Integrated Treatment and Prevention for People Who Inject Drugs

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02935296
• Date of registration: 12/10/2016
• Prospective Registration: No
• Primary sponsor: HIV Prevention Trials Network
• Public title: Integrated Treatment and Prevention for People Who Inject Drugs
• Scientific 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
• Date of first enrolment: February 2015
• Target sample size: 1281
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02935296
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Indonesia, Ukraine, Vietnam

Contacts

• Name: William Miller, MD
• Affiliation: Ohio State University

Key inclusion & exclusion 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:

-



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

HIV Positive

Intervention(s)

Behavioral: Integrated Intervention

Primary Outcome(s)

enrollment and retention of HIV-infected PWID and their HIV-uninfected network injection partners [Time Frame: 18 months]

HIV incidence among network injection partners of index participants [Time Frame: 18 months]

Secondary Outcome(s)

size and stability of drug using networks [Time Frame: 18 months]

HIV incidence among network injection partners of index participants in the intervention arm [Time Frame: 18 months]

Number of participants in either arm engaged in substance use treatment [Time Frame: 18 months]

Engagement in care for ART treatment services of control arm vs intervention [Time Frame: 18 months]

social harms and benefits [Time Frame: 18 months]

phylogenetics to describe HIV transmission dynamics [Time Frame: 18 months]

Secondary ID(s)

HPTN 074

UM1AI068619

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute on Drug Abuse (NIDA)

National Institute of Allergy and Infectious Diseases (NIAID)