Mobile Medical Unit for HIV Prevention in Women

(IFE4Her Trial)

Overseen By Lauren Hill, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: PrEP, PEP

Disqualifiers: HIV-positive, Male, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

466 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lauren Hill, PhD

Principal Investigator

UNC Chapel Hill

Carol Golin, MD

Principal Investigator

UNC-Chapel Hill

Eligibility Criteria

This trial is for women over 18 years old living in Durham Housing Authority housing who are not currently on PrEP or PEP, HIV-negative, and not pregnant, trying to conceive, or lactating. It aims to help those who might benefit from increased awareness and access to HIV prevention services.

Inclusion Criteria

Currently reside in Durham Housing Authority (DHA) housing

I identify as female.

Exclusion Criteria

I am currently taking medication to prevent HIV.

HIV-positive

I am mentally capable of understanding and giving consent for treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive enhanced PrEP messaging and access to a mobile medical unit for PrEP consultation and other health services

3 months

Multiple visits (in-person) as needed for PrEP consultation and health services

Follow-up

Participants are monitored for PrEP persistence and satisfaction with the intervention

3-6 months

Follow-up interviews and chart reviews at 3 and 6 months

Treatment Details

Interventions

• I'm Fully Empowered for Her (IFE4Her)

Trial Overview The study is exploring the effectiveness of a mobile medical unit delivering enhanced messaging about Pre-exposure Prophylaxis (PrEP) as a way to prevent HIV. The goal is to see if this approach can improve PrEP awareness and access among women in public housing.

Participant Groups

Group I: Mobile Medical Unit Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine