Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05547048
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
250
2
2
54
125
2.3

Study Details

Study Description

Brief Summary

The purpose of this 2-site (CT, AL) study is to test innovative interventions to reduce stigma and improve the pre-exposure prophylaxis (PrEP) and opioid use disorder (OUD) care continua in women involved in the criminal justice system (WICJ).

This study evaluates a newly validated PrEP decision aid and eHealth for integrated PrEP and MOUD compared to a decision aid-only for WICJ with OUD.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Decision Aid
  • Combination Product: Athena strategy
N/A

Detailed Description

Problem: There is urgent need to reach women involved in criminal justice (WICJ) for lifesaving, evidence-based PrEP and medications for OUD (MOUD), using innovative healthcare delivery models that surmount existing social and structural barriers to engagement.

Purpose: This study uses a newly validated decision aid and eHealth to remotely deliver integrated PrEP and MOUD to community-based WICJ with OUD in New Haven, Connecticut (CT) and Birmingham, Alabama (AL).

Methods: 250 PrEP-eligible WICJ with OUD will undergo randomization to: a) the "Athena" strategy, which includes the decision aid + eHealth for remote integrated PrEP/MOUD with a provider using outputs from the decision aid; or b) decision aid-only with referral to community-based PrEP/MOUD. Randomization will be stratified by site; past 6-month use of any stimulants; and baseline receipt of MOUD. Follow-up study assessments occur at months 1, 3, and 6. To understand implementation, the investigators will conduct population modeling and engage with relevant stakeholders through focus groups using nominal group technique and in-depth individual interviews.

Aims: The Aims of the project are: 1) To compare the Athena strategy to decision aid-only in terms of patient-level engagement in the PrEP and OUD care continua, considering key site differences; and 2) To assess scale-up potential of the Athena strategy in terms of modelled long-term outcomes and how stakeholders interact with eHealth for integrated PrEP/MOUD in WICJ in two diverse epidemiological and implementation contexts (CT and AL), using standardized definitions of implementation outcomes.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study will compare the Athena strategy to a decision aid-only intervention.This study will compare the Athena strategy to a decision aid-only intervention.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Integrated eHealth for HIV and Substance Use Disorders in Justice Involved Women
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Nov 30, 2027
Anticipated Study Completion Date :
Nov 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Athena Strategy

Virtual care model that includes direct synchronous videoconferencing with a provider, telephone/ texting communication, electronic health records, e-prescribing for the purposes of delivering PrEP and medications for opioid use disorder. This is combined with a decision aid for PrEP

Combination Product: Athena strategy
eHealth for integrated PrEP/medications for opioid use disorder + decision aid

Active Comparator: Decision Aid

Decision aid for PrEP tailored for justice-involved women with opioid use disorder

Behavioral: Decision Aid
Decision aid for PrEP tailored for justice-involved women with opioid use disorder

Outcome Measures

Primary Outcome Measures

  1. Change in PrEP initiation [Month 1, Month 3, and Month 6]

    PrEP in initiation will be determined using dates of prescription and pharmacy fill and medication type (brand/generic)

Secondary Outcome Measures

  1. Change in PrEP Adherence [Month 1, Month 3, and Month 6]

    PrEP adherence will be assessed using a urine assay for measuring tenofovir levels (single point of care qualitative immunoassay reflecting past 48-hour adherence), where a positive test results indicates adherence.

  2. Change in Opioid use disorder treatment cascade engagement [Month 1, Month 3, and Month 6]

    The opioid use disorder treatment cascade engagement is composed of and defined by: 1) initiation of medications for opioid use disorder (or other evidence-based treatment); 2) 6-month retention on treatment; and 3) remission. The study will assess for complexity of substance use disorder treatment (e.g., court mandated vs. voluntary, behavioral vs. MOUD, residential vs. outpatient, detoxification program, etc.).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. cis-women; 2) ages 18-49y (because they experience the highest HIV risk); 3) have access to a working mobile or landline phone; 4) CJ-involved (currently on probation, parole, intensive pretrial or community supervision, or are within 60 days after release from prison/jail; 5) are confirmed HIV-negative by point-of-care 4th generation HIV Ag/Ab test;
  2. meet clinical criteria for PrEP; and 7) have opioid use disorder (regardless of baseline treatment status)
Exclusion Criteria:
  1. unable or unwilling to provide informed consent; 2) pregnant or breast-feeding; 3) currently taking PrEP at the time of study enrollment or 4) not comfortable conversing in English or Spanish.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama in Birmingham Birmingham Alabama United States 35294
2 Yale University New Haven Connecticut United States 06519

Sponsors and Collaborators

  • Yale University
  • National Institute on Drug Abuse (NIDA)

Investigators

  • Study Director: Carolina Price, MPA, Yale University
  • Principal Investigator: Jaimie P Meyer, MD, MS, FACP, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT05547048
Other Study ID Numbers:
  • 2000033006
  • 1R01DA057342-01
First Posted:
Sep 21, 2022
Last Update Posted:
Sep 21, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2022