Clinical trials: PrEP Adherence, open to volunteers
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
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 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 Infections, Contraception
DYnamic decisioN Support for IntegrAting PrEP in Clinics for Young People in Alabama and Botswana
This study evaluates strategies to improve access to HIV prevention through the integration of pre-exposure prophylaxis (PrEP) into existing healthcare settings, rather than limiting delivery to specialty clinics.
- Conditions
- HIV Infections, Contraception, PrEP
- Trial name
- DYNAMIC PrEP (NCT07597824)
- Testing
- Observational cohort (PrEP use in real-world settings)
- Where
- Botswana
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
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
Human Immunodeficiency Virus
Feasibility of an Ingestible Sensor System to Measure PrEP Adherence in YMSM
The goal of this study is to evaluate an integrated technology system that confirms ingestion of oral PrEP, monitors adherence both in real-time and longitudinally, and provides visual feedback mechanisms to promote enhanced…
- Trial name
- NCT02891720
- Testing
- Proteus Sensor System
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hektoen Institute for Medical Research
People Who Inject Drugs, PrEP Adherence
CARE: Comprehensive Assessment of Real-world Effectiveness of F/TAF in Persons Who Use Drugs (PWUD)
This study looks at how to help people who use drugs start and keep taking medicine that can prevent HIV. The medicine is called PrEP (pre-exposure prophylaxis).
- Trial name
- CARE (NCT07385183)
- Testing
- PrEP adherence, PrEP perspectives
- Volunteers
- 200 people
- Sponsor
- Heather Henderson
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 Prevention
Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM
The goal of this clinical trial is to learn if two interventions-C4 and C4+3MV-can improve PrEP adherence (taking medication to prevent HIV) among Black men who have sex with men (MSM).
- Trial name
- C4+3MV (NCT06661343)
- Testing
- C4 Program, C4 + 3MV Program
- Where
- 2 sites in United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Yale University
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
Drug Use Disorders, PrEP Uptake
Reducing Co-occurring Substance Use and HIV Risk Among Stimulant-using Men at High Risk for HIV in the United States of America.
This intervention will focus on stimulant-using men at high risk for HIV who are in need of tailored behavioral interventions to mitigate co-occurring stimulant use and HIV risk in the era of pre-exposure prophylaxis (PrEP).
- Conditions
- Drug Use Disorders, PrEP Uptake, PrEP Adherence, HIV Risk Behavior
- Trial name
- NCT07281378
- Testing
- Tailored Positive Affect Intervention, Contingency Management
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- University of Florida
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.
PrEP, PrEP Adherence Monitoring
Prevention ICONA Dedicated Ensemble
Despite significant advances in HIV treatment, transmission remains a public health concern. In 2022, there were 1.3 million new HIV infections worldwide and 1,888 new diagnoses in Italy, with sexual transmission being the…
- Conditions
- PrEP, PrEP Adherence Monitoring, HIV, HIV -1 Infection
- Trial name
- PrIDE (NCT07186244)
- Where
- 53 sites in Italy
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Fondazione ICONA
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
HIV Infections, Mental Health
Testing the WeCare Intervention to Address Mental Health and Medication Adherence Challenges Among MSM in South Africa
The goal of this clinical trial is to learn if the WeCare intervention-an adapted Friendship Bench program that integrates problem-solving therapy, minority-stress-informed content, and explicit PrEP/ART adherence skills-improves…
- Trial name
- NCT07226323
- Testing
- WeCare, Standard of Care
- Where
- South Africa
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Emory University
Substance Use
Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Intervention for Women with Trauma-related Conditions
The investigators have previously developed an integrated bio-behavioral intervention to promote PrEP uptake and adherence in cisgender women who are undergoing treatment for trauma-related mental health conditions and who are at…
- Trial name
- NCT06558825
- Testing
- Integrated Intervention to Promote PrEP Uptake, Standard Treatment Condition
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- The University of Texas Health Science Center, Houston
HIV Pre-exposure Prophylaxis
Long-Acting Injectable HIV PrEP PROs
The goal of this observational study is to learn about the real world effectiveness, patient satisfaction and clinical outcomes of LAI PrEP with lenacapavir (LEN) versus cabotegravir (CAB) through surveys and interviews.
- Trial name
- IMPACT (NCT07379658)
- Testing
- Interview and survey to evaluate patient reported outcomes between the two medications.
- Where
- 3 sites in United States
- Volunteers
- 128 people
- Sponsor
- Anupama Raghuram MD
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