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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03331978
• Other study ID #: R01NR017334
• Status: Completed
• Phase: N/A
• Start date: January 23, 2018
• Est. completion date: November 7, 2021

Study information

• Verified date: December 2022
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: November 7, 2021
• Est. primary completion date: November 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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.

Locations

Country	Name	City	State
United States	AIDS Project Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
RAND

Country where clinical trial is conducted

United States, 

References & Publications (148)

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* Note: There are 148 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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