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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
PrEP Trial 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.Check my eligibility
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.See study design
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.
PrEP Trial 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.
PrEP Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intervention acceptability
Intervention feasibility changes
PrEP uptake changes
Secondary outcome measures
Biological measures of HIV, STIs and pregnancy
Clinic visit adherence changes
PrEP adherence
PrEP 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.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,565 Previous Clinical Trials
2,268,233 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,774 Previous Clinical Trials
2,674,178 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,918 Previous Clinical Trials
13,192,710 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current status of recruitment for this clinical trial?
"Per the information on clinicaltrials.gov, enrollment in this trial has been closed since June 13th 2022 - though it was initially posted April 14th 2020. However, 1185 other trials are actively recruiting patients at present."
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