Clinical trial NCT05644834: Pilot Mobile Medical Unit Study for I'm Fully Empowered4Her
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Prevention
Pre-exposure Prophylaxis
PrEP
Prevention
Women's Health
Mobile Health
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
name: Duke University
First posted: 2022-12-09
Enrollment: 466
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Intervention Description

1. Communication campaign

   1. Communication Materials - PrEP Posters and Infographics that provide information about PrEP for women, and materials on complementary health services including hypertension screening, blood glucose screening, and HIV-testing.
   2. Peer Networker Information Dissemination - Trained Peer Networkers will disseminate information about PrEP, complementary women's health issues, and the mobile medical unit through distribution of communication materials and in-person communication.
2. Mobile Medical Unit All study-related clinical services will occur in a safe, confidential, and private space in a mobile medical unit. The mobile medical unit will offer the following services: blood pressure checks, blood glucose monitoring, rapid HIV antibody testing, and for those interested, PrEP consultation and clinical assessment and care as indicated. These services will be provided by university health care system clinicians. Participants receiving PrEP will be receive follow-up care in the university health care system.

Of note, no study drug is being tested. The PrEP medication emtricitabine/tenofovir disoproxil fumarate (trade name Truvada®) that providers will write prescriptions for is the only medication currently approved for women. It is very well tolerated and taken once daily. Truvada prescriptions will be provided in accordance with standard clinical care. These decisions are not protocol/study-driven and not an intervention being studied by the trial.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Identify as female
* Currently reside in Durham Housing Authority (DHA) housing

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Intervention Acceptability - Mean Score of Satisfaction Questionnaire (range 1-5 with higher scores meaning greater satisfaction)
timeFrame: Immediately post-mobile medical unit visit (assessed an average of 10 minutes post mobile medical unit visit)
measure: Intervention Acceptability - Number of Completed PrEP Consultations
timeFrame: Immediately post-mobile medical unit visit (assessed an average of 10 minutes post mobile medical unit visit)
measure: Intervention Acceptability Assessed Qualitatively
timeFrame: 3 months
Secondary outcomes:
measure: PrEP uptake - Number of PrEP Prescriptions Written in the Mobile Clinic
timeFrame: Immediately post-mobile medical unit visit (assessed an average of 10 minutes post mobile medical unit visit)
measure: PrEP persistence -Proportion of Participants Receiving a PrEP Prescription Who Completed a Follow-Up visit and Received a Follow-Up PrEP Prescription
timeFrame: 3 months
measure: PrEP Consultation Requests - Number of PrEP Appointments Requested
timeFrame: Baseline
measure: PrEP Consultation Uptake - Number of PrEP Consultations Completed
timeFrame: Immediately post-mobile medical unit visit (assessed an average of 10 minutes post mobile medical unit visit)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Carol Golin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC Chapel Hill
name: Lauren Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References: