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Integrated e-Health for Substance Use Disorders and HIV/AIDS
Phase 3
Recruiting
Led By Jaimie P Meyer, MD, MS, FACP
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will test if an online decision aid and eHealth program can help reduce stigma and improve PrEP and opioid use disorder care for women involved in the criminal justice system.
Who is the study for?
This trial is for women involved in the criminal justice system who are HIV-negative, have opioid use disorder, and meet criteria for PrEP (a medication to prevent HIV). They must not be pregnant or breastfeeding, already on PrEP, or unable to consent. Comfort with English or Spanish is required.
What is being tested?
The study tests a new PrEP decision aid and eHealth strategy aimed at reducing stigma and improving care for opioid use disorder among these women. It compares the effectiveness of integrated eHealth support with just the decision aid.
What are the potential side effects?
Specific side effects are not detailed here but may include typical reactions related to electronic health interventions such as discomfort from discussing sensitive topics or privacy concerns.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants who initiate PrEP
Secondary study objectives
Number of participants who are adherent to PrEP
Therapeutic procedure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Athena StrategyExperimental Treatment1 Intervention
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
Group II: Decision AidActive Control1 Intervention
Decision aid for PrEP tailored for justice-involved women with opioid use disorder
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,224 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,607 Previous Clinical Trials
3,329,565 Total Patients Enrolled
Carolina Price, MPAStudy DirectorYale University
Jaimie P Meyer, MD, MS, FACPPrincipal InvestigatorYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a cisgender woman.I meet the requirements for HIV prevention medication.I am not comfortable speaking in English or Spanish.I am currently taking medication to prevent HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Athena Strategy
- Group 2: Decision Aid
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.