Integrated Treatment and Prevention for People Who Inject Drugs

HIV Positive Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• HIV Positive
• HIV Seropositivity

• NCT number: NCT02935296
• Study type: Interventional
• Source: HIV Prevention Trials Network
• Status: Completed
• Phase: Phase 3
• Start date: February 2015
• Completion date: June 30, 2018