Trial Outcomes & Findings for Increasing HIV/STI Home Testing Via a Digital Intervention Among Black Women (NCT NCT05390541)
NCT ID: NCT05390541
Last Updated: 2026-04-27
Results Overview
Self-report of use of HIV test within 4 days of receiving the test.
TERMINATED
NA
31 participants
4 days
2026-04-27
Participant Flow
31 participants were enrolled. The study was terminated prior to randomization into pilot portion of the trial.
Participant milestones
| Measure |
Educational Control
Participants will receive a generic standard of care via a combination of videos, audio, and text/graphics across 5 sessions during 4 weeks.
Educational 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.
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Empowered to Test Yourself
There will be 5 tailored web based sessions of the intervention over 4 weeks, all of which will follow the same format.
Empowered 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.
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Overall Study
STARTED
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Overall Study
COMPLETED
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Increasing HIV/STI Home Testing Via a Digital Intervention Among Black Women
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 4 daysPopulation: Study was terminated prior to data collection
Self-report of use of HIV test within 4 days of receiving the test.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 daysPopulation: Study was terminated prior to data collection
Self-report of mailing at-home HIV test within 2 days; verification from Kind Clinic that test was received.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 7 daysPopulation: Study was terminated prior to data collection
Self-report of HIV test results checked within 7 days after Kind Clinic receives the at home HIV test; results verified by Kind Clinic.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 7 daysPopulation: Study was terminated prior to data collection
If HIV test is positive, self-report of treatment for HIV; results verified by Kind Clinic.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 7 daysPopulation: Study was terminated prior to data collection
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 daysPopulation: Study was terminated prior to data collection
Self-report of use of STI test within 4 days of receiving STI home test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days of positive HIV testPopulation: Study was terminated prior to data collection
If applicable (if STI test is positive), self-report of treatment for STI(s); results verified by Kind Clinic.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post intervention up to 1 weekPopulation: Study was terminated prior to data collection
Scale is Completely disagree (1) to Completely agree (5). Scores average 4 items; higher scores indicate greater feasibility.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post intervention up to 1 weekPopulation: Study was terminated prior to data collection
Scale is Completely disagree (1) to Completely agree (5). Scores average 4 items; higher scores indicate greater acceptability.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineMeasures adapted from the Acceptability of Intervention Measure (AIM). Scale is Completely disagree (1) to Completely agree (5). Scores average 4 items; higher scores indicate greater acceptability.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Post intervention up to 1 weekMeasures are adapted from other researchers: 1) The questions were easy to understand. 2) The questions were respectful. 3) The intervention instructions were bothersome (reverse score). Scale is Completely disagree (1) to Completely agree (5). Scores average 3 items; higher scores indicate greater acceptability.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Post intervention up to 1 weekMeasures are adapted from other researchers: 1) The intervention instructions were easy to understand. 2) The intervention instructions were respectful. 3) The intervention instructions were bothersome (reverse score). Scale is Completely disagree (1) to Completely agree (5). Scores average 3 items; higher scores indicate greater acceptability.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 daysThe proportion of participants who completed the intervention divided by how many participants started the intervention compared to the proportion of participants who completed the educational control condition divided by how many participants started the educational control condition. Larger proportions indicate higher retention rates.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineRace, age, gender, fluent in English, location (county), smart phone and/or internet access, income, employment, insurance.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineTested for HIV/STIs and unprotected sex. Testing will be measured with 3 items by asking participants have they ever been tested for each HIV/STI individually and the answer options will be 3, 6, 12, more than 12 months ago, and never. Those who responded that they had been tested will be asked what the results the results of the test (negative, positive, or they do not know). Participants who tested more than 12 months ago or never will be eligible. Unprotected sex will as if participants had unprotected vaginal or anal sex with a man in the past 12 months. Only participants who respond "yes" will be eligible.
Outcome measures
Outcome data not reported
Adverse Events
Educational Control
Empowered to Test Yourself
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Liesl Nydegger
Johns Hopkins Bloomberg School of Public Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place