Testing a Mobile Health Application to Improve HIV Prevention and Substance Use Treatment Among W… (NCT07432555) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Testing a Mobile Health Application to Improve HIV Prevention and Substance Use Treatment Among Women Involved in the Carceral System
United States74 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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)
Exclusion Criteria:
* 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 prio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pre-exposure Prophylaxis (PrEP) linkage
Timeframe: Immediate post intervention (3 months)
2
Medications for Opioid Use Disorder (MOUD) Linkage