HPTN Studies
HPTN research studies are developed by protocol teams that include CTU investigators and recognized experts in HIV prevention. As study protocols are developed, they undergo a rigorous intra- and extra-network review process that ensures compliance with current ethical guidelines and regulatory procedures.
To view detailed information about studies, including performance sites and enrollment figures, select a protocol number from the tables below. Each Study Protocol is available once version 1.0 is approved and distributed to the performance sites. The CORE Protocol Contact can provide additional information and materials.
Ongoing Studies and Studies in Development
| Protocol Number | Protocol Title | Status |
|---|---|---|
|
(11917) |
Treatment as prevention for injection drug users: A pilot study for a network-based randomized HIV prevention trial |
In Development |
|
(11894) |
Pre-Exposure Prophylaxis (PrEP) Initiation and Adherence among Black Men who have Sex with Men (BMSM) in Three U.S. Cities |
Pending |
|
(11865) |
Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART): A cluster-randomized trial of the impact of a combination prevention package on population-level HIV incidence in Zambia and South Africa |
Pending |
|
(11789) |
Phase II Randomized, Double-Blind, Study of Safety and Tolerability of Maraviroc, Maraviroc + Emtricitabine, Maraviroc + Tenofovir or Tenofovir + Emtricitabine for PreExposure Prophylaxis to Prevent HIV Transmission in At-Risk Men Who Have Sex with Men |
Enrolling |
|
(11710) |
Effects of cash transfer for the prevention of HIV in young South African women |
Closed to Accrual |
|
(10852) |
A Phase II, Randomized, Open-Label, Pharmacokinetic and Behavioral Study of the Use of Intermittent Oral Emtricitabine/Tenofovir Disoproxil Fumarate Pre-Exposure Prophylaxis (PrEP) |
Enrolling |
|
(10851) |
Dose-Proportionality and Intra-Individual Variability of Intracellular Tenofovir Diphosphate and Emtricitabine Triphosphate in Healthy Volunteers |
Re-Opened |
|
(11685) |
TLC-Plus: A Study to Evaluate the Feasibility of an Enhanced Test, Link to Care, Plus Treat Approach for HIV Prevention in the United States |
Enrolling |
|
(10705) |
The Women’s HIV SeroIncidence Study (ISIS) |
Closed to Follow Up |
|
(10668) |
Preparing for international prevention trials involving HIV-infected individuals in care settings |
Closed to Accrual |
|
(10666) |
Feasibility of a community-level, multi-component intervention for Black MSM in preparation for a Phase IIB community-level randomized trial to test the efficacy of the intervention in reducing HIV incidence among Black MSM |
Closed to Follow Up |
|
(10144) |
A Phase III randomized controlled trial to evaluate the efficacy of drug treatment and death in prevention of HIV infection and death among opiate dependent injectors |
Closed to Follow Up |
|
(10143) |
A Phase I Open Label Trial of the Safety and Pharmacokinetics of Tenofovir Disoproxil Fumarate in HIV-1 Infected Pregnant Women and their Infants |
Closed to Follow Up |
|
(10068) |
A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples |
Closed to Accrual |
Completed Studies
| Protocol Number | Protocol Title | Status |
|---|---|---|
|
11797 |
International Test and Linkage to Care and Treatment |
Withdrawn |
|
10667 |
Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals with Acute and Early HIV-Infection |
Closed |
|
10145 |
Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1% Tenofovir Gel |
Concluded |
|
|
Characterization of Baseline Mucosal Indices of Injury and Inflammation in Men for Use in Rectal Microbicide Trials |
Concluded |
|
|
HIV Prevention Preparedness Study |
Concluded |
|
|
A Population-based Randomized Trial of Targeted Versus Combined Nevirapine Access to Improve Drug Coverage in Settings of High HIV Prevalence |
Withdrawn |
|
|
Phase I Safety and Acceptability Study of the Vaginal Microbicide Agent PMPA Gel |
Concluded |
|
|
Phase I Safety and Acceptability Study of the Vaginal Microbicide 6% Cellulose Sulfate Gel Among HIV-Infected Women |
Concluded |
|
|
A Phase I Safety and Acceptability Study of the Investigational Vaginal Microbicide PRO 2000/5 Gel (P) |
Concluded |
|
10142 |
Phase III Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV Infected Women to Prevent Vertical HIV Transmission During Breastfeeding |
Participants Off Study & Primary Analysis Complete |
|
|
A Phase III Randomized Controlled Trial of Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand |
Participants Off Study & Primary Analysis Complete |
|
10067 |
Ancillary Study: Prospective Cohort Study of HPTN 039 Seroconverters: The Effect of HSV-2 Suppression on HIV-1 Viral Set Point |
Concluded |
|
10066 |
A Phase III, randomized, double-blind, placebo-controlled trial of acyclovir for the reduction of HIV acquisition among high risk HSV-2 seropositive, HIV-seronegative individuals |
Concluded |
|
|
Ph I/II Study to Evaluation Safety and Feasibility of a Peer-Activism and Empowerment Intervention for HIV-Positive IDUs |
Withdrawn |
|
10125 |
A Phase III Randomized Study to Evaluate the Efficacy of a Network-oriented Peer Educator Intervention for the Prevention of HIV Transmission Among Injection Drug Users And Their Network Members |
Concluded |
|
|
HIV Prevalence, Incidence, and HSV-2 Prevalence Among High-Risk MSM in Perú |
Concluded |
|
10065 |
Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO2000/5 Gel (P) for the Prevention of HIV Infection in Women |
Concluded |
|
10199 |
HIV Incidence and Participant Retention Protocol, Pune, India |
Concluded |
|
|
HIV Prevention Preparedness Study |
Concluded |
|
|
Male Tolerance Study of BufferGel and PRO 2000/5 Gel (P) |
Concluded |
|
10141 |
A Phase I Study to Evaluate the Safety and Immunogenicity of ALVAC-HIV vCP1521 in Infants Born to HIV-1 Infected Women in Uganda |
Participants Off Study & Primary Analysis Complete |
|
|
Phase III Trial of Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission |
Concluded |
|
|
Condom Promotion and Counseling Study |
Concluded |
|
|
EXPLORE: A Randomized Clinical Trial of the Efficacy of a Behavioral Intervention to Prevent Acquisition of HIV among Men who have Sex with Men (MSM) |
Concluded |
|
|
A Phase IIB Trial to Determine the Efficacy of Oral AZT and the Efficacy of Oral Nevirapine for the Prevention of Vertical Transmission of HIV-1 Infection in Pregnant Ugandan Women and Their Neonates |
Concluded |
