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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: Rise - Treatment Education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rise - Treatment Education<br>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. | Behavioral: Rise - Treatment Education<br>* 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.<br>|
| No Intervention: Control - No Treatment Education<br>The Usual Care control group will only receive standard of care through their HIV clinics. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline | 
| Medical Mistrust | 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. | baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Antiretroviral treatment, Black/ AfricanAmerican