Evaluating an Interactive Digital Toolkit for Women's PrEP Implementation
2 other identifiers
interventional
125
1 country
4
Brief Summary
The goal of this study is to test if a Digital PrEP Toolkit helps cisgender women learn about and access PrEP in Alabama and Mississippi. PrEP is a medication that prevents HIV infection. The main questions it aims to answer are: Can participants complete the Digital PrEP Toolkit in under 10 minutes? Do participants find the Digital PrEP Toolkit useful and easy to use? Does the Digital PrEP Toolkit increase the number of women who start taking PrEP? 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2025
CompletedFirst Posted
Study publicly available on registry
December 18, 2025
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 19, 2026
March 1, 2026
1.7 years
November 24, 2025
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Feasibility: Toolkit completion rate
Percentage of eligible women who complete the PrEP Toolkit out of women screened and enrolled
Throughout 12-month enrollment period
Feasibility: Toolkit Completion Time
Average time needed to complete PrEP Toolkit activities
Throughout 12-month enrollment period
Acceptability: Participant Satisfaction
Participant satisfaction will be assessed using a study-specific satisfaction questionnaire measuring perceived value and ease of use of the Digital PrEP Toolkit. The questionnaire includes Likert-scale items (range: 1-5, with higher scores indicating greater satisfaction) evaluating Toolkit usability, perceived usefulness, and overall satisfaction.
From enrollment to the end of the 3 month follow-up period at 15-months
Preliminary Efficacy: Participant PrEP Uptake
Proportion of eligible women who initiate PrEP after using the PrEP Toolkit to eligible clients screened
From enrollment to the end of the 3 month follow up period at 15-months
Preliminary Efficacy: Clinic-level PrEP uptake
Comparison of PrEP uptake rates up to 12-months prior to study start to PrEP uptake rates during the approximately 12-month study enrollment period among eligible women at the partnering clinic sites
From enrollment to the end of the 3 month follow up period at 15-months
Preliminary Efficacy: HIV and PrEP Knowledge
Changes in HIV and PrEP knowledge will be assessed using an adapted version of the updated HIV Knowledge Questionnaire (range: 0-31, with higher scores indicating greater knowledge).
From enrollment to the end of the 3 month follow up period at 15-months
Secondary Outcomes (4)
Number of Participants by Sexual Health Priority
Throughout 12-month enrollment period
Number of Participants by HIV Prevention Preference
Throughout 12-month enrollment period
Number of Participants by PrEP Modality Choice
From enrollment to the end of the 3 month follow up period at 15-months
PrEP Persistence
From enrollment to the end of the 6 month follow up period at 18-months
Study Arms (1)
Implementation of interactive digital PrEP toolkit for increased PrEP uptake
EXPERIMENTALThe 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.
Interventions
Evaluation of an Interactive Digital PrEP Toolkit for women in AL and MS
Eligibility Criteria
You may qualify if:
- HIV-negative
- Cisgender women
- years or older
- English-speaking
- Report sexual activity in the last six months or anticipate sexual activity in the next six months.
You may not qualify if:
- Younger than 18 years of age
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
Five Horizons Health Services
Montgomery, Alabama, 36111, United States
Five Horizons Health Services
Tuscaloosa, Alabama, 35401, United States
Five Horizons Health Services
Starkville, Mississippi, 39759, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mirjam-Colette Kempf, PhD, MPH
University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- University Professor
Study Record Dates
First Submitted
November 24, 2025
First Posted
December 18, 2025
Study Start
April 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be available after analysis is completed.
- Access Criteria
- Only de-identified information will be available.
Our current plans call for the results of the process and outcome evaluations collected as part of this project will be shared via professional presentations and publications and will also be shared upon request. De-identified data will also be electronically encrypted and archived for use by others who are interested in using this data. New procedures, protocols, data collection instruments and analytic routines will be made available to interested investigators.