Evaluating an Interactive Digital Toolkit for Women's PrEP Implementation
NCT ID: NCT07292584
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
125 participants
INTERVENTIONAL
2026-03-31
2027-12-31
Brief Summary
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Investigators will work with up to 125 women at 3 HIV and STI clinics in Alabama and Mississippi.
Participants will use the Digital PrEP Toolkit on a tablet at the clinic. They will answer questions about their HIV knowledge before and after using the Toolkit. Participants will then discuss PrEP options with a healthcare staff member and decide if they want to start PrEP. Participants will answer follow-up questions at 3 months. Investigators will also review participants' medical records at 6 months to see if they started PrEP and are still taking it.
Detailed Description
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This study will test an Interactive Digital PrEP Toolkit that includes HIV prevention education tailored to women in the Southeast, information about different PrEP medication options (i.e., daily oral pills, monthly injections, and twice-yearly injections), questions to help identify HIV prevention preferences, and testimonials from women using PrEP. The study will enroll up to 125 cisgender women at 3 HIV and STI clinic locations in Alabama and Mississippi over approximately 12 months.
Study Outcomes:
Primary outcomes include feasibility, acceptability, and preliminary efficacy. Feasibility will be measured by Toolkit completion rate, average time to complete the Toolkit, proportion of participants who initiate PrEP, and changes in HIV and PrEP knowledge. Acceptability will be measured through participant satisfaction surveys assessing how valuable and easy to use participants find the Digital PrEP Toolkit. Preliminary efficacy will be measured by comparing clinic-level PrEP uptake rates during up to 12 months preceding the study start to those during the approximately 12-month study period among all eligible female clients seen at participating clinics.
Secondary outcomes will include documentation of participants' sexual health priorities, HIV prevention preferences, and PrEP modality choices across the clinic sites. Investigators will also assess retention in PrEP care at 6 months post-enrollment.
Study Procedures:
Participants will complete a 30-minute enrollment visit at the clinic. They will provide informed consent, complete baseline assessments on HIV and PrEP knowledge, health-related questions, and demographics, and use the Interactive Digital PrEP Toolkit on a tablet. After completing the Toolkit, participants will receive a Personalized HIV Prevention Summary and meet with a healthcare staff member to discuss PrEP. Participants interested in PrEP will be scheduled for a PrEP clinic appointment.
At 3 months, Research staff will contact participants by phone for a follow-up interview about HIV and PrEP knowledge, sexual health, PrEP uptake and adherence, and experiences with the Toolkit. Research staff will also review medical records at 3 months for PrEP prescriptions.
At 6 months, research staff will review medical records for continued PrEP prescriptions. Participants will not be contacted at 6 months.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Implementation of interactive digital PrEP toolkit for increased PrEP uptake
The goal of the intervention is to strengthen the PrEP care continuum by developing and testing an interactive digital PrEP toolkit designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use.
Interactive Digital PrEP Toolkit
Evaluation of an Interactive Digital PrEP Toolkit for women in AL and MS
Interventions
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Interactive Digital PrEP Toolkit
Evaluation of an Interactive Digital PrEP Toolkit for women in AL and MS
Eligibility Criteria
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Inclusion Criteria
* Cisgender women
* 18 years or older
* English-speaking
* Report sexual activity in the last six months or anticipate sexual activity in the next six months.
Exclusion Criteria
* Do not identify as female and/or were not biologically assigned female at birth
* Living with HIV
* Report no sexual activity in the past six months and no anticipated sexual activity in the next six months
* Unable or unwilling to provide informed consent
18 Years
FEMALE
Yes
Sponsors
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Massachusetts General Hospital
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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Mirjam-Colette Kempf
University Professor
Principal Investigators
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Mirjam-Colette Kempf, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Five Horizons Health Services
Montgomery, Alabama, United States
Five Horizons Health Services
Tuscaloosa, Alabama, United States
Five Horizons Health Services
Starkville, Mississippi, United States
Countries
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Central Contacts
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Facility Contacts
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Victoria McDonald, MPH
Role: primary
Director of Research and Grant Administration
Role: primary
Director of Research and Grant Administration
Role: primary
Director of Research and Grant Administration
Role: primary
Other Identifiers
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000548592
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB-300015561
Identifier Type: -
Identifier Source: org_study_id