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

NCT04499781 | Completed Results DMC

• 1 other identifier: 20-01135
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (8)

• Self-Reported ART Adherence

  3-day self-report of ART adherence was collected to describe subjective adherence behavior. Investigators will compute an cumulative average missed dose calculation: # of doses missed divided by total number of prescribed doses over the past 3 days. (scores range from 0 to 100%; higher scores = better adherence)

  Baseline

• Self-Reported ART Adherence

  3-day self-report of ART adherence was collected to describe subjective adherence behavior. Investigators will compute an cumulative average missed dose calculation: # of doses missed divided by total number of prescribed doses over the past 3 days. (scores range from 0 to 100%; higher scores = better adherence)

  Week 12

• Self-Reported ART Adherence

  3-day self-report of ART adherence will be collected to describe subjective adherence behavior. Investigators will compute an average missed dose calculation: # of doses missed divided by total number of prescribed doses over the past 3 days. (scores range from 0 to 100%; higher scores = better adherence )

  Week 24

• Log10 Viral Load

  Measured to eliminate the potential for social desirability bias associated with self-reported adherence. Viral load data was extracted from the medical records of participants.

  Baseline

• Annualized Change in Log10 Viral Load (Copies/mL)

  Annualized change in log10 viral load is a useful metric for conveying change over time while accounting for varying time points and number of viral load data measurements. All available viral load data for study participants was included and some participants had more than 3 viral loads included.

  Baseline, Week 24

• Adherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)

  Assessment of adherence self-efficacy. The HIV MT SES is a 26-item survey measure that uses an 10-point Likert scale (1=not confident; 10=completely confident) to assess HIV-medication taking self-efficacy belief and outcome expectancy. Higher scores indicate higher levels of self-efficacy.

  Baseline

• Adherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)

  Assessment of adherence self-efficacy. The HIV MT SES is a 26-item survey measure that uses an 10-point Likert scale (1=not confident; 10=completely confident) to assess HIV-medication taking self-efficacy belief and outcome expectancy. Higher scores indicate higher levels of self-efficacy.

  Week 12

• Adherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)

  Assessment of adherence self-efficacy. The HIV MT SES is a 26-item survey measure that uses an 10-point Likert scale (1=not confident; 10=completely confident) to assess HIV-medication taking self-efficacy belief and outcome expectancy. Higher scores indicate higher levels of self-efficacy.

  Week 24

Secondary Outcomes (33)

• Knowledge About ART Measured With the HIV Treatment Knowledge Scale

  Baseline

• Knowledge About ART Measured With the HIV Treatment Knowledge Scale

  Week 12

• Knowledge About ART Measured With the HIV Treatment Knowledge Scale

  Week 24

• HIV Stigma Measured With the HIV Stigma Scale

  Baseline

• HIV Stigma Measured With the HIV Stigma Scale

  Week 12

Study Arms (2)

HIV-infected youth: Intervention

EXPERIMENTAL

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.

Behavioral: ACCESS II mHealth Intervention

HIV-infected youth: control

ACTIVE COMPARATOR

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.

Behavioral: ACCESS II control condition

Interventions

ACCESS II mHealth Intervention BEHAVIORAL

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.

HIV-infected youth: Intervention

ACCESS II control condition BEHAVIORAL

Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.

HIV-infected youth: control

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Jacobi Medical Center: collaborator

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Ann-Margaret Navarra, PhD, CPNP-PC
• Organization: NYU Langone Health

amd363@nyu.edu

631-638-0859

Study Officials

• Ann-Margaret Navarra, PhD, CPNP-PC

  NYU Meyers College of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 5, 2020
• Study Start: February 14, 2022
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: September 24, 2025
• Results First Posted: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements
• Access Criteria: Requests may be directed to amd363@nyu.edu

Locations

US (1)