A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans

N/ACompletedNCT03331978

RAND306 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

306

Conditions

HIV/AIDS

Interventions

Rise - Treatment EducationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

AIDS Project Los Angeles

Los Angeles, California, United States

Outcomes

Primary Outcomes

Continuous Adherence

Percentage of doses taken of those prescribed from electronic monitoring. Here we present all data collected at all time points used in analysis. Evaluation of intervention efficacy was performed with repeated measures regression using continuous adherence measurements at all 6 months post-intervention (7th through 12th month post-baseline) and was restricted to those with adherence data at baseline.

Time frame: baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline

Dichotomous Adherence

Number of Participants who Reported Taking Greater Than or Equal to 75% of Prescribed Dosage, based on electronic monitoring. Here we present all data collected at all time points used in analysis. Evaluation of intervention efficacy was performed with repeated measures regression using adherence measurements at all 6 months post-intervention (7th through 12th month post-baseline) and was restricted to those with adherence data at baseline.

Time frame: baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline

Viral Suppression

Viral load undetectable per venipuncture or medical records

Time frame: 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

Internalized HIV Stigma

Measure is count of participants who "slightly agree" or "strongly agree" with either "Most people with AIDS are responsible for having their illness" or "A person with AIDS must have done something wrong and deserves to be punished."

Time frame: baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline

Data from ClinicalTrials.gov

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