Timing of Referral to Adherence Clubs for Antiretroviral Therapy (TRAC)
Timing of Referral to Adherence Clubs for Antiretroviral Therapy - a Randomised Controlled Trial
調査の概要
詳細な説明
Following on from the huge need for scaled-up models of ART (anti-retroviral therapy) delivery to improve patient adherence and viral suppression, the ART adherence club model was piloted from 2007 with the aim of assessing whether this group-based, lay-counsellor led service, with an emphasis on social support and adherence, could help address retention in care and viral suppression. Since the initial pilots, the club model has been scaled up rapidly with more than 400 clubs meeting in the Cape Town metro. As this model is being scaled-up and implemented rapidly, there is an urgent necessity to further assess its effectiveness.
Whilst adherence clubs have been shown to be locally implementable, popular (with buy-in by clinic staff and patients) and cost-effective, and whilst community-based interventions have been shown to improve retention, evidence of local adherence club effectiveness in improving viral suppression and retention has only been observationally obtained. This observational evidence is highly subject to selection bias.
This trial aims to address this by using a randomised controlled trial design with two arms - ART patients receiving care in clinic as per the Standard-of-Care (this arm will have delayed referral to Adherence clubs at 12 months post-initiation) and ART patients receiving care in Adherence clubs (this arm will have early referral to Adherence clubs at 4 months post-initiation). By doing this the investigators hope to generate robust evidence regarding both the effectiveness of clubs and the optimal timing of club referral.
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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Western Cape
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Cape Town、Western Cape、南アフリカ、7750
- Gugulethu Community Health Centre
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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:
- Documented HIV infection with ART initiation 4 months ago
- Suppressed viral load at 4 months post-initiation (<400 copies/ml)
- All other month 4 blood results within normal limits
- Willingness to be randomised and return for study measurement visits
- Able to willing to attend service visits at either the clinic or a club
- Able to provide informed consent for research
Exclusion Criteria:
- Intention to relocate out of Cape Town permanently during the study period
- Any medical, psychiatric or social condition which in the opinion of the investigators would affect the ability to consent and/or participate in the study
- Pregnant
- Current co-morbidity requiring additional health care, either acutely eg tuberculosis or chronically eg hypertension
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Clinic-based Care
Clinic-based care is the current Standard-of-Care whereby newly initiated ART patients attend the ART clinic.
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実験的：Adherence Club Care
Adherence club care involves referral to community-based ART services in the form of Adherence clubs, which are led by community health workers and supported by ART clinic nurses.
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Participants will be referred to an Adherence Club at 4 months post-ART initiation.
Adherence club visits occur 2-4 monthly at a community hall near the Community Health Centre (CHC).
At routine visits, which last 1-2 hours, community health workers provide health education, weigh patients, ask about symptoms and dispense pre-packed ART.
Symptomatic patients are sent back to the ART clinic for clinician assessment.
An assigned nurse takes blood tests annually at each club, and then returns on the subsequent visit to perform a clinical assessment and check the results.
Patients requiring more follow-up or with high viral loads are referred back to the ART clinic at the CHC by the nurse.
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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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Viral suppression
時間枠：Up to 12 months post-ART initiation
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Viral load <400 copies/ml with secondary analyses at other thresholds
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Up to 12 months post-ART 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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Retention in care
時間枠：Up to 12 months post-ART initiation
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Numbers of missed visits and loss-to-follow up
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Up to 12 months post-ART initiation
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Physical and Mental Health
時間枠：Up to 12 months post-ART initiation
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As captured in the study visit questionnaires
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Up to 12 months post-ART initiation
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Acceptability of the ART service
時間枠：Up to 12 months post-ART initiation
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As captured in the study visit questionnaires
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Up to 12 months post-ART initiation
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Landon Myer, MBChB PhD、University of Cape Town
出版物と役立つリンク
一般刊行物
- Luque-Fernandez MA, Van Cutsem G, Goemaere E, Hilderbrand K, Schomaker M, Mantangana N, Mathee S, Dubula V, Ford N, Hernan MA, Boulle A. Effectiveness of patient adherence groups as a model of care for stable patients on antiretroviral therapy in Khayelitsha, Cape Town, South Africa. PLoS One. 2013;8(2):e56088. doi: 10.1371/journal.pone.0056088. Epub 2013 Feb 13.
- Grimsrud A, Sharp J, Kalombo C, Bekker LG, Myer L. Implementation of community-based adherence clubs for stable antiretroviral therapy patients in Cape Town, South Africa. J Int AIDS Soc. 2015 May 27;18(1):19984. doi: 10.7448/IAS.18.1.19984. eCollection 2015.
- Grimsrud A, Lesosky M, Kalombo C, Bekker LG, Myer L. Implementation and Operational Research: Community-Based Adherence Clubs for the Management of Stable Antiretroviral Therapy Patients in Cape Town, South Africa: A Cohort Study. J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):e16-23. doi: 10.1097/QAI.0000000000000863.
- Takuva S, Brown AE, Pillay Y, Delpech V, Puren AJ. The continuum of HIV care in South Africa: implications for achieving the second and third UNAIDS 90-90-90 targets. AIDS. 2017 Feb 20;31(4):545-552. doi: 10.1097/QAD.0000000000001340.
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
キーワード
その他の研究ID番号
- 764/2016
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
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