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

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.

Study Overview

• Status: Completed
• Conditions: HIV Positive
• Intervention / Treatment: Behavioral: Integrated Intervention

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 Type: Interventional
• Enrollment (Actual): 1281
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia
    • CIPTO
• Ukraine
  • Kiev, Ukraine
    • Ukrainian Institute on Public Health Policy
• Vietnam
  • Hanoi, Vietnam
    • Pho Yen Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of Care
Experimental: Integrated Intervention; Standard of care plus an integrated system of psychosocial counseling and systems navigation for HIV treatment and Substance Use treatment	Behavioral: Integrated Intervention; systems navigation, psychosocial counseling

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HIV Prevention Trials Network
• Collaborators: National Institute on Drug Abuse (NIDA); National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: William Miller, MD, Ohio State University

Publications and helpful links

General Publications

• Sivay MV, Grabowski MK, Zhang Y, Palumbo PJ, Guo X, Piwowar-Manning E, Hamilton EL, Viet Ha T, Antonyak S, Imran D, Go V, Liulchuk M, Djauzi S, Hoffman I, Miller W, Eshleman SH. Phylogenetic Analysis of Human Immunodeficiency Virus from People Who Inject Drugs in Indonesia, Ukraine, and Vietnam: HPTN 074. Clin Infect Dis. 2020 Nov 5;71(8):1836-1846. doi: 10.1093/cid/ciz1081.
• Miller WC, Hoffman IF, Hanscom BS, Ha TV, Dumchev K, Djoerban Z, Rose SM, Latkin CA, Metzger DS, Lancaster KE, Go VF, Dvoriak S, Mollan KR, Reifeis SA, Piwowar-Manning EM, Richardson P, Hudgens MG, Hamilton EL, Sugarman J, Eshleman SH, Susami H, Chu VA, Djauzi S, Kiriazova T, Bui DD, Strathdee SA, Burns DN. A scalable, integrated intervention to engage people who inject drugs in HIV care and medication-assisted treatment (HPTN 074): a randomised, controlled phase 3 feasibility and efficacy study. Lancet. 2018 Sep 1;392(10149):747-759. doi: 10.1016/S0140-6736(18)31487-9.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2015
• Primary Completion (Actual): June 16, 2017
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (Estimated): October 17, 2016

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; HIV Seropositivity
• Other Study ID Numbers: HPTN 074; UM1AI068619 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no individual data will be shared