Clinical trials: PrEP, open to volunteers
Breastfeeding, HIV Prevention
Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi
The goal of the Leveraging Infant Visit PrEP INtegration \& tasK Shifting to Improve Postpartum HIV Prevention in Malawi (LINK) study is to evaluate both the effectiveness of a postpartum prevention package ("LINK model") among…
- Trial name
- LINK (NCT06506188)
- Testing
- LINK model
- Where
- Malawi
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV, PrEP
Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services
The LYPS intervention is a multi-level intervention that combines: a) structural-level delivery of PrEP and PrEP services by a community health professional (CHP) at a designated place in the community being offered by the SC…
- Conditions
- HIV, PrEP, PrEP Adherence
- Trial name
- LYPS (NCT07438041)
- Testing
- LYPS, Enhanced Standard of Care
- Where
- 4 sites in United States
- Volunteers
- 272 people, healthy volunteers welcome
- Sponsor
- Westat
Cerebral Palsy (CP)
Metacognitive Strategy Training Intervention for Transition-Age Youth With Cerebral Palsy
This exploratory randomized controlled trial will examine the feasibility and preliminary effects of a remote PREP intervention compared to an attention control for transition-age youth with cerebral palsy and their caregivers.
- Trial name
- NCT07424079
- Testing
- Pathways and Resources for Engagement and Participation, Attention Control Condition
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Missouri-Columbia
HIV Infections
Getting to Zero Among HHI MSM in the American South
This study will evaluate a status-neutral integrated strategy to improve access to and uptake of HIV prevention and treatment services for the highest HIV incidence (HHI) men who have sex with men (MSM) in participating…
- Trial name
- NCT05075967
- Testing
- Health Access Coalitions, Social Media, Peer Support
- Where
- United States
- Volunteers
- 2,700 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
HIV Infections, Pregnancy Related
Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe
The purpose of this study is to develop a multi-level PrEP adherence and persistence intervention as an adaptation of the TENDAI ('grateful' in Shona) program, a problem-solving approach to reduce depression and increase HIV…
- Conditions
- HIV Infections, Pregnancy Related, Depression, Anxiety
- Trial name
- TENDAI4PrEP (NCT06226155)
- Testing
- TENDAI4PrEP, Enhanced treatment as usual
- Where
- Zimbabwe
- Volunteers
- 165 people
- Sponsor
- Massachusetts General Hospital
Sexually Transmitted Infections (STIs), HIV
Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain
Objective: To develop and validate a predictive model for acquiring sexually transmitted infections (STIs) in individuals using HIV pre-exposure prophylaxis (PrEP) within the national program providing this strategy.
- Conditions
- Sexually Transmitted Infections (STIs), HIV, PrEP
- Trial name
- STI_PrEPare (NCT06860945)
- Testing
- No Intervention: Observational Cohort
- Where
- 26 sites in Spain
- Volunteers
- 9,000 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario de Valme
HIV
The 'Comprehensive Adherence Resource and Empowerment Support' (CARES) Study
The primary aim of this study is to adapt the Comprehensive Adherence Resource and Empowerment Support (CARES) intervention to support adolescent girls and young women (AGYW) aged 16-24 in Zimbabwe and South Africa in effectively…
- Trial name
- CARES (NCT07666139)
- Testing
- Comprehensive Adherence Resource and Empowerment Support' (CARES)
- Where
- 2 sites in South Africa, Zimbabwe
- Volunteers
- 2,100 people, healthy volunteers welcome
- Sponsor
- RTI International
Hiv
Systems Analysis and Improvement Approach to Improve Integration of HIV Prevention and Treatment Services
East and Southern Africa is home to 6.2% of the world's population but includes 54% of all people living with HIV (PLWH). In this region, three out of five PLWH are women, and there is a particularly high burden of HIV amongst…
- Trial name
- FP HIV SCALE (NCT05404958)
- Testing
- Systems Analysis and Improvement Approach (SAIA)
- Where
- Kenya
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infection, Sexual and Reproductive Health
PrEPared to Choose (PtC) is an Implementation Study of the Delivery of Cabotegravir Long-acting, an Injectable Pre-exposure Prophylaxis (PrEP) Option for HIV Prevention. Injectable PrEP Will be Offered Alongside Oral and Vaginal Ring PrEP From Within a Real-world Context in Cape Town, South Africa.
The goal of this clinical trial is to offer adolescents and young people in Cape Town, South Africa different HIV pre-exposure prophylaxis (PrEP) products and describe how they use these products over an 18-month period.
- Trial name
- PtC (NCT06807736)
- Testing
- Cabotegravir long-acting, Tenofovir emtricitabine, Dapivirine containing vaginal ring
- Where
- South Africa
- Volunteers
- 1,800 people, healthy volunteers welcome
- Sponsor
- Desmond Tutu HIV Foundation
Pregnancy, HIV Infections
Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR
To evaluate adherence to a single dual-prevention pill (DPP) compared with a two-pill regimen (2PR) for pre-exposure prophylaxis (PrEP) and pregnancy prevention in women without HIV.
