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Incentives to Promote Medication Adherence Among HIV-Infected Youth

2016年6月20日 更新者：St. Jude Children's Research Hospital

Investigation of Incentives to Promote Medication Adherence Among HIV-Infected Youth on Antiretroviral Therapy

Medication adherence is one of the most salient predictors of patient outcomes in the era following development of effective treatment for HIV infection. Evolving strategies to improve adherence, specifically incentive interventions and real-time medication monitoring, have shown some success in limited studies. Further investigation into incentive interventions for HIV-infected adolescents with poor medication adherence is necessary.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

PRIMARY OBJECTIVE:

  • To describe the effects of a novel incentive intervention model on HIV-infected youths' patterns of antiretroviral medication adherence.

SECONDARY OBJECTIVES:

  • To evaluate the feasibility of an outpatient incentive intervention model.
  • To assess participant satisfaction with the incentive intervention model.
  • To evaluate the effect of an outpatient incentive intervention model on targeted health behaviors (numbers of missed appointments and STI diagnoses).
  • To measure the effect of the incentive intervention on HIV viral load and CD4+ count.
  • To determine the overall and per patient cost of the incentive intervention model.
  • To describe associations between adherence measures: real-time medication monitor data, pharmacy pill count, pharmacy prescription pick-up data, medication possession ratio, and self-report.

Upon enrollment, participants will receive education and a real-time medication monitor. Participants will be followed monthly in the clinic and will be prescribed thirty-day supplies of medication. During weeks 1-4 participants will establish a baseline with the real-time medication monitor. During weeks 5-28, participants will receive remote incentives based on their level of medication adherence as measured by the real-time medication monitor. Additional lottery-style incentives will occur at regular follow-up visits. No incentives will be applied during weeks 29-48. Participants will complete the protocol at the week 48 visit.

研究の種類

観察的

入学 (実際)

25

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Tennessee
      • Memphis、Tennessee、アメリカ、38105
        • St. Jude Children's Research Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

16年～24年 (子、大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Youth with HIV who meet eligibility criteria.

説明

Inclusion Criteria:

  • ≥16 and ≤ 24 years old
  • Documented diagnosis of HIV
  • Adolescent is aware of his/her HIV diagnosis
  • Adolescent understands either written or spoken English.
  • Adolescent is willing and able to provide informed consent or assent.
  • Adolescent has access to a phone and the internet at the time of enrollment.

  • Adolescent meets the definition of inadequate ARV adherence, which is any of the following in the previous 12 months:

    • < 80% adherent to any ARV by pharmacy pill count
    • ≥ 7 days delay in scheduled ARV prescription pick-up
    • Detectable viral load after being on ARVs for at least 12 weeks

Exclusion Criteria:

  • Adolescent has a documented diagnosis of mental retardation or a significant motor or sensory impairment that would preclude participation.
  • Adolescent has a documented acute psychiatric illness, including suicidal ideation, homicidal ideation or active psychosis.
  • Adolescent was diagnosed with HIV in the previous 6 months.
  • Adolescent has a planned transition to alternative care setting prior to study completion (e.g. relocation, pregnancy or planned pregnancy, transition to adult care).
  • Concurrent enrollment on a research study with an intervention targeted at increasing adherence to antiretroviral regimens.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 観測モデル：コホート
  • 時間の展望：見込みのある

コホートと介入

グループ/コホート
介入・治療
Study Participants
All participants who meet eligibility requirements and who consent to participation will use an incentive intervention model.
行動：Incentive intervention model
All participants will receive a real-time electronic medication monitor to monitor daily pill-taking behavior. Participants with qualifying levels of adherence will receive a weekly incentive during the intervention period. At all clinic visits participants will participate in a lottery incentive to reinforce clinic attendance and negative STI screening tests.

