An interventional study of Interactive Digital PrEP Toolkit in HIV Prevention, HIV Risk and Sexual and Reproductive Health, sponsored by University of Alabama at Birmingham. Recruiting at 4 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention
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Among 106 studies in Health Education with a site in United States — 20 open to participants now, 25 under way, none of them phase 3. Health Education · United States.
Among the 106 studies in Health Education with a site in United States, this one is the 57th largest by planned enrollment of the 101 interventional ones that give a count, is one of 10 that started in 2026, is one of 90 with no phase, reaches primary completion later than 14 of the 24 other live ones, and was the 93rd registered.
483 studies on the registry are indexed under Health Education; 112 are open to participants now.
Browse Health Education studies →20 of the 106 studies in Health Education with a site in United States are open now. Recruiting first, the newest first:
Case Western Reserve University · Sites in United States
Ages 18+ · Women only · Healthy volunteers
University of California, San Francisco · Sites in United States
Ages 18+
The University of Texas Health Science Center, Houston · Sites in United States
Healthy volunteers
Loyola University · Sites in United States
Ages 18+ · Women only
David S Black, PhD · Sites in United States
Ages 35+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 46 Health Education studies recruiting now, 29 (63%) set no upper age limit and 14 (30%) stop at 75 or younger; 11 take children under 18; 18 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
106 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 10 · Phase 3 3 · Phase 4 1
First in 1983; this study’s year is marked. 10 started in 2026.
This study's planned enrollment of 125 is close to the median of 132 across 452 interventional studies indexed under Health Education.
Median enrollment 150 across the 101 interventional studies, 392 across the 3 observational. Of the 74 that completed or were terminated, 17 (23%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 106 have an industry lead sponsor. The 10 most frequent:
University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
University of Alabama at Birmingham has 1 study filed under Health Education — fewer than ten, so there is no comparison to draw.
9 of the studies in Health Education with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07034352University of MichiganHealth Impact 360: Advancing Physical, Social, and Mental Health Toward Cardiovascular Disease Prevention in Community Settings | 2026-12 |
| NCT06667661University of Kansas Medical CenterA Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers | 2026-12-31 |
| NCT05416060Scripps Whittier Diabetes InstituteDulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age | 2026-12-31 |
| NCT06938555Arizona State UniversityThe RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors | 2026-12-31 |
| NCT05580536Scripps Whittier Diabetes InstituteProject Dulce for Arab Americans With Type 2 Diabetes | 2026-12-31 |
Add all 9 to your calendar (.ics) → With an account.
Among the 106 studies in Health Education with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Interactive Digital PrEP Toolkit
Evaluation of an Interactive Digital PrEP Toolkit for women in AL and MS
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 period
Feasibility: Toolkit Completion Time
Average time needed to complete PrEP Toolkit activities
Time frame: Throughout 12-month enrollment period
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-months
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-months
Preliminary Efficacy: Clinic-level PrEP uptake
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
Time frame: From enrollment to the end of the 3 month follow up period at 15-months
Preliminary Efficacy: HIV and PrEP Knowledge
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).
Time frame: From enrollment to the end of the 3 month follow up period at 15-months
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 period
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 period
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-months
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-months
Plan to share: Yes — Our current plans call for the results of the process and outcome evaluations collected as part of this project will be shared via professional presentations and publications and will also be shared upon request. De-identified data will also be electronically encrypted and archived for use by others who are interested in using this data. New procedures, protocols, data collection instruments and analytic routines will be made available to interested investigators.
Time frame: Data will be available after analysis is completed.
Access criteria: Only de-identified information will be available.
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Dec 2027, 20 months after the start.
Of 292 non-industry interventional studies with no phase under Health Education, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 24. This study's planned 20 months is above that.
Counting every sponsor, half of 293 studies reached it within 11 months; a quarter within 3 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
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University of Alabama at Birmingham →