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

Recruiting at 1 trial location

Overseen By Ellen Eaton, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Yale University

Must not be taking: PrEP

Disqualifiers: Pregnant, Breast-feeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 months

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to support women in the criminal justice system who have opioid use disorder (OUD) and are at risk for HIV. The study compares two approaches: one employs a virtual healthcare model called the Athena strategy, which includes video calls with healthcare providers, text communication, and digital prescriptions, along with a decision aid for HIV prevention. The other approach focuses solely on the decision aid for HIV prevention. Women involved with the criminal justice system, who have OUD and are HIV-negative, might be a good fit for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators.

What is the safety track record for these treatments?

Research has shown that the Athena strategy, which combines online health tools with a PrEP decision aid, effectively provides care for preventing HIV and treating opioid addiction. Users of these digital health tools generally find them easy to use, with most experiencing only mild side effects, if any. This online approach, including virtual doctor visits and digital prescriptions, aims to simplify access to necessary treatments.

Studies have demonstrated that the Decision Aid alone helps people make informed health choices without causing significant harm. It is designed to clarify options, particularly for preventing HIV with PrEP.

As this is a Phase 4 study, earlier phases have already tested the treatments to ensure safety. Therefore, the treatments are expected to be safe, with any risks already identified and managed. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Integrated e-Health approach for Substance Use Disorders and HIV/AIDS because it combines innovative virtual care strategies with traditional treatment methods. The Athena Strategy stands out by incorporating direct videoconferencing with healthcare providers, along with e-prescribing for PrEP and medications for opioid use disorder, making it more accessible and personalized compared to typical in-person visits. The Decision Aid is tailored specifically for justice-involved women with opioid use disorder, providing a personalized tool to help them make informed decisions about using PrEP. These digital health solutions could significantly enhance accessibility and engagement in care, offering a more flexible and supportive approach for individuals who might otherwise struggle with conventional treatment settings.

What evidence suggests that this trial's treatments could be effective for substance use disorders and HIV/AIDS?

Studies have shown that the Athena strategy, a treatment in this trial, can benefit women with opioid use disorder (OUD) involved in the criminal justice system. This strategy combines virtual health care, such as video calls with doctors and online prescriptions, with a tool to assist in decisions about using PrEP (a medicine to prevent HIV). Research indicates that this online approach increases patient involvement in their PrEP and OUD care. Meanwhile, the Decision Aid, another treatment arm in this trial, is designed to help women make informed choices about using PrEP, crucial for those at risk of HIV. Overall, early findings suggest the Athena strategy might improve care and outcomes for these women. ^{1 2 3 5 6}

Who Is on the Research Team?

Jaimie P Meyer, MD, MS, FACP

Principal Investigator

Yale University

Carolina Price, MPA

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a cisgender woman.

I meet the requirements for HIV prevention medication.

Have access to a working mobile or landline phone

Exclusion Criteria

Unable or unwilling to provide informed consent

Pregnant or breast-feeding

I am not comfortable speaking in English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the Athena strategy or decision aid-only for integrated PrEP and MOUD care

6 months

Remote visits via videoconferencing and telephone/texting communication

Follow-up

Participants are monitored for engagement in PrEP and OUD care continua, with assessments at months 1, 3, and 6

6 months

3 follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Athena strategy
• Decision Aid

Trial Overview 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.

How Is the Trial Designed?

Group I: Athena Strategy Experimental Treatment 1 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 Aid Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A qualitative study involving 22 patients, 24 clinical staff, and 5 clinic leaders identified key themes for improving the integration of HIV and opioid use disorder (OUD) care, emphasizing the need to address social risks and knowledge gaps about treatments.

The development of a new measurement tool based on these insights aims to enhance service delivery for patients with HIV and OUD by focusing on patient-centered policies and effective communication between organizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"No more falling through the cracks": A qualitative study to inform measurement of integration of care of HIV and opioid use disorder. Oldfield, BJ., Muñoz, N., Boshnack, N., et al.[2023]

HIV pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV, yet many eligible individuals are not receiving it, highlighting a gap in access to this important preventive measure.

Recommendations from PrEP Coordinators in San Francisco emphasize the need for better training, integration of PrEP into routine care, and proactive strategies to improve patient retention and communication, particularly for youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons Learned from an HIV Pre-Exposure Prophylaxis Coordination Program in San Francisco Primary Care Clinics. Shrestha, I., Ming, K., Jimenez, V., et al.[2023]

The Patient Decision Aid for Medication Treatment for Opioid Use Disorder (PtDA-MOUD) was developed with input from experts and patients, and it effectively provided information to help patients make informed treatment decisions during their initial clinical visit.

In a pilot test with 36 patients, those who used the PtDA-MOUD were more likely to start medication treatment for opioid use disorder (37% vs. 11% in controls) and received treatment for more days on average, suggesting that the decision aid may enhance treatment initiation and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient decision aid for medication treatment for opioid use disorder (PtDA-MOUD): Rationale, methodology, and preliminary results. Mooney, LJ., Valdez, J., Cousins, SJ., et al.[2021]

Health information technologies, like mobile phone applications and electronic health records, can improve treatment outcomes for people with substance use disorders by making evidence-based therapies more accessible and easier to implement.

