Pilot Mobile Medical Unit Study for I'm Fully Empowered4Her

NCT05644834 | Completed

• 1 other identifier: 22-1570
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Prevention; Pre-exposure Prophylaxis; PrEP; Prevention; Women's Health; Mobile Health

Outcome Measures

Primary Outcomes (3)

• Intervention Acceptability - Mean Score of Satisfaction Questionnaire (range 1-5 with higher scores meaning greater satisfaction)

  Perceived satisfaction with the intervention as assessed through survey items

  Immediately post-mobile medical unit visit (assessed an average of 10 minutes post mobile medical unit visit)

• Intervention Acceptability - Number of Completed PrEP Consultations

  Number of mobile clinic clients completing a PrEP consultation with a study provider as recorded by study staff in service records

  Immediately post-mobile medical unit visit (assessed an average of 10 minutes post mobile medical unit visit)

• Intervention Acceptability Assessed Qualitatively

  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.

  3 months

Secondary Outcomes (4)

• 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 Requests - Number of PrEP Appointments Requested

  Baseline

• 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)

Study Arms (1)

Mobile Medical Unit

EXPERIMENTAL

Participants utilizing the mobile medical unit will be offered an appointment with a university system healthcare provider to receive blood pressure check, blood glucose check, HIV testing and/or Pre-exposure Prophylaxis (PrEP) consultation.

Other: I'm Fully Empowered for Her (IFE4Her)

Interventions

I'm Fully Empowered for Her (IFE4Her) OTHER

IFE4Her consists of 2 key components: 1) An awareness-raising messaging campaign with messages about PrEP that includes posters and Peer Networkers; and 2) access via a mobile medical unit outreach delivery model linking women in public housing to care from the PrEP providers of a university healthcare system and other complementary screening services (i.e., blood pressure, blood glucose monitoring, and HIV testing).

Mobile Medical Unit

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Identify as female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Gilead Sciences: collaborator
• Duke University: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Study Officials

• Carol Golin, MD

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

• Lauren Hill, PhD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: April 18, 2023
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)