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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants who initiate PrEP

Secondary outcome measures

Number of participants who are adherent to PrEP

Therapeutic procedure

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,851 Previous Clinical Trials

2,737,963 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,469 Previous Clinical Trials

2,619,159 Total Patients Enrolled

Carolina Price, MPAStudy DirectorYale University

Media Library

Athena strategy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05547048 — Phase 3

eHealth Research Study Groups: Athena Strategy, Decision Aid

eHealth Clinical Trial 2023: Athena strategy Highlights & Side Effects. Trial Name: NCT05547048 — Phase 3

Athena strategy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05547048 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any possibility of my becoming a participant in this research?

"This clinical trial, which is open to cis-women between 18 and 49 years of age who have HIV, requires participants to possess a functioning cellphone or landline phone. In addition, they must be confirmed as being HIV negative through point-of-care 4th generation Ag/Ab testing and meet certain criteria for Prep usage. Moreover, the study seeks individuals with opioid use disorder (irrespective of baseline treatment)."

Answered by AI

What is the main focus of this experiment?

"The main outcome the team will track over a one-month, three-month and six-month frame is the number of participants who commence Prep. The secondary goals include assessing changes in adherence to PrEP by means of urine tests as well as tracking individuals engaging with opioid use disorder treatments. Additionally, researchers want to evaluate the complexity of substance use disorder therapies received (e.g., court mandated vs voluntary, residential vs outpatient)."

Answered by AI

Is this study enrolling elderly participants who are 85 or older?

"This medical trial is specifically targeting patients aged 18 to 49 years old. Simultaneously, there are 147 trials for minors and 576 studies involving elderly individuals."

Answered by AI

Are there any opportunities for patients to join this experiment now?

"As per the data posted to clinicaltrials.gov, this experiment is not actively employing participants at present. Initially listed on June 1st 2023 and recently amended on September 26th 2022; nevertheless, there are currently 771 other studies that are in need of volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05547048.