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Clinical trial Recruiting at 4 sites Interventional Ages 18 and up Women only

Digital PrEP Toolkit to help cisgender women in the Southeast access PrEP

Official title: Evaluating an Interactive Digital Toolkit for Women's PrEP Implementation

Run by University of Alabama at Birmingham · NCT07292584 · Data updated 2026-11-12

A Digital PrEP Toolkit is being tested to see if it helps cisgender women in Alabama and Mississippi learn about PrEP and start using it.

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment125 (estimated)
SponsorUniversity of Alabama at Birmingham
Academic / other
Locations4 sites (Birmingham, Alabama and 3 other locations)
StatusRecruiting
StartedApril 20, 2026
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedJune 23, 2026
Trial IDNCT07292584 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Cisgender women, 18 years and older, English-speaking, HIV-negative, sexually active or planning to be.

Probably not a fit

Participants who are not interested in PrEP or who face barriers beyond education may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests a tablet-based Digital PrEP Toolkit designed for cisgender women in the rural Southeast. It measures whether the toolkit can be completed in under 10 minutes, be found useful and easy to use, and lead to higher PrEP uptake. Up to 125 participants at three HIV/STI clinics will complete the toolkit, discuss options with staff, and be followed up at 3 and 6 months to assess PrEP initiation and knowledge changes. The study focuses on feasibility, acceptability, and preliminary efficacy of the digital intervention in increasing PrEP use among the target population.

Why it matters

Potential benefit: If successful, the toolkit could streamline PrEP education and help more women start PrEP.

How similar studies have gone: Other digital health interventions have shown promise in improving HIV prevention knowledge and uptake in similar populations, but this exact toolkit is novel for this setting.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

  • University of Alabama at Birmingham
    Birmingham, Alabama, United States     Recruiting
  • Five Horizons Health Services
    Montgomery, Alabama, United States     Recruiting
  • Five Horizons Health Services
    Tuscaloosa, Alabama, United States     Recruiting
  • Five Horizons Health Services
    Starkville, Mississippi, United States     Recruiting

Study contacts

  • Principal investigator: Mirjam-Colette Kempf, PhD, MPH — University of Alabama at Birmingham
  • Study coordinator: Mirjam-Colette Kempf, PhD, MPH
  • Email: mkempf@uab.edu
  • Phone: 205-934-9333

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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HIV Prevention 282Sexual and Reproductive Health 7University of Alabama at Birmingham 1432
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.