Study Details

Protocol Status: Closed to Follow Up
Study Purpose:

After the originally scheduled Exit visit, Index participants will be offered the opportunity to re-enroll in the study for up to 12 additional months in order to further assess the durability of ART uptake and HIV viral suppression in the intervention. Should an effect of the intervention during the first part phase of the study be realized during the additional 12 months of follow-up, participants in the standard of care arm will be offered all components of the intervention

Study Design:

This is a 9-12 month extension for Index participants from the main study.

Study Population:
Study Size:

504 Index (HIV-positive) participants, from three sites

Study Duration:

9-12 months

Treatment Regimen:

Index participants will be re-enrolled into the same arm (intervention vs. standard of care) that they were randomized to in the main study. Index participants in the intervention arm will receive (in addition to the standard harm reduction package) an integrated intervention that includes supported ART regardless of CD4 cell count and facilitated referral for substance use treatment. The psychosocial component of the integrated intervention is designed to improve engagement and retention in HIV care and substance use treatment, and includes systems navigation, counseling to encourage engagement in care and adherence, and social support. Index participants in the standard of care arm will receive referrals for the in-country standard of care for ART and substance use treatment and a standardized harm reduction package. Network injection partners in both arms will receive a standardized harm reduction package with referral for substance use treatment, consistent with national guidelines.

Primary Objectives:

• To assess the feasibility of a future randomized controlled trial by:
a) estimating the HIV incidence among network injection partners of index participants in the standard of care arm in three distinct global settings with epidemics driven predominantly by injection drug use;
b) evaluating enrollment and retention of HIV-infected PWID and their HIV-uninfected network injection partners over a period of 12-36 months for index participants and 12-24 months for partners.
c) assess the durability of ART uptake and viral suppression in the intervention arm
• To assess the feasibility, barriers, and uptake of an integrated intervention for prevention of HIV transmission among HIV-infected index participants.

Secondary Objectives:

• To explore the effect of the integrated intervention, as compared to standard of care, on engagement in HIV care, initiation of ART, retention on ART, ART adherence, and virologic suppression among ART-eligible index participants (index participants meeting national guidelines in the standard of care arm; all index participants in the intervention arm). If an effect is observed on ART uptake or HIV viral suppression in the intervention arm vs. standard of care arm, participants in the standard of care arm will be offered the intervention for the remainder of the study.