
Pharmacokinetic Study of the Dapivirine Vaginal Ring in Lactating Women
Human Immunodeficiency VirusPhase 1 PK Study of the Dapivirine Vaginal Ring in Lactating Women.

Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine
HIV InfectionsThe purpose of this study is to evaluate the safety and immune response to an HIV clade C vaccine and to an MF59- or alum-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.

iSTEP - an mHealth Physical Activity and Diet Intervention for Persons With HIV
HIV/AIDSHIV is associated with a pattern of neurocognitive deficits, metabolic dysfunction, and an elevated risk for cardiovascular disease (CVD), phenomena that remain untreated despite the use of medications to control the disease. This proposal will examine the effect of a personalized, automated, interactive mobile phone text message intervention (iSTEP) designed to increase moderate physical activity (PA), decrease sedentary behavior (SB), and promote a healthy Mediterranean-style diet (MedDiet) in persons living with HIV (PLWH). The investigators propose that participants who receive the iSTEP intervention will increase the amount of physical activity, improve their diet, show a reduction in risk factors for CVD, and exhibit improved neurocognitive performance.

Development of a Tailored HIV Prevention Intervention for Young Men
HIV InfectionsThis study uses an interactive design and development process to develop tailored messages that align YMSM's relationship experiences and desires with HIV prevention strategies. The study includes a tailored online prevention, intervention, as well as an attention control non--tailored HIV prevention (NTHP) comparison intervention. The pilot RCT will compare the intervention (N=120) to NTHP (N=60) to assess intervention feasibility and acceptability, and gather preliminary behavioral data to inform a subsequent application. Follow-up assessments will be collected at thirty (30), sixty (60), and ninety (90) days post-intervention.

Addressing Overdose Risk Among Recently Incarcerated People Living With HIV/AIDS
Drug Overdose AccidentalThe overall objective of this study is to evaluate an educational overdose prevention intervention's effectiveness among incarcerated people living with HIV/AIDS, specifically within the context of other outcomes related to health and experiences after incarceration. Results will be used to develop tailored interventions to reduce overdose deaths among high-risk correctional populations. The research has the following aims: Aim 1: Evaluate a pilot program to provide HIV+ inmates with 1:1 overdose prevention training while incarcerated; Aim 2: Identify the criminal justice, health, and HIV-related factors associated with overdose risk; and Aim 3: Describe the overdose risk experiences of HIV+ former inmates who use opioids after release.

Using CBPR to Reduce HIV Risk Among Immigrant Latino MSM
HIV/AIDSThe intervention is based on social cognitive theory and theory of empowerment education and was developed using community-based participatory research (CBPR). This study is a result of a long-term community-university partnership that has used and will continue to use CBPR throughout all phases of research. A total of 21 Latino MSM in rural NC have been screened and recruited to serve as LHAs. The CBPR partnership selected LHAs based on qualities of natural helpers and informal leaders and having existing social networks of other Latino MSM. Eight members of each LHA's social network have been screened and recruited to participate as well. The LHAs, coupled with their social networks, have been randomized to intervention or delayed-intervention groups. LHAs (n=11) in the intervention group were trained and serve as LHAs within their social networks in Year 2. Delayed-intervention LHAs (n=10) receive the same LHA training and serve as LHAs within their social networks in Year 3. Quantitative assessment data is collected from each LHA (n=21) and the 8 members of his social network (n=189) longitudinally at: (1) baseline, (2) immediate post-intervention, and (3) 12-month follow-up. This is an "intent-to-treat" study, in which participant data are analyzed based on their randomization group. The investigators hypothesize that participants in the HIV prevention intervention, relative to those in the delayed intervention comparison group, will demonstrate (1) increased self-reported use of condoms during sexual intercourse and (2) increased self-reported HIV testing. The results and products from this study will be disseminated to inform public health practice, research, and policy. Results and products will include: (1) a Spanish-language intervention that is: culturally congruent and gender-specific; designed to reduce HIV risk among Latino MSM; and ready for dissemination and adaptation; (2) a deeper understanding of HIV risk and intervention among Latino MSM; and (3) insight into a CBPR process that includes community members, organizational representatives, and academic researchers.

Safety and Pharmacokinetic Study of Oral Maraviroc and Maraviroc 1% Gel in HIV-1 Seronegative Adults...
HIV/AIDSThe purpose of the study is to evaluate the safety, acceptability, and PK/PD profile of maraviroc gel following rectal and vaginal administration. The study also includes oral exposure to maraviroc.

The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis...
HIV InfectionsPre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV. This study will examine the feasibility of different methods of dosing for a PrEP regimen. Three methods of delivery will be compared: daily, time-based, and event-based.

A Randomized Controlled Trial of the Bruthas Project
HIV InfectionAfrican American men who have sex with men and women (AAMSMW) are at particular risk for contracting and transmitting HIV, and represent a priority population for developing effective interventions. Despite the urgent need for effective prevention approaches for AAMSMW, to our knowledge no evidence-based HIV interventions have been developed and tested for this population. This study is a randomized controlled trial of the Bruthas Project(BP), an individual-level HIV prevention intervention, which builds on standardized HIV counseling and testing. Delivered in a series of four sessions by trained African American male counselors, the BP focuses on reviewing HIV transmission routes for male and female partners, strengthening sexual communication skills with both male and female partners, and improving condom use skills and other safer sex negotiation strategies. A randomized controlled trial of BP is necessary to determine the efficacy of the intervention and can lead to improved public health efforts at reducing HIV risk behavior among AAMSMW and in the African American community more generally. To evaluate the effect of the BP, the investigators will recruit and enroll a cohort of 400 AAMSMW who will be randomly assigned to either the intervention condition, in which they will be offered BP, or to the comparison condition, in which they will receive standardized HIV testing and counseling with referral to case management. The investigators will follow the cohort over 9 months and will assess participants at three time points: baseline, 3 months follow-up, and 6 months follow-up.

Study in Healthy Volunteers of the Safety and Metabolism of Different Doses of the Anti-HIV Drug...
HIV InfectionTMC278 (also called rilpivirine) is a new drug being developed to treat HIV. Usually TMC278 is taken as a tablet, by mouth, once a day, but a 'long acting' formulation has been developed so the drug stays in the bloodstream for a longer time - this allows the drug to be given by injection and less often. It is hoped that this injectable version of the drug may be used to help prevent HIV transmission in the future by giving it to people who are at risk of HIV. This is similar to the way travellers to areas with malaria may take antibiotics to prevent infection. The investigators aim to investigate the feasibility of using TMC278 as a preventative medication by performing this study. The purpose of this study is to investigate the levels of drug which can be measured in the blood, as well as the tissues and fluids of the rectum (the lowest part of the bowels just before the opening of the anus) as well as the safety of the drug and how well tolerated it is when given as a single dose. In this study, the investigators will not be investigating whether the drug prevents HIV so the investigators will recruit people who are HIV negative, and whose lifestyle does not put them at risk of becoming infected before or during the study. If the study shows the drug is well tolerated and produces appropriate levels of the drug (in the bloodstream and the rectal compartment) to suggest that it could be effective, it will help design future studies looking at preventing HIV.