HIV, Substance Abuse
Conditions
Keywords
Substance Abuse, HIV prevention, PreEP, Medications for Opioid Use Disorder, Re-entry, Women Involved in the Carceral System (WICS)
Brief 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.
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
BEHAVIORALTool 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.
Sponsors
Temple University
National Institute on Drug Abuse (NIDA)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-exposure Prophylaxis (PrEP) linkage | Immediate post intervention (3 months) | Assess via medical record whether participant has been linked to PrEP services. Yes/No |
| Medications for Opioid Use Disorder (MOUD) Linkage | Immediate post intervention (3 months) | Assess via medical record whether participant has been linked to MOUD services. Yes/No |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Engagement with intervention | Immediate post intervention (3 months) | Number and types of contact with navigator. Gotten from app data and EMR navigator reports |
| Usability of PA-Links | Immediate post intervention (3 months) | User logs on what parts of application were used most; Survey questions asking which parts of app they used, yes/no. |
| PrEP treatment referral | Immediate post intervention (3 months); Three month post intervention follow-up (six months) | Accepted referral to PrEP. Data from FIGHT EMR. Yes/no |
| MOUD treatment referral | Immediate post intervention (3 months); Three month post intervention follow-up (six months) | Accepted MOUD treatment referral. Data from FIGHT EMR. Yes/No |
| HIV Risk | Baseline, before intervention begins; Immediate post intervention (3 months); Three month post intervention follow-up (six months) | 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. |
| Overdose risk | Baseline, before intervention begins; Immediate post intervention (3 months); Three month post intervention follow-up (six months) | 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. |
| PrEP perceptions | Baseline, before intervention begins; Immediate post intervention (3 months); Three month post intervention follow-up (six months) | 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. |
| MOUD perceptions | Baseline before intervention begins; Immediate post intervention (3 months); Three month intervention followup (6 months) | 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 to Linkage of PrEP | Immediate post intervention (3 months); Three month post intervention follow-up (six months) | Time in months from navigator first contact to linkage to PrEP. EMR data from FIGHT. |
| Receipt of prescription of PrEP | Immediate post intervention (3 months); Three month post intervention follow-up (six months) | Receipt of prescription of PrEP. EMR data from FIGHT. Yes/no |
| Filling of PrEP prescription | Immediate post intervention (3 months); Three month post intervention follow-up (six months) | If PrEP prescription was filled. EMR data from FIGHT. Yes/No |
| PrEP adherence | Immediate post intervention (3 months); 3 months intervention follow up (6 months) | 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 |
| PrEP knowledge | Baseline; Immediate intervention post-test (3 months); 3 month intervention follow-up (6 months) | 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 to MOUD Linkage | Immediate post intervention (3 months); Three month post intervention follow-up (six months) | Time in months from navigator first contact to linkage to MOUD. EMR data from FIGHT. |
| Receipt of MOUD Prescription | Immediate post intervention (3 months); 3 month post intervention follow-up (6 months) | Receipt of MOUD prescription. EMR data from FIGHT. Yes/no |
| Filling of MOUD prescription | Immediate post intervention (3 months); 3 months intervention follow up (6 months) | Filling of MOUD prescription. EMR data from FIGHT. Yes/no |
| MOUD adherence | Immediate post intervention (3 months); 3 months intervention follow up (6 months) | Assess if participant in adherent to MOUD based on FIGHT EMR data. Could be from physician notes or blood work, if taken. Yes/No |
| MOUD Knowledge | Baseline; Immediate intervention post -test (3 months); 3 month intervention follow-up (six months) | 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. |
| Client Intervention Satisfaction | Immediate post intervention (3 months) | 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. |
| mHealth feasibility/satisfaction | Immediate post intervention (3 months) | 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. |
| Usability of mHealth app | Immediate post intervention (3 months) | 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. |
Countries
United States
Contacts
CONTACTSarah Bass, MPH, PhD
CONTACTEmily F Dauria, PhD
Outcome results
None listed