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Completed

NCT Number: NCT03331978

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

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AIDS Project Los Angeles

Los Angeles, California, 90016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rise - Treatment Education

Behavioral

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 outcomes

  1. Continuous Adherence

    Time frame: 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.

  2. Dichotomous Adherence

    Time frame: 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.

  3. Viral Suppression

    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

    Viral load undetectable per venipuncture or medical records

Secondary outcomes

  1. Internalized HIV Stigma

    Time frame: 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."

  2. Medical Mistrust

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

RAND

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 6, 2017
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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