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| ID | Type | Description | Link |
|---|---|---|---|
| 000548592 | Other Grant/Funding Number | Gilead Sciences |
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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive Digital PrEP Toolkit | Behavioral | Evaluation of an Interactive Digital PrEP Toolkit for women in AL and MS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Toolkit completion rate | Percentage of eligible women who complete the PrEP Toolkit out of women screened and enrolled | Throughout 12-month enrollment period |
| Feasibility: Toolkit Completion Time | Average time needed to complete PrEP Toolkit activities | 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. | 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 | 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 | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Throughout 12-month enrollment period |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mirjam-Colette Kempf, PhD, MPH | Contact | 205-934-9333 | mkempf@uab.edu | |
| Victoria McDonald, MPH | Contact | vwmcdona@uab.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mirjam-Colette Kempf, PhD, MPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35205 | United States |
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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Data will be available after analysis is completed.
Only de-identified information will be available.
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| ID | Term |
|---|---|
| D003075 | Coitus |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
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| From enrollment to the end of the 3 month follow up period at 15-months |
| 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. | Throughout 12-month enrollment period |
| Number of Participants by PrEP Modality Choice | Documentation of clients' decisions on PrEP methods (e.g., oral, injectable) | 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 | From enrollment to the end of the 6 month follow up period at 18-months |
| Five Horizons Health Services | Recruiting | Montgomery | Alabama | 36111 | United States |
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| Five Horizons Health Services | Recruiting | Tuscaloosa | Alabama | 35401 | United States |
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| Five Horizons Health Services | Recruiting | Starkville | Mississippi | 39759 | United States |
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| D010349 |
| Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |