studies

 

Our studies strive to prevent HIV infection through the use of antiretroviral drugs, interventions for substance use, 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
HPTN 112 (39057)

Improving HIV prevention among heterosexual men seeking STI services in Malawi: examining the benefits, acceptability, and associated costs of a systems-navigator-delivered integrated prevention package

Enrolling Integrated Strategy
HPTN 111 (39062)

Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative Among Heterosexual Men in Kalangala Islands, Uganda: A Cluster Randomized Trial

Closed to Accrual Integrated Strategy
HVTN 143/HPTN 109 (39015)

A phase 1- clinical trial to evaluate the safety, tolerability, pharmacokinetics and tolerability of combinations of monoclonal antibodies VRC01.23LS, PGT121.414.LS, and PGDM1400LS administered via intravenous infusion in adults without HIV

Withdrawn Antibody Mediated Prevention
A5416/HVTN 806/HPTN 108 (39006)

A Phase I, Randomized, Placebo-Controlled Study of the Safety, Antiviral & Immunomodulatory Activity of Broadly Neutralizing Antibodies 3BNC117-LS-J and 10-1074-LS-J in Combination in ART-treated Adults in sub-Saharan Africa Living with HIV during a Monitored Analytical Treatment Interruption

Enrolling Antibody Mediated Prevention
DMID 19-0004/HPTN 107

A Phase II randomized, observer-blind, placebo-controlled study, to assess efficacy of meningococcal Group B vaccine rMenB+OMV NZ (Bexsero) in preventing gonococcal infection.

Enrolling
HPTN 106 (39002)

A Phase 2 Crossover Study of On Demand PrEP Formulations Comparing Rectal and Oral TFV-Based PrEP Evaluating Extended Safety, Acceptability, and PK/PD

Open to Accrual
HVTN 140/HPTN 101 (154188)

A phase 1 dose-escalation clinical trial to evaluate the safety, tolerability, and pharmacokinetics of PGDM1400LS alone and in combination with VRC07-523LS and PGT121.414.LS in healthy, HIV-uninfected adult participants

Closed to Follow Up Antibody Mediated Prevention
CoVPN 5002 (38749)

SARS-CoV-2 Prevalence Survey

Closed to Follow Up COVID-19
HPTN 083-02 (38645)

Factors Influencing Adherence to Injectable PrEP and Retention in an Injectable PrEP Research Study

Closed to Follow Up PrEP
HPTN 096 (38561)

Getting to Zero Among Black MSM in the American South: Testing the Efficacy of an Integrated Intervention Strategy

Enrolling Integrated Strategy
HVTN 804/HPTN 095 (38632)

Antiretroviral analytical treatment interruption (ATI) to assess immunologic and virologic responses in participants who received VRC01 or placebo and became HIV-infected during HVTN 704/HPTN 085

Closed to Accrual Other
HPTN 094 (38715)

INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit to Link Persons who Inject Drugs to Integrated Care and Prevention for Addiction, HIV, HCV and Primary Care.

Closed to Accrual Integrated Strategy
HVTN 805/HPTN 093 (38691)

Antiretroviral analytical treatment interruption (ATI) to assess immunologic and virologic responses in participants who initiated ART in early HIV infection after having received VRC01 or placebo in HVTN 703/HPTN 081

Closed to Follow Up Other
HPTN 084-01 (38655)

Ancillary Study: Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (LA CAB) for the Prevention of HIV among Adolescents

Closed to Follow Up PrEP
HPTN 083-01 (38654)

Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV among Adolescent Males – A sub-study of HPTN 083

Closed to Follow Up PrEP
HVTN 136/HPTN 092 (38634)

A phase 1 dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous infusion or via subcutaneous injections in healthy, HIV-uninfected adult participants.

Closed to Follow Up Antibody Mediated Prevention
HPTN 091 (38695)

Integrating HIV Prevention, Gender-Affirmative Medical Care, and Peer Health Navigation to Prevent HIV Acquisition and HIV Transmission for Transgender Women in the Americas: A Vanguard Feasibility and Acceptability Study

Closed to Accrual Integrated Strategy
HVTN 130/HPTN 089 (38531)

A phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered via intravenous infusion in healthy, HIV-uninfected adult participants

Concluded Antibody Mediated Prevention
HVTN 127/HPTN 087 (38458)

A multicenter, randomized, partially blinded phase 1 clinical trial to evaluate the safety and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and routes to healthy, HIV-uninfected adults.

Concluded Antibody Mediated Prevention
HPTN 084 (38070)

A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women.

Closed to Accrual PrEP
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.

Concluded 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

Closed to Accrual PrEP
HPTN 082 (12068)

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

Concluded PrEP
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 in women in sub-Saharan Africa.

Concluded Antibody Mediated Prevention
HPTN 078 (11995)

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

Concluded 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

Concluded PrEP
HPTN 076 (11944)

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

Concluded PrEP
HPTN 075 (11943)

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

Concluded 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

Concluded Treatment as Prevention
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

Archived 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

Concluded PrEP
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

Concluded PrEP
HPTN 068 (11710)

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

Concluded 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)

Concluded 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

Concluded Integrated Strategy
HPTN 064 (10705)

The Women’s HIV SeroIncidence Study

Concluded Behavioral
HPTN 063 (10668)

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

Concluded Behavioral
HPTN 062 (10667)

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

Concluded 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

Concluded Behavioral
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 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 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

Concluded Treatment as Prevention
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 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 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 049

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

Concluded Microbicides
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 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 033

HIV Prevention Preparedness Study

Concluded Substance Use
HPTN 050

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

Concluded Microbicides
HPTN 036

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

Concluded STD Control
HPTN 034 (10199)

HIV Incidence and Participant Retention Protocol, Pune, India

Concluded Other
HPTN 047

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

Concluded Microbicides
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 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 024

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

Concluded Perinatal
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