N/A
N=245
A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans
HIV/AIDS
Bottom Line
View on ClinicalTrials.gov: NCT03331978 ↗Enrolled (actual)
245
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Continuous Adherence — 68.80; 70.95; 72.76; 70.02 percentage of doses taken — p=.08
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rise - Treatment Education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- RAND
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Continuous Adherence |
68.80; 70.95; 72.76; 70.02; 72.09; 64.62 | .08 |
| PRIMARY Dichotomous Adherence |
45; 43; 44; 40; 43; 38 | .0257 sig |
| PRIMARY Viral Suppression |
45; 60; 50; 56 | .26 |
| SECONDARY Internalized HIV Stigma |
25; 29; 15; 26 | .05 |
| SECONDARY Medical Mistrust |
2.62; 2.65; 2.41; 2.56 | .0199 sig |
Summary
Project Rise is a randomized controlled trial (RCT) of an innovative, culturally congruent treatment education (TE) intervention for African Americans with HIV that targets cultural and social issues contributing to health disparities.
Eligibility Criteria
Inclusion Criteria
- HIV-positive
- 18 years of age or older
- Self-identified as African American/Black
- Been prescribed antiretroviral therapy (ART) in the past 12 months
- Self-reported adherence problems (i.e. missed at least 1 ART dose in the past month) and/or detectable viral load
- Willing to use Medication Events Monitoring System (MEMS) for electronic adherence monitoring.
Exclusion Criteria
- HIV-negative
- 17 years of age or younger
- Not self-identified as African American/Black, not on antiretroviral therapy (ART) or not prescribed ART therapy in the last than 12 months
- No self-reported adherence problems and/or no detectable viral load
- Not willing to use Medication Events Monitoring System (MEMS) for electronic adherence monitoring.
Data sourced from ClinicalTrials.gov (NCT03331978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.