Increasing HIV/STI Home Testing Via a Digital Intervention Among Black Women
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|ClinicalTrials.gov Identifier: NCT05390541|
Recruitment Status : Recruiting
First Posted : May 25, 2022
Last Update Posted : May 25, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hiv Sexually Transmitted Diseases Economic Problems||Behavioral: Empowered to Test Yourself||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Increasing HIV/STI Home Testing, Linkage to Care, and Linkage to PrEP Via a Digital Intervention Among Black Women in a Geographic Hotspot|
|Actual Study Start Date :||February 2, 2022|
|Estimated Primary Completion Date :||March 31, 2024|
|Estimated Study Completion Date :||June 30, 2024|
Experimental: Educational Control
Participants will receive the HIV/STI home testing kit, instructions to mail in the kit, notification when their results are ready to check online, treatment from a provider at Kind Clinic for positive results, and referral to Kind Clinic for PrEP. Participants will receive a web-based standard of care via a combination of videos, audio, and text/graphics across 5 sessions. Each session and assessment will occur every 3 days. Session 1: Basic information about STIs. Session 2: HIV and stigma, basic information about HIV, and HIV transmission facts and myths. Session 3: Four stories about different people who are HIV-positive, how they contracted HIV, and one story about a woman who contracted herpes and how they all cope and live healthy lives. Session 4: How to tell someone you have an STI. Session 5: Basic information about PrEP, and information on how to correctly use a male condom, female condom, and dental dam.
Behavioral: Empowered to Test Yourself
There will be 5 sessions of the intervention, all of which will follow the same format. Participants will be sent push notifications for each session. Each session will begin with using relevant constructs from sIMB (i.e., information and behavioral skills). Next, participants will choose positive outcomes resulting from the behavior, barriers to performing the behavior (mental contrasting), select situational cues and action plans to overcome selected barriers (implementation intentions), and practice typing in implementation intentions and positive outcomes from memory (memory practice). To ensure participants retain the implementation intentions, we will use memory practice. Participants will be asked to self-code if they are correct or incorrect. Lastly, participants will learn behavioral skills to engage in each of the 5 actions to increase self-efficacy.
- Used Home HIV test [ Time Frame: Within 4 days of receiving HIV home test ]Self-report of use of HIV test.
- Mailed HIV test [ Time Frame: Within 2 days of mailing the HIV home test. ]Self-report of mailing at home HIV test; verification from Kind Clinic that test was received.
- Checked HIV results [ Time Frame: Within 7 days after Kind Clinic receives the at home HIV test ]Self-report of HIV test results; results verified by Kind Clinic.
- Received HIV treatment [ Time Frame: Within 7 days of positive HIV test ]If applicable (if HIV test is positive), self-report of treatment for HIV; results verified by Kind Clinic.
- Attended PrEP evaluation [ Time Frame: Within 7 days after receipt of negative HIV test ]If applicable (HIV test is negative), self-report of attending appointment for PrEP evaluation; appointment attendance verified by Kind Clinic.
- Used home STI test [ Time Frame: Within 4 days of receiving STI home test ]Self-report of use of STI test.
- Mailed STI test [ Time Frame: Within 2 days of mailing the HIV home test. ]Self-report of mailing at home STI test; verification from Kind Clinic that test was received.
- Checked STI results [ Time Frame: Within 7 days after Kind Clinic receives the at home HIV test ]Self-report of STI test results; results verified by Kind Clinic.
- Received STI treatment [ Time Frame: Within 7 days of positive HIV test ]If applicable (if STI test is positive), self-report of treatment for STI(s); results verified by Kind Clinic.
- Feasibility [ Time Frame: Within 1 week after completing 28-day intervention ]Will be assessed by asking participants on a 5- point scale and open ended questions how easy or difficult each step was in both the intervention and educational control, how safe they felt using the home test, their preference of using the home test over testing at a clinic and why, and the ease of using and navigating the web-based intervention.
- Acceptability [ Time Frame: Within 1 week after completing 28-day intervention ]Will be assessed on a 5-point scale and open-ended questions asking how acceptable each step was in the intervention (i.e., taking the home test, mailing the kit, checking results, obtaining treatment, and attending PrEP appointment), their overall experience, their interaction with providers from Kind Clinic, their experience (positive or negative) with using the web-based intervention, the technology they used the most to complete the intervention or educational controls sessions and assessments (computer, tablet, or cell phone) and any difficulties with their chosen technology, and overall intervention or educational control feedback.
- Recruitment strategy [ Time Frame: Baseline assessment prior to intervention beginning ]Feedback on study social media advertisement.
- Measures appropriate and no errors [ Time Frame: Within 1 week after completing 28-day intervention ]Feedback on measures such as wording, clarity, cultural appropriateness, measured at during all assessments in Phase 2 to identify any potential changes prior to Phase 3.
- Clear instructions [ Time Frame: Within 1 week after completing 28-day intervention ]Feedback on intervention or educational control instructions such as ease of understanding, confusing phrases, areas to improve clarity and comprehension.
- Retention [ Time Frame: During 28-day intervention ]Completion rate of intervention sessions, educational control sessions, and all assessments.
- Demographic eligibility [ Time Frame: Baseline assessment prior to intervention beginning ]Race, age, gender, fluent in English, location (county), smart phone and/or internet access.
- Sexual risk eligibility [ Time Frame: Baseline assessment prior to intervention beginning ]Tested for HIV/STIs and unprotected sex. Testing will be measured with 3 items by asking participants have they ever been tested for each HIV/STI individually and the answer options will be 3, 6, 12, more than 12 months ago, and never. Those who responded that they had been tested will be asked what the results the results of the test (negative, positive, or they do not know). Participants who tested more than 12 months ago or never will be eligible. Unprotected sex will as if participants had unprotected vaginal or anal sex with a man in the past 12 months. Only participants who respond "yes" will be eligible.
- Other demographics [ Time Frame: Baseline assessment prior to intervention beginning ]Income, employment, and insurance status. For income, current numbers of adult household and monthly income to calculate and compare to federal poverty line. As incomes, employment, and insurance change.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05390541
|Contact: Liesl A Nydegger, PhDemail@example.com|
|United States, Texas|
|University of Texas at Austin||Recruiting|
|Austin, Texas, United States, 78712|
|Contact: Elena Mota 512-232-1419 firstname.lastname@example.org|
|Principal Investigator: Liesl A Nydegger, PhD|
|Principal Investigator:||Liesl A Nydegger, PhD||University of Texas at Austin|