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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
15 - 59 years of age
Identify as a cisgender woman
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study 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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 15 and 59 years old.
Select...
I identify as a cisgender woman.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

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 more
Secondary outcome measures
Acceptability of Intervention Measure (AIM) score
Feasibility of Intervention Measure (FIM) score
Number of Participants Who Received STI treatment
+1 more
Other outcome measures
Acceptability of Measures Developed by Study Team
Acceptability of Program Instructions Developed by Study Team
Baseline demographic characteristics
+3 more

Trial 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.

Find a Location

Who is running the clinical trial?

Johns Hopkins Bloomberg School of Public HealthLead Sponsor
410 Previous Clinical Trials
2,116,890 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,776 Previous Clinical Trials
2,673,700 Total Patients Enrolled
University of Texas at AustinLead Sponsor
348 Previous Clinical Trials
80,312 Total Patients Enrolled

Media Library

Empowered to Test Yourself (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05390541 — N/A
Sexually Transmitted Infections Research Study Groups: Empowered to Test Yourself, Educational Control
Empowered to Test Yourself (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05390541 — N/A
Sexually Transmitted Infections Clinical Trial 2023: Empowered to Test Yourself Highlights & Side Effects. Trial Name: NCT05390541 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction for participation in this clinical trial?

"This trial seeks volunteers who are between 15 and 59 years old."

Answered by AI

Is my eligibility sufficient to partake in this experiment?

"This scientific research is enrolling 90 participants aged 15 to 59, who have contracted a sexually transmitted disease. Criteria for inclusion encompass being between the age bracket of likely HIV contraction (15-59), identifying as cis-gender female and Black/African American (including mixed race/ethnicity) , having English proficiency, not taking an HIV or STI test in the past 12 months, living in Travis County with recent unprotected sexual contact and access to both technology and internet."

Answered by AI

How many participants have been recruited to participate in this medical experiment?

"Affirmative. The trial, which was initially posted on February 2nd 2022 is currently recruiting patients as seen in the clinicaltrials.gov database entry that was last updated on May 19th 2022. To date, 90 participants need to be sourced from 1 healthcare facility."

Answered by AI

Is this investigation actively searching for participants?

"According to the clinicaltrials.gov listing, this trial is in need of participants as it was first launched on February 2nd 2022 and revised most recently on May 19th 2022."

Answered by AI

What is the principal aim of this experiment?

"The primary goal of this trial is to determine the effectiveness of Prep Evaluation. Secondary objectives include determining whether participants mailed their STI tests, received necessary treatment for any positive results, and if they actually made use of the provided home test kits. These outcomes will be tracked within two days after mailing out HIV home testing materials."

Answered by AI
~6 spots leftby Jun 2024