IGHID 12227 - Pilot Mobile Medical Unit Study for I'm Fully Empowered4Her (IFE4Her) Intervention on HIV Pre-Exposure Prophylaxis (PrEP) Uptake by Women Living in Durham Housing Authority - Affiliated Communities (IFE4Her Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Intervention Acceptability - Mean Score of Satisfaction Questionnaire (range 1-5 with higher scores meaning greater satisfaction)
研究概览
简要总结
The overarching objective for the pilot study is to test the feasibility of using a mobile medical unit as a delivery mode combined with enhanced Pre-exposure Prophylaxis (PrEP) messaging to increase awareness of PrEP and access to PrEP medical services among women living in public housing.
详细描述
This is a single arm feasibility study with 3-month follow-up.
African American cisgender women in the South are disproportionately affected by HIV infection yet have inequitable access to Pre-exposure Prophylaxis (PrEP). To promote equitable use of PrEP by women living in low-income housing in Durham, North Carolina (NC) (the vast majority of whom are African American), the investigators aim to conduct a formative study to develop and refine a scalable PrEP delivery approach which addresses the two key barriers of access and awareness. In this pilot study the investigators will test the feasibility of the delivery mode and features of a community outreach PrEP mobile unit and provide Peer Networkers and PrEP messaging tailored to women living in public housing.
The objectives of the study are to evaluate the feasibility of delivering the IFE4Her intervention in public housing communities. The IFE4Her intervention consists of: 1) a communication campaign including enhanced PrEP messaging and peer networker communication; 2) A mobile PrEP clinic. Assessments will include a satisfaction survey for participants receiving services in the mobile clinic, service records, follow-up in-depth interviews at 3 months, and chart review at 6 months to assess 3-month outcomes.
Study Duration Each participant's study duration will depend upon the study activities they elect to engage in. Each subject's participation in the anonymous survey will last approximately 10 minutes immediately after their medical visit. Each subject's participation in the follow-up interview which will take place approximately 3 months after the mobile medical visit and will last approximately one hour. Medical record data (specifically follow up visit participation and prescription completion as described in detail below) will be collected after the 3 month visit but up to 6 months after participation in the initial medical visit.
The entire pilot study is expected to last up to 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Identify as female
- •Currently reside in Durham Housing Authority (DHA) housing
排除标准
- •Currently on PrEP or Post-Exposure Prophylaxis (PEP)
- •HIV-positive
- •Being Male Gender
- •Altered mental status precluding participant to provide informed consent
- •Currently Pregnant or Trying to get Pregnant or Lactating.
结局指标
主要结局
Intervention Acceptability - Mean Score of Satisfaction Questionnaire (range 1-5 with higher scores meaning greater satisfaction)
时间窗: Immediately post-mobile medical unit visit (assessed an average of 10 minutes post mobile medical unit visit)
Perceived satisfaction with the intervention as assessed through survey items
Intervention Acceptability - Number of Completed PrEP Consultations
时间窗: Immediately post-mobile medical unit visit (assessed an average of 10 minutes post mobile medical unit visit)
Number of mobile clinic clients completing a PrEP consultation with a study provider as recorded by study staff in service records
Intervention Acceptability Assessed Qualitatively
时间窗: 3 months
Perceived acceptability of the intervention as assessed in qualitative in-depth interviews with mobile clinic clients To gain deeper insights about the perceived acceptability of the intervention the investigators will ask participants in in-depth interviews about how they about different aspects of the intervention, including services provided and their delivery. Acceptability will be defined as a positive rating (and reason for that rating) of participant satisfaction with each aspect of the intervention.
次要结局
- PrEP Consultation Requests - Number of PrEP Appointments Requested(Baseline)
- PrEP uptake - Number of PrEP Prescriptions Written in the Mobile Clinic(Immediately post-mobile medical unit visit (assessed an average of 10 minutes post mobile medical unit visit))
- PrEP persistence -Proportion of Participants Receiving a PrEP Prescription Who Completed a Follow-Up visit and Received a Follow-Up PrEP Prescription(3 months)
- PrEP Consultation Uptake - Number of PrEP Consultations Completed(Immediately post-mobile medical unit visit (assessed an average of 10 minutes post mobile medical unit visit))