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

• Sponsor: Yale University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05786027
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV	Behavioral: PDI	N/A

Detailed Description

The investigators will develop and pilot 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.

Aim 1: To develop, conduct, and assess the feasibility and the immediate and durable effects of a 12-week within-prison PDI to reduce HIV risk and increase uptake of primary HIV prevention among prisoners who abuse drugs and are ≥1 year prior to release at baseline. The quasi-experimental design where two prisons will be assigned to experiment and two comparable prisons will be assigned to control, will strive to account for the potential threats to internal validity (e.g. history and maturation), and to external validity (e.g. various interaction effects between characteristics of selected participants and their engagement in HIV prevention). The focus of this registration is Aim 1.

Aim 2: Using the data from structured ethnographic observation of PDI sessions, and qualitative interviews immediately after the PDI with prisoner participants, staff of prison addiction treatment programs, and researchers who implemented the PDI, to explore why the PDI is successful (or not), and optimize the PDI manual.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Exploring the Feasibility of a Peer-Driven Intervention to Improve HIV Prevention Among Prisoners Who Inject Drugs
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Peer Driven Intervention (PDI) 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; 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.
No Intervention: Treatment As Usual (TAU) 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.

Outcome Measures

Primary Outcome Measures

1. Number of participants enrolled in MMT or Atlantis 12-step addiction recovery program [up to 12 weeks]

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

2. Number of participants enrolled in MMT or Atlantis 12-step addiction recovery program [Month 9]

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

Secondary Outcome Measures

1. Number of times participants relapsed [Month 6]

   Number of times participants had any kind of relapse at Month 6.

2. Number of times participants relapsed [Month 9]

   Number of times participants had any kind of relapse at Month 9.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prison System	Bishkek		Kyrgyzstan	720051

Sponsors and Collaborators

• Yale University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Julia Rozanova, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT05786027
• Other Study ID Numbers: 2000023524; 1K01DA047194-01; 1K01DA047194-05
• First Posted: Mar 27, 2023
• Last Update Posted: Mar 27, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 27, 2023