Medication Adherence in Human Immunodeficiency Virus (HIV)
Targeting Enhanced Adherence to Medication: A Pilot Study in Adolescents and Young Adults With Human Immunodeficiency Virus (HIV)
Although effective treatments are currently available to treat human immunodeficiency virus (HIV), the retrovirus leading to acquired immune deficiency syndrome (AIDS), strict adherence to the treatment regimen is required. Nonadherence to highly active antiretroviral therapy (HAART) regimens is well documented in individuals with HIV. This is especially true for adolescents and young adults (AYA), where rates of adherence range from 20 to 100%. Nonadherence has significant implications for subsequent treatment response and health outcomes, including poor virologic response, development of drug resistance, and mortality. Of note, previous research has suggested that every 1% increase in nonadherence is related to a 2% increased likelihood of detectable viral load (VL) in youth with behaviorally acquired HIV. Furthermore, higher VL is the most salient variable related to increased risk of virus transmission. Thus, nonadherence to HAART is a significant public health issue.
The objective of the proposed research plan is to systematically examine an individualized, behavioral intervention targeting HAART nonadherence in AYAs initiating HAART. The current intervention will support AYA participation in brief, staff-delivered instruction in adherence-promotion skills. Individualized behavioral analysis and motivational interviewing will be applied to provide effective solutions for current barriers to HAART adherence before and after HAART initiation, as recommended by the Panel on Antiretroviral Guidelines for Adults and Adolescents.
研究概览
地位
条件
详细说明
The proposed pilot study will utilize a randomized controlled trial to estimate the feasibility, acceptability, and preliminary efficacy of a novel intervention for AYAs diagnosed with behaviorally-acquired HIV initiating HAART.
Standard care for HIV at St. Jude Children's Research Hospital (SJCRH) includes a placebo pill trial to assess patient readiness for therapy prior to starting HAART. Participants on this study will be randomized to either: a control arm of standard therapy, or standard therapy plus an individualized behavioral, staff-delivered intervention (Pill Trial+).
Participants in the control arm will receive standard clinical care. Participants in the Pill Trial+ arm will receive standard therapy plus three 25-minute individualized, behavioral, staff-delivered intervention sessions at HAART initiation, and 1-, and 3-month follow-up visits. Two brief booster sessions will also be provided to the Pill Trial+ arm following sessions 1 (in clinic) and 2 (by phone). In-person intervention sessions and all questionnaires will be completed in conjunction with scheduled clinical care visits. Sessions and measures will be completed by phone at designated time points if a participant becomes unavailable to return to clinic due to extenuating circumstances.
As recommended by Panel guidelines, discussion of placebo pill trial adherence during the first 25-minute session will provide a novel mechanism to discuss barriers to adherence and provide intervention prior to HAART initiation. Remaining sessions will promote adherence following HAART initiation using behavioral problem-solving and motivational interviewing strategies.
Primary Objective:
- To estimate a) rate of consent to the randomized trial and b) differences between the intervention and control conditions with respect to HAART adherence, as measured by pill count.
Secondary Objectives:
- To estimate differences between the intervention and control conditions with respect to other measures of adherence, including HAART self-reported adherence, HAART pharmacy refill, and clinic attendance.
- To examine disease and patient-reported outcomes during the first 6 months following HAART initiation and their relationship to participation in the Pill Trial+ intervention.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Tennessee
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Memphis、Tennessee、美国、38105
- St. Jude Children's Research Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Behaviorally acquired HIV diagnosis, confirmed via medical chart review.
- Currently followed in the St. Jude Children's Research Hospital (SJCRH) HIV clinic.
- Initiating HAART.
- Recommended a placebo trial.
- 13-24 years of age at time of study entry.
- If 15 years of age or over, willing to give informed consent. If under the age of 15, willing to give assent and accompanied by legal guardian/representative to give informed consent.
- Fluent in English
Exclusion Criteria:
- Previous HAART exposure.
- Unable to understand English and/or not cognitively intact (known IQ < 70) such that the study questionnaires cannot be understood and completed.
- Pregnant female.
- Enrolled on another protocol that excludes participation in this study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Standard Care
Participants in the Standard Care group will complete a demographic questionnaire at the time of consent as well as other questionnaires during the course of the study.
They will receive standard clinical care.
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Participants will complete a questionnaire developed for the purposes of the current study assessing basic background information.
Self-reported adherence, health-related quality of life and other questionnaire measures will be administered using a password protected laptop the same day as participants' regularly scheduled outpatient clinic appointments.
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实验性的：Pill Trial+
Participants in the Pill Trial+ group will complete a demographic questionnaire at the time of consent as well as other questionnaires during the course of the study.
They will receive standard clinical care plus three 25-minute individualized, behavioral, staff-delivered intervention sessions at HAART initiation, and 1-, and 3-month follow-up visits.
Two brief booster sessions will also be provided following sessions 1 (in clinic) and 2 (by phone).
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Participants will complete a questionnaire developed for the purposes of the current study assessing basic background information.
Self-reported adherence, health-related quality of life and other questionnaire measures will be administered using a password protected laptop the same day as participants' regularly scheduled outpatient clinic appointments.
In addition to standard clinical care, participants in the Pill Trial+ arm will receive staff-delivered intervention sessions individualized for each participant at HAART initiation, 1-month, and 3-month follow-up.
Two booster sessions will also be provided at two weeks following intervention session 1 (in clinic) and intervention session 2 (by phone) to assess any difficulties using the created adherence plans.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rate of consent to trial participation
大体时间：Day 1
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Day 1
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Pill count values compared between arms
大体时间：3 months post-HAART initiation
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Using Fisher Exact tests
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3 months post-HAART initiation
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Pill count values compared between arms
大体时间：6 months post-HAART initiation
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Using Fisher Exact tests
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6 months post-HAART initiation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Adherence rates compared between groups
大体时间：3 months post-HAART initiation
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Self-reported adherence rates, pharmacy refill, and clinic attendance will be included in this analysis.
Fisher exact tests will be performed to compare adherence rates between groups.
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3 months post-HAART initiation
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Patient outcome
大体时间：6 months following HAART initiation
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Disease and patient-reported outcomes will be examined as well as their relationship to participation in the Pill Trial+ intervention.
Viral load (VL), CD4 count/%, health-related quality of life (HRQOL) scores, and beliefs about medication (BAM) scores will be analyzed.
Mixed effects models will be employed to explore the efficacy of the intervention on virologic response, HRQOL, and medical beliefs.
VL, CD4 count/%, HRQOL, and beliefs will be used as the response variables, respectively, while time since treatment, intervention, and their interaction will be included as covariates.
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6 months following HAART initiation
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Adherence rates compared between groups
大体时间：6 months post-HAART initiation
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Self-reported adherence rates, pharmacy refill, and clinic attendance will be included in this analysis.
Fisher exact tests will be performed to compare adherence rates between groups.
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6 months post-HAART initiation
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Change in adherence rates compared between groups
大体时间：Baseline through 6 months post-HAART initiation
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Self-reported adherence rates, pharmacy refill, and clinic attendance will be included in this analysis.
Mixed effects models and logistic link will be used to examine differences between groups adherence data and within-subject changes in adherence over time.
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Baseline through 6 months post-HAART initiation
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合作者和调查者
调查人员
- 首席研究员：Megan Wilkins, PhD、St. Jude Children's Research Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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