Evaluating an Interactive Digital Toolkit for Women's PrEP Implementation

March 18, 2026 updated by: Mirjam-Colette Kempf, University of Alabama at Birmingham

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cisgender women in the rural southeastern United States face substantial HIV risk. Despite this, pre-exposure prophylaxis (PrEP) use among women remains alarmingly low. PrEP is a medication that prevents HIV infection. Barriers to PrEP use among women include limited PrEP awareness and knowledge, low HIV risk perception, challenging client-provider conversations about sexual health, and structural challenges like transportation difficulties and time constraints.

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.

Study Type

Interventional

Enrollment (Estimated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mirjam-Colette Kempf, PhD, MPH
  • Phone Number: 205-934-9333
  • Email: mkempf@uab.edu

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • University of Alabama at Birmingham
        • Contact:
      • Montgomery, Alabama, United States, 36111
        • Five Horizons Health Services
        • Contact:
      • Tuscaloosa, Alabama, United States, 35401
        • Five Horizons Health Services
        • Contact:
    • Mississippi
      • Starkville, Mississippi, United States, 39759
        • Five Horizons Health Services
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • HIV-negative
  • 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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Interactive Digital PrEP Toolkit
Evaluation of an Interactive Digital PrEP Toolkit for women in AL and MS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: Toolkit completion rate
Time Frame: Throughout 12-month enrollment period
Percentage of eligible women who complete the PrEP Toolkit out of women screened and enrolled
Throughout 12-month enrollment period
Feasibility: Toolkit Completion Time
Time Frame: Throughout 12-month enrollment period
Average time needed to complete PrEP Toolkit activities
Throughout 12-month enrollment period
Acceptability: Participant Satisfaction
Time Frame: From enrollment to the end of the 3 month follow-up period at 15-months
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
Time Frame: From enrollment to the end of the 3 month follow up period at 15-months
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
Time Frame: From enrollment to the end of the 3 month follow up period at 15-months
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
Time Frame: From enrollment to the end of the 3 month follow up period at 15-months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants by Sexual Health Priority
Time Frame: Throughout 12-month enrollment period
Documentation of participants' sexual health priorities will be assessed using a study-specific questionnaire capturing: (1) reasons for PrEP consideration, and (2) factors most important to participants when considering HIV prevention and sexual wellness (e.g., effectiveness, convenience, privacy, cost).
Throughout 12-month enrollment period
Number of Participants by HIV Prevention Preference
Time Frame: Throughout 12-month enrollment period
Participants' HIV prevention preferences will be assessed using a study-specific questionnaire capturing stated interest in daily PrEP, injectable PrEP, both options, non-medication options, or no current interest.
Throughout 12-month enrollment period
Number of Participants by PrEP Modality Choice
Time Frame: From enrollment to the end of the 3 month follow up period at 15-months
Documentation of clients' decisions on PrEP methods (e.g., oral, injectable)
From enrollment to the end of the 3 month follow up period at 15-months
PrEP Persistence
Time Frame: From enrollment to the end of the 6 month follow up period at 18-months
Proportion of clients who initiated PrEP and continue to be engaged in PrEP care at 3 months and 6 months
From enrollment to the end of the 6 month follow up period at 18-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Massachusetts General Hospital

Investigators

  • Principal Investigator: Mirjam-Colette Kempf, PhD, MPH, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300015561
  • 000548592 (Other Grant/Funding Number: Gilead Sciences)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be available after analysis is completed.

IPD Sharing Access Criteria

Only de-identified information will be available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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