Clinical trials: PrEP
PrEP Adherence Monitoring
IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project
The overall aim of this study is to assess attitudes toward PrEP, feasibility of Truvada PrEP procurement through the established access procedures, and adherence to Truvada PrEP among US women at risk for HIV acquisition.
- Trial name
- NCT03058835
- Testing
- tenofovir disoproxil and emtricitabine
- Where
- 4 sites in United States
- Volunteers
- 162 people, healthy volunteers welcome
- Sponsor
- Rutgers, The State University of New Jersey
IPV, HIV
Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health
This study will test the effectiveness of a youth-designed multilevel intervention, Tu'Washindi, to increase PrEP use and reduce intimate partner violence (IPV) among Kenyan AGYW and to identify implementation challenges and…
- Conditions
- IPV, HIV, PrEP
- Trial name
- NCT05599581
- Testing
- Tu'Washindi
- Where
- 2 sites in Kenya
- Volunteers
- 1,562 people, healthy volunteers welcome
- Sponsor
- RTI International
HIV, PrEP
Bringing Medicines for HIV Prevention to a Family Planning Clinic
The goal of this clinical trial is to understand what patients and physicians think about providing medications to prevent HIV transmission to patients in a family planning clinic.
- Trial name
- NCT06930508
- Testing
- Patient participant screening, Physician participant training
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Women and Infants Hospital of Rhode Island
Pre-Exposure Prophylaxis (PrEP), Breast Feeding
Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana
The goal of this this hybrid safety/implementation study is to evaluate whether using long-acting cabotegravir (CAB-LA) for HIV prevention (PrEP) is acceptable, feasible and safe in post-partum people who are breastfeeding.
- Trial name
- Tshireletso (NCT05986084)
- Testing
- Cabotegravir Injection [Apretude]
- Where
- 2 sites in United States, Botswana
- Volunteers
- 500 people
- Sponsor
- Beth Israel Deaconess Medical Center
PrEP Adherence Monitoring
A Hybrid Effectiveness-Implementation Trial of Urine Point-of-Care Assay to Increase PrEP Adherence Among Women in Kenya
The goal of this randomized trial study is to learn if drug-level feedback counseling works to improve oral PrEP adherence in adolescent girls and young women. Researchers will compare urine TFV assay positivity between arms.
- Trial name
- NCT07725679
- Testing
- POC urine TFV test with DLFB
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV, PrEP
Pharmacy-based Provision of Pre-exposure Prophylaxis (PrEP) for Adolescent Girls and Young Women in Tanzania
Implementation study comparing standard pre-exposure prophylaxis (PrEP) services to four models of pharmacy-based PrEP access for young women aged 18-24 (YW) in Tanzania.
- Trial name
- MWOTAJI (NCT07687888)
- Testing
- Pharmacy-based PrEP services, Distribution of HIV self-test kits
- Where
- Tanzania
- Volunteers
- 2,818 people, healthy volunteers welcome
- Sponsor
- Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation
Long-acting Injectable Cabotegravir for PrEP, Oral Pre-Exposure Prophylaxis (PrEP)
BetterInfo on Women's PrEP Choices and Outcomes in Malawi
The purpose of this study is to understand PrEP user choices, preferences and implementation impact of the roll-out of long-acting injectable PrEP alongside oral PrEP among women in Blantyre, Malawi.
- Trial name
- NCT07579754
- Testing
- Tracing Strategy
- Where
- Malawi
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Pre-Exposure Prophylaxis (PrEP)
eSTEP: An Integrated mHealth Intervention to Engage High-risk Individuals Along the Full PrEP Care Continuum
The long-term goal of this research is to develop a theoretically grounded, effective, accessible and sustainable mHealth PrEP care continuum intervention for men who have sex with men (MSM) and transgender women (TW).
- Trial name
- eSTEP (NCT06159582)
- Testing
- eSTEP, Usual Care
- Where
- United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- San Diego State University
PrEP Education
Encouraging Multiple PrEP Options for Women Engaged in PRimary Care
This study will address the significant yet often overlooked problem of HIV among cisgender women. To do this, researchers will adapt and test a multilingual technology-based strategy supporting informed decision-making for PrEP…
- Trial name
- EMPOWER (NCT06785038)
- Testing
- EMPOWER Strategy, Attention Control
- Where
- United States
- Volunteers
- 132 people
- Sponsor
- Northwestern University
PrEP Adherence, Sexually Transmitted Infections (STIs)
STI Testing to Enhance PrEP Use in Pregnancy
The investigators are conducting a study in Botswana to see if offering STI testing along with expanded HIV prevention options (PrEP) helps more pregnant women start and continue using PrEP during and after pregnancy.
