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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05786027
• Other study ID #: 2000023524
• Secondary ID: 1K01DA047194-011
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
Kyrgyzstan	Prison System	Bishkek

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

Kyrgyzstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of times participants relapsed	Number of times participants had any kind of relapse at Month 6.	Month 6
Secondary	Number of times participants relapsed	Number of times participants had any kind of relapse at Month 9.	Month 9