HIV PreventionNCT07292584
Evaluating an Interactive Digital Toolkit for Women's PrEP Implementation
A study testing Interactive Digital PrEP Toolkit in people with HIV Prevention and HIV Risk, run by University of Alabama at Birmingham at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, HIV Risk, Sexual and Reproductive Health
- What is being tested?
- Interactive Digital PrEP Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Apr 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Victoria McDonald, MPH contact
United States4 sites, 4 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Victoria McDonald, MPH, 205-975-5713, vwmcdona@uab.edu
- Recruiting
Five Horizons Health Services
Montgomery, Alabama, 36111
Director of Research, 334-386-0855, bwilliams@fivehorizons.org
- Recruiting
Five Horizons Health Services
Starkville, Mississippi, 39759
Director of Research and Grant Administration, 334-386-0855, bwilliams@fivehorizons.org
- Recruiting
Five Horizons Health Services
Tuscaloosa, Alabama, 35401
Director of Research and Grant Administration, 334-386-0855, bwilliams@fivehorizons.org
About this study
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.
Read the 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.
- Conditions
- HIV Prevention, HIV Risk, Sexual and Reproductive Health
- Being tested
- Interactive Digital PrEP Toolkit
- Keywords
- PrEP, HIV prevention, cisgender women, Digital Health, Digital Intervention, Health Education, Decision Support Tool, Alabama, Mississippi, Southeast United States
- Medical subject headings
- Coitus, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Digital PrEP ToolkitBehavioural
Evaluation of an Interactive Digital PrEP Toolkit for women in AL and MS
| Study group | Role | What they receive |
|---|---|---|
| Implementation of interactive digital PrEP toolkit for increased PrEP uptake | Experimental | 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. Receives: Behavioral: Interactive Digital PrEP Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Toolkit completion rate
Percentage of eligible women who complete the PrEP Toolkit out of women screened and enrolled
Measured: Throughout 12-month enrollment period
Feasibility: Toolkit Completion Time
Average time needed to complete PrEP Toolkit activities
Measured: 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.
Measured: 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
Measured: 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
Measured: 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).
Measured: From enrollment to the end of the 3 month follow up period at 15-months
Secondary outcomes (4)
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).
Measured: 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.
Measured: Throughout 12-month enrollment period
Number of Participants by PrEP Modality Choice
Documentation of clients' decisions on PrEP methods (e.g., oral, injectable)
Measured: 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
Measured: From enrollment to the end of the 6 month follow up period at 18-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start20 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Mirjam-Colette Kempf, University of Alabama at Birmingham
- Investigators
- Mirjam-Colette Kempf, PhD, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292584
- Sponsor's protocol ID
- IRB-300015561
- Other IDs
- 000548592
- Status last verified
- Jun 2026
- First submitted
- 24 Nov 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an Interactive Digital Toolkit for Women's PrEP Implementation
- ClinicalTrials.gov ID
- NCT07292584
- Acronym / sponsor ID
- IRB-300015561
- Conditions
- HIV Prevention, HIV Risk, Sexual and Reproductive Health
- Keywords
- PrEP, HIV prevention, cisgender women, Digital Health, Digital Intervention, Health Education, Decision Support Tool, Alabama
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implementation of interactive digital PrEP toolkit for increased PrEP uptake | Experimental | Behavioral: Interactive Digital PrEP ToolkitThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Digital PrEP ToolkitEvaluation of an Interactive Digital PrEP Toolkit for women in AL and MS | Behavioural | Implementation of interactive digital PrEP toolkit for increased PrEP uptake |
Primary outcome
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).
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victoria McDonald, MPH contact
Mirjam-Colette Kempf, PhD, MPH principal investigator
University of Alabama at Birmingham
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Digital PrEP Toolkit in people with HIV Prevention and HIV Risk, run by University of Alabama at Birmingham at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mirjam-Colette Kempf, PhD, MPH (205-934-9333, mkempf@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Toolkit completion rate (time frame: Throughout 12-month enrollment period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.