- Trial name
- NCT07288190
- Testing
- DPP, 2PR, Free Choice
- Where
- 3 sites in Eswatini, Uganda and 1 more
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
HIV Infections
Improving Access to PrEP (HIV Prevention Medication) for People in Underserved Areas of Rio de Janeiro
This study aims to improve access to HIV prevention using pre-exposure prophylaxis (PrEP) among underserved populations in Rio de Janeiro, including gay and bisexual men, transgender women, and sex workers.
- Trial name
- NCT07584122
- Testing
- Oral Pre-Exposure Prophylaxis (PrEP) (Tenofovir Disoproxil Fumarate/Emtricitabine), Community-Based PrEP Delivery Model, Telehealth and mHealth Support
- Where
- 2 sites in Brazil
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Oswaldo Cruz Foundation
Oral Pre-exposure Prophylaxis (PrEP), Long-acting Injectable Cabotegravir for PrEP
PathToScale: The PERSIST Trial
The purpose of this study is to identify the effectiveness of a bundle of strategies to support continuation of clients on pre-exposure prophylaxis, including long-acting injectable cabotegravir and oral pre-exposure prophylaxis…
- Trial name
- NCT07221747
- Testing
- Standard of Care (SoC), Enhanced continuation support package
- Where
- Malawi
- Volunteers
- 9,900 people, healthy volunteers welcome
- Sponsor
- Georgetown University
Hiv
PrEPARE-SCALE: Scaling up Integrated PrEP Delivery in Kenyan Maternal and Child Health Clinics
This project aims to develop a community of practice; then test a combination of community of practice, quality improvement, and a training toolkit, to enhance implementation and clinical outcomes; and identify patterns…
- Trial name
- NCT06526507
- Testing
- Implementation strategy package
- Where
- 5 sites in Kenya
- Volunteers
- 17,000 people
- Sponsor
- University of Washington
HIV
Integrating Supports to Promote PrEP for Black Adolescents Working With Apps- Alabama
This study applies Social Cognitive Theory to develop behavioral interventions promoting PrEP adherence. It seeks to adapt and test the enhanced HMP app for feasibility and acceptability among Black adolescents and young adults…
- Trial name
- NCT06876324
- Testing
- HealthMPowerment App
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Emory University
Burnout
Professional Readiness Through Emotional Preparedness (PREP)
The purpose of this study is to examine the impact of the PREP program on participants' psychological and occupational well-being, and work readiness
- Trial name
- PREP (NCT07472127)
- Testing
- Professional Readiness through Emotional Preparedness (PREP) program
- Where
- United States
- Volunteers
- 212 people, healthy volunteers welcome
- Sponsor
- AdventHealth
HIV
ALIGN: A Non-randomised Study Delivering Injectable Lenacapavir for HIV Prevention Within a Pre-exposure Prophylaxis (PrEP) Choice Context in Cape Town, South Africa.
The ALIGN study will evaluate the delivery of injectable Lenacapavir (LEN), a long-acting injectable formulation for HIV pre-exposure prophylaxis (PrEP), amongst adolescents and young people (aged 15-35 years) living within the…
- Trial name
- ALIGN (NCT07390409)
- Testing
- Lenacapavir Injection, Cabotegravir (CAB) LA, Tenofovi-Emtricitabine (TDF/FTC) tablet
- Where
- South Africa
- Volunteers
- 3,700 people, healthy volunteers welcome
- Sponsor
- Desmond Tutu HIV Foundation
HIV Infections, Sexually Transmitted Diseases
Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
The purpose of this study is to compare the effectiveness of two mobile health technologies (text messaging or a mobile app) designed to help people take HIV pre-exposure prophylaxis (PrEP) as directed by the clinic.
- Trial name
- PCORI PrEP (NCT04855773)
- Testing
- PrEPmate, Dot Diary
- Where
- 4 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
HIV Infections
Screen2Prevent (S2P)
Screen2Prevent is a study intended to improve HIV prevention and detection through implementation and evaluation of three different broad-scale HIV screening approaches a) targeted, b) universally offered opt-in, and c)…
- Trial name
- S2P (NCT07728123)
- Testing
- HIV screening strategies
- Where
- 5 sites in United States
- Volunteers
- 84,000 people, healthy volunteers welcome
- Sponsor
- Westat
HIV Preexposure Prophylaxis
The SwissPrEPared Study
Nested within the SwissPrEPared Program, the "SwissPrEPared Study" - a large, multicentric, nation-wide cohort study - aims to longitudinally follow individuals asking for PrEP prescription over a period of 3 years.
- Trial name
- NCT03893188
- Where
- 41 sites in Switzerland
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- University of Zurich
Depression, Posttraumatic Stress Disorder
Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa
Pregnant women in South Africa (SA) are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) use during pregnancy is both safe and effective in preventing HIV.
- Conditions
- Depression, Posttraumatic Stress Disorder, Pregnancy Related, Medication Adherence
- Trial name
- NCT05624931
- Testing
- Brief CBT-Based Intervention, Enhanced Treatment as Usual
- Where
- 2 sites in United States, South Africa
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Boston University Charles River Campus