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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.

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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

HPTN 080

(11997)

SexPro: A Phase Iia trial of a combination prevention strategy for MSM and transgender women in the Americas

In Development

HPTN 078

(11995)

Optimizing Surveillance and Enhancing Treatment for Men Who Have Sex with (MSM) in the U. S.

In Development

HPTN 077

(11964)

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

Pending

HPTN 076

(11944)

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

Pending

HPTN 075

(11943)

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

Pending

HPTN 074

(11917)

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

Pending

HPTN 073

(11894)

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

(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

Enrolling

HPTN 069

(11789)

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

(11710)

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

Closed to Accrual

HPTN 067

(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)

Closed to Accrual

HPTN 066

(10851)

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

Closed to Follow Up

HPTN 065

(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

HPTN 063

(10668)

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

Closed to Follow Up

HPTN 052

(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

HPTN 079

11996

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

Withdrawn

HPTN 070

11797

International Test and Linkage to Care and Treatment

Withdrawn

HPTN 064

10705

The Women’s HIV SeroIncidence Study (ISIS)

Participants Off Study & Primary Analysis Complete

HPTN 062

10667

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

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

Participants Off Study & Primary Analysis Complete

HPTN 059

10145

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

Concluded

HPTN 058

10144

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

Concluded

HPTN 057

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

Participants Off Study & Primary Analysis Complete

HPTN 056

 

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

Concluded

HPTN 055

 

HIV Prevention Preparedness Study

Concluded

HPTN 054

 

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

Withdrawn

HPTN 050

 

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

Concluded

HPTN 049

 

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

Concluded

HPTN 047

 

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

Concluded

HPTN 046

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

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

Participants Off Study & Primary Analysis Complete

HPTN 039-01

10067

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

Concluded

HPTN 039

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

HPTN 038

 

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

Withdrawn

HPTN 037

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

HPTN 036

 

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

Concluded

HPTN 035

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

HPTN 034

10199

HIV Incidence and Participant Retention Protocol, Pune, India

Concluded

HPTN 033

 

HIV Prevention Preparedness Study

Concluded

HPTN 032

 

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

Concluded

HPTN 027

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

HIVNET 024

 

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

Concluded

HIVNET 016A

 

Condom Promotion and Counseling Study

Concluded

HIVNET 015

 

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

HIVNET 012

 

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