Substance AbusePA-LinksNCT07432555
Testing a Mobile Health Application to Improve HIV Prevention and Substance Use Treatment Among Women Involved in the Carceral System
A study testing Tool to provide re-entry support and improve linkage to healthcare and social services in people with Substance Abuse and HIV, run by Temple University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Substance Abuse, HIV
- What is being tested?
- Tool to provide re-entry support and improve linkage to healthcare and social services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2026to 30 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Temple University
Philadelphia, Pennsylvania, 19122
Sarah Bass, MPH, PhD, 2152040377, sbass@temple.edu
Katie J Singley, MPH, 215-204-1956, katie.singley@temple.edu
About this study
Official title: 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
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.
Read the 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
- Being tested
- Tool to provide re-entry support and improve linkage to healthcare and social services
- Keywords
- Substance Abuse, HIV prevention, PreEP, Medications for Opioid Use Disorder, Re-entry, Women Involved in the Carceral System (WICS)
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tool to provide re-entry support and improve linkage to healthcare and social servicesBehavioural
Also called PA-Links
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Tool to provide re-entry support and improve linkage to healthcare and social services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-exposure Prophylaxis (PrEP) linkage
Assess via medical record whether participant has been linked to PrEP services. Yes/No
Measured: 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
Measured: Immediate post intervention (3 months)
Secondary outcomes (21)
Engagement with intervention
Number and types of contact with navigator. Gotten from app data and EMR navigator reports
Measured: 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.
Measured: Immediate post intervention (3 months)
PrEP treatment referral
Accepted referral to PrEP. Data from FIGHT EMR. Yes/no
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediate post intervention (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start20 Oct 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Pittsburgh
- Responsible party
- Principal investigator, Sarah Bass, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432555
- Sponsor's protocol ID
- 30036
- Other IDs
- 5R34DA057891-03
- Acronym
- PA-Links
- Status last verified
- Sep 2026
- First submitted
- 13 Feb 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No