NCT07292584 · University of Alabama at Birmingham
Evaluating an Interactive Digital Toolkit for Women's PrEP Implementation
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Interactive Digital PrEP Toolkit
Evaluation of an Interactive Digital PrEP Toolkit for women in AL and MS
Primary outcome measures
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
Feasibility: Toolkit Completion Time
Time frame: Throughout 12-month enrollment period
Average time needed to complete PrEP Toolkit activities
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.
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
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
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Birmingham, Alabama
- Montgomery, Alabama
- Tuscaloosa, Alabama
- Starkville, Mississippi
Collaborators
Massachusetts General Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations