Testing a Mobile Health Application to Improve HIV Prevention and Substance Use Treatment Among Women Involved in the Carceral System

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTemple University

About this trial

Women involved in the carceral system (WICS) are at higher risk for both HIV and substance use than the general public. WICS are also more likely to engage in behaviors both before and after release that put them at risk for HIV and for overdose, due to opioid use. Despite these risk factors, WICS are less likely to be aware of, use, or adhere to pre-exposure prophylaxis (PrEP) and have less access to medications for opioid use disorder (MOUD). The primary goal of the proposed research is to pilot test a systematically developed PrEP and MOUD uptake intervention for WICS using contextually relevant messages developed through novel formative research methods and embedded in a web-based application in a rigorous research design. The investigators will then test this approach (called PA-LINKS) in a pilot randomized trial with women who have recently been incarcerated in Philadelphia in partnership with Philadelphia FIGHT, a federally qualified health center, for promise of efficacy, and to assess feasibility and acceptability.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 of years of age or older

Self-identified woman

Previous experience (past six months) with the carceral system (jail, prison, on parole or under supervision)

Speaks and reads English

Disqualifiers

Under 18 years old

Does not read or speak English

Does not identify as a woman

Has been diagnosed with HIV

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tool to provide re-entry support and improve linkage to healthcare and social services

    Behavioral

    The PA Links application is a web-based application (meaning it does not have to be downloaded to a smart phone and can be accessed via a URL link from any device connected to the Internet). This design ensures broader access and avoids excluding individuals without smartphones. This was developed along with our technology partner Nurelm (https://nurelm.com/). Women randomized to this arm of the intervention will go through an onboarding session to assist them in creating a unique login username and password to the PA Links system (see onboarding document attached). Only those with a registered username and password can access and use the PA Links system and Nurelm will not be able to access the application after it is "live" for the pilot RCT. The application will be housed on the AWS server, which also does not have access to data or information in the app.

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Control ArmNo intervention 0 interventions
Group B: Intervention ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pre-exposure Prophylaxis (PrEP) linkage

Assess via medical record whether participant has been linked to PrEP services. Yes/No

Time frame
Immediate post intervention (3 months)
2

Medications for Opioid Use Disorder (MOUD) Linkage

Assess via medical record whether participant has been linked to MOUD services. Yes/No

Time frame
Immediate post intervention (3 months)

Secondary outcomes

1

Engagement with intervention

Number and types of contact with navigator. Gotten from app data and EMR navigator reports

Time frame
Immediate post intervention (3 months)
2

Usability of PA-Links

User logs on what parts of application were used most; Survey questions asking which parts of app they used, yes/no.

Time frame
Immediate post intervention (3 months)
3

PrEP treatment referral

Accepted referral to PrEP. Data from FIGHT EMR. Yes/no

Time frame
Immediate post intervention (3 months); Three month post intervention follow-up (six months)
4

MOUD treatment referral

Accepted MOUD treatment referral. Data from FIGHT EMR. Yes/No

Time frame
Immediate post intervention (3 months); Three month post intervention follow-up (six months)

Other outcomes

Sponsors and contacts

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Temple University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

University of Pittsburgh

Collaborator

This trial is not recruiting at the moment. You can still explore other options: