Increasing HIV/STI Home Testing Via a Digital Intervention Among Black Women

Study Overview
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Brief Summary
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The proposed intervention is a web-based intervention guided by theoretical components to increase HIV home testing among Black women at risk for HIV and sexually transmitted infections (STIs) in a HIV hotspot in the South. The intervention will promote using the home test, linkage to care, and linkage to pre-exposure prophylaxis (PrEP) evaluation. The intervention has the potential to be implemented on a large scale and tailored based on location and population to increase testing, treatment, and PrEP adoption.

Detailed Description
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In Travis County, Texas, deemed a HIV geographic hotspot due to high HIV rates, Black women are 18.4 times more likely to contract HIV compared to women of other races/ethnicities. Black women also have higher rates of sexually transmitted infections (STIs) than other women; many STIs have no symptoms, are undiagnosed, and are untreated. Having an STI triples one's risk for contracting HIV. In Travis County, over 20% of women learned one year after contracting HIV that they were HIV-positive, highlighting barriers to testing. Home HIV/STI testing has promise to increase rates of testing by circumventing barriers and thereby reduce medical costs through early detection and care. Home HIV/STI testing is also a prime opportunity to link Black women at high risk for HIV to pre-exposure prophylaxis (PrEP). Yet, home testing alone may not overcome all barriers. Pairing home testing with an intervention designed to increase motivation and overcome barriers has the most promise to increase HIV/STI testing rates. The proposed project draws on 3 components, the situated, information-motivation-behavioral (sIMB) model, mental contrasting, and implementation intentions to develop a new, web-based intervention. This intervention is comprised of 5 sessions: 1) using the HIV/STI home testing kit, 2) mailing in the kit, 3) checking results, 4) obtaining treatment, and 5) attending an appointment for PrEP. Each session is structured the same: information regarding the importance of each behavior (i.e., taking the home test, mailing in the test, checking results, linkage to care, and linkage to PrEP), motivation via mental contrasting (identifying positive outcomes and barriers to each session) and methods to overcome the identified barriers (implementation intentions), and behavioral skills to increase self-efficacy. The project will occur in 3 phases that coincide with the aims to develop and culturally tailor the intervention. 1) Conduct formative research to develop the intervention. Four focus groups (n=4-6), with 24 Black women from Travis County will explore the constructs of sIMB, mental contrasting, and implementation intentions to develop the intervention protocol to be field tested in Aim 2. 2) Field test the intervention. We will test the preliminary feasibility and acceptability of the intervention with 6 participants to make any necessary adjustments for Aim 3. 3) Conduct a feasibility pilot of the intervention. The investigators will determine the feasibility, acceptability, and preliminary efficacy among 60 Black women in Travis County. Participants will be randomly assigned to the intervention or a web-based educational control. The investigators hypothesize that the intervention will be feasible, acceptable, and demonstrate a trend toward efficacy for completion of home testing, linkage to care, and linkage to PrEP. Follow-up web-based assessments will be administered 2-, 4-, and 6-months after baseline. The web-based design of the intervention greatly increases the opportunity for implementation on a large scale. The long-term goal is to increase HIV/STI testing among low-income Black women via scalable and sustainable methods to decrease HIV transmission and subsequent disparities.

Official Title
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Increasing HIV/STI Home Testing, Linkage to Care, and Linkage to PrEP Via a Digital Intervention Among Black Women in a Geographic Hotspot

Conditions
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Hiv, Sexually Transmitted Diseases, Economic Problems

Intervention / Treatment
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* Behavioral: Empowered to Test Yourself


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants a) are 15 - 59 years of age (ages most likely to contract HIV [62]), b) identify as a cis-gender woman, c) identify as Black/African-American (Black/African American mixed race/ethnicity is included), d) read/speak/type in English e), f) have not tested for HIV/STIs in the past 12 months, g) live in Travis County, h) had unprotected sex in the past 12 months, and I) have access to a smart phone and internet. Exclusion Criteria: Exclusion criteria include individuals who a) are over the age of 59 or younger than 15 years, b) identify as any gender other than a cisgender woman, c) identify as any race/ethnicity other than Black/African-American, d) are unable to fluently speak, read, or type in English, e) took a HIV/STI test within the past 12 months, f) live outside of Travis County, g) have used a condom 100% of the time during sex in the past 12 months, or h) do not have a smart phone or internet access.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational Control<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Used Home HIV test | Self-report of use of HIV test. | Within 4 days of receiving HIV home test | 
| Mailed HIV test | Self-report of mailing at home HIV test; verification from Kind Clinic that test was received. | Within 2 days of mailing the HIV home test. | 
| Checked HIV results | Self-report of HIV test results; results verified by Kind Clinic. | Within 7 days after Kind Clinic receives the at home HIV test | 
| Received HIV treatment | If applicable (if HIV test is positive), self-report of treatment for HIV; results verified by Kind Clinic. | Within 7 days of positive HIV test | 
| Attended PrEP evaluation | If applicable (HIV test is negative), self-report of attending appointment for PrEP evaluation; appointment attendance verified by Kind Clinic. | Within 7 days after receipt of negative HIV test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Used home STI test | Self-report of use of STI test. | Within 4 days of receiving STI home test | 
| Mailed STI test | Self-report of mailing at home STI test; verification from Kind Clinic that test was received. | Within 2 days of mailing the HIV home test. | 
| Checked STI results | Self-report of STI test results; results verified by Kind Clinic. | Within 7 days after Kind Clinic receives the at home HIV test | 
| Received STI treatment | If applicable (if STI test is positive), self-report of treatment for STI(s); results verified by Kind Clinic. | Within 7 days of positive HIV test | 
| Feasibility | 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. | Within 1 week after completing 28-day intervention | 
| Acceptability | 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. | Within 1 week after completing 28-day intervention |