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Completed

NCT Number: NCT04499781

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

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.

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Key information

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jacobi Medical Center

The Bronx, New York, 10461, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Self-Reported ART Adherence

    Time frame: Baseline

    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)

  2. Self-Reported ART Adherence

    Time frame: Week 12

    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)

  3. Self-Reported ART Adherence

    Time frame: Week 24

    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 )

  4. Log10 Viral Load

    Time frame: Baseline

    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.

  5. Annualized Change in Log10 Viral Load (Copies/mL)

    Time frame: Baseline, Week 24

    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.

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

    Time frame: Baseline

    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.

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

    Time frame: Week 12

    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.

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

    Time frame: Week 24

    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.

Secondary outcomes

  1. Knowledge About ART Measured With the HIV Treatment Knowledge Scale

    Time frame: Baseline

    The HIV Treatment Knowledge Scale is a 21-item instrument that uses true and false questions to assess knowledge of adherence, side effects and antiretroviral resistance. The score is calculated as the number of correct responses; scores range from 0-21, where higher scores = increased knowledge.

  2. Knowledge About ART Measured With the HIV Treatment Knowledge Scale

    Time frame: Week 12

    The HIV Treatment Knowledge Scale is a 21-item instrument that uses true and false questions to assess knowledge of adherence, side effects and antiretroviral resistance. The score is calculated as the number of correct responses; scores range from 0-21, where higher scores = increased knowledge.

  3. Knowledge About ART Measured With the HIV Treatment Knowledge Scale

    Time frame: Week 24

    The HIV Treatment Knowledge Scale is a 21-item instrument that uses true and false questions to assess knowledge of adherence, side effects and antiretroviral resistance. The score is calculated as the number of correct responses; scores range from 0-21, where higher scores = increased knowledge.

  4. HIV Stigma Measured With the HIV Stigma Scale

    Time frame: Baseline

    The HIV Stigma Scale is a 40-item questionnaire assessing HIV stigma. Each item is rated on a 4-point Likert scale ranging from 1-4. The total score is the sum of responses and ranges from 40 to 160; higher scores indicate a greater level of perceived HIV-related stigma.

  5. HIV Stigma Measured With the HIV Stigma Scale

    Time frame: Week 12

    The HIV Stigma Scale is a 40-item questionnaire assessing HIV stigma. Each item is rated on a 4-point Likert scale ranging from 1-4. The total score is the sum of responses and ranges from 40 to 160; higher scores indicate a greater level of perceived HIV-related stigma.

  6. HIV Stigma Measured With the HIV Stigma Scale

    Time frame: Week 24

    The HIV Stigma Scale is a 40-item questionnaire assessing HIV stigma. Each item is rated on a 4-point Likert scale ranging from 1-4. The total score is the sum of responses and ranges from 40 to 160; higher scores indicate a greater level of perceived HIV-related stigma.

  7. Depression Measured With the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline

    Depression was 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). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater levels of depression.

  8. Depression Measured With the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Week 12

    Depression was 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). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater levels of depression.

  9. Depression Measured With the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Week 24

    Depression was 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). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater levels of depression.

  10. Anxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline

    Generalized anxiety disorder (GAD) was assessed with the Generalized Anxiety Disorder-7 (GAD-7). The measure includes 7 items about symptoms in the past two weeks. Each item is rated on 4-point Likert scale from 0-3. The total score is the sum of responses and ranges from 0-21; higher scores indicate greater levels of anxiety.

  11. Anxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Week 12

    Generalized anxiety disorder (GAD) was assessed with the Generalized Anxiety Disorder-7 (GAD-7). The measure includes 7 items about symptoms in the past two weeks. Each item is rated on 4-point Likert scale from 0-3. The total score is the sum of responses and ranges from 0-21; higher scores indicate greater levels of anxiety.

  12. Anxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Week 24

    Generalized anxiety disorder (GAD) was assessed with the Generalized Anxiety Disorder-7 (GAD-7). The measure includes 7 items about symptoms in the past two weeks. Each item is rated on 4-point Likert scale from 0-3. The total score is the sum of responses and ranges from 0-21; higher scores indicate greater levels of anxiety.

  13. Number of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)

    Time frame: Baseline

    Post-traumatic stress disorder (PTSD) was 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. The total score is the number of "Yes" responses and ranges from 0-5. Higher scores indicate probable or positive screen for PTSD. A participant was considered to have "trauma" if they reported 3 or more trauma symptoms in the past month.

  14. Number of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)

    Time frame: Week 12

    Post-traumatic stress disorder (PTSD) was 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. The total score is the number of "Yes" responses and ranges from 0-5. Higher scores indicate probable or positive screen for PTSD. A participant was considered to have "trauma" if they reported 3 or more trauma symptoms in the past month.

  15. Number of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)

    Time frame: Week 24

    Post-traumatic stress disorder (PTSD) was 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. The total score is the number of "Yes" responses and ranges from 0-5. Higher scores indicate probable or positive screen for PTSD. A participant was considered to have "trauma" if they reported 3 or more trauma symptoms in the past month.

  16. Social Support and Isolation Measured With the Adolescent Medicine Trials Network (ATN) iTech Short Measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship Scales - Companionship Score

    Time frame: Baseline

    The ATN short measure is a 20-item tool where each item is rated on a 5-point Likert scale (1-5). The Companionship subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.2-63.1 with a mean of 50 and standard deviation of 10; higher scores reflect greater companionship.

  17. Social Support and Isolation Measured With the Adolescent Medicine Trials Network (ATN) iTech Short Measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship Scales - Companionship Score

    Time frame: Week 12

    The ATN short measure is a 20-item tool where each item is rated on a 5-point Likert scale (1-5). The Companionship subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.2-63.1 with a mean of 50 and standard deviation of 10; higher scores reflect greater companionship.

  18. Social Support and Isolation Measured With the Adolescent Medicine Trials Network (ATN) iTech Short Measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship Scales - Companionship Score

    Time frame: Week 24

    The ATN short measure is a 20-item tool where each item is rated on a 5-point Likert scale (1-5). The Companionship subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.2-63.1 with a mean of 50 and standard deviation of 10; higher scores reflect greater companionship.

  19. Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score

    Time frame: Baseline

    The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Emotional Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.7-62.0 with a mean of 50 and standard deviation of 10; higher scores reflect greater emotional support.

  20. Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score

    Time frame: Week 12

    The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Emotional Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.7-62.0 with a mean of 50 and standard deviation of 10; higher scores reflect greater emotional support.

  21. Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score

    Time frame: Week 24

    The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Emotional Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.7-62.0 with a mean of 50 and standard deviation of 10; higher scores reflect greater emotional support.

  22. Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score

    Time frame: Baseline

    The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Informational Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.6-65.6 with a mean of 50 and standard deviation of 10; higher scores reflect greater informational support.

  23. Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score

    Time frame: Week 12

    The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Informational Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.6-65.6 with a mean of 50 and standard deviation of 10; higher scores reflect greater informational support.

  24. Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score

    Time frame: Week 24

    The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Informational Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 25.6-65.6 with a mean of 50 and standard deviation of 10; higher scores reflect greater informational support.

  25. Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score

    Time frame: Baseline

    The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Instrumental Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 29.3-63.3 with a mean of 50 and standard deviation of 10; higher scores reflect greater instrumental support.

  26. Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score

    Time frame: Week 12

    The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Instrumental Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 29.3-63.3 with a mean of 50 and standard deviation of 10; higher scores reflect greater instrumental support.

  27. Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score

    Time frame: Week 24

    The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Instrumental Support subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 29.3-63.3 with a mean of 50 and standard deviation of 10; higher scores reflect greater instrumental support.

  28. Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score

    Time frame: Baseline

    The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Social Isolation subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 34.8-74.2 with a mean of 50 and standard deviation of 10; higher scores reflect greater social isolation.

  29. Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score

    Time frame: Week 12

    The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Social Isolation subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 34.8-74.2 with a mean of 50 and standard deviation of 10; higher scores reflect greater social isolation.

  30. Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score

    Time frame: Week 24

    The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The Social Isolation subscale comprises 4 items of the ATN short measure. The subscale raw score is the sum of responses; the raw score is converted to a T-score ranging from 34.8-74.2 with a mean of 50 and standard deviation of 10; higher scores reflect greater social isolation.

  31. Tobacco - Lifetime Use

    Time frame: Baseline

    Substance use was assessed with a modified Adolescent Trials Network (ATN) measure designed for use in clinical settings. Presented as the number of participants with lifetime tobacco use.

  32. Marijuana - Lifetime Use

    Time frame: Baseline

    Substance use was assessed with a modified Adolescent Trials Network (ATN) measure designed for use in clinical settings. Presented as the number of participants with lifetime marijuana use.

  33. Alcohol - Lifetime Use

    Time frame: Baseline

    Substance use was assessed with a modified Adolescent Trials Network (ATN) measure designed for use in clinical settings. Presented as the number of participants with lifetime alcohol use.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Jacobi Medical Center

Registry information

Acronym: ACCESS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 5, 2020
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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