Clinical trial NCT05390541: Increasing HIV/STI Home Testing Via a Digital Intervention Among Black Women
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Sexually Transmitted Diseases
Economic Problems
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-05-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to the intervention or educational control conditions. Participants in both conditions will receive HIV/STI self-testing kits. The intervention condition will have 5 tailored sessions over 4 weeks. The education control condition will have 5 generic sessions equally dispersed over 4 weeks.
Primary purpose: PREVENTION

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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 15 - 59 years of age
* Identify as a cisgender woman
* Identify as Black/African-American (Black/African American mixed race/ethnicity is included)
* 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 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 uses condoms 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.

Primary outcomes:
measure: Number of participants who used Home HIV Test
timeFrame: 4 days
measure: Number of participants who mailed HIV test
timeFrame: 2 days
measure: Number of participants who checked HIV results
timeFrame: 7 days
measure: Number of HIV positive participants who received HIV treatment
timeFrame: 7 days
measure: Number of HIV negative participants who attended PrEP evaluation
timeFrame: 7 days
Secondary outcomes:
measure: Number of participants who used home STI test
timeFrame: 4 days
measure: Number of Participants Who Received STI treatment
timeFrame: Within 7 days of positive HIV test
measure: Feasibility of Intervention Measure (FIM) score
timeFrame: Post intervention up to 1 week
measure: Acceptability of Intervention Measure (AIM) score
timeFrame: Post intervention up to 1 week
Other outcomes:
measure: Recruitment Materials Acceptability Developed by Study Team
timeFrame: Baseline
measure: Acceptability of Measures Developed by Study Team
timeFrame: Post intervention up to 1 week
measure: Acceptability of Program Instructions Developed by Study Team
timeFrame: Post intervention up to 1 week
measure: Participant Retention Rate of Intervention and Educational Control Session.
timeFrame: 28 days
measure: Baseline demographic characteristics
timeFrame: Baseline
measure: Number of participants with high sexual risk
timeFrame: Baseline
Locations:
city: Austin
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Texas
city: Dallas
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Texas
city: Houston
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Texas
city: San Antonio
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Texas
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Liesl A Nydegger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
citation: Ondersma SJ, Chase SK, Svikis DS, Schuster CR. Computer-based brief motivational intervention for perinatal drug use. J Subst Abuse Treat. 2005 Jun;28(4):305-12. doi: 10.1016/j.jsat.2005.02.004.