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

NCT07432555 | Not Yet Recruiting DMC

• 2 other identifiers: 300365R34DA057891-03
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance Abuse; HIV

Keywords

Substance Abuse; HIV prevention; PreEP; Medications for Opioid Use Disorder; Re-entry; Women Involved in the Carceral System (WICS)

Outcome Measures

Primary Outcomes (2)

• Pre-exposure Prophylaxis (PrEP) linkage

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

  Immediate post intervention (3 months)

• Medications for Opioid Use Disorder (MOUD) Linkage

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

  Immediate post intervention (3 months)

Secondary Outcomes (21)

• Engagement with intervention

  Immediate post intervention (3 months)

• Usability of PA-Links

  Immediate post intervention (3 months)

• PrEP treatment referral

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

• MOUD treatment referral

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

• HIV Risk

  Baseline, before intervention begins; Immediate post intervention (3 months); Three month post intervention follow-up (six months)

Study Arms (2)

Control Arm

NO INTERVENTION

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.

Intervention Arm

EXPERIMENTAL

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.

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

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.

Also known as: PA-Links

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Self-reported negative HIV status
• Indicates at least one HIV risk (i.e. any of the following in the past 6 months or in the six months prior to the most recent incarceration that call for consideration of PrEP as per the CDC risk indices: have engaged in condomless sex; have an HIV-positive sex partner; have had an STI; have had multiple \[\>6\] partners; have engaged in transactional sex; have injected drugs, shared injection or drug use preparation equipment, or have been enrolled in opiate substitution therapy because of IDU; previous overdose)
• Self-report using opioids in the past six months or six months prior to the most recent incarceration (prescription or not) OR self-report using medications for opioid use disorder in the past year.
• Have access to the internet through some device - smart phone, computer or tablet (personal or at community location such as library or organization)

You may not qualify if:

• Under 18 years old
• Does not read or speak English
• Does not identify as a woman
• Has been diagnosed with HIV
• Does not have previous experience with the criminal legal system within the last 6 months
• Does not have HIV risk in last six months or six months prior to being incarcerated
• Has not used opioids in past six months or six months prior to being incarcerated or MOUD in last year
• Does not have access to internet
• Cannot provide informed consent

Sponsors & Collaborators

• Temple University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Social Work

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Sarah Bass, MPH, PhD

CONTACT

215-204-0377; sbass@temple.edu

Emily F Dauria, PhD

CONTACT

412-383-0732; efd16@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Women will be randomized to receive either the Navigation + PA Links intervention (regular navigation plus access to the PA Links app) or the Basic Navigation intervention, which is regular navigation services already provided by Philadelphia FIGHT.

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 25, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)