Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05786027 |
Other study ID # |
2000023524 |
Secondary ID |
1K01DA047194-011 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.