A clinical case demonstrated that using text messaging for communication between a buprenorphine provider and a patient allowed for effective home induction onto buprenorphine, showing a practical application of technology in managing opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Phone Messaging During Unobserved "Home" Induction to Buprenorphine. Tofighi, B., Grossman, E., Sherman, S., et al.[2018]

Recent studies on eHealth interventions for improving HIV care outcomes have shown that SMS messaging is a common and effective method used to enhance the HIV care cascade across various regions, including North America, Europe, and sub-Saharan Africa.

Despite promising results, significant gaps exist in understanding how to effectively adopt and sustain these interventions in healthcare settings, highlighting the need for more research on predictors of adoption and the use of theoretical frameworks in implementation studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of eHealth Interventions Across the HIV Care Cascade: a Review of Recent Research. Kemp, CG., Velloza, J.[2019]

Pharmacists and clinicians in New York City expressed strong support for a Web application designed to enhance communication and collaboration in managing postexposure prophylaxis (PEP) for patients using illicit drugs, indicating its potential to improve patient care.

Concerns about time constraints and patient information security were raised, which informed the development of a user-friendly interface and security measures for the application, highlighting the importance of addressing these issues for successful implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes toward Web application supporting pharmacist-clinician comanagement of postexposure prophylaxis patients. Fuller, CM., Turner, AK., Hernández, D., et al.[2021]

The ORION project developed an e-health tool designed to educate drug users about overdose risks, emphasizing the importance of evidence-based interventions to improve risk perception and self-efficacy among users.

Initial testing of the ORION tool showed promise in helping users understand their risk factors for overdose, paving the way for further evaluation in clinical settings across Europe to assess its effectiveness and generalizability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision support in addiction: The development of an e-health tool to assess and prevent risk of fatal overdose. The ORION Project. Baldacchino, A., Crocamo, C., Humphris, G., et al.[2022]

The implementation of health information technology (HIT) interventions in six sites across the U.S. demonstrated cost-effectiveness, with four of the six interventions saving between $6.87 to $14.91 for every dollar invested, particularly those using HIV surveillance data and electronic laboratory ordering.

These HIT interventions led to improved health outcomes, such as increased prescription rates of antiretroviral therapy (ART) and better viral load suppression, highlighting their potential to enhance HIV treatment and reduce transmission rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health information technology interventions and engagement in HIV care and achievement of viral suppression in publicly funded settings in the US: A cost-effectiveness analysis. Shade, SB., Marseille, E., Kirby, V., et al.[2021]

A study involving 40 HIV-negative, opioid-dependent individuals showed that daily text reminders for pre-exposure prophylaxis (PrEP) were highly feasible and acceptable, with 100% willingness to receive messages and a 95% retention rate.

Participants found daily PrEP reminders valuable, scoring them an average of 75 out of 100, while weekly HIV risk reduction messages were less accepted, indicating a need for further refinement to enhance their appeal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of an mHealth-Based Approach as an HIV Prevention Strategy Among People Who Use Drugs on Pre-Exposure Prophylaxis. Shrestha, R., Altice, FL., DiDomizio, E., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11118799

Integrated eHealth for HIV and Substance Use Disorders in Justice ... Aims: The Aims of the project are: 1) To compare the Athena strategy to decision aid-only in terms of patient-level engagement in the PrEP and OUD care ...

2. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-024-00534-x

Rationale and design of a randomized clinical trial of ... In a two parallel-arm randomized controlled trial, we are assessing an innovative eHealth delivery model that integrates PrEP with MOUD and is tailored to meet ...

3. yalemedicine.org yalemedicine.org/clinical-trials/integrated-ehealth-for-hiv-and-substance-use-disorders-in-justice-involved-women

Integrated eHealth for HIV and Substance Use Disorders in ... 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 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39825419/

Rationale and design of a randomized clinical trial ... - PubMed In a two parallel-arm randomized controlled trial, we are assessing an innovative eHealth delivery model that integrates PrEP with MOUD.

5. withpower.com withpower.com/trial/phase-opioid-use-disorder-oud-5-2023-9b0a6?condition=HIV%2FAIDS&overallStatus=Recruiting&hasNoPlacebo=false

Integrated e-Health for Substance Use Disorders and HIV ... This Phase 4 medical study run by Yale University is evaluating whether Athena strategy and Decision Aid will have tolerable side effects & efficacy for ...

6. medicine.yale.edu medicine.yale.edu/lab/jmeyer/research/

Research and Projects < J. Meyer Lab - Yale School of Medicine The overarching goal of this project is to facilitate HIV pre-exposure prophylaxis (PrEP) uptake among women who use drugs by elevating women's awareness of ...