Exploring the Feasibility of a Peer-Driven Intervention to Improve HIV Prevention Among Prisoners Who Inject Drugs

NCT05786027 | Completed

• 3 other identifiers: 20000235241K01DA047194-011K01DA047194-05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop, conduct, and assess the feasibility of a) a pilot peer-driven intervention (PDI) to reduce HIV risk and increase the uptake of primary HIV prevention services (i.e. prison addiction treatment programs), and b) explore the PDI's usefulness from the perspective of both prisoners and prison staff to make recommendations for the PDI future improvement and adaptation.

Conditions

HIV

Outcome Measures

Primary Outcomes (2)

• Number of participants enrolled in MMT or Atlantis 12-step addiction recovery program

  Number of participants that enrolled in MMT or Atlantis 12-step addiction recovery program from baseline up to 12 weeks.

  up to 12 weeks

• Number of participants enrolled in MMT or Atlantis 12-step addiction recovery program

  Number of participants that enrolled in MMT or Atlantis 12-step addiction recovery program at month 9.

  Month 9

Secondary Outcomes (2)

• Number of times participants relapsed

  Month 6

• Number of times participants relapsed

  Month 9

Study Arms (2)

Peer Driven Intervention (PDI)

EXPERIMENTAL

Participants from two experimental (E) prisons that are HIV-negative will be assigned to this arm. Participants will receive 12 weeks of PDI and weekly opioid urine tests. Prior to intervention participants will receive training by a Health Educator (HE) in Health Advocate (HA) and Peer roles.

Behavioral: PDI

Treatment As Usual (TAU)

NO INTERVENTION

Participants from two control (C) prisons that are HIV-negative will be assigned to this arm. Participants will receive treatment as usual (which includes universal access to SSP, MMT, and Atlantis program for individuals with opioid dependence) and weekly urine opioid tests for 12 weeks.

Interventions

PDI BEHAVIORAL

A 12-week in-prison peer-driven intervention to increase the uptake of primary HIV prevention strategies (readiness to initiate addiction treatment (MMT or Atlantis), initiation of MMT/Atlantis, retention in MMT/Atlantis; or the use of SSP), and reduce the use of opioids and HIV risk behaviors, in HIV-negative PWID in prison.

Peer Driven Intervention (PDI)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: There is only one female prison in KYR and few women PWID in prison (about 1% of the total female prisoner population) per our recent bio-behavioral study. Thus, only men will be included into the pilot PDI in this instance.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV negative by self-report before the study confirmed by HIV rapid test
• Has ever injected drugs
• ≥1 year before prison release (release dates are fixed and accurate)
• currently not enrolled in MMT/Atlantis
• Capable of providing informed consent.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Prison System

Bishkek, 720051, Kyrgyzstan

Location

Study Officials

• Julia Rozanova, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: January 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KY (1)