HIV PreventionIFE4HerNCT05644834
Pilot Mobile Medical Unit Study for I'm Fully Empowered4Her
A study testing I'm Fully Empowered for Her (IFE4Her) in people with HIV Prevention and Pre-exposure Prophylaxis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV Prevention, Pre-exposure Prophylaxis, PrEP
- What is being tested?
- I'm Fully Empowered for Her (IFE4Her)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2023to 11 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Identify as female
- Currently reside in Durham Housing Authority (DHA) housing
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27514
About this study
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)
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.
Read the 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
- Communication campaign
- 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.
- 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.
- 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.
- Conditions
- HIV Prevention, Pre-exposure Prophylaxis, PrEP, Prevention, Women's Health, Mobile Health
- Being tested
- I'm Fully Empowered for Her (IFE4Her)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: I'm Fully Empowered for Her (IFE4Her) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 3 months
Secondary outcomes (4)
PrEP uptake - Number of PrEP Prescriptions Written in the Mobile Clinic
PrEP uptake, assessed as PrEP prescriptions written for women in the target population from the mobile PrEP unit evaluated through service records
Measured: 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
Persistence in PrEP care, assessed via chart review of follow-up appointments and prescriptions documented in Duke clinic records as the proportion of participants who received a PrEP prescription and completed a follow-up visit and received a follow-up PrEP prescription at 3 months (assessed retrospectively at 6 months).
Measured: 3 months
PrEP Consultation Requests - Number of PrEP Appointments Requested
Number of mobile unit PrEP consultations (either scheduled or walk-in) requested as recorded in study tracking records and service logs.
Measured: Baseline
PrEP Consultation Uptake - Number of PrEP Consultations Completed
Number of mobile unit PrEP consultations (either scheduled or walk-in) completed as recorded in mobile unit service logs
Measured: Immediately post-mobile medical unit visit (assessed an average of 10 minutes post mobile medical unit visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start18 Apr 2023
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, Duke University
- Responsible party
- Sponsor
- Investigators
- Carol Golin, MD, Principal investigator, UNC-Chapel HillLauren Hill, PhD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644834
- Sponsor's protocol ID
- 22-1570
- Acronym
- IFE4Her
- Status last verified
- Aug 2025
- First submitted
- 1 Dec 2022
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Golin CE, Hill LM, Ayangeakaa SD, Allison O, Keshishian TH, Michel T, Pulliam A, Woodley A, Amola K, Harding C, Hall N, Jacobs T, Jones M, Parrish T, Wiggins D, Riggins L, Lightfoot AF, Choi Y, Navarro I, Frye J, Burns CM, McKellar MS. Assessing the Feasibility and Acceptability of a Mobile Medical Unit Program-(IFE4Her) to Enhance PrEP Awareness and Access Among Cis-gender Women in Low-Income Southeastern Communities: A Pilot Study. AIDS Behav. 2026 Jun 5. doi: 10.1007/s10461-026-05134-1. Online ahead of print.
PubMed 42247072
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05644834
- Acronym / sponsor ID
- IFE4Her / 22-1570
- Conditions
- HIV Prevention, Pre-exposure Prophylaxis, PrEP, Prevention, Women's Health, Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Gilead Sciences, Duke University
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Communication campaign
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Medical Unit | Experimental | Other: I'm Fully Empowered for Her (IFE4Her)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 may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Identify as female
- Currently reside in Durham Housing Authority (DHA) housing
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I'm Fully Empowered for Her (IFE4Her)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). | Other | Mobile Medical Unit |
Primary outcome
Intervention Acceptability - Mean Score of Satisfaction Questionnaire (range 1-5 with higher scores meaning greater satisfaction)
Time frame: 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
Time frame: 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
Time frame: 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.
4 secondary outcomes
PrEP uptake - Number of PrEP Prescriptions Written in the Mobile Clinic
Time frame: 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
Time frame: 3 months
PrEP Consultation Requests - Number of PrEP Appointments Requested
Time frame: Baseline
PrEP Consultation Uptake - Number of PrEP Consultations Completed
Time frame: Immediately post-mobile medical unit visit (assessed an average of 10 minutes post mobile medical unit visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Derived from this study: PubMed 42247072Golin CE, Hill LM, Ayangeakaa SD, Allison O, Keshishian TH, Michel T, Pulliam A, Woodley A, Amola K, Harding C, Hall N, Jacobs T, Jones M, Parrish T, Wiggins D, Riggins L, Lightfoot AF, Choi Y, Navarro I, Frye J, Burns CM, McKellar MS. Assessing the Feasibility and Acceptability of a Mobile Medical Unit Program-(IFE4Her) to Enhance PrEP Awareness and Access Among Cis-gender Women in Low-Income Southeastern Communities: A Pilot Study. AIDS Behav. 2026 Jun 5. doi: 10.1007/s10461-026-05134-1. Online ahead of print.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Golin, MD principal investigator
UNC-Chapel Hill
Lauren Hill, PhD principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I'm Fully Empowered for Her (IFE4Her) in people with HIV Prevention and Pre-exposure Prophylaxis, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Acceptability - Mean Score of Satisfaction Questionnaire (range 1-5 with higher scores meaning greater satisfaction) (time frame: Immediately post-mobile medical unit visit (assessed an average of 10 minutes post mobile medical unit visit)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05644834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025; AzTrials last refreshed its copy on 30 Oct 2026.