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Completed

NCT Number: NCT05786027

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

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Prison System

Bishkek, 720051, Kyrgyzstan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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

    Time frame: Month 9

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

Secondary outcomes

  1. Number of times participants relapsed

    Time frame: Month 6

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

  2. Number of times participants relapsed

    Time frame: Month 9

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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 27, 2023
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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