NCT07432555

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Temple University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The primary goal of the proposed research is to pilot test a systematically developed intervention for women who have been recently incarcerated to engage with pre-exposure prophalaxis (PrEP) and medication for opioid use disorder (MOUD) to prevent HIV infection and overdose. The intervention will use contextually relevant messages developed through novel formative research methods and be embedded in a web-based application called PA Links. The investigators will then test this approach in a pilot randomized trial with women who have recently been incarcerated. The purpose is to enhance communication in an existing post-release navigation model embedded in a community-based health services organization in Pennsylvania (Philadelphia FIGHT) to increase PrEP and MOUD uptake. The app is meant to enhance communication among navigators, patients, and providers, as well as provide easy communication channels among participants for peer support. We will examine the feasibility/acceptability of the intervention with more traditional navigation support and examine preliminary data regarding its potential efficacy in engaging women in PrEP and MOUD. For the pilot test, we will: 1. Conduct a pilot test with women who have recently been incarcerated (n=60) in Philadelphia randomized to an "Enhanced" intervention that includes patient navigation with the PA-Links web-based app + navigation, compared to a "Basic" intervention that includes existing navigation. To assess promise of efficacy, we will compare linkage to PrEP and MOUD (primary outcomes) during the three-month intervention at immediate post and 3-month follow-up and assess self-reported knowledge and attitudes. Qualitative exit interviews will inform feasibility and acceptability.

Conditions

• Substance Abuse
• HIV

Interventions

Type	Name	Description
BEHAVIORAL	Tool to provide re-entry support and improve linkage to healthcare and social services	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-08-30
• Completion: 2026-08-30
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States