isentress (raltegravir) as an alternative to Kaletra for intolerance. An IND has been filed with the FDA for the use of these agents in a non-FDA approved study context (IND # 104,989) and the study is overseen and all study documents approved by the UCLA Institutional Review Board. Since opening the program, the P-QUAD has enrolled 30 participants as of May 6, 2010 [29 at LAGLC and 1 at OASIS], with an initially planned enrollment of 100 participants (50 at each site).

Feasibility and Acceptability of PrEP and Non-occupational Npep for HIV Prevention in Los Angeles

This is a qualitative study of knowledge, attitudes, beliefs, and perceived barriers to implementation of biomedical prevention strategies among MSM in metropolitan Los Angeles, California. Three focus groups comprised of sixteen unique individual participants were conducted at the UCLA Center for Clinical AIDS Research and Education between April 2008 and June 2008. Additionally, five key informants were interviewed individually. Three interviews were performed face-to-face, and two were performed via telephone for participant convenience.

MSM in metropolitan Los Angeles were recruited via Craigslist (www.craigslist.com), newspaper/magazine advertising, and palm-card and flyer distribution at MSM-focused locations including bars, restaurants, dance clubs, and commercial sex venues. Twenty men responded to advertising and were scheduled for three focus group dates; 16 men presented for focus group participation. Key Informants were recruited on a first-responder basis from a master list of HIV providers and community based organization staff and activists who attend UCLA HIV-related symposia and events. Each participant (focus group and key informant) was compensated $20 for their time.

Interventions, Training Manuals, etc. :

Feasibility and Acceptability of PrEP and Non-occupational PEP for HIV Prevention - Final Study Report
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