Clinical trials: PrEP
HIV Prevention, HIV Infection Primary
Intervention to Enhance PrEP Persistence
The investigators will conduct a fully powered randomized controlled trial (RCT) to test the effect of a patient navigation intervention on PrEP initiation, adherence and retention in care.
- Trial name
- NCT06872307
- Testing
- RAMP-It-Up Initiation, Adherence, and Retention Intervention
- Where
- 3 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Brown University
HIV Infections, Viral Hepatitis B
Sexual and Reproductive Health (Including PrEP and HBV) for Female Sex Workers in Côte d'Ivoire
The PRINCESSE study will implement a comprehensive package of services in sexual and reproductive health for female sex workers in the region of San Pedro in Cote d'Ivoire, including screening, prevention and treatment for HIV…
- Conditions
- HIV Infections, Viral Hepatitis B, Sexually Transmitted Diseases, Contraception
- Trial name
- ANRS 12381 (NCT03985085)
- Testing
- Comprehensive package of sexual and reproductive health services
- Where
- Côte d’Ivoire
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Pre-exposure Prophylaxis
Optimizing PrEP Uptake for African American Women in the South by Empowering Women to Make Informed HIV Prevention and Sexual Health Choices
Pilot testing of EMPOWER, a group sexual health intervention, to increase uptake and persistence of PrEP
- Trial name
- EMPOWER (NCT07173816)
- Testing
- EMPOWER
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Georgia
HIV
PrEP Demonstration Project (PRELUDE Study)
Significant increases in HIV diagnoses among gay and other homosexually active men, in Australia and internationally, have been observed since the late 1990s.
- Trial name
- PRELUDE (NCT02206555)
- Testing
- emtricitabine/tenofovir disoproxil fumarate
- Where
- 5 sites in Australia
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- Kirby Institute
HIV, Prevention
Optimizing PrEP Regimens for Pregnant Women in Sub-Saharan Africa (O-PrEP Study) - Stage 1
This study aims: (1) to determine the optimal dose of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for daily oral pre-exposure prophylaxis (PrEP) during pregnancy based on drug pharmacokinetics, and (2) evaluate the…
- Conditions
- HIV, Prevention, Pregnancy
- Trial name
- NCT06435026
- Testing
- FTC/TDF 200mg/300mg, FTC/TDF 300mg/450mg, FTC/TDF 400mg/600mg
- Where
- 2 sites in Malawi, Zimbabwe
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Pre-exposure Prophylaxis Use
PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence
PrEP4U is designed as a pragmatic, randomized implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir.
- Trial name
- NCT07335289
- Testing
- Choice of follow up, Follow up via standard clinic
- Where
- 2 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
HIV Infections, STI
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
The goal of this clinical trial is to test the efficacy of a mobile app, Combine, to increase the uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP) over 24 months and to assess the effects of different…
- Conditions
- HIV Infections, STI, HIV Pre-exposure Prophylaxis
- Trial name
- CombineApp (NCT06205368)
- Testing
- Combine mobile app, Motivational interview, HIV/STI testing
- Where
- United States
- Volunteers
- 473 people, healthy volunteers welcome
- Sponsor
- Emory University
HIV/AIDS
The Prevention Options for Women Evaluation Research (POWER) Cohort
The POWER Cohort study is a PrEP implementation project to demonstrate Pre-exposure prophylaxis (PrEP) delivery for young women in Cape Town and Johannesburg, South Africa and Kisumu, Kenya.
- Trial name
- NCT03490058
- Testing
- Truvada
- Where
- 3 sites in Kenya, South Africa
- Volunteers
- 2,255 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infection
Factors Affecting PrEP Adherence
The purpose of this study is to test a new way to take a questionnaire that asks about adherence (whether the person is taking the medicine correctly). This new questionnaire is called Interactive Questionnaire System (iQS).
- Trial name
- NCT02411630
- Testing
- Emtricitabine/tenofovir disoproxil
- Where
- 12 sites in United States
- Volunteers
- 167 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections
SEPA+PrEP-Women Pilot Trial for HIV Prevention Among Women at Risk for HIV
The purpose of this randomized pilot trial is to evaluate the preliminary efficacy of SEPA+PrEP-Women (Salud/Health, Educación/Education, Prevención/Prevention, Autocuidado/Self-Care plus Pre-Exposure Prophylaxis [PrEP]).
