Adherence Connection for Counseling, Education, and Support (ACCESS) II
- Conditions
- HIV Infections
- Interventions
- Behavioral: ACCESS II mHealth InterventionBehavioral: ACCESS II control condition
- Registration Number
- NCT04499781
- Lead Sponsor
- NYU Langone Health
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HIV-infected youth: Intervention ACCESS II mHealth 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. HIV-infected youth: control ACCESS II control condition 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.
- Primary Outcome Measures
Name Time Method Self-Reported ART Adherence 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 )
Change in Serum HIV RNA Quantitative Viral Load Baseline, Week 24 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)
Change in HIV Medication Taking Self-Efficacy Scale Score Baseline, Week 24 Assessment of adherence self-efficacy. The HIV MT SES is a 27-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. The total score ranges from 27 to 270; higher scores indicate higher levels of self-efficacy.
- Secondary Outcome Measures
Name Time Method Change in HIV Treatment Knowledge Scale Score Baseline, 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.
Change in HIV Stigma Scale Score Baseline, 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.
Change in Patient Health Questionnaire (PHQ-9) Score Baseline, Week 24 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). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater levels of depression.
Change in Generalized Anxiety Disorder - 7 (GAD-7) Score Baseline, Week 24 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. 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.
Change in Primary Care-PTSD Screen-5 (PC-PTSD) Score Baseline, Week 24 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. The total score is the number of "Yes" responses and ranges from 0-5. Higher scores indicate probable or positive screen for PTSD.
Change in Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship - Adolescent Trials Network (ATN) iTech Score Baseline, Week 24 Social support and isolation are assessed using the ATN iTech short measure of the PROMIS Social Relationship scales. The ATN short measure is a 20-item where each item is rated on a 5-point Likert scale (1-5). The total score ranges from 20 to 100; higher scores suggest increased social support and decreased isolation.
Number of Participants who report Use of Tobacco Week 24 Substance use will be assessed with a modified ATN designed for use in clinical settings.
Number of Participants who report Use of Marijuana Week 24 Substance use will be assessed with a modified ATN designed for use in clinical settings.
Number of Participants who report Use of Alcohol Week 24 Substance use will be assessed with a modified ATN designed for use in clinical settings.
Number of Participants who report Use of Other Drugs Week 24 Substance use will be assessed with a modified ATN designed for use in clinical settings. "Other drugs" refers to cocaine or crack, amphetamine type stimulants, inhalants, sedatives, hallucinogens and opioids.
Trial Locations
- Locations (1)
Jacobi Medical Center
🇺🇸Bronx, New York, United States