NCT05547048 · Yale University
Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Decision Aid
Decision aid for PrEP tailored for justice-involved women with opioid use disorder
COMBINATION_PRODUCT
Athena strategy
eHealth for integrated PrEP/medications for opioid use disorder + decision aid
Primary outcome measures
Number of participants who initiate PrEP
Time frame: up to 6 months
PrEP in initiation will be determined using dates of prescription and pharmacy fill and medication type (brand/generic)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
Exclusion criteria
- 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.
Where
- Birmingham, Alabama
- New Haven, Connecticut
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations