HIV Prevention, HIV Risk, Sexual and Reproductive Health
Conditions
Keywords
PrEP, HIV prevention, cisgender women, Digital Health, Digital Intervention, Health Education, Decision Support Tool, Alabama, Mississippi, Southeast United States
Brief 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. 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
BEHAVIORALInteractive Digital PrEP Toolkit
Evaluation of an Interactive Digital PrEP Toolkit for women in AL and MS
Sponsors
University of Alabama at Birmingham
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Toolkit completion rate | Throughout 12-month enrollment period | Percentage of eligible women who complete the PrEP Toolkit out of women screened and enrolled |
| Feasibility: Toolkit Completion Time | Throughout 12-month enrollment period | Average time needed to complete PrEP Toolkit activities |
| Acceptability: Participant Satisfaction | 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 | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants by Sexual Health Priority | Throughout 12-month enrollment period | 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). |
| Number of Participants by HIV Prevention Preference | Throughout 12-month enrollment period | 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. |
| Number of Participants by PrEP Modality Choice | From enrollment to the end of the 3 month follow up period at 15-months | Documentation of clients' decisions on PrEP methods (e.g., oral, injectable) |
| PrEP Persistence | From enrollment to the end of the 6 month follow up period at 18-months | Proportion of clients who initiated PrEP and continue to be engaged in PrEP care at 3 months and 6 months |
Countries
United States
Contacts
CONTACTMirjam-Colette Kempf, PhD, MPH
CONTACTVictoria McDonald, MPH
PRINCIPAL_INVESTIGATORMirjam-Colette Kempf, PhD, MPH
University of Alabama at Birmingham
Outcome results
None listed