Overview

This trial is active, not recruiting.

Condition hiv positive
Treatment integrated intervention
Phase phase 3
Sponsor HIV Prevention Trials Network
Collaborator National Institute on Drug Abuse (NIDA)
Start date February 2015
End date July 2017
Trial size 1281 participants
Trial identifier NCT02935296, HPTN 074, UM1AI068619

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(No Intervention)
Standard of Care
(Experimental)
Standard of care plus an integrated system of psychosocial counseling and systems navigation for HIV treatment and Substance Use treatment
integrated intervention
systems navigation, psychosocial counseling

Primary Outcomes

Measure
HIV incidence among network injection partners of index participants
time frame: 18 months
enrollment and retention of HIV-infected PWID and their HIV-uninfected network injection partners
time frame: 18 months

Secondary Outcomes

Measure
HIV incidence among network injection partners of index participants in the intervention arm
time frame: 18 months
Engagement in care for ART treatment services of control arm vs intervention
time frame: 18 months
Number of participants in either arm engaged in substance use treatment
time frame: 18 months
size and stability of drug using networks
time frame: 18 months
social harms and benefits
time frame: 18 months
phylogenetics to describe HIV transmission dynamics
time frame: 18 months

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

Inclusion Criteria: Index participants: - Age 18-45 years at the Screening visit (age verification procedures will be defined in the Study Specific Procedures [SSP] Manual) - Able to provide informed consent - Active injection drug user, defined as self-report of: a) injecting drugs approximately two or more times per week for the past three months, and b) ability to identify the anatomical location of the most recent injection site, as determined by study staff - Reports sharing needles/syringes or drug solutions at least once in the last month - HIV-infected based on a study-defined testing algorithm (defined in the SSP Manual) - Viral load ≥1,000 copies/mL at Screening - Willing and able to identify, recruit, and have enrolled at least one HIV-uninfected network injection partner who is eligible for study participation according to the criteria below - Have no plans to move outside the study area for at least one year after study enrollment - Willing to participate in intervention activities, including regular phone contact HIV uninfected injection partners: - Age 18-45 years at the Screening visit (age verification procedures will be defined in the SSP Manual) - Able to provide informed consent - Active injection drug user, defined as: a) self-report of injecting drugs approximately two times per week for the past three months, and b) ability to identify the anatomical location of the most recent injection site, as determined by study staff - Confirmed injection partner, using referral identification cards, of index participant within the past 1 month - HIV-uninfected based on the study-defined testing algorithm* (defined in the Study SSP Manual) - Have no plans to move outside the study area for at least one year after study enrollment Exclusion Criteria:

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by HIV Prevention Trials Network.