Evaluating an Interactive Digital Toolkit for Women's PrEP Implementation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interactive Digital PrEP Toolkit.
- Who it may be relevant to
- Registry conditions: HIV Prevention, HIV Risk, Sexual and Reproductive Health. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
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]
- 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]
Secondary outcome measures (4)
- Number of Participants by Sexual Health Priority [Time frame: Throughout 12-month enrollment period]
- Number of Participants by HIV Prevention Preference [Time frame: 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]
- PrEP Persistence [Time frame: From enrollment to the end of the 6 month follow up period at 18-months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 4 centers
- University of Alabama at Birmingham — Birmingham
- Five Horizons Health Services — Montgomery
- Five Horizons Health Services — Tuscaloosa
- Five Horizons Health Services — Starkville
Identifiers
NCT: NCT07292584 · IRB-300015561 · 000548592