- Trial name
- NCT07864766
- Testing
- SEPA+PrEP Women
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University of Miami
Acne Vulgaris
Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate Acne
The objectives of this study were to evaluate the efficacy and safety of drospirenone 3 mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with moderate acne vulgaris during 6 treatment cycles
- Trial name
- NCT00656981
- Testing
- YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
- Where
- 22 sites in United States
- Volunteers
- 541 people, healthy volunteers welcome
- Sponsor
- Bayer
Acne Vulgaris
Evaluate Safety and Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne.
The objectives of this study were to evaluate the efficacy and safety of drospirenone 3 mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with moderate acne vulgaris during 6 treatment cycles.
- Trial name
- NCT00651469
- Testing
- YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
- Where
- 27 sites in United States
- Volunteers
- 534 people, healthy volunteers welcome
- Sponsor
- Bayer
HIV Infections
A Peer-Driven Intervention to Increase PrEP Uptake Among Minority MSM
The objective of this study is to develop an effective peer-driven intervention (PDI) approach and assess its feasibility and efficacy on pre-exposure prophylaxis (PrEP) uptake among men who have sex with men.
- Trial name
- NCT05161663
- Testing
- Peer-driven intervention
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- The Miriam Hospital
HIV
SEARCH SAPPHIRE Phase B
This study will evaluate the effects of optimized dynamic prevention and treatment packages delivered in a precision community health model on HIV incidence, as well as other health outcomes, in a community randomized trial…
- Trial name
- NCT05768763
- Testing
- Community-enhanced reach activities, Person-centered care delivery, Data system enhancement to improve reach and person-centered delivery
- Where
- 2 sites in Kenya, Uganda
- Volunteers
- 81,952 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV Preexposure Prophylaxis
A Promotion and Implementation Project of HIV Pre-Exposure Prophylaxis Among High Risk Population
This study aims to use a social media mini-application-enabled intervention to successfully promote the initiation and persistence of pre-exposure prophylaxis (PrEP) among at-risk people 18 years and above (including men who have…
- Trial name
- NCT04754139
- Testing
- WeChat mobile mini-application
- Where
- 2 sites in China
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- University of Chicago
HIV Prevention
Pharmacy Delivery to Expand the Reach of PrEP in Kenya
3 consecutive studies to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery.
- Trial name
- NCT04558554
- Testing
- pharmacy-based PrEP delivery
- Where
- 2 sites in Kenya
- Volunteers
- 1,216 people, healthy volunteers welcome
- Sponsor
- University of Washington
Hiv
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women
To reach HIV-uninfected pregnant and breastfeeding women in South Africa, who are at very high risk of HIV, researchers will test a new and innovative package of interventions: 1) pre-exposure prophylaxis (PrEP), which is a daily…
- Trial name
- SCOPE-PP (NCT05322629)
- Testing
- PrEP adherence biofeedback, Standard of care counseling
- Where
- South Africa
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
HIV Infections
PrEP Seguro: Antiretroviral-based HIV Prevention Among Men at High Risk in Mexico
The objective of this R34 application is to prepare for testing innovative user-centered ways to promote PrEP adherence at scale.
- Trial name
- NCT03674983
- Testing
- Conditional Economic Incentive (CEI)
- Where
- Mexico
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Brown University
HIV, Substance Use
Couples Health CoOp Plus
This study addresses HIV prevention and treatment for young couples living in Cape Town, South Africa, through a comprehensive biobehavioral multilevel approach-the Couples Health CoOp Plus (CHC+).
- Conditions
- HIV, Substance Use, Stigma, Social
- Trial name
- CHC+ (NCT05310773)
- Testing
- Community Stigma Awareness and Education Workshop, Couples Health CoOp Plus (CHC+)
- Where
- South Africa
- Volunteers
- 962 people, healthy volunteers welcome
- Sponsor
- RTI International
Misinformation, Lenacapavir
Protecting Against Lenacapavir Misinformation With Young Women in Gauteng, South Africa ( PROTECT-L)
Adolescent girls and young women (AGYW) in South Africa remain disproportionately affected by HIV, with prevalence among 15-24-year-olds at 9.4% in 2024 despite expanded access to condoms, HIV testing, and oral PrEP.
- Trial name
- PROTECT-L (NCT07518914)
- Testing
- Diabetes information, Enhanced inoculation message
- Where
- South Africa
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania