Clinical trial NCT04499781: Adherence Connection for Counseling, Education, and Support (ACCESS) II
Official title: Adherence Connection for Counseling, Education, and Support (ACCESS) II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Jacobi Medical Center
First posted: 2020-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The ACCESS II RCT uses a two group, parallel, longitudinal study design. Participants will be randomized to the ACCESS synchronous peer intervention or the asynchronous web-based HIV ART adherence control. Block randomization will be used; the randomization scheme will be developed by the biostatistician and implemented in Research Electronic Data Capture (REDCap) to ensure that assignment to treatment condition is evenly distributed within each site.
Primary purpose: OTHER

Brief 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.

Eligibility 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

Primary outcomes:
measure: Self-Reported ART Adherence
timeFrame: Baseline
measure: Self-Reported ART Adherence
timeFrame: Week 12
measure: Self-Reported ART Adherence
timeFrame: Week 24
measure: Change in Serum HIV RNA Quantitative Viral Load
timeFrame: Baseline, Week 12
measure: Change in Serum HIV RNA Quantitative Viral Load
timeFrame: Baseline, Week 24
measure: Change in HIV Medication Taking Self-Efficacy Scale Score
timeFrame: Baseline, Week 12
measure: Change in HIV Medication Taking Self-Efficacy Scale Score
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change in HIV Treatment Knowledge Scale Score
timeFrame: Baseline, Week 12
measure: Change in HIV Treatment Knowledge Scale Score
timeFrame: Baseline, Week 24
measure: Change in HIV Stigma Scale Score
timeFrame: Baseline, Week 12
measure: Change in HIV Stigma Scale Score
timeFrame: Baseline, Week 24
measure: Change in Patient Health Questionnaire (PHQ-9) Score
timeFrame: Baseline, Week 12
measure: Change in Patient Health Questionnaire (PHQ-9) Score
timeFrame: Baseline, Week 24
measure: Change in Generalized Anxiety Disorder - 7 (GAD-7) Score
timeFrame: Baseline, Week 12
measure: Change in Generalized Anxiety Disorder - 7 (GAD-7) Score
timeFrame: Baseline, Week 24
measure: Change in Primary Care-PTSD Screen-5 (PC-PTSD) Score
timeFrame: Baseline, Week 12
measure: Change in Primary Care-PTSD Screen-5 (PC-PTSD) Score
timeFrame: Baseline, Week 24
measure: Change in Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship - Adolescent Trials Network (ATN) iTech Score
timeFrame: Baseline, Week 12
measure: Change in Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship - Adolescent Trials Network (ATN) iTech Score
timeFrame: Baseline, Week 24
measure: Number of Participants who report Use of Tobacco
timeFrame: Baseline
measure: Number of Participants who report Use of Tobacco
timeFrame: Week 12
measure: Number of Participants who report Use of Tobacco
timeFrame: Week 24
measure: Number of Participants who report Use of Marijuana
timeFrame: Baseline
measure: Number of Participants who report Use of Marijuana
timeFrame: Week 12
measure: Number of Participants who report Use of Marijuana
timeFrame: Week 24
measure: Number of Participants who report Use of Alcohol
timeFrame: Baseline
measure: Number of Participants who report Use of Alcohol
timeFrame: Week 12
measure: Number of Participants who report Use of Alcohol
timeFrame: Week 24
measure: Number of Participants who report Use of Other Drugs
timeFrame: Baseline
measure: Number of Participants who report Use of Other Drugs
timeFrame: Week 12
measure: Number of Participants who report Use of Other Drugs
timeFrame: Week 24
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
Study officials:
affiliation: NYU Meyers College of Nursing
name: Ann-Margaret Navarra, PhD, CPNP-PC
role: PRINCIPAL_INVESTIGATOR
References: