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

RanD

Status: Completed

Conditions: HIV/AIDS

Treatments: Behavioral: Rise - Treatment Education

Study type: Interventional

Funder types: Other

Identifiers

NCT03331978

R01NR017334

Details and patient eligibility

About

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.

Full 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.

Enrollment: 306 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

306 participants in 2 patient groups

Rise - Treatment Education

Experimental group

Description:

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.

Treatment:

Behavioral: Rise - Treatment Education

Control - No Treatment Education

No Intervention group

Description:

The Usual Care control group will only receive standard of care through their HIV clinics.