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Integrated e-Health for Substance Use Disorders and HIV/AIDS

University of Alabama in Birmingham, Birmingham, AL

Targeting 3 different conditionsAthena strategy +1 morePhase 3RecruitingLed by Jaimie P Meyer, MD, MS, FACPResearch Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

are confirmed HIV-negative by point-of-care 4th generation HIV Ag/Ab test

cis-women

Must not have

Be younger than 18 years old

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 6 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

Eligible Conditions

eHealth
HIV/AIDS
Opioid Use Disorder

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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Individuals who were assigned female at birth.

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You meet the medical requirements for PrEP (pre-exposure prophylaxis).

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You have a problem with using opioid drugs, regardless of whether you are receiving treatment for it or not.

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

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,806 Previous Clinical Trials

2,711,431 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,398 Previous Clinical Trials

2,060,784 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 e 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.