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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Pre-exposure Prophylaxis (PrEP) linkage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Control Arm
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
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.
干预措施: Tool to provide re-entry support and improve linkage to healthcare and social services (Behavioral)
结局指标
主要结局
Pre-exposure Prophylaxis (PrEP) linkage
时间窗: 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
时间窗: Immediate post intervention (3 months)
Assess via medical record whether participant has been linked to MOUD services. Yes/No
次要结局
- Engagement with intervention(Immediate post intervention (3 months))
- Usability of PA-Links(Immediate post intervention (3 months))
- PrEP treatment referral(Immediate post intervention (3 months); Three month post intervention follow-up (six months))
- MOUD treatment referral(Immediate post intervention (3 months); Three month post intervention follow-up (six months))
- HIV Risk(Baseline, before intervention begins; Immediate post intervention (3 months); Three month post intervention follow-up (six months))
- Overdose risk(Baseline, before intervention begins; Immediate post intervention (3 months); Three month post intervention follow-up (six months))
- PrEP perceptions(Baseline, before intervention begins; Immediate post intervention (3 months); Three month post intervention follow-up (six months))
- MOUD perceptions(Baseline before intervention begins; Immediate post intervention (3 months); Three month intervention followup (6 months))
- Time to Linkage of PrEP(Immediate post intervention (3 months); Three month post intervention follow-up (six months))
- Receipt of prescription of PrEP(Immediate post intervention (3 months); Three month post intervention follow-up (six months))
- Filling of PrEP prescription(Immediate post intervention (3 months); Three month post intervention follow-up (six months))
- PrEP adherence(Immediate post intervention (3 months); 3 months intervention follow up (6 months))
- PrEP knowledge(Baseline; Immediate intervention post-test (3 months); 3 month intervention follow-up (6 months))
- Time to MOUD Linkage(Immediate post intervention (3 months); Three month post intervention follow-up (six months))
- Receipt of MOUD Prescription(Immediate post intervention (3 months); 3 month post intervention follow-up (6 months))
- Filling of MOUD prescription(Immediate post intervention (3 months); 3 months intervention follow up (6 months))
- MOUD adherence(Immediate post intervention (3 months); 3 months intervention follow up (6 months))
- MOUD Knowledge(Baseline; Immediate intervention post -test (3 months); 3 month intervention follow-up (six months))
- Client Intervention Satisfaction(Immediate post intervention (3 months))
- mHealth feasibility/satisfaction(Immediate post intervention (3 months))
- Usability of mHealth app(Immediate post intervention (3 months))