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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Tool to provide re-entry support and improve linkage to healthcare and social services
BehavioralThe 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
Trial outcomes
Primary outcomes
Pre-exposure Prophylaxis (PrEP) linkage
Assess via medical record whether participant has been linked to PrEP services. Yes/No
Medications for Opioid Use Disorder (MOUD) Linkage
Assess via medical record whether participant has been linked to MOUD services. Yes/No
Secondary outcomes
Engagement with intervention
Number and types of contact with navigator. Gotten from app data and EMR navigator reports
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.
PrEP treatment referral
Accepted referral to PrEP. Data from FIGHT EMR. Yes/no
MOUD treatment referral
Accepted MOUD treatment referral. Data from FIGHT EMR. Yes/No
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: