HPTN Studies

Our studies strive to prevent HIV infection through the use of antiretroviral drugs, interventions for substance abuse, behavioral risk reduction, and structural interventions.


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.

Study Listing

Protocol Number Title Protocol Status Research Area
HVTN 704/HPTN 085 (30095)

A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection among men and transgender persons who have sex with men

Enrolling Antibody Mediated Prevention
HVTN 703/HPTN 081 (12045)

A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection among women in seven countries in sub-Saharan Africa

Enrolling Antibody Mediated Prevention
HPTN 083 (20725)

A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), for Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women who have Sex with Men

Pending PrEP
HPTN 082 (12068)

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

Pending PrEP
HPTN 078 (11995)

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

Open to Accrual Integrated Strategy
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

Closed to Accrual PrEP
HPTN 076 (11944)

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

Closed to Accrual PrEP
HPTN 075 (11943)

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

Enrolling Behavioral
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

Closed to Accrual Treatment as Prevention
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 Follow Up PrEP
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 Treatment as Prevention
HPTN 070 (11797)

International Test and Linkage to Care and Treatment

Withdrawn Other
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 Follow Up PrEP
HPTN 068 (11710)

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

Closed to Accrual Structural
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 Follow Up PrEP
HPTN 066 (10851)

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

Concluded Antiretroviral Therapy
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

Closed to Follow Up Integrated Strategy
HPTN 064 (10705)

The Women’s HIV SeroIncidence Study (ISIS)

Participants Off Study and Primary Analysis Completed Behavioral
HPTN 063 (10668)

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

Closed to Follow Up Behavioral
HPTN 062 (10667)

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

Participants Off Study and Primary Analysis Completed Behavioral
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 and Primary Analysis Completed Behavioral
HPTN 059 (10145)

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

Concluded Microbicides
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 Substance Use
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

Concluded Perinatal
HPTN 056 ()

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

Concluded Microbicides
HPTN 055 ()

HIV Prevention Preparedness Study

Concluded Microbicides
HPTN 054 ()

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

Withdrawn Perinatal
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 Follow Up Treatment as Prevention
HPTN 050 ()

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

Concluded Microbicides
HPTN 049 ()

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

Concluded Microbicides
HPTN 048 ()

Phase I safety study of a vaginal microbicide: Polystyren

Other
HPTN 047 ()

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

Concluded Microbicides
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

Concluded Perinatal
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

Concluded Structural
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 STD Control
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 STD Control
HPTN 038 ()

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

Withdrawn Other
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 Substance Use
HPTN 036 ()

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

Concluded STD Control
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 Microbicides
HPTN 034 (10199)

HIV Incidence and Participant Retention Protocol, Pune, India

Concluded Other
HPTN 033 ()

HIV Prevention Preparedness Study

Concluded Substance Use
HPTN 032 ()

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

Concluded Microbicides
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

Concluded Perinatal
HIVNET 024 ()

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

Concluded Perinatal
HIVNET 016A ()

Condom Promotion and Counseling Study

Concluded Microbicides
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 Behavioral
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 Perinatal