Clinical trial NCT05786027: Exploring the Feasibility of a Peer-Driven Intervention to Improve HIV Prevention Among Prisoners Who Inject Drugs
Official title: Exploring the Feasibility of a Peer-Driven Intervention to Improve HIV Prevention Among Prisoners Who Inject Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-03-27
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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:

Primary outcomes:
measure: Number of participants enrolled in MMT or Atlantis 12-step addiction recovery program
timeFrame: up to 12 weeks
measure: Number of participants enrolled in MMT or Atlantis 12-step addiction recovery program
timeFrame: Month 9
Secondary outcomes:
measure: Number of times participants relapsed
timeFrame: Month 6
measure: Number of times participants relapsed
timeFrame: Month 9
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: Prison System
Study officials:
affiliation: Yale University
name: Julia Rozanova, PhD
role: PRINCIPAL_INVESTIGATOR
References: