Kulindana: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission
Kulindana: Expanding Access and Impact of Tuberculosis Preventative Therapy: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission
The goal of this clinical trial is to learn if differentiated service delivery (DSD) of TB preventive therapy (TPT) improves uptake and completion of TPT in two populations: household contacts (HHC) of index TB patients and people living with HIV (PWH). The main questions it aims to answer are:
- Is community-based and multi-month dispensing of short-course TPT with minimal clinic and laboratory monitoring associated with higher rates of initiation and completion of TPT, compared to standard of care, in both HHC and PWH?
- Does community-based and DSD TPT reduce household and community TB transmission?
Researchers will compare DSD TPT delivery to standard of care (SoC) to see if DSD TPT delivery has an effect on TPT uptake and completion.
Participants will:
- Be assessed for TPT eligibility through either DSD TPT service delivery of SoC including differentiated TB screening procedures.
- If eligible, receive DSD TPT service delivery or SoC TPT service delivery.
- Over 12 weeks receive either DSD or SoC TPT adherence assessment and follow-up.
- Have TPT completion assessed at 12 weeks following enrolment.
- A subset of participants will be assess for TB incidence at 9 months following enrolment.
調査の概要
状態
詳細な説明
The investigators will conduct a two-arm, non-blinded, randomized controlled trial (RCT) comparing differentiated TPT delivery to standard of care (SOC) clinic-based TPT. The central hypothesis is that decentralized, differentiated-service delivery approaches to TPT will improve TPT uptake and completion in Kenya. This study will be conducted in seven HIV clinics in Kisumu County, a high HIV/TB burden region in western Kenya. This study has two populations:
(A) Household contacts (HHC) of Index TB patients (Index patients: any age, diagnosed with pulmonary TB (or any TB if <18 years), who live with at least one other person not currently taking TB treatment). The TB index patients and household contacts include children.
(B) People living with HIV (PWH), aged 15+ who are eligible for TPT per Kenyan guidelines.
The primary outcome, 3 months after enrollment, is completion of a course of TPT, defined as taking 11 weeks of TPT within 16 weeks.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Gillian O'Bryan
- 電話番号：240-444-0098
- メール：gilliano@uw.edu
研究連絡先のバックアップ
- 名前：Adrienne Shapiro, MD, PhD
- メール：aeshapir@uw.edu
研究場所
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-
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Kisumu、ケニア
- Centre for Family Health Research and Development (CEFERD) located at Jaramogi Oginga Odinga Teaching and Referral Hospital
-
コンタクト：
- Celestine Atieno
- 電話番号：+254 713 053766
- メール：catien00@uw.edu
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Household contacts (HHC) are eligible for enrolment if the participant shares a residential dwelling with an index TB patient and can provide informed consent (or parental consent, with assent if appropriate).
- People living with HIV (PWH) are eligible for enrolment if the participant is an adult aged 15 and over, is eligible for TPT according to Kenyan National Guidelines, and can provide informed consent.
Exclusion Criteria:
- HHC will be excluded if the participant plans on permanently relocating from the area within the next three months, is not willing to receive TPT screening and initiation at home, or is enrolled in any other investigational/interventional HIV or TB study.
- PWH will be excluded if the participant plans on permanently relocating from the area within the next three months, has contraindications for TPT according to the Kenyan National Guidelines, or is enrolled in any other investigational/interventional HIV or TB 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：他の
- 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 |
|---|---|
|
実験的：Differentiated service delivery (DSD) of TPT
In the household contact (HHC) population DSD TPT will be delivered at home in a single dispense of a full course of TPT; in the people living with HIV (PWH) population DSD TPT will be delivered at the clinic in a single dispense of a full course of TPT.
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TPT is normally provided at clinics with monthly visits for refills, but the full course of TPT can also be provided all at once through differentiated service delivery (DSD) of TPT.
By doing the Kulindana study, the investigators hope to learn which way of delivering TPT to participants (through usual clinic practice, or all at once) is best for helping participants finish a full course of TPT.
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介入なし：Clinic-based standard of care
Both the household contact (HHC) population and the people living with HIV (PWH) population have TPT dispensed at the clinic according to standard practice, typically one month at a time.
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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 |
|---|---|---|
|
TB preventive therapy completion
時間枠：16 weeks
|
Proportion of participants completing 11 out of 12 weeks of TPT within 16 weeks
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16 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
IGRA conversion
時間枠：9 months
|
Proportion of child household contacts (age <15 years) who convert their IGRA result from negative to positive.
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9 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Adrienne Shapiro, MD, PhD、University of Washington
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00024388
- R01AI183979-01A1 (米国 NIH グラント/契約)
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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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