The HPTN is a partnership between scientists and communities around the world to develop, evaluate and implement cutting-edge biomedical, behavioral and structural interventions to reduce the transmission of HIV. The HPTN has more than 80 research sites in 15 countries and more than 50 clinical trials ongoing or completed.

Studies main image

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

HVTN 703/HPTN 081


A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection


HPTN 083

( )

A Phase 2b/3 Double Blind Efficacy Study Of Quarterly Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (Truvada), For Pre-Exposure Prophylaxis in HIV-Uninfected Men and Transgender Women who have Sex With Men

In Development

HPTN 082

( )

Evaluation of Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study

In Development

HPTN 078


Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected Men Who Have Sex with Men (MSM) in the United States

In Development

HPTN 077


A Phase IIa Safety, Tolerability and Acceptability Study of an Investigational Injectable HIV Integrase Inhibitor, GSK1265744, for PrEP in HIV Uninfected Men and Women


HPTN 076


Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278 LA, for Pre Exposure Prophylaxis (PrEP)

Closed to Accrual

HPTN 075


Feasibility of HIV Prevention Cohort Studies Among MSM in Sub-Saharan Africa

Open to Accrual

HPTN 074


Integrated Treatment and Prevention for People Who Inject Drugs: A Vanguard study for a Network-based Randomized HIV Prevention Trial Comparing an Integrated Intervention Including Supported Antiretroviral Therapy to the Standard of Care


HPTN 073


Pre-Exposure Prophylaxis (PrEP) Initiation and Adherence among Black Men who have Sex with Men (BMSM) in Three U.S. Cities

Closed to Accrual

HPTN 071


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


HPTN 069


A Phase II Randomized, Double-Blind, Study of the Safety and Tolerability of Maraviroc (MVC), Maraviroc + Emtricitabine (MVC+FTC), Maraviroc + Tenofovir disoproxil fumarate (MVC+TDF), or Tenofovir disoproxil fumarate + Emtricitabine (TDF+FTC) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission in At-Risk Men Who Have Sex with Men and in At-Risk Women

Closed to Accrual

HPTN 068


Effects of cash transfer for the prevention of HIV in young South African women

Closed to Accrual

HPTN 067


A Phase II, Randomized, Open-Label, Pharmacokinetic and Behavioral Study of the Use of Intermittent Oral Emtricitabine/Tenofovir Disoproxil Fumarate Pre-Exposure Prophylaxis (PrEP)

Closed to Follow Up

HPTN 066


Dose-Proportionality and Intra-Individual Variability of Intracellular Tenofovir Diphosphate and Emtricitabine Triphosphate in Healthy Volunteers

Closed to Follow Up

HPTN 065


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

Closed to Follow Up

HPTN 063


Preparing for international prevention trials involving HIV-infected individuals in care settings

Closed to Follow Up

HPTN 052


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 Follow Up

Completed Studies

Protocol Number Protocol Title Status

HPTN 080


SexPro: A Phase IIa Trial of a Combination Prevention Strategy for MSM and Transgender Women in the Americas


HPTN 079


Circumcision for reducing HIV risk among men who have sex with men – A Phase II, Multi-site Feasibility Study


HPTN 070


International Test and Linkage to Care and Treatment


HPTN 064


The Women’s HIV SeroIncidence Study (ISIS)

Participants Off Study & Primary Analysis Complete

HPTN 062


Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals with Acute and Early HIV-Infection

Participants Off Study & Primary Analysis Complete

HPTN 061


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

Participants Off Study & Primary Analysis Complete

HPTN 059


Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1% Tenofovir Gel


HPTN 058


A Phase III randomized controlled trial to evaluate the efficacy of drug treatment in prevention of HIV infection and death among opiate dependent injectors


HPTN 057


A Phase I Open Label Trial of the Safety and Pharmacokinetics of Tenofovir Disoproxil Fumarate in HIV-1 Infected Pregnant Women and their Infants


HPTN 056


Characterization of Baseline Mucosal Indices of Injury and Inflammation in Men for Use in Rectal Microbicide Trials


HPTN 055


HIV Prevention Preparedness Study


HPTN 054


A Population-based Randomized Trial of Targeted Versus Combined Nevirapine Access to Improve Drug Coverage in Settings of High HIV Prevalence


HPTN 050


Phase I Safety and Acceptability Study of the Vaginal Microbicide Agent PMPA Gel


HPTN 049


Phase I Safety and Acceptability Study of the Vaginal Microbicide 6% Cellulose Sulfate Gel Among HIV-Infected Women


HPTN 047


A Phase I Safety and Acceptability Study of the Investigational Vaginal Microbicide PRO 2000/5 Gel (P)


HPTN 046


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


HPTN 043


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


HPTN 039-01


Ancillary Study: Prospective Cohort Study of HPTN 039 Seroconverters: The Effect of HSV-2 Suppression on HIV-1 Viral Set Point


HPTN 039


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


HPTN 038


Phase I/II Study to Evaluation Safety and Feasibility of a Peer-Activism and Empowerment Intervention for HIV-Positive IDUs


HPTN 037


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


HPTN 036


HIV Prevalence, Incidence, and HSV-2 Prevalence Among High-Risk MSM in Perú


HPTN 035


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


HPTN 034


HIV Incidence and Participant Retention Protocol, Pune, India


HPTN 033


HIV Prevention Preparedness Study


HPTN 032


Male Tolerance Study of BufferGel and PRO 2000/5 Gel (P)


HPTN 027


A Phase I Study to Evaluate the Safety and Immunogenicity of ALVAC-HIV vCP1521 in Infants Born to HIV-1 Infected Women in Uganda




Phase III Trial of Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission




Condom Promotion and Counseling Study




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)




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