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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a mobile medical unit can help women in public housing learn about and access HIV prevention services. The main focus is on increasing awareness and use of Pre-exposure Prophylaxis (PrEP), a medication that helps prevent HIV infection. Women aged 18 and older living in Durham Housing Authority homes may be suitable candidates, especially if they are not already on PrEP or HIV-positive. Participants will receive health checks and consultations about PrEP through the mobile unit. The program is called "I'm Fully Empowered for Her" (IFE4Her). As an unphased trial, this study offers participants a unique opportunity to access innovative HIV prevention resources and support early.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on whether you are currently on PrEP or PEP, as those are exclusion criteria.

What prior data suggests that this mobile medical unit is safe for delivering HIV prevention services?

Research has shown that the "I'm Fully Empowered for Her" (IFE4Her) program has been included in studies focused on preventing HIV. These studies primarily assess the program's effectiveness in increasing awareness and use of pre-exposure prophylaxis (PrEP), a medication that helps prevent HIV. Although specific side effect information for IFE4Her is limited, the program has been tested in community settings.

Similar HIV prevention programs have been well-received in related studies, with no major safety issues reported. These programs typically offer educational and health services, such as blood pressure and blood sugar checks, rather than introducing new medications. As IFE4Her is part of these broader prevention efforts, it is expected to be well-tolerated. However, since this trial is a feasibility study, detailed safety information is still being collected. Participants can feel reassured that the focus remains on providing preventive care tools and education, not on untested drugs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Medical Unit for HIV prevention in women because it brings healthcare services directly to the community, making it easier for women to access essential care. Unlike traditional clinic visits, this approach offers on-the-go services like blood pressure and blood glucose checks, HIV testing, and consultations for Pre-exposure Prophylaxis (PrEP) right where people live and work. This mobile method aims to overcome barriers such as transportation issues and time constraints, potentially increasing the uptake of preventive measures and improving overall health outcomes for women at risk of HIV.

What evidence suggests that using a mobile medical unit is effective for increasing PrEP awareness and access among women?

Research has shown that empowering women can help prevent HIV. One study found that women who feel empowered are more likely to get tested for HIV and ask their partners to use condoms. Another study demonstrated that programs aimed at empowering women led to fewer cases of HIV and other sexually transmitted infections. In this trial, the "I'm Fully Empowered for Her" (IFE4Her) approach uses a mobile unit to promote Pre-exposure Prophylaxis (PrEP), a medication that can help prevent HIV. Although specific data on the IFE4Her program is limited, these empowerment strategies have shown promise in reducing HIV risk among women. ^{1 4 6 7 8}

Who Is on the Research Team?

Lauren Hill, PhD

Principal Investigator

UNC Chapel Hill

Carol Golin, MD

Principal Investigator

UNC-Chapel Hill

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. withpower.com withpower.com/trial/phase-hiv-prevention-11-2022-7d567

Mobile Medical Unit for HIV Prevention in Women 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10686950/

The Association of Women's Empowerment with HIV-Related ... Our results reveal that highly empowered women are more likely to have ever been tested for HIV, being able to ask their partner to use a condom ...

3. researchgate.net researchgate.net/publication/380419081_We_carried_her_in_a_wheelbarrow_to_the_clinic_Process_evaluation_of_the_AMETHIST_intervention_combining_microplanning_with_self-help_groups_to_improve_HIV_prevention_and_treatment_among_female_sex_wor

(PDF) We carried her in a wheelbarrow to the clinic Increased service use did not increase effective prevention. Over 80% FSW reported condomless sex and PrEP adherence was insufficient to achieve ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2589537025001087

The effects of the Determined, Resilient, Empowered, AIDS ... Evidence suggests that DREAMS results in a reduction in HIV incidence and may reduce sexually transmitted infections (STI).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1448416/

Efficacy of a Woman-Focused Intervention to Reduce HIV ... Objectives. This study compares 3- and 6-month outcomes of a woman-focused HIV intervention for crack abusers, a revised National Institute on Drug Abuse ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7686290/

Awareness of and attitudes toward pre-exposure ... This community assessment survey was conducted in the context of Project IFE (I'm Fully Empowered; R34MH104081), a community-engaged study to adapt a CDC ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2953934/

Three City Feasibility Study of a Body Empowerment and ... The Women Fighting Infection Together (Women FIT) feasibility study enrolled 189 women in three US cities (Providence, New York, Philadelphia) with drug-using ...

8. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-020-09426-6

suggestions from women in urban high HIV burden counties in ... To this end, the goal of the current study was to identify suggestions for HIV prevention programs among women residing in cities with a high ...