An interventional study of Tool to provide re-entry support and improve linkage to healthcare and social services in Substance Abuse and HIV, sponsored by Temple University. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Temple University · Not applicable, Interventional, and Prevention
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.
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.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 74 is below the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Temple University is the lead sponsor of 223 studies on the registry; 29 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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
Pre-exposure Prophylaxis (PrEP) linkage
Assess via medical record whether participant has been linked to PrEP services. Yes/No
Time frame: 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
Time frame: Immediate post intervention (3 months)
Engagement with intervention
Number and types of contact with navigator. Gotten from app data and EMR navigator reports
Time frame: Immediate post intervention (3 months)
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.
Time frame: Immediate post intervention (3 months)
PrEP treatment referral
Accepted referral to PrEP. Data from FIGHT EMR. Yes/no
Time frame: Immediate post intervention (3 months); Three month post intervention follow-up (six months)
MOUD treatment referral
Accepted MOUD treatment referral. Data from FIGHT EMR. Yes/No
Time frame: Immediate post intervention (3 months); Three month post intervention follow-up (six months)
HIV Risk
Self reported HIV behavior risk. Using the HIV Risk-Taking Behavior Scale. This scale is 11 items, assessing drug use and sexual behavior risk. Responses to each item are coded on a 6-point scale from 0 to 5, with higher values associated with more risky behaviors. Summary scores are obtained by adding up the ordinal values of responses obtained; a score of 0 would indicate no risky behaviors and a score of 55 would indicate maximal risky behaviors.
Time frame: Baseline, before intervention begins; Immediate post intervention (3 months); Three month post intervention follow-up (six months)
Overdose risk
Overdose risk and experience during intervention. Based on the Overdose Risk self-assessment, participants are asked about overdose risks answering yes or no. The more yes responses indicates a higher overdose risk.
Time frame: Baseline, before intervention begins; Immediate post intervention (3 months); Three month post intervention follow-up (six months)
PrEP perceptions
Perceptions of barriers and benefits to PrEP use. Study created scales - 12 statements on the benefits of using PrEP and 12 statements on barriers to using PrEP, answered on a zero -10 scale. Higher numbers mean higher agreement with the statement. These will be compared at the time points to assess if there is an increase in perceived benefits and a decrease in perceived barriers.
Time frame: Baseline, before intervention begins; Immediate post intervention (3 months); Three month post intervention follow-up (six months)
MOUD perceptions
Perceptions of barriers and benefits to MOUD use. Study created scales - 11 statements on the benefits of using MOUD and 10 statements on barriers to using MOUD, answered on a zero -10 scale. Higher numbers mean higher agreement with the statement. These will be compared at the time points to assess if there is an increase in perceived benefits and a decrease in perceived barriers.
Time frame: Baseline before intervention begins; Immediate post intervention (3 months); Three month intervention followup (6 months)
Time to Linkage of PrEP
Time in months from navigator first contact to linkage to PrEP. EMR data from FIGHT.
Time frame: Immediate post intervention (3 months); Three month post intervention follow-up (six months)
Receipt of prescription of PrEP
Receipt of prescription of PrEP. EMR data from FIGHT. Yes/no
Time frame: Immediate post intervention (3 months); Three month post intervention follow-up (six months)
Filling of PrEP prescription
If PrEP prescription was filled. EMR data from FIGHT. Yes/No
Time frame: Immediate post intervention (3 months); Three month post intervention follow-up (six months)
PrEP adherence
Assess if participant is being adherent to PrEP based on FIGHT EMR data. Could be physician notes or blood work results, if taken. Yes/No
Time frame: Immediate post intervention (3 months); 3 months intervention follow up (6 months)
PrEP knowledge
True/False statements about PrEP. Five statements about PrEP. A composite score based on the number of correct answers will be assessed and compared across timepoints.
Time frame: Baseline; Immediate intervention post-test (3 months); 3 month intervention follow-up (6 months)
Time to MOUD Linkage
Time in months from navigator first contact to linkage to MOUD. EMR data from FIGHT.
Time frame: Immediate post intervention (3 months); Three month post intervention follow-up (six months)
Receipt of MOUD Prescription
Receipt of MOUD prescription. EMR data from FIGHT. Yes/no
Time frame: Immediate post intervention (3 months); 3 month post intervention follow-up (6 months)
Filling of MOUD prescription
Filling of MOUD prescription. EMR data from FIGHT. Yes/no
Time frame: Immediate post intervention (3 months); 3 months intervention follow up (6 months)
MOUD adherence
Assess if participant in adherent to MOUD based on FIGHT EMR data. Could be from physician notes or blood work, if taken. Yes/No
Time frame: Immediate post intervention (3 months); 3 months intervention follow up (6 months)
MOUD Knowledge
True/False statements about MOUD. Five statements about MOUD. A composite score based on the number of correct answers will be assessed and compared across timepoints.
Time frame: Baseline; Immediate intervention post -test (3 months); 3 month intervention follow-up (six months)
Client Intervention Satisfaction
Assessed via survey using five items from the the Study Participant Feedback Questionnaire. Two items are yes/no answers. Yes answers indicate they agree they were informed about the study. Three questions are on a 0-4 scale, with a zero indicating they strongly disagree with the statement and a 4 that they strongly agree. Higher number answers indicate higher intervention satisfaction.
Time frame: Immediate post intervention (3 months)
mHealth feasibility/satisfaction
Assessed using the mHealth App Usability Questionnaire (MAUQ). It is a 21 item scale, with 8 items that assess Ease of use and satisfaction; 6 items on system information arrangement, and 7 items on usefulness. All use a 1 to 7 scale, indicating amount of agreement with a 7 as strongly agree. Each individual item will be assessed and a composite score for each area will also be assessed.
Time frame: Immediate post intervention (3 months)
Usability of mHealth app
Assessed using the Usability of e-health interventions scale. It consists of 10 items scored on a 1-5 scale, indicating level of agreement, with a 5 meaning they strongly agree with the statement. The higher the score, the more they agree that the app was usable.
Time frame: Immediate post intervention (3 months)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.