Clinical trial NCT02935296: Integrated Treatment and Prevention for People Who Inject Drugs
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Positive
Lead sponsor: HIV Prevention Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2016-10-17
Enrollment: 1281
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: HIV incidence among network injection partners of index participants
timeFrame: 18 months
measure: enrollment and retention of HIV-infected PWID and their HIV-uninfected network injection partners
timeFrame: 18 months
Secondary outcomes:
measure: HIV incidence among network injection partners of index participants in the intervention arm
timeFrame: 18 months
measure: Engagement in care for ART treatment services of control arm vs intervention
timeFrame: 18 months
measure: Number of participants in either arm engaged in substance use treatment
timeFrame: 18 months
measure: size and stability of drug using networks
timeFrame: 18 months
measure: social harms and benefits
timeFrame: 18 months
measure: phylogenetics to describe HIV transmission dynamics
timeFrame: 18 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: CIPTO
city: Kiev
country: Ukraine
facility: Ukrainian Institute on Public Health Policy
city: Hanoi
country: Vietnam
facility: Pho Yen Health Center
Study officials:
affiliation: Ohio State University
name: William Miller, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.