
HIV Prevention Among Latina Transgender Women Who Have Sex With Men: Evaluation of a Locally Developed...
HIV InfectionsWake Forest University and its partners, Triad Health Project, and the University of North Carolina, Greensboro, will be evaluating the effectiveness of ChiCAS (Chicas Creando Acceso a la Salud or Girls Creating Access to Health), a locally developed, Spanish language small group behavioral intervention that promotes access to and participation by Hispanic/Latina transgender women who are HIV negative and who have sex with men in pre-exposure prophylaxis (PrEP), medically supervised hormone therapy, and consistent condom use.

DASH - Decision Making in Adolescent Sexual Health
HIV/AIDSThis is a randomized controlled trial to contrast an intervention that relies on well-developed cognitive control systems (Motivational Interviewing; MI) to an intervention that relies on a more basic response to scheduled reward (Behavioral Skills Training; BST).

Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in Adolescents
HIV InfectionsTruvada (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF) is a type of antiretroviral (ARV) medicine that is commonly used to treat HIV. Truvada is also used as pre-exposure prophylaxis (PrEP) to prevent HIV infection in HIV-negative adults. The purpose of this study is to evaluate the acceptability, safety, and use of daily Truvada PrEP as part of a comprehensive HIV prevention package in healthy, HIV-uninfected adolescents 15 to 19 years of age.

Demonstrating Safety and Effective Delivery of Daily Oral Pre-exposure Prophylaxis (PrEP) for Sex...
HIV InfectionFemale sex workers (FSWs) in India are at high risk of HIV infection, and while correct and consistent condom use is an effective means of preventing HIV transmission, many FSWs have difficulty insisting on their use. Alternative HIV prevention options are needed for FSWs who are unable to correctly and consistently use condoms with their clients or regular partners. Oral pre-exposure prophylaxis (PrEP) may be an important tool to fill this critical prevention gap, and a demonstration project is required to assess the impact and feasibility of the use of PrEP as an HIV prevention intervention among most at risk FSWs in India. The proposed project will take place at two sites in India and will assess the use of a risk assessment tool to identify FSWs who would most benefit from PrEP, collect information about the reasons why FSWs choose to accept or decline PrEP, evaluate two different PrEP delivery strategies (weekly clinic pick-up or home delivery by peer educators every second day), monitor adherence to and discontinuation of PrEP, and evaluate unintended consequences of the use of PrEP in these communities (e.g. reduction of condom use, drug side effects or adverse events, social harms or resistance). To ensure the safety of study participants, a community advisory board will be set up and will meet regularly to inform study staff of any concerns that the community may have related to the study, so that the study staff can respond in a timely manner. A data safety and monitoring board will also be established to monitor participant safety.

Evaluating the Safety and Immune Response to Different Combinations of the DNA-HIV-PT123 and AIDSVAX®...
HIV InfectionsThis study will evaluate the safety, tolerability, and immune response to different combinations of two experimental HIV vaccines-the DNA-HIV-PT123 vaccine and the AIDSVAX® B/E vaccine-in healthy adults who are not infected with HIV.

PRO 140 for Human Immunodeficiency Virus Infection
HIVPRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female adult subjects infected with CCR5-tropic HIV-1.

Economic and Social Empowerment To Increase Upwards Mobility Among Women
Sexually Transmitted InfectionsHuman Immunodeficiency VirusThe proposed research aims to pilot a multi-strategy structural intervention combining community mobilization to promote gender equity alongside an economic intervention (microfinance and business training) in order to reduce gender-based violence and HIV risk among female sex workers (FSW) in Tijuana, Mexico. The program will be called ESTIMA: "Economic and Social Empowerment To Increase Upwards Mobility Among Women." The evaluation will employ a randomized controlled design, recruiting FSW (n=120, 60 in each arm) who will be randomized to: 1) ESTIMA (gender equity/community mobilization program and economic intervention) or 2) a wait-list control group. For this preliminary work, at 12 months follow-up, we hypothesize that compared to control participants, intervention participants will have: 1) significantly greater economic security (e.g. decreased debt, increased income, decreased number of sex trades) and 2) significantly greater perceived collective power (i.e. collective efficacy) to address gendered power imbalances within social structures and the community. The long-term goal of this program, upon future refinement and large scale implementation, is to reduce HIV risk behaviors, STI/HIV, GBV, and ultimately, alleviate a multitude of health burdens among women. Furthermore, we expect that such work will highlight the need for HIV prevention initiatives in Mexico, and elsewhere, to more broadly consider women's 'life contexts' - addressing economic and social burdens in women's lives, to reduce the burden of poverty, gender, and HIV, as well as the intersection of these among women.

Safety and Immunogenicity Study of SeV-G(NP) HIV Vaccine Administered Intranasally and Ad35-GRIN...
HIV InfectionsThe purpose of this study is to evaluate the safety, tolerability and immunogenicity of Sendai HIV vaccine SeV-G(NP) given intranasally and Ad35-GRIN administered intramuscularly in prime-boost regimens in HIV-uninfected, healthy adult volunteers.

Behavioral Intervention to Enhance HIV Test/Treat
HIV/AIDSPrevention strategies that aim to test and treat people for HIV infection are undermined by HIV treatment non-adherence and sexually transmitted co-infections (STI). The proposed study will test a theory-based behavioral intervention to reduce HIV infectiousness by simultaneously improving HIV treatment adherence and reducing sexually transmitted co-infections in people living with HIV-AIDS who use alcohol and other drugs. The intervention is delivered in a single office-based counseling session followed by 4 cell phone delivered counseling sessions in a model that will be ready for immediate dissemination to case management and clinical services for people living with HIV/AIDS in resource constrained settings.

An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among...
HIV InfectionApproximately 100 HIV-uninfected YMSM at high risk of acquiring HIV infection, between the ages of 15 and 17 inclusive will be enrolled across all participating Adolescent Medicine Trial Units (AMTUs). Subjects will complete the behavioral intervention selected by all participating sites, Personalized Cognitive Counseling (PCC), and will then be provided with open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as pre-exposure prophylaxis (PrEP). Behavioral and biomedical data will be collected at baseline and at 0, 4, 8, 12, 24, 36 and 48 weeks. Any subject who becomes HIV infected during the course of the study will be discontinued from the study agent and be followed for an additional 24 weeks after the study visit at which HIV infection is confirmed. Those subjects who meet specific bone or renal criteria at the Week 48 visit or the 24-Week HIV Seropositive visit will be followed for an additional 48 weeks in the Extension Phase to monitor longer-term outcomes of potential concerns.