NCT04499781

Adherence Connection for Counseling, Education, and Support (ACCESS) II

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 29 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the proposed clinical trial, Adherence Connection for Counseling, Education, and Support (ACCESS)-II, is to test the efficacy of ACCESS-II on antiretroviral treatment (ART) adherence and HIV-viral load in Black and Hispanic HIV-infected (HIV+) adolescents and young adults (AYA), ages 18-29 years (N=120) using a longitudinal (12 and 24 week outcomes), two-group, randomized control trial (RCT). Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral/motivational sessions for improved ART adherence. Participants in the control will connect asynchronously to a web-based HIV ART adherence education condition.

Detailed description

To achieve these aims, a longitudinal (12 and 24- week study outcomes), two-group, randomized control trial (RCT) is proposed in a sample population of 120 perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral47-50 motivational18 sessions for improved ART adherence. Participants in the control will connect asynchronously to a web-based HIV ART adherence education condition. Study participants will access the intervention and control conditions outside of the clinical setting using study funded smart phones. Self-reported adherence and viral load (extracted from the medical records) of study participants will be measured, and uploaded to RedCAP. ART knowledge, adherence self-efficacy, HIV stigma, social support, psychological distress, and substance use will be measured using survey measures. Statistical analyses will be computed to assess the potential impact of ACCESS on adherence and HIV viral suppression, and will also be computed to assess changes in ART knowledge, adherence self-efficacy, HIV stigma, social support, psychological distress, and substance use among participants in both the intervention and control conditions.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BEHAVIORAL	ACCESS II mHealth Intervention	Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
BEHAVIORAL	ACCESS II control condition	Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.

Timeline

• Start date: 2022-02-14
• Primary completion: 2024-07-25
• Completion: 2024-07-25
• First posted: 2020-08-05
• Last updated: 2025-09-24
• Results posted: 2025-09-24

Locations

1 site across 1 country: United States