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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 below
Select...
I am an African American woman over 18, speak English, at risk for HIV or have used PrEP recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 12 months for reporting.

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

Cultural adaptation of a patient-provider communication tool (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04373551 — N/A
HIV/AIDS Research Study Groups: Cultural adaptation of a patient-provider communication tool
HIV/AIDS Clinical Trial 2023: Cultural adaptation of a patient-provider communication tool Highlights & Side Effects. Trial Name: NCT04373551 — N/A
Cultural adaptation of a patient-provider communication tool (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04373551 — N/A
~12 spots leftby Nov 2025