HIV PrEP + STI PEP for HIV Prevention

Not yet recruiting at 4 trial locations
KG
MR
Overseen ByMichelle Robinson
Age: 18 - 65
Sex: Male
Trial Phase: Phase 3
Sponsor: HIV Prevention Trials Network
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV pre-exposure prophylaxis (PrEP) and sexually transmitted infection (STI) post-exposure prophylaxis (PEP) for Young Men

Who Is on the Research Team?

JG

Jorge Gallardo-Cartagena, MD

Principal Investigator

Centro de Investigaciones Tecnológicas Biomédicas y Medioambientales

SB

Susan Buchbinder, MD

Principal Investigator

San Francisco Department of Public Health and University of California San Francisco

TT

Thiago Torres, MD

Principal Investigator

Instituto Nacional de Infectología Evandro Chagas

Are You a Good Fit for This Trial?

This trial is for young men at risk of HIV or sexually transmitted infections (STIs). Participants should not already have HIV, certain cancers like Non-Hodgkin's Lymphoma, or hepatitis B. The study is focused on those who could benefit from preventive treatments.

Inclusion Criteria

I am a man living in a community heavily affected by HIV.
Have certain risk factors for HIV acquisition in the past 6 months: reporting gonorrhea, chlamydia, or syphilis diagnosis
Must not share the mobile phone used for their participation in the study
See 11 more

Exclusion Criteria

Plans to move away from the study area within the next year
Participated in HPTN 113-01
Currently participating in another interventional trial of PrEP agents or prior enrollment in studies of long-acting PrEP including HPTN 083
See 6 more

What Are the Treatments Tested in This Trial?

Interventions

  • 3P mHealth package
  • CAB-LA
  • Doxycycline as Doxy-PEP
  • F/TAF
  • F/TDF
  • Handout about HIV PrEP options available at the site
  • Standard-of-care HIV PrEP counseling from qualified study staff

Trial Overview

The trial compares different ways to prevent HIV and STIs: daily or long-acting PrEP medications (F/TDF, F/TAF, CAB-LA), STI prevention with doxycycline after sex (Doxy-PEP), a mobile health support package, educational handouts about PrEP options, and standard counseling.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: 3P mHealth packageExperimental Treatment5 Interventions
Group II: Standard-of-care servicesActive Control4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

HIV Prevention Trials Network

Lead Sponsor

Trials
31
Recruited
569,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3,361
Recruited
5,516,000+

Gilead Sciences

Industry Sponsor

Trials
1,150
Recruited
878,000+
Daniel O'Day profile image

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger profile image

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

ViiV Healthcare

Industry Sponsor

Trials
379
Recruited
479,000+
Founded
2009
Headquarters
London, England, UK
Known For
HIV Research
Top Products
- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)
Dr. Harmony Garges profile image

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse profile image

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration