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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline
Awards & highlights
Study Summary
This trial is testing a new education intervention for African Americans with HIV that focuses on cultural and social issues that contribute to health disparities.
Eligible Conditions
- HIV/AIDS
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Continuous Adherence
Dichotomous Adherence
Viral Suppression
Secondary outcome measures
Internalized HIV Stigma
Medical Mistrust
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Rise - Treatment EducationExperimental Treatment1 Intervention
Rise consists of a one-month intensive intervention (with three core 60-minute counseling sessions at weeks 1, 2, and 4) followed by two booster sessions (at weeks 12 and 20). If participants show nonadherence during booster sessions, they are offered up to four additional booster sessions (i.e., extra booster sessions if <85% of prescribed doses were taken in the past month). Thus, participants receive three core sessions in the first month, followed by 2-6 booster sessions over the next four months.
Group II: Control - No Treatment EducationActive Control1 Intervention
The Usual Care control group will only receive standard of care through their HIV clinics.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rise - Treatment Education
2018
N/A
~310
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Who is running the clinical trial?
RANDLead Sponsor
137 Previous Clinical Trials
509,945 Total Patients Enrolled
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