Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04069624 |
| Other study ID # |
51656 |
| Secondary ID |
1UG1DA050069-01 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 17, 2020 |
| Est. completion date |
April 30, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
University of Kentucky |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This trial will test the effectiveness of delivering medication for opioid use disorder
(MOUD) pre-treatment via telehealth, alone and with peer navigation, to increase MOUD
initiation and maintenance in the community following jail release. This trial will focus on
incarcerated women in 6 experimental and 3 control sites in Kentucky. Enrollment is not open
to the general public.
Description:
This study will incorporate random assignment for two study conditions: medication for opioid
use disorder (MOUD) PreTreatment Telehealth or MOUD PreTreatment Telehealth with Peer
Navigation using a rigorous randomized block design. Women in the experimental conditions
will be stratified by sites (6 sites; 3 urban and 3 non-urban) and by offender classification
level of felony versus misdemeanor (due to potential differences in community supervision).
Three comparison sites with existing jail-based MOUD treatment for women will not be
randomized but will be included in analyses within planned, non-randomized comparisons.
1. MOUD PreTreatment Telehealth: Participants who screen positive for moderate to high-risk
opioid use and complete the baseline interview will be connected via telehealth to the
community MOUD provider for a psychosocial assessment. The study data coordinator will
assist with linking the participant to the community MOUD provider via telehealth, as
well as collecting initial in-person biological specimens for medical evaluation. The
psychosocial assessment with the community MOUD provider will involve a more detailed
examination of OUD using the Diagnostic and Statistical Manual of Mental Disorders (DSM)
5 criteria. Type of medication (naltrexone, buprenorphine, or methadone) will depend on
the psychosocial assessment and medical evaluation. Indications for the most appropriate
course of treatment will be determined by the community MOUD provider in conjunction
with the study participant. Women in this condition will also receive general education
about MOUD options including risks and benefits, and they will be given the opportunity
to ask questions about the medication. The community MOUD provider will also use
motivational interviewing to assess each woman's readiness to engage in MOUD and to
better understand possible barriers to MOUD utilization. At the end of the education
session, the study participant and the MOUD community provider will develop a re-entry
plan for ongoing care, which will include a plan for insurance coverage of medications
in the community.
2. MOUD PreTreatment Telehealth + Peer Navigation: In addition to MOUD PreTreatment
Telehealth, women in this arm will be connected with a peer, a woman in recovery who is
employed by Voices of Hope (VOH) in Lexington, KY. Peer Navigators will be located in
Lexington through a partnership with VOH. VOH is a non-profit recovery support
organization which provides peer recovery support services. In conjunction with the
study data coordinators, the Peer Navigator will schedule an initial session via
telehealth with the participant, assist with scheduling a follow-up appointment with the
community MOUD provider, and provide recovery support for community MOUD initiation and
maintenance. Peer Navigators will be certified Peer Support Specialists trained and
supervised by VOH in accordance with state statutory requirements. When a woman returns
to the community, Peer Navigators will engage her in weekly telephone recovery services
(TRS) for 12 weeks, which may include identifying personal goals and strength-based,
practical strategies for success. In addition to MOUD linkages to care, Peer Navigators
will suggest strategies to maintain sobriety and improve recovery capital, including
safe housing, transportation, financial counseling, continued education, employment
skills, and sober social activities.
3. Services as Usual: Women in this arm will not be randomized, but will receive substance
abuse treatment as usual in three comparison jail sites. Each of these jails has a
women's substance abuse program (SAP) managed by the Kentucky Department of Corrections
(KY-DOC with the option to initiate MOUD prior to jail release. These programs operate
as modified therapeutic communities with transitional support following release.
