Integrated Treatment and Prevention for People Who Inject Drugs

NCT02935296 | Completed DMC

• 2 other identifiers: HPTN 074UM1AI068619
• Study Type: interventional
• Target: 1,281
• Locations: 3 countries
• Sites: 3

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.

Conditions

HIV Positive

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• HIV incidence among network injection partners of index participants in the intervention arm

  18 months

• Engagement in care for ART treatment services of control arm vs intervention

  18 months

• Number of participants in either arm engaged in substance use treatment

  18 months

• size and stability of drug using networks

  18 months

• social harms and benefits

  18 months

Study Arms (2)

Control

NO INTERVENTION

Standard of Care

Integrated Intervention

EXPERIMENTAL

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

Behavioral: Integrated Intervention

Interventions

Integrated Intervention BEHAVIORAL

systems navigation, psychosocial counseling

Integrated Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• HIV Prevention Trials Network: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (3)

CIPTO

Jakarta, Indonesia

Location

Ukrainian Institute on Public Health Policy

Kiev, Ukraine

Location

Pho Yen Health Center

Hanoi, Vietnam

Location

Related Publications (2)

• 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.

  PMID: 31794031 DERIVED

• 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.

  PMID: 30191830 DERIVED

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• William Miller, MD

  Ohio State University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 17, 2016
• Study Start: February 4, 2015
• Primary Completion: June 16, 2017
• Study Completion: June 30, 2018
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1); VN (1); ID (1)