NCT02329782

Supporting Treatment Adherence Readiness Through Training (START)

Controlled Evaluation of the Adherence Readiness Program for ART Adherence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: RAND · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multi-site, randomized controlled trial of the Adherence Readiness Program (ARP) adherence intervention for HIV clients starting or restarting antiretroviral therapy (ART) for the purpose of achieving and sustaining optimal levels of ART adherence and virologic suppression. Eligible participants will be randomized to receive either the ARP intervention or usual care (no intervention) and followed for 24 months.

Detailed description

This study will evaluate the effects of the Adherence Readiness Program (ARP) intervention on the primary outcomes of dose-taking HIV antiretroviral (ART) adherence and undetectable HIV viral load in a multi-site randomized controlled trial. The ARP is based on the Information Motivation Behavioral skills (IMB) model of behavior change and includes (1) brief pill taking practice trials for enhancing pre-treatment adherence counseling and providing a behavioral criterion for determining adherence readiness and the start of treatment, and (2) a performance driven dose regulation mechanism to tailor the amount of counseling (from pre-treatment through the full course of treatment) to the individual needs of the patient and conserve limited resources. Participants will be randomized to receive either the ARP (adherence counseling sessions) or usual care. Primary assessments will be administered at screening and every 6 months after ART initiation over a 24-month follow-up, making it one of the few studies to examine intervention effects longer than one year. Secondary outcomes include dose-timing adherence and CD4 count. If effective, the ARP will provide clinicians with an intervention that (1) informs providers and patients when the patient is ready to adhere well and start treatment, (2) enhances adherence readiness from the outset of treatment through the full course of therapy, and (3) tailors the amount of adherence support based on individual patient need and performance, thus more efficiently using clinic resources, fostering better acceptance from providers and patients, and increasing the likelihood of successful program adoption and dissemination. This emphasis on efficient use of resources will be complemented by a cost-effectiveness analysis to further inform policy decisions regarding the transportability of the intervention and its potential for more wide scale use and sustainability if effective.

Conditions

• HIV Medication Adherence

Interventions

Type	Name	Description
BEHAVIORAL	Adherence Readiness Program	The ARP consists of pre-treatment (including practice trials to determine readiness for and timing of ART initiation), early-treatment, and ongoing maintenance training (using a performance-based, dose regulation mechanism to tailor the amount and intensity) phases

Timeline

• Start date: 2015-02-01
• Primary completion: 2020-03-30
• Completion: 2020-03-30
• First posted: 2015-01-01
• Last updated: 2020-10-06

Locations

3 sites across 1 country: United States