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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Temple University
Study ID
NCT07432555
Status
Not Yet Recruiting

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Conditions

  • HIV
  • Substance Abuse

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Aug 30, 2026
Completion
Aug 30, 2026

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Control Arm
    For those participants randomized to the "Basic" arm of the intervention, standard of care navigation already provided by Philadelphia FIGHT will be provided, without the use of the PA Links application. Each participant will be assigned a navigator or care coordinator who will assist people by scheduling initial/first appointments, making appointment reminder calls, coordinating services, providing education, and facilitating communication among FIGHT departments. Navigation occurs from initial patient contact until the patient has their first visit. Then a care coordinator is assigned, who assists patients in overcoming ongoing barriers to care and doing similar tasks as the navigators after the first visit. Participants in the basic arm will thus receive all the services any other patient at FIGHT would receive.
  • Experimental: Intervention Arm
    Women in the intervention arm will receive all the same navigation services at FIGHT along with access to the PA Links web-based app. This app will enhance the usual care by: 1. Sending up the three resources every week based on a participant's interests and needs. 2. Providing one quiz a week. At the beginning of each week of the intervention, participants will receive a pop-up message when they log in with a true/false question. 3. Sending at least two supportive messages a week. 4. Posting reminders and messages from navigators about appointments, medication use, or for other issues. 5. Being able to interact with other participants via an embedded communication widget.

Primary Outcome Measure

Pre-exposure Prophylaxis (PrEP) linkage [ Time Frame: Immediate post intervention (3 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Temple UniversityPhiladelphiaPennsylvania19122
Sarah Bass, MPH, PhD
[email protected]
2152040377
Katie J Singley, MPH
[email protected]
215-204-1956
Sarah Bass, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By condition
HIV
By specialty
Infectious disease
By research site
Temple University· Philadelphia, PA

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