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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331978
Recruitment Status : Active, not recruiting
First Posted : November 6, 2017
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
RAND

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Rise - Treatment Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

No Intervention: Control - No Treatment Education
The Usual Care control group will only receive standard of care through their HIV clinics.



Primary Outcome Measures :
  1. Change in Continuous Adherence [ Time Frame: change in adherence over 12 months from enrollment to 12 months post-enrollment ]
    Percentage of doses taken, of those prescribed, self-report and from electronic monitoring, at all post-intervention time-points

  2. Change in Categorical Adherence [ Time Frame: change in adherence over 12 months from enrollment to 12 months post-enrollment ]
    Dichotomous percentage of doses taken, of those prescribed (dichotomized at less than or greater than or equal to 85%), self-report and from electronic monitoring, at all post-intervention time-points

  3. Change in Viral Suppression [ Time Frame: change in viral suppression over 12 months from enrollment to 12 months post-enrollment ]
    Viral suppression (suppressed vs not suppressed), immediately and 6-months post-intervention, from blood draws and medical records


Secondary Outcome Measures :
  1. Change in Adherence-related motivation [ Time Frame: change in motivation over 12 months from baseline to 13 months post-baseline ]
    Increased desire and motivation to maintain ART medication adherence, as measured by ACASI survey responses, at all post-intervention time-points

  2. Change in Internalized HIV stigma [ Time Frame: change in stigma over 12 months from baseline to 13 months post-baseline ]
    Change in Decreased rates of internalized HIV stigma, as measured by ACASI survey responses, at all post-intervention time-points

  3. Change in Medical mistrust [ Time Frame: change in mistrust over 12 months from baseline to 13 months post-baseline ]
    Decreased rates of medical mistrust, as measured by ACASI survey responses, at all post-intervention time-points

  4. Change in Unmet needs [ Time Frame: change in unmet needs over 12 months from baseline to 13 months post-baseline ]
    Decreased level of unmet needs, as measured by ACASI survey responses, at all post-intervention time-points



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331978


Locations
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United States, California
AIDS Project Los Angeles
Los Angeles, California, United States, 90016
Sponsors and Collaborators
RAND
  Study Documents (Full-Text)

Documents provided by RAND:
Study Protocol  [PDF] October 26, 2017
Informed Consent Form  [PDF] October 26, 2017
Statistical Analysis Plan  [PDF] October 30, 2017

Publications:
Centers for Disease Control and Prevention. Complete Listing of Medication Adherence Evidence-based Behavioral Interventions. 2015; Available at: http://www.cdc.gov/hiv/research/interventionresearch/compendium/ma/complete.html.
Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings. Available at: http://www.samhsa.gov/data/sites/default/files/NSDUHresultsPDFWHTML2013/Web/NSDUHresults2013.pdf.
Thorn B, Tadler C, Huret N, et al. WIC Participant and Program Characteristics 2014. Prepared by Insight Policy Research under Contract No. AG-3198-C-11-0010. Alexandria, VA: U.S. Department of Agriculture, Food and Nutrition Service. Available at: http://www.fns.usda.gov/sites/default/files/ops/WICPC2014.pdf;2015.
Truman JL, Langton L. Criminal Victimization, 2014. U.S. Department of Justice, Office of Justice Programs. Available at: http://www.bjs.gov/content/pub/pdf/cv14.pdf;2015.
LifeWindows Project Team. The LifeWindows Information Motivation Behavioral Skills ART adherence questionnaire (LW-IMB-AAQ). 2006; http://www.chip.uconn.edu/int/F_LWIMBARTQuestionnaire.pdf.
MacKinnon DP, Lockwood CM, Williams J. Predicted and observed power rates. 2004; Available at: http://ripl.faculty.asu.edu/wp-content/uploads/2013/01/MacKinnon-Lockwood-Williams-2004-Pred-and-Obs-Power-Rates.pdf. Accessed February 7, 2014.

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Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT03331978    
Other Study ID Numbers: R01NR017334 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RAND:
Adherence
Antiretroviral treatment
Black/ AfricanAmerican
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases