NCT02935296

Integrated Treatment and Prevention for People Who Inject Drugs

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,281 (actual)
• Sponsor: HIV Prevention Trials Network · Network
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the feasibility of a future trial that will assess whether an integrated intervention combining psychosocial counseling and supported referrals for antiretroviral therapy (ART) at any CD4 cell count and substance use treatment for HIV-infected people who inject drugs (PWID) will reduce HIV transmission to HIV-uninfected injection partners, as compared to routine care dictated by national guidelines for HIV-infected PWID.

Detailed description

This is a multi-site, two-arm, randomized, vanguard study. Network units will consist of an HIV-infected index participant and his/her HIV-uninfected network injection partner(s). Network units will be randomized to the intervention or standard of care arms in a 1:3 ratio, stratified by site. To assess feasibility of the intervention, additional interviews will be conducted with study staff (systems navigators and counselors) and clinic-based stakeholders at each study site. Approximately 500 Index participants and their partners will be enrolled.

Conditions

• HIV Positive

Interventions

Type	Name	Description
BEHAVIORAL	Integrated Intervention	systems navigation, psychosocial counseling

Timeline

• Start date: 2015-02-04
• Primary completion: 2017-06-16
• Completion: 2018-06-30
• First posted: 2016-10-17
• Last updated: 2025-04-01

Locations

3 sites across 3 countries: Indonesia, Ukraine, Vietnam