- Conditions
- PrEP Adherence, Sexually Transmitted Infections (STIs), Pregnancy
- Trial name
- STEP-UP (NCT06919614)
- Testing
- Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing
- Where
- Botswana
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Botswana Harvard AIDS Institute Partnership
Pre-Exposure Prophylaxis (PrEP), HIV Prevention
A Self-administered PrEP Decisional Aid for Dissemination With HIV Self-test Kits (DASH)
People using HIV self-testing (HIVST) need access to quality HIV-prevention programming, including education and exploration of pre-exposure prophylaxis (PrEP) - an effective biomedical prevention tool that continues to expand in…
- Trial name
- DASH (NCT07614165)
- Testing
- PrEP Decisional Aid for dissemination with Self-administered HIV test kits (DASH)
- Where
- United States
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- University of Michigan
HIV Pre-exposure Prophylaxis, PrEP
HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department Study
Our primary objective is to increase HIV pre-exposure prophylaxis (PrEP) awareness and uptake among people who want, need, or would benefit from PrEP in Dallas, TX through a pilot program of immediate PrEP prescribing in the…
- Trial name
- PrEP ED (NCT07462611)
- Testing
- PrEP Uptake with Rapid Start, Pre-Exposure Prophylaxis (PrEP) Persistence
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
PrEP, PrEP Adherence Experiences
PrEP-LANA (Pre-exposure Prophylaxis- Long-acting Novel Antiviral Agent)
The goal of this 12-month implementation science study is to generate the evidence required to ensure long-acting cabotegravir (LA CAB) as pre-exposure prophylaxis (PrEP) can be delivered in an equitable manner within the NHS.
- Conditions
- PrEP, PrEP Adherence Experiences, PrEP Adherence Perspectives, PrEP Uptake
- Trial name
- PrEP-LANA (NCT07620730)
- Volunteers
- 220 people
- Sponsor
- Queen Mary University of London
PrEP Uptake
PrEP Optimization Among Women to Enhance Retention and Uptake
Black women experience one of the highest incidences of HIV among all subpopulations in the United States, but pre-exposure prophylaxis (PrEP) use among Black cisgender women is very limited.
- Trial name
- POWER Up (NCT05626452)
- Testing
- PrEP Education, Provider training, EMR Optimization
- Where
- United States
- Volunteers
- 724 people, healthy volunteers welcome
- Sponsor
- University of Chicago
HCV, Buprenorphine
Hepatitis C Treatment to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior
This is an open label, non-randomized, observational pilot study to evaluate a model of care for treatment of hepatitis C in people with ongoing injection drug use.
- Conditions
- HCV, Buprenorphine, PreP
- Trial name
- ANCHOR (NCT03221309)
- Testing
- Evaluate model of care for HCV-infected adults with on-going opioid misuse
- Where
- 2 sites in United States
- Volunteers
- 198 people
- Sponsor
- University of Maryland, Baltimore
HIV Prevention, Sexually Transmitted Infections (STI)
California MEPS Hub
The California Hub for HIV/SUD Prevention Research with Reentry Populations addresses the question: "Can the evidence-based MEPS intervention be adapted and implemented at a range of organizations to effectively serve a wider…
- Conditions
- HIV Prevention, Sexually Transmitted Infections (STI), Preexposure Prophylaxis (PrEP), Incarceration
- Trial name
- NCT07433985
- Testing
- Mobile Enhanced Prevention Support (MEPS), Control
- Where
- 3 sites in United States
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
HIV Prevention, HIV Related Stigma
Evaluation of mHealth Intervention to Promote HIV Prevention and Overcome Stigma Among Transgender Women (EMPOW.HER)
This study aims to develop and evaluate a multi-component mHealth intervention (mHC and FRESH) to reduce HIV-related and intersectional stigma and improve PrEP use among HIV-negative young transgender women (TGW) in Thailand.
- Conditions
- HIV Prevention, HIV Related Stigma, PrEP Adherence
- Trial name
- NCT07509827
- Testing
- Mobile Healthy Choices (mHC)+SPC, FRESH + SPC, mHC + FRESH + SPC
- Where
- 3 sites in Thailand
- Volunteers
- 108 people
- Sponsor
- Institute of HIV Research and Innovation Foundation, Thailand
HIV Prevention, PrEP
A Multi-Level Trauma-Informed Approach to Increase HIV Pre-exposure Prophylaxis Initiation Among Black Women
U.S. epidemiological data indicates that Black women are a high-risk HIV disparity group, yet initiation of novel prevention strategies like pre-exposure prophylaxis (PrEP) among this group is stagnant.
- Conditions
- HIV Prevention, PrEP, Women, Intimate Partner Violence (IPV)
- Trial name
- MATCH (NCT06703060)
- Testing
- Peer Navigation Group
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
HIV Self-testing, Male Partners of HIV-negative Postpartum Women
HIV Self-testing for Partners of HIV-uninfected Postpartum Women
The purpose of this study is to test the feasibility and acceptability of a combination intervention to promote HIV self-testing (HIVST) for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").
- Conditions
- HIV Self-testing, Male Partners of HIV-negative Postpartum Women, PrEP Uptake, Feasibility
- Trial name
- NCT07194902
- Testing
- HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").
- Where
- South Africa
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
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