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

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Rise - Treatment Education	Rise - Treatment Education	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.

Primary Outcome Measures

Name	Time	Method
Viral Suppression	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	Viral load undetectable per venipuncture or medical records
Dichotomous Adherence	baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline	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.
Continuous Adherence	baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline	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.

Secondary Outcome Measures

Name	Time	Method
Medical Mistrust	baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline	Outcome is mean agreement with 9 HIV-related conspiracy beliefs, each measured on a 5-point scale from 1=Strongly Disagree to 5=Strongly Agree.
Internalized HIV Stigma	baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline	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."