View clinical trials related to HIV Prevention.
Filter by:Home HIV self-testing has been FDA approved and allows users to read their own HIV test results at home, while home sexually transmitted infection (STI) test self-collection allows men to use a swab at home and mail it in for testing. The purpose of this study is to learn how Men who have Sex with Men (MSM) use these new testing options, a set of online support tools, and the option to test with someone to support them (a testing "buddy"). We will also evaluate whether the online tools help these men to connect with HIV prevention services such as Pre-Exposure Prophylaxis (PrEP) if they test HIV negative, and to HIV care services if they test HIV positive.
To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement.
Investigators will conduct a two-arm, comparative effectiveness randomized controlled trial of two culturally adapted, empirically based programs (EBP) - Narrative Exposure Therapy (NET) vs. Motivational Interviewing with Skills Training (MIST) in terms of lowering HIV sexual-risk behaviors (HSB) for American Indian / Alaska Native (AIAN) men and women. NET addresses Posttraumatic Stress Disorder (PTSD) as a pathway to preventing substance use disorders (SUD) and HSB whereas MIST addresses substance misuse as a way of preventing SUD and HSB.
The purpose of this study is describe the safety and single-dose pharmacokinetics of rectally-administered IQP (ImQuest Pharmaceuticals)-0528 (DuoGel) in plasma, rectal tissue biopsies, vaginal tissue biopsies, rectal fluid and cervicovaginal fluid as well as to assess the luminal distribution of IQP-0528 in the rectum. Sixteen healthy volunteers will receive a single rectal dose of DuoGel, followed by blood, tissue and fluid sampling over the following 72 hours.
This is an open-label, steady-state study of Tenofovir (TFV) and Emtricitabine (FTC) pharmacokinetics (PK) in transgender women taking feminizing hormones. Half of the participants will be transgender women on feminizing hormones, the other half will be male volunteers not taking any hormone therapy.
The purpose of the study is to evaluating the acceptability, use and adherence of a pre-exposure prophylaxis (PrEP) program using the co-formulation tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg (TDF/FTC) administered daily by mouth, at four health facilities and one community-based organization providing health care services for MSM and transgender women. This is an Observational, longitudinal, multicenter, open-label study to evaluate the acceptability, use and adherence to TDF/FTC-based PrEP in volunteer men who have sex with men and transgender women at substantial high risk of acquiring HIV, who were prescribed for PrEP , following the clinical guidelines to prevent HIV infection of the U.S. Centers for Disease Control and Prevention (2014) and the World Health Organization (2015). Follow-up: Participants will be followed for 96 weeks (approximately two years) after the start of prophylactic treatment. Implementation Target Population: Adults (≥18 years of age), without HIV infection diagnosis, and who were prescribed with PrEP and have a substantial risk of acquiring HIV infection according to the international guidelines for HIV prevention. Sample Size: 1,000 participants Implementation Sites: 1. Asociación Civil Impacta Salud y Educación, Barranco study site 2. Asociación Civil Impacta Salud y Educación, San Miguel study site 3. Asociación Civil Selva Amazónica, ACSA study site 4. Asociación Vía Libre, Vía Libre study site 5. Espacio Común, Epicentro study site Primary Objectives: 1. Describing the acceptability and its socio-demographic and sexual behavior correlates for the use of PrEP. 2. Evaluate the persistence of the use of PrEP and its correlates with risk behaviors 3. Evaluating the adherence to the PrEP using self-reporting and pill counts Secondary Objectives: 1. Describing the changes over time in risky sexual behavior among study participants. 2. Describing the number of participants who acquire HIV infection. 3. Evaluate the deviation of the indication of use of PrEP through self- reporting of its sale or sharing with third parties.
Background: Human immunodeficiency virus (HIV) is a global health threat. The body uses antibodies to fight infection. VRC07-523LS is an antibody directed against HIV. It may be used to prevent mother-to-child transmission of HIV. It may also prevent sexual transmission of HIV and treat HIV-1 infected people. Objective: To test the safety, tolerability, dose, and pharmacokinetics of VRC07-523LS in healthy adults. Eligibility: Healthy people ages 18-50 Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Participants will be assigned to 1 of 7 groups: Groups 1-5 will get the drug at 1 visit and then be observed for 24 weeks. Groups 6 and 7 will get the drug at 1 visit every 12 weeks, for a total of 3 doses over 48 weeks. Participants will get the drug in 1 of 2 ways: Infusion into a vein over at least 30 minutes. Participants will have blood tests 1, 3, and 6 hours after the infusion. They will have 1-3 visits during that week. Those in Group 7 will have 4-5 visits in the week after their second and third doses. Injection into the fatty tissue under the skin. Participants will have blood tests before the injection. They will have 1-3 visits during that week. Those in Group 6 will have 4-5 visits after the second and third doses. Visits include: Physical exam Blood and urine tests Optional oral swabs to collect saliva Participants will keep a diary of their temperature and symptoms for 3 days after each dose.
This study has three specific aims: 1. To conduct a 2-arm randomized controlled trial comparing IMARA to a family-based health program (FUELTM). The investigators will: a. Randomly assign 300 14-18 year-old AA or black girls and their primary female caregivers to IMARA (N=150) or FUELTM (N=150). Women and girls will be recruited four ways: 1) from mental health clinics using clinic liaisons, 2) flyers will be posted in clinic recruitment sites and other agencies instructing interested families to call our recruiter, 3) IMARA participants will hand flyers to interested women and girls they know, and 4) COIP field station staff will pass out flyers and recruit interested women and girls at the field stations and in the community. Investigators will examine the effects of IMARA on women and girls' sexual behavior at 6- and 12-months. 2. To evaluate the impact of IMARA on theoretical mediators posited by the Theory of Gender and Power and the Social-Personal framework associated with AA women and girls' risky sex. Investigators will: 1. Assess changes in women and girls' Individual Attributes (HIV/AIDS knowledge, attitudes, and beliefs, mental health/emotion regulation, ethnic identity); Peer and Partner Processes (partner characteristics, relationship power dynamics, peer influences, partner communication); and Family Context (mother-daughter relationship and communication, parental monitoring) at baseline and follow-ups. 2. Evaluate mediation and moderation of theoretical mechanisms on women and girls' sexual behavior. 3. To assess the impact of IMARA compared to FUELTM on sexually transmitted infections (STIs). Investigators will: 1. Test women and girls' urine for three common STIs at baseline and 12-month follow up. 2. Explore linkages between biological outcomes and targeted mediators and moderators of change.
A follow-on, open label trial to assess continued safety of and adherence to the Dapivirine(25mg) vaginal ring-004 in healthy, HIV-negative women
PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel