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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: ACCESS II mHealth Intervention; Behavioral: ACCESS II control 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ann-Margaret Navarra, PhD, CPNP-PC; Phone Number: 212-998-9009; Email: amd363@nyu.edu
• Study Contact Backup: Name: Lloyd Goldsamt, PhD; Phone Number: 212-998-5315; Email: lloydgoldsamt@nyu.edu

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Jacobi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIV-infected youth: Intervention; 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; 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.
Active Comparator: HIV-infected youth: control; 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; Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 )	3 Days
Change in serum HIV RNA quantitative viral load	Measured to eliminate the potential for social desirability bias associated with self-reported adherence. Viral load data will be extracted from the medical records of participants at baseline (pre-intervention), and 12 and 24-weeks. In cases where a visit does not include a biological assessment of HIV viral load, we will use the most recent assessment in the medical record (within two-weeks of the visit)	Baseline, 12 weeks, 24 weeks
Adherence self-efficacy	Assessed with the HIV Medication Taking Self-Efficacy Scale. This 27-item survey measure, including sub-scales, uses a 10-point Likert scale (0=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, 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Knowledge about ART	Assessed with the HIV Treatment Knowledge Scale: This 21-item instrument uses true and false questions to assess knowledge of adherence, side effects and antiretroviral resistance (scores range from 0-21; higher scores = increased knowledge).	Baseline, 12 weeks, 24 weeks
Change in HIV stigma	Assessed with the HIV Stigma Scale. 40 item questionnaire. Items are scored as follows: strongly disagree = 1 disagree = 2 agree = 3 strongly agree = 4. The range of possible scores depends on the number of items in the scale. For the total HIV Stigma Scale, scores can range from 40 to 160 [1 x 40 items to 4 x 40 items]. For the personalized stigma subscale, scores can range from 18 to 72. For the disclosure subscale, scores can range from 10 to 40. For the negative self-image subscale, scores can range from 13 to 52. For the public attitudes subscale, scores can range from 20 to 80.	Baseline, 12 weeks, 24 weeks
Change in Depression	Depression will be measured with the Patient Health Questionnaire (PHQ-9). The PHQ-9 includes 9 items from the DSM-IV criteria for depression with scores on a 4-point Likert scale (0=not at all, 3=nearly every day). Depression is scored as mild, moderate, moderately severe, and severe using composite scores of 5, 10, 15, and 20, respectively.	Baseline, 12 weeks, 24 weeks
Change in Anxiety	Generalized anxiety disorder (GAD) will be assessed with the Generalized Anxiety Disorder - 7 (GAD-7). The measure includes 7 items about symptoms in the past two weeks. Scores > 10 indicate a probable case of GAD, with scores > 15 considered to be severe.	Baseline, 12 weeks, 24 weeks
Change in Psychological Distress	Post-traumatic stress disorder (PTSD) will be measured with the Primary Care-PTSD Screen-5 (PC-PTSD). The PC-PTSD is a brief measure using four-items to screen for symptoms of PTSD (re-experiencing, numbness, hyperarousal and avoidance behaviors) in primary care or ambulatory settings. Total scores range from 0 to 4 with a score of 3 or greater indicating probable or positive screen for PTSD.	Baseline, 12 weeks, 24 weeks
Change in Social support and isolation	Assessed with the Adolescent Trials Network (ATN) iTech short measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship scales. The ATN short measure is a 20-item tool which uses a 5-point Likert scale with total possible composite scores of 25 to 125; higher scores suggest increased social support and decreased isolation. This measure assesses five domains of social support: emotional, informational, instrumental, companionship, and isolation.	Baseline, 12 weeks, 24 weeks
Change in Substance use	Substance use will be assessed with a modified ATN designed for use in clinical settings. The measure will assess use of tobacco, alcohol, marijuana and other drugs (i.e., cocaine or crack, amphetamine type stimulants, inhalants, sedatives, hallucinogens and opioids). The modified measure will assess substance use frequency, substance use related problems (i.e., health, social, financial), interference with functional status, concern from others regarding substance use, and failure to cut down on substance use.	Baseline, 12 weeks, 24 weeks
Client Satisfaction and Ease of Use of web-based platform	Client Satisfaction and Ease of Use of the web-based platform will be assessed using a modified Client Satisfaction Questionnaire and Perceived Ease of Use Scale. The measure will be used to assess the participant's satisfaction with the support and education received from the eight sessions in the web-based platform, along with the overall ease of use in operating and functioning the web-based platform.	Baseline, 12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Jacobi Medical Center
• Investigators: Principal Investigator: Ann-Margaret Navarra, PhD, CPNP-PC, NYU Meyers College of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: 20-01135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to amd363@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements
• IPD Sharing Access Criteria: Requests may be directed to amd363@nyu.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No