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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: ACCESS II mHealth Intervention
* Behavioral: ACCESS II control condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |