Evaluating an Interactive Digital Toolkit for Women's PrEP Implementation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
HIV-negative
Cisgender women
18 years or older
English-speaking
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Interactive Digital PrEP Toolkit
BehavioralEvaluation of an Interactive Digital PrEP Toolkit for women in AL and MS
Treatment groups
125 Participants
are divided into 1 treatment groupGroup A: Implementation of interactive digital PrEP toolkit for increased PrEP uptakeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility: Toolkit completion rate
Percentage of eligible women who complete the PrEP Toolkit out of women screened and enrolled
Time frame
Throughout 12-month enrollment period2
Feasibility: Toolkit Completion Time
Average time needed to complete PrEP Toolkit activities
Time frame
Throughout 12-month enrollment period3
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.
Time frame
From enrollment to the end of the 3 month follow-up period at 15-months4
Preliminary Efficacy: Participant PrEP Uptake
Proportion of eligible women who initiate PrEP after using the PrEP Toolkit to eligible clients screened
Time frame
From enrollment to the end of the 3 month follow up period at 15-monthsSecondary outcomes
1
Number of Participants by Sexual Health Priority
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).
Time frame
Throughout 12-month enrollment period2
Number of Participants by HIV Prevention Preference
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.
Time frame
Throughout 12-month enrollment period3
Number of Participants by PrEP Modality Choice
Documentation of clients' decisions on PrEP methods (e.g., oral, injectable)
Time frame
From enrollment to the end of the 3 month follow up period at 15-months4
PrEP Persistence
Proportion of clients who initiated PrEP and continue to be engaged in PrEP care at 3 months and 6 months
Time frame
From enrollment to the end of the 6 month follow up period at 18-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
Massachusetts General Hospital
Collaborator
Source ClinicalTrials.gov