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
Percentage of dosages taken within 2 hours of prescribed time per month
時間枠：Monthly through week 48
Data collected by a real-time medication monitor that records pillbox opening times.
Monthly through week 48
Pharmacy pill count
時間枠：Monthly from 6 months prior to study start through week 48
Pharmacy pill count data is collected at each participant encounter, approximately once per month.
Monthly from 6 months prior to study start through week 48

二次結果の測定

結果測定
メジャーの説明
時間枠
Feasibility - Accrual percentage
時間枠：End of study (week 48)
Number of people enrolled in study/number approached for enrollment.
End of study (week 48)
Feasibility - Drop out rate
時間枠：End of study (week 48)
Number of people ending protocol early/ total enrollment
End of study (week 48)
Feasibility - Participant reported device concerns
時間枠：End of study (week 48)
Problems with the Wisepill devices as spontaneously reported by participants or as assessed at routine follow-up.
End of study (week 48)
Feasibility - Device replacement rate
時間枠：End of study (week 48)
Number of devices requiring replacement due to loss/theft/breakage
End of study (week 48)
Feasibility - Contact failure rate
時間枠：End of study (week 48)
Number of failed attempts to contact participants/total number of contact attempts made
End of study (week 48)
Feasibility - Staff hours per week
時間枠：End of study (week 48)
Hours spent providing remote incentives
End of study (week 48)
Feasibility - Adverse effects of incentives
時間枠：End of study (week 48)
Unexpected risks/harms of providing incentives as self-reported by participants.
End of study (week 48)
Percentage of participants who are satisfied with the incentive intervention
時間枠：Enrollment (week 0) and end of study (week 48)
To assess participant satisfaction with the incentive intervention model. Patient satisfaction, assessed by ACASI survey, will be summarized and tabulated for baseline (week 0) and follow-up (week 48) measurements.
Enrollment (week 0) and end of study (week 48)
Effect of incentives on missed appointment rate
時間枠：Enrollment (week 0) and end of study (week 48)
Descriptive statistics of numbers of missed appointments such as mean, interquartile range and median, during each study phase will be computed and compared
Enrollment (week 0) and end of study (week 48)
Effect of incentives on STI rates
時間枠：Enrollment (week 0) and end of study (week 48)
Descriptive statistics of numbers of STI rates such as mean, interquartile range and median, during each study phase will be computed and compared
Enrollment (week 0) and end of study (week 48)
Change in biological parameters
時間枠：At weeks 0, 12, 24, 36 and 48
To measure the effect of the incentive intervention on HIV viral load and CD4+ count. HIV viral load and CD4+ count measured at week 0, 12, 24, 36 and 48 will be summarized and plotted by descriptive statistics, such as mean and standard deviation. Mixed effects models will be applied to explore the effect of the intervention on HIV viral load and CD4+ count.
At weeks 0, 12, 24, 36 and 48
Overall cost of incentive intervention
時間枠：End of study (week 48)
To determine the overall and per patient cost of the incentive intervention model the accumulated overall and per patient cost till week 48 will be summarized and tabulated.
End of study (week 48)
Association between adherence measures
時間枠：End of study (week 48)
To describe associations between adherence measures: Wisepill data, pharmacy pill count, pharmacy prescription pick-up data, medication possession ratio, and self-report. Associations of Wisepill adherence rates with pill count and pick up rates will be described by Pearson or Spearman's correlation coefficients and intraclass correlation coefficients as appropriate.
End of study (week 48)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

St. Jude Children's Research Hospital

捜査官

  • 主任研究者：Ronald Dallas, PhD、St. Jude Children's Research Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2014年7月1日

一次修了 (実際)

2016年6月1日

研究の完了 (実際)

2016年6月1日

試験登録日

最初に提出

2014年7月30日

QC基準を満たした最初の提出物

2014年7月30日

最初の投稿 (見積もり)

2014年8月1日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年6月21日

QC基準を満たした最後の更新が送信されました

2016年6月20日

最終確認日

2015年6月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • INMED

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

HIVの臨床試験

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