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Behavioral Intervention
Communication Tool Adaptation for HIV Prevention (PrEP Trial)
N/A
Waitlist Available
Led By Mirjam-Colette Kempf, PhD, MPH
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cisgender African American HIV-uninfected women aged 18 years or older who speak English and report HIV risk and/or recent PrEP use
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months and 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will adapt and test a communication tool to increase PrEP uptake among at-risk African American women in rural areas of the southern US.
Who is the study for?
This trial is for African American, cisgender women over the age of 18 who speak English and are at risk for HIV but not infected. They should recognize their HIV risk or have used PrEP recently. Healthcare providers such as physicians, nurses, or social workers cannot participate.
What is being tested?
The study aims to increase PrEP uptake among at-risk African American women in rural Alabama by adapting a communication tool from the CDC's PrEP toolkit. This tool will help with recognizing HIV risk and interest in starting PrEP through referrals to local clinics.
What are the potential side effects?
Since this trial focuses on cultural adaptation of a communication tool rather than a medical intervention, traditional side effects associated with medications are not applicable here.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an African American woman over 18, speak English, at risk for HIV or have used PrEP recently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Intervention acceptability
Intervention feasibility changes
PrEP uptake changes
Secondary study objectives
Clinic visit adherence changes
PrEP adherence
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cultural adaptation of a patient-provider communication toolExperimental Treatment1 Intervention
Strengthening of the PrEP care continuum by developing and testing an intervention designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at substantial risk for HIV infection; developing and testing an intervention to reduce racial/disparities in PrEP uptake and use.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cultural adaptation of a patient-provider communication tool
2020
N/A
~70
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,906 Previous Clinical Trials
2,738,842 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,640 Previous Clinical Trials
2,332,023 Total Patients Enrolled
Massachusetts General HospitalOTHER
3,006 Previous Clinical Trials
13,307,215 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an African American woman over 18, speak English, at risk for HIV or have used PrEP recently.I am a healthcare provider or social worker who speaks English.
Research Study Groups:
This trial has the following groups:- Group 1: Cultural adaptation of a patient-provider communication tool
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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