Economic Problems, Hiv, Sexually Transmitted Diseases
Conditions
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.
Interventions
BEHAVIORALEmpowered 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, the investigators will use memory practice. Participants will be asked to self-code if the participant is correct or incorrect. Lastly, participants will learn behavioral skills to engage in each of the 5 actions to increase self-efficacy.
OTHEREducational Control
Participants will receive the HIV/STI home testing kit, instructions to mail in the kit, notification when results are ready to check online, treatment from a provider at Kind Clinic for positive results, and referral to Kind Clinic for PrEP. 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 HIV was contracted, and one story about a woman who contracted herpes and how to all cope and live healthy lives. Session 4: How to disclose positive STI status. Session 5: Basic information about PrEP, and information on how to correctly use a male condom, female condom, and dental dam.
Sponsors
Johns Hopkins Bloomberg School of Public Health
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 59 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Used Home HIV Test | 4 days | Self-report of use of HIV test within 4 days of receiving the test. |
| Number of Participants Who Mailed HIV Test | 2 days | Self-report of mailing at-home HIV test within 2 days; verification from Kind Clinic that test was received. |
| Number of Participants Who Checked HIV Results | 7 days | Self-report of HIV test results checked within 7 days after Kind Clinic receives the at home HIV test; results verified by Kind Clinic. |
| Number of HIV Positive Participants Who Received HIV Treatment | 7 days | If HIV test is positive, self-report of treatment for HIV; results verified by Kind Clinic. |
| Number of HIV Negative Participants Who Attended PrEP Evaluation | 7 days | If HIV test is negative, self-report of attending appointment for PrEP evaluation within 7 days after receipt of negative HIV test; appointment attendance verified by Kind Clinic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Used Home STI Test | 4 days | Self-report of use of STI test within 4 days of receiving STI home test. |
| Number of Participants Who Received STI Treatment | 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 of Intervention Measure (FIM) Score | Post intervention up to 1 week | Scale is Completely disagree (1) to Completely agree (5). Scores average 4 items; higher scores indicate greater feasibility. |
| Acceptability of Intervention Measure (AIM) Score | Post intervention up to 1 week | Scale is Completely disagree (1) to Completely agree (5). Scores average 4 items; higher scores indicate greater acceptability. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLiesl A Nydegger, PhD
Johns Hopkins Bloomberg School of Public Health
Participant flow
Pre-assignment details
31 participants were enrolled. The study was terminated prior to randomization into pilot portion of the trial.
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed