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

Last updated: July 1, 2024
Sponsor: Johns Hopkins Bloomberg School of Public Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv

Treatment

Educational Control

Empowered to Test Yourself

Clinical Study ID

NCT05390541
IRB00023755
7R34MH128054-03
  • Ages 15-59
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 15 - 59 years of age

  • Identify as a cisgender woman

  • Identify as Black/African-American (Black/African American mixed race/ethnicity isincluded)

  • Read/speak/type in English

  • Have not tested for HIV/STIs in the past 12 months

  • Live in urban or suburban areas in Austin, Dallas, Houston, or San Antonio, Texas

  • Had condom-less sex in the past 6 months

  • Have access to a device (i.e., smart phone, tablet, or computer/laptop)

  • Have access to the internet

  • Reports at least one of the following:

  • A sexual partner who is living with HIV

  • Does not use or uses condoms inconsistently for vaginal/anal sex

  • Injects drugs with a partner who is living with HIV

  • Shared drug preparation or injection equipment with others

Exclusion

Exclusion Criteria:

  • Over the age of 59 or younger than 15 years

  • Identify as any gender other than a cisgender woman

  • Identify as any race/ethnicity other than Black/African-American

  • Are unable to fluently speak, read, or type in English

  • Had an HIV/STI test within the past 12 months

  • Live in rural areas of Texas or urban/suburban areas other than Austin, Dallas,Houston, or San Antonio, Texas

  • Use condoms 100% of the time during vaginal/anal sex in the past 6 months

  • Do not have access to a device (i.e., smart phone, tablet, or computer/laptop)

  • Do not have access to the internet

  • Reports that they do not have a sexual partner who is living with HIV, always usescondoms for vaginal/anal sex, does not inject drugs with a partner living with HIV,and does not share drug preparation or injection equipment with others.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Educational Control
Phase:
Study Start date:
February 02, 2022
Estimated Completion Date:
September 30, 2025

Study 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 the the individual is 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. The investigators 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.

Connect with a study center

  • Johns Hopkins Bloomberg School of Public Health

    Austin, Texas 78701
    United States

    Active - Recruiting

  • University of Texas at Austin

    Austin, Texas 78712
    United States

    Active - Recruiting

  • Johns Hopkins Bloomberg School of Public Health

    Dallas, Texas 75202
    United States

    Active - Recruiting

  • Johns Hopkins Bloomberg School of Public Health

    Houston, Texas 77019
    United States

    Active - Recruiting

  • Johns Hopkins Bloomberg School of Public Health

    San Antonio, Texas 78205
    United States

    Active - Recruiting

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