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

Recruiting at 1 trial location

Overseen By Jaimie P Meyer, MD, MS, FACP

Age: 18+

Sex: Female

Trial Phase: Phase 3

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)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Athena strategy for Substance Use Disorders and HIV/AIDS?

The use of health information technology (HIT) interventions has been shown to be cost-effective in improving HIV care and achieving viral suppression, which suggests that similar eHealth strategies could be beneficial for integrated care in HIV and substance use disorders. Additionally, decision aids have been found to help individuals with opioid use disorder make informed treatment decisions, indicating that such tools could enhance the effectiveness of Project ATHENA's integrated approach. ^{1 2 3 4 5}

What makes the Integrated e-Health for Substance Use Disorders and HIV/AIDS treatment unique?

This treatment is unique because it integrates e-health technology to provide comprehensive care for both substance use disorders and HIV/AIDS, using tools like mobile phone messaging and decision aids to enhance patient engagement and care coordination. ^{1 6 7 8 9}

Research Team

Carolina Price, MPA

Principal Investigator

Yale University

Jaimie P Meyer, MD, MS, FACP

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Patient decision aid for medication treatment for opioid use disorder (PtDA-MOUD): Rationale, methodology, and preliminary results. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Implementation of eHealth Interventions Across the HIV Care Cascade: a Review of Recent Research. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Lessons Learned from an HIV Pre-Exposure Prophylaxis Coordination Program in San Francisco Primary Care Clinics. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Attitudes toward Web application supporting pharmacist-clinician comanagement of postexposure prophylaxis patients. [2021]

6. Ireland 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. [2022]

7. New Zealand 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. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile Phone Messaging During Unobserved "Home" Induction to Buprenorphine. [2018]

9. United States 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. [2023]