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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
Sponsor:
Information provided by (Responsible Party):
University of Texas at Austin

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hiv Sexually Transmitted Diseases Economic Problems Behavioral: Empowered to Test Yourself Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Used Home HIV test [ Time Frame: Within 4 days of receiving HIV home test ]
    Self-report of use of HIV test.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. Used home STI test [ Time Frame: Within 4 days of receiving STI home test ]
    Self-report of use of STI test.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Other Outcome Measures:
  1. Recruitment strategy [ Time Frame: Baseline assessment prior to intervention beginning ]
    Feedback on study social media advertisement.

  2. 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.

  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.

  4. Retention [ Time Frame: During 28-day intervention ]
    Completion rate of intervention sessions, educational control sessions, and all assessments.

  5. Demographic eligibility [ Time Frame: Baseline assessment prior to intervention beginning ]
    Race, age, gender, fluent in English, location (county), smart phone and/or internet access.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 59 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cisgender Black women are eligible for this study.
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Liesl A Nydegger, PhD 323-453-2822 liesl.nydegger@austin.utexas.edu

Locations
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United States, Texas
University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Elena Mota    512-232-1419    evmota@austin.utexas.edu   
Principal Investigator: Liesl A Nydegger, PhD         
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Liesl A Nydegger, PhD University of Texas at Austin
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Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT05390541    
Other Study ID Numbers: 1R34MH128054-01 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2022    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators will share the findings through presentations at national and international conferences. They will also seek to publish findings in key scientific outlets. The investigators will assure that they are in compliance with NIH requirements to deposit peer reviewed publications with the PubMed Central repository, thus facilitating dissemination of findings to the scientific community and general public. The investigators will willingly share the data with scholars wishing to collaborate on publications related to the project. To improve the ease of collaboration the investigators will thoroughly document all decisions regarding how they classify and code our transcribed and quantitative data.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data will become available in the Texas Data repository within 1 year after study completion where it will remain for 5 years.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Communicable Diseases
Infections
Disease Attributes
Pathologic Processes