Study Stopped
Study was terminated by NIH
Increasing HIV/STI Home Testing Via a Digital Intervention Among Black Women
2 other identifiers
interventional
31
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv
Started Feb 2022
Typical duration for not_applicable hiv
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2022
CompletedFirst Submitted
Initial submission to the registry
May 16, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedResults Posted
Study results publicly available
April 24, 2026
CompletedApril 27, 2026
April 1, 2026
3.4 years
May 16, 2022
April 3, 2026
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Number of Participants Who Used Home HIV Test
Self-report of use of HIV test within 4 days of receiving the test.
4 days
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.
2 days
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.
7 days
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.
7 days
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.
7 days
Secondary Outcomes (4)
Number of Participants Who Used Home STI Test
4 days
Number of Participants Who Received STI Treatment
Within 7 days of positive HIV test
Feasibility of Intervention Measure (FIM) Score
Post intervention up to 1 week
Acceptability of Intervention Measure (AIM) Score
Post intervention up to 1 week
Other Outcomes (6)
Recruitment Materials Acceptability Developed by Study Team
Baseline
Acceptability of Measures Developed by Study Team
Post intervention up to 1 week
Acceptability of Program Instructions Developed by Study Team
Post intervention up to 1 week
- +3 more other outcomes
Study Arms (2)
Educational Control
ACTIVE COMPARATORParticipants will receive a generic standard of care via a combination of videos, audio, and text/graphics across 5 sessions during 4 weeks.
Empowered to Test Yourself
EXPERIMENTALThere will be 5 tailored web based sessions of the intervention over 4 weeks, all of which will follow the same format.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Johns Hopkins Bloomberg School of Public Health
Austin, Texas, 78701, United States
Johns Hopkins Bloomberg School of Public Health
Dallas, Texas, 75202, United States
Johns Hopkins Bloomberg School of Public Health
Houston, Texas, 77019, United States
Johns Hopkins Bloomberg School of Public Health
San Antonio, Texas, 78205, United States
Related Publications (2)
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.
PMID: 28851459BACKGROUNDOndersma 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.
PMID: 15925264BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Liesl Nydegger
- Organization
- Johns Hopkins Bloomberg School of Public Health
Study Officials
- PRINCIPAL INVESTIGATOR
Liesl A Nydegger, PhD
Johns Hopkins Bloomberg School of Public Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2022
First Posted
May 25, 2022
Study Start
February 2, 2022
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
April 27, 2026
Results First Posted
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.