Clinical trials: Pre-exposure Prophylaxis (PrEP) Adherence
Human Immunodeficiency Virus (HIV)
Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting
This study identifies social and behavioral factors likely to influence PrEP acceptability and adherence among men who have sex with men (MSM), and collaborates with a community health center to evaluate a two-stage intervention…
- Trial name
- SPARK (NCT02037594)
- Testing
- Sexual Health Counseling, Enhanced Adherence Intervention, PrEP Information (Active Control)
- Where
- United States
- Volunteers
- 438 people, healthy volunteers welcome
- Sponsor
- Hunter College of City University of New York
HIV
IPREP Study #2: Evaluating Enhanced PrEP Packages for Young Female Sex Workers in Kisumu, Kenya
This is an open-label randomized controlled trial (n=200) in which HIV-negative young female sex workers (FSW) will be randomized to receive oral PrEP combined with specific behavioral and structural adherence interventions…
- Trial name
- NCT03988387
- Testing
- Peer Support (PS), Reminder and Resource Transfer (RRT), daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]
- Where
- Kenya
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Columbia University
Patient Adherence
Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM
CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs. standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV infection (ClinicalTrials.gov Identifier: NCT01761643).
- Trial name
- CCTG595VitD (NCT02367599)
- Testing
- Vitamin D Supplement
- Where
- 3 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
HIV, Pre-exposure Prophylaxis
Life Steps for PrEP for Youth
This is a formative study, designed to provide information required to tailor Life-Steps for Pre-Exposure Prophylaxis (PrEP), an evidence-based cognitive behavioral adherence intervention, to enhance PrEP uptake and adherence in…
- Conditions
- HIV, Pre-exposure Prophylaxis, Medication Adherence
- Trial name
- LSPY (NCT03805451)
- Testing
- Life Steps for PrEP for Youth
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Fenway Community Health
HIV Infection
A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-risk Populations in Uganda, Africa
This study will evaluate the safety and acceptability of intermittent and daily pre-exposure prophylaxis (PrEP) regimens with FTC/TDF (emtricitabine/tenofovir disoproxil fumarate) in HIV discordant couples, and it will directly…
- Trial name
- NCT00931346
- Testing
- FTC/TDF
- Where
- Uganda
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
HIV/AIDS, Gender
Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - PK Study
To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases.
- Conditions
- HIV/AIDS, Gender, Behavior and Behavior Mechanisms
- Trial name
- NCT03652623
- Testing
- TDF/FTC
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Hektoen Institute for Medical Research
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.
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/AIDS, Gender
Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Intervention Development
To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases.
- Conditions
- HIV/AIDS, Gender, Behavior and Behavior Mechanisms
- Trial name
- NCT04077138
- Where
- 3 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Hektoen Institute for Medical Research
HIV/AIDS, Gender
Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Demonstration Project
To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases.
- Conditions
- HIV/AIDS, Gender, Behavior and Behavior Mechanisms
- Trial name
- NCT04077151
- Testing
- PrEP Demonstration Project
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Hektoen Institute for Medical Research
HIV/AIDS
Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis for Adoption and Adherence for Black Canadians
Aim 1: Adapt Ottawa Decision Support Framework for the HIV PrEP decisional needs of African, Caribbean and Black (ACB) Canadian patients Aim 2.
- Trial name
- PrEPDSA (NCT03637244)
- Testing
- Decision Support Aid and PrEP for Black Canadians
- Where
- Canada
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto
Medication Adherence
Pre-exposure Prophylaxis Adherence Intervention for MSM
Following formative work, the proposed study is an open-label, pilot, randomized, two arm trial where subjects will receive pre-exposure prophylaxis (PrEP) for 6 months and either a cognitive-behavioral based adherence…
- Trial name
- PrEPare (NCT01632397)
- Testing
- CBT-based counseling, Health education and supportive counseling
- Where
- United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Fenway Community Health
HIV Infections
Storytelling to Increase Family Support for Pre Exposure Prophylaxis Use
Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV infection but requires high levels of medication adherence, particularly among women.
- Trial name
- PrEP (NCT04071470)
- Testing
- Storytelling, PrEP
- Where
- Mozambique
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
HIV
Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
To assess the acceptance rate, adherence, acceptability, and continuation of oral pre-exposure prophylaxis (PrEP) among young southern African women.
- Trial name
- NCT02732730
- Testing
- Truvada, Drug level counseling at Weeks 8 and 13
- Where
- 3 sites in South Africa, Zimbabwe
- Volunteers
- 451 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
HIV/AIDS, Adherence, Medication
Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users
Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine…
- Conditions
- HIV/AIDS, Adherence, Medication, Drug Use
- Trial name
- NCT03584282
- Testing
- Text Messaging, Peer Navigation
- Where
- 2 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of Washington
Human Immunodeficiency Virus
Biomarkers for Event-driven PrEP Adherence
This study aims to recruit 40 participants who will take the combination anti-HIV drug tenofovir+emtricitabine (TDF/FTC) at specified times.
- Trial name
- NCT04298697
- Testing
- Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Emory University
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 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
Relationship Dynamics, Pre-exposure Prophylaxis (PrEP) Adherence
CHARISMA Expansion Study
The CHARISMA Expansion Study is a two-arm, randomized (1:1), controlled study of a behavioral intervention-the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA)-to reduce social…
- Trial name
- CHARISMA (NCT04092114)
- Testing
- Control, CHARISMA Intervention
- Where
- South Africa
- Volunteers
- 407 people, healthy volunteers welcome
- Sponsor
- RTI International
HIV Infections, Pregnancy Related
mWACh-PrEP: A SMS-based Support Intervention to Enhance PrEP Adherence During Pregnancy and Breastfeeding
In high HIV prevalence regions, women are at high risk for HIV during pregnancy and breastfeeding. To protect women and reach elimination of mother-to-child HIV transmission, the World Health Organization recommends offering oral…
- Conditions
- HIV Infections, Pregnancy Related, Adherence, Medication
- Trial name
- NCT04472884
- Testing
- mWACh-PrEP, Standard of Care
- Where
- 4 sites in Kenya
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- University of Washington