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HivNCT05390541

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

A study testing Empowered to Test Yourself in people with Hiv and Sexually Transmitted Diseases, run by Johns Hopkins Bloomberg School of Public Health at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 59 years, women onlyHealthy volunteers can take part
What is being tested?
Empowered to Test Yourself
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
4 sitesUnited States
Study dates
2 Feb 2022to 30 Jun 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 59 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • Johns Hopkins Bloomberg School of Public Health

    Austin, Texas, 78701

  • Johns Hopkins Bloomberg School of Public Health

    Dallas, Texas, 75202

  • Johns Hopkins Bloomberg School of Public Health

    Houston, Texas, 77019

  • Johns Hopkins Bloomberg School of Public Health

    San Antonio, Texas, 78205

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Empowered to Test Yourself, Educational Control
Medical subject headings
Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empowered to Test YourselfBehavioural

    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.

  • Educational ControlOther

    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.

Study groups in NCT05390541
Study groupRoleWhat they receive
Educational ControlActive comparatorParticipants will receive a generic standard of care via a combination of videos, audio, and text/graphics across 5 sessions during 4 weeks.
Receives: Other: Educational Control
Empowered to Test YourselfExperimentalThere will be 5 tailored web based sessions of the intervention over 4 weeks, all of which will follow the same format.
Receives: Behavioral: Empowered to Test Yourself

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Used Home HIV Test

    Self-report of use of HIV test within 4 days of receiving the test.

    Measured: 4 days

  2. Number of Participants Who Mailed HIV Test

    Self-report of mailing at-home HIV test within 2 days; verification from Kind Clinic that test was received.

    Measured: 2 days

  3. Number of Participants Who Checked HIV Results

    Self-report of HIV test results checked within 7 days after Kind Clinic receives the at home HIV test; results verified by Kind Clinic.

    Measured: 7 days

  4. Number of HIV Positive Participants Who Received HIV Treatment

    If HIV test is positive, self-report of treatment for HIV; results verified by Kind Clinic.

    Measured: 7 days

  5. Number of HIV Negative Participants Who Attended PrEP Evaluation

    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.

    Measured: 7 days

Secondary outcomes (4)
  1. Number of Participants Who Used Home STI Test

    Self-report of use of STI test within 4 days of receiving STI home test.

    Measured: 4 days

  2. Number of Participants Who Received STI Treatment

    If applicable (if STI test is positive), self-report of treatment for STI(s); results verified by Kind Clinic.

    Measured: Within 7 days of positive HIV test

  3. Feasibility of Intervention Measure (FIM) Score

    Scale is Completely disagree (1) to Completely agree (5). Scores average 4 items; higher scores indicate greater feasibility.

    Measured: Post intervention up to 1 week

  4. Acceptability of Intervention Measure (AIM) Score

    Scale is Completely disagree (1) to Completely agree (5). Scores average 4 items; higher scores indicate greater acceptability.

    Measured: Post intervention up to 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2022
  2. Study start2 Feb 2022
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Why it stopped: Study was terminated by NIH

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05390541
Sponsor's protocol ID
IRB00023755
Other IDs
7R34MH128054-03
Status last verified
Apr 2026
First submitted
16 May 2022
Last updated
27 Apr 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 28851459
  • 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.

    PubMed 15925264

Questions about this trial

What is this clinical trial studying?

A study testing Empowered to Test Yourself in people with Hiv and Sexually Transmitted Diseases, run by Johns Hopkins Bloomberg School of Public Health at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Used Home HIV Test (time frame: 4 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05390541, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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