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

NYU Langone Health

Status: Completed

Conditions: HIV Infections

Treatments: Behavioral: ACCESS II mHealth Intervention; Behavioral: ACCESS II control condition

Study type: Interventional

Funder types: Other

Identifiers

NCT04499781

20-01135

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 29 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for participation in this study are:

• HIV seropositive status (perinatally and behaviorally infected youth)
• Ages 18-29 years
• English speaking
• Currently being prescribed an antiretroviral treatment regimen
• Evidence of virologic failure or (detectable quantitative HIV serum viral load>200 copies/ml)
• No neuro-cognitive deficits which would impede participation in videoconferencing sessions or completion of study measures

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

HIV-infected youth: Intervention

Experimental group

Description:

Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation.

Treatment:

Behavioral: ACCESS II mHealth Intervention

HIV-infected youth: control

Active Comparator group

Description:

Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years). Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation.

Treatment:

Behavioral: ACCESS II control condition