Clinical trial NCT03331978: A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans
Official title: A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Adherence
Antiretroviral treatment
Black/ AfricanAmerican
Lead sponsor: RAND
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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. TE facilitates patient navigation through the medical system and provides treatment education and client-centered counseling to improve adherence and retention in care. TE targets structural issues in healthcare and patients' lives by advocating to providers to improve patient-provider relationships, recommending changes in treatment and/or providers, and referring patients to mental health and social services.

A total of 350 Black participants will be recruited through APLA Health and randomly assigned to the intervention or usual care control group (175 per group). Adherence will be electronically monitored daily (and downloaded bi-monthly) from baseline to 13-months post-baseline. Viral load will be assessed through venipuncture at baseline and 6- and 13-months post-baseline. It is hypothesized that the intervention group will show better adherence and have a greater likelihood of suppressed viral load than the control group over time.

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.

Primary outcomes:
measure: Continuous Adherence
timeFrame: baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline
measure: Dichotomous Adherence
timeFrame: baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline
measure: Viral Suppression
timeFrame: baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline. For 7M, medical records were used if within 90 days of survey completion; for 13 months, medical records were used if within 90 days before or 180 days after survey
Secondary outcomes:
measure: Internalized HIV Stigma
timeFrame: baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline
measure: Medical Mistrust
timeFrame: baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AIDS Project Los Angeles
state: California
Study officials:
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