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

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

Overview

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.

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.

Interventions

• 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 usernam

Primary outcome measures

• Pre-exposure Prophylaxis (PrEP) linkage [Time frame: Immediate post intervention (3 months)]
• Medications for Opioid Use Disorder (MOUD) Linkage [Time frame: Immediate post intervention (3 months)]

Secondary outcome measures (12)

• Engagement with intervention [Time frame: Immediate post intervention (3 months)]
• Usability of PA-Links [Time frame: Immediate post intervention (3 months)]
• PrEP treatment referral [Time frame: Immediate post intervention (3 months); Three month post intervention follow-up (six months)]
• MOUD treatment referral [Time frame: Immediate post intervention (3 months); Three month post intervention follow-up (six months)]
• HIV Risk [Time frame: Baseline, before intervention begins; Immediate post intervention (3 months); Three month post intervention follow-up (six months)]
• Overdose risk [Time frame: Baseline, before intervention begins; Immediate post intervention (3 months); Three month post intervention follow-up (six months)]
• PrEP perceptions [Time frame: Baseline, before intervention begins; Immediate post intervention (3 months); Three month post intervention follow-up (six months)]
• MOUD perceptions [Time frame: Baseline before intervention begins; Immediate post intervention (3 months); Three month intervention followup (6 months)]
• Time to Linkage of PrEP [Time frame: Immediate post intervention (3 months); Three month post intervention follow-up (six months)]
• Receipt of prescription of PrEP [Time frame: Immediate post intervention (3 months); Three month post intervention follow-up (six months)]
• Filling of PrEP prescription [Time frame: Immediate post intervention (3 months); Three month post intervention follow-up (six months)]
• PrEP adherence [Time frame: Immediate post intervention (3 months); 3 months intervention follow up (6 months)]

Eligibility criteria

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 prior to being incarcerated or MOUD in last year
• Does not have access to internet
• Cannot provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Temple University — Philadelphia

Identifiers

NCT: NCT07432555 · 30036 · 5R34DA057891-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