Integrated Treatment and Prevention for People Who Inject Drugs

Not Applicable

Completed

• Conditions: HIV Positive
• Interventions: Behavioral: Integrated Intervention

• Registration Number: NCT02935296
• Lead Sponsor: HIV Prevention Trials Network

Brief 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.

Study Timeline

• Study Start: 2015-02-04
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-17
• Primary Completion: 2017-06-16
• Study Completion: 2018-06-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1281

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated Intervention	Integrated Intervention	Standard of care plus an integrated system of psychosocial counseling and systems navigation for HIV treatment and Substance Use treatment

Primary Outcome Measures

Name	Time	Method
enrollment and retention of HIV-infected PWID and their HIV-uninfected network injection partners	18 months	Number of participants enrolled, and number of participants with a final study visit.
HIV incidence among network injection partners of index participants	18 months	Number of HIV seroconversions to partners to control arm Index participants

Secondary Outcome Measures

Name	Time	Method
Number of participants in either arm engaged in substance use treatment	18 months	self reported on case report forms
social harms and benefits	18 months	self report via questionnaire
HIV incidence among network injection partners of index participants in the intervention arm	18 months	Number of HIV seroconversions to partners of Intervention arm participants
Engagement in care for ART treatment services of control arm vs intervention	18 months	Number of participants in both arms who report being in ART (case report forms) care, as well as testing stored plasma for HIV RNA suppression
phylogenetics to describe HIV transmission dynamics	18 months	stored plasma samples from those persons who are HIV positive and those who become HIV positive during the study
size and stability of drug using networks	18 months	self reported data via questionnaire of drug sharing habits and partners at each study visit

Trial Locations

Locations (3)

CIPTO; 🇮🇩 Jakarta, Indonesia

Pho Yen Health Center; 🇻🇳 Hanoi, Vietnam

Ukrainian Institute on Public Health Policy; 🇺🇦 Kiev, Ukraine