Recruiting

Digital PrEP Toolkit

Sponsor:

University of Alabama at Birmingham

Code:

NCT07292584

Conditions

HIV Prevention

HIV Risk

Sexual and Reproductive Health

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Interactive Digital PrEP Toolkit

Study Details

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.

Conditions

HIV Prevention

HIV Risk

Sexual and Reproductive Health

Study ID

NCT07292584

Start date

Apr 20, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

125 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Interactive Digital PrEP Toolkit

Evaluation of an Interactive Digital PrEP Toolkit for women in AL and MS

Primary outcome measure

  • Feasibility: Toolkit completion rate [ Time Frame: Throughout 12-month enrollment period ]
  • Feasibility: Toolkit Completion Time [ Time Frame: 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 ]
  • Preliminary Efficacy: Participant PrEP Uptake [ Time Frame: 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 ]
  • Preliminary Efficacy: HIV and PrEP Knowledge [ Time Frame: From enrollment to the end of the 3 month follow up period at 15-months ]

Central Contacts and Locations

Central contacts

Mirjam-Colette Kempf, PhD, MPH

205-934-9333mkempf@uab.edu

Victoria McDonald, MPH

vwmcdona@uab.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Victoria McDonald, MPH

205-975-5713vwmcdona@uab.edu

Five Horizons Health Services

Recruiting

Montgomery, Alabama, United States, 36111

Contacts

Director of Research

334-386-0855bwilliams@fivehorizons.org

Five Horizons Health Services

Recruiting

Tuscaloosa, Alabama, United States, 35401

Contacts

Director of Research and Grant Administration

334-386-0855bwilliams@fivehorizons.org

Five Horizons Health Services

Recruiting

Starkville, Mississippi, United States, 39759

Contacts

Director of Research and Grant Administration

334-386-0855bwilliams@fivehorizons.org

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • PrEP
  • HIV prevention
  • cisgender women
  • Digital Health
  • Digital Intervention
  • Health Education
  • Decision Support Tool
  • Alabama
  • Mississippi
  • Southeast United States

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-06-23.