NCT05547048

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_4 hiv

Timeline
11mo left

Started Jul 2023

Typical duration for phase_4 hiv

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jul 2023Apr 2027

First Submitted

Initial submission to the registry

September 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

July 25, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

3.7 years

First QC Date

September 15, 2022

Last Update Submit

May 13, 2025

Conditions

HIVOpioid Use DisordereHealth

Outcome Measures

Primary Outcomes (1)

  • Number of participants who initiate PrEP

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

    up to 6 months

Secondary Outcomes (2)

  • Number of participants who are adherent to PrEP

    up to 6 months

  • Number of participants who engage in opioid use disorder treatment

    up to 6 months

Study Arms (2)

Athena Strategy

EXPERIMENTAL

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

Decision Aid

ACTIVE COMPARATOR

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

Behavioral: Decision Aid

Interventions

Decision AidBEHAVIORAL

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

Decision Aid
Athena strategyCOMBINATION_PRODUCT

eHealth for integrated PrEP/medications for opioid use disorder + decision aid

Athena Strategy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cis-women
  • have access to a working mobile or landline phone
  • Lifetime CJ-involvement (probation, parole, intensive pretrial or community supervision, or release from prison/jail)
  • are confirmed HIV-negative by point-of-care 3rd generation HIV antibody test
  • meet clinical criteria for PrEP
  • have opioid use disorder (regardless of baseline treatment status)

You may not qualify if:

  • unable or unwilling to provide informed consent
  • pregnant or breast-feeding
  • currently taking PrEP at the time of study enrollment
  • not comfortable conversing in English or Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alabama in Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Yale University

New Haven, Connecticut, 06519, United States

RECRUITING

Related Publications (1)

  • Meyer JP, Brunson S, Price CR, Mulrain M, Nguyen J, Altice FL, Kyriakides TC, Cropsey K, Eaton E. Rationale and design of a randomized clinical trial of integrated eHealth for PrEP and medications for opioid use disorders for women in the criminal legal system. The Athena study. Addict Sci Clin Pract. 2025 Jan 17;20(1):4. doi: 10.1186/s13722-024-00534-x.

    PMID: 39825419DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Carolina Price, MPA

    Yale University

    STUDY DIRECTOR

  • Jaimie P Meyer, MD, MS, FACP

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrienne L Marable

CONTACT

(203) 737-3393gcat5@yale.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study will compare the Athena strategy to a decision aid-only intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 21, 2022

Study Start

July 25, 2023

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)