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Behavioral Intervention
Digital Intervention for HIV/STI Testing in Black Women
N/A
Recruiting
Led By Liesl A Nydegger, PhD
Research Sponsored by Johns Hopkins Bloomberg School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Summary
This trial will test a new way to get more black women in the South to test for HIV at home, which could lead to earlier treatment and prevention.
Who is the study for?
This trial is for Black women aged 15-59 living in Travis County who haven't tested for HIV/STIs in the past year, had unprotected sex during that time, and can use a smartphone with internet. It's not open to those outside this age range or location, who've been recently tested, always used protection, or lack English fluency.Check my eligibility
What is being tested?
The study tests a web-based intervention aimed at increasing home testing for HIV among Black women at risk. The program encourages self-testing and connects participants to healthcare services and PrEP evaluation to prevent HIV infection.See study design
What are the potential side effects?
Since this is a digital intervention promoting home testing without direct medical treatment involved, there are no traditional side effects like you'd expect from medication. However, users may experience stress or anxiety related to self-testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of HIV negative participants who attended PrEP evaluation
Number of HIV positive participants who received HIV treatment
Number of participants who checked HIV results
+2 moreSecondary outcome measures
Acceptability of Intervention Measure (AIM) score
Feasibility of Intervention Measure (FIM) score
Number of Participants Who Received STI treatment
+1 moreOther outcome measures
Acceptability of Measures Developed by Study Team
Acceptability of Program Instructions Developed by Study Team
Baseline demographic characteristics
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Empowered to Test YourselfExperimental Treatment1 Intervention
There will be 5 tailored web based sessions of the intervention over 4 weeks, all of which will follow the same format.
Group II: Educational ControlActive Control2 Interventions
Participants will receive a generic standard of care via a combination of videos, audio, and text/graphics across 5 sessions during 4 weeks.
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,820 Previous Clinical Trials
2,692,759 Total Patients Enrolled
Johns Hopkins Bloomberg School of Public HealthLead Sponsor
412 Previous Clinical Trials
2,113,687 Total Patients Enrolled
University of Texas at AustinLead Sponsor
359 Previous Clinical Trials
81,693 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 15 and 59 years old.I identify as a cisgender woman.I am either over 59 years old or younger than 15.I do not identify as a cisgender woman.
Research Study Groups:
This trial has the following groups:- Group 1: Empowered to Test Yourself
- Group 2: Educational Control
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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