Adherence Connection for Counseling, Education, and Support (ACCESS) II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Self-Reported ART Adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: ACCESS II mHealth Intervention (Behavioral)
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.
干预措施: ACCESS II control condition (Behavioral)
结局指标
主要结局
Self-Reported ART Adherence
时间窗: 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 )
Self-Reported ART Adherence
时间窗: 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 )
Log10 Viral Load
时间窗: 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.
Annualized Change in Log10 Viral Load (Copies/mL)
时间窗: 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.
Adherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)
时间窗: 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.
Self-Reported ART Adherence
时间窗: 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)
Self-Reported ART Adherence
时间窗: 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)
Adherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)
时间窗: 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.
Adherence Self-Efficacy Measured by the HIV Medication Taking Self-Efficacy Scale (HIV MT SES)
时间窗: 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.
次要结局
- Knowledge About ART Measured With the HIV Treatment Knowledge Scale(Week 24)
- HIV Stigma Measured With the HIV Stigma Scale(Week 24)
- Depression Measured With the Patient Health Questionnaire-9 (PHQ-9)(Week 24)
- Tobacco - Lifetime Use(Baseline)
- Anxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)(Week 24)
- Number of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)(Week 24)
- 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(Week 24)
- Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score(Week 24)
- Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score(Week 24)
- Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score(Week 24)
- Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score(Week 24)
- Marijuana - Lifetime Use(Baseline)
- Alcohol - Lifetime Use(Baseline)
- Knowledge About ART Measured With the HIV Treatment Knowledge Scale(Baseline)
- Knowledge About ART Measured With the HIV Treatment Knowledge Scale(Week 12)
- HIV Stigma Measured With the HIV Stigma Scale(Baseline)
- HIV Stigma Measured With the HIV Stigma Scale(Week 12)
- Depression Measured With the Patient Health Questionnaire-9 (PHQ-9)(Baseline)
- Depression Measured With the Patient Health Questionnaire-9 (PHQ-9)(Week 12)
- Anxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)(Baseline)
- Anxiety Measured With the Generalized Anxiety Disorder-7 (GAD-7)(Week 12)
- Number of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)(Baseline)
- Number of Participants With Trauma Measured With the Primary Care-PTSD Screen-5 (PC-PTSD)(Week 12)
- 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(Baseline)
- 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(Week 12)
- Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score(Baseline)
- Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Emotional Support Score(Week 12)
- Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score(Baseline)
- Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Informational Support Score(Week 12)
- Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score(Baseline)
- Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Instrumental Support Score(Week 12)
- Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score(Baseline)
- Social Support and Isolation Measured With the ATN iTech Short Measure of the PROMIS Social Relationship Scales - Social Isolation Score(Week 12)