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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Tennessee
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Memphis、Tennessee、アメリカ、38105
- St. Jude Children's Research Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Rate of consent to trial participation
時間枠：Day 1
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Day 1
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Pill count values compared between arms
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adherence rates compared between groups
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Megan Wilkins, PhD、St. Jude Children's Research Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- P1TEAM
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