An Enhanced Package of Care to Reduce Reduce Mortality in Advanced HIV Disease (ENCORE)
A Community-based Phase III, Cluster Randomized Trial of Point-of-care CD4 Testing and Enhanced Screening and Prophylaxis in Advanced HIV Disease
調査の概要
状態
介入・治療
詳細な説明
The study will be carried out in a population of HIV-infected adults with advanced HIV disease (CD4 <200 cells/µL) in Uganda. It will be a Randomized controlled trial, Phase III in Uganda over a duration of 5 years assessing 24 weeks survival with retention in care. @4 clinic will be randomized to either receive the enhanced package or standard of care.
Description of Intervention Arm
- Point-of-care CD4 testing via Visitect (point of care semi Quantitaive CD4 LFA) lateral flow assay (LFA)
Enhanced package of opportunistic infection screening and prophylaxis for CD4<200, including:
- FujiFilm SILVAMP TB LAM (FujiLAM)
- Isoniazid (INH) + rifapentine: 1 month of therapy for latent TB(Tuberculosis) infection
- Cryptococcal Antigen semi-quantitative (CrAg-SQ) LFA (Immy)
- Treatment for disseminated CNS cryptococcal infection if high blood CrAg titer (>3+ CrAg SQ)
Description of Standard of Care Arm
- CD4 testing by flow cytometry
WHO recommended package of OI screening and prophylaxis, including:
- Urine TB LAM
- INH ( isoniazid 6 months)
- CrAg LFA
- Fluconazole for asymptomatic CrAg+ o 800mg daily x 2 weeks, then 400mg daily x 8 weeks, then 200mg daily.
Problem statement: Current lab-based CD4 testing results in a delay to either start ART(Antiretroviral therapy) or a delay in screening persons with low CD4s for OIs. At present, prioritization has been on ART initiation without systematic OI screening. Those with subclinical OIs started on ART unmask their OIs, with hospitalization / deaths for OIs such as cryptococcosis and TB.
We hypothesize that with point of care CD4 testing, same-day OI screening can occur, yet not interrupt prompt ART initiation for those at low risk (FujiLAM and CrAg-SQ negative) of unmasking immune reconstitution syndrome.
We hypothesize that point-of-care CD4 testing will improve 6-month survival by reducing lag time in CD4 results, thereby facilitating ART initiation, retention-in-care, and OI screening and prophylaxis.
We hypothesize that enhanced screening with the point-of-care FujiLAM, CrAg-SQ LFA, with enhanced prophylaxis for TB (1 month of INH and rifapentine) and with treatment for disseminated CNS cryptococcal infection in those CrAg+ with high titers (>3+) will improve 6-month survival compared to current WHO-recommended standard practice in persons with advanced HIV disease.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Radha Rajasingham, MD
- 電話番号：612 626-8171
- メール：radha@umn.edu
研究連絡先のバックアップ
- 名前：Elizabeth Nalintya, MBChB,MPH
- 電話番号：0414307000
- メール：nalintyaelizabeth@gmail.com
研究場所
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-
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Kampala、ウガンダ
- 募集
- kisugu health center IV
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コンタクト：
- Teopista Namuli
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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:
- Age >18 years
- CD4<200 cells/µL
- Ability and willingness to give informed consent for the enhanced package of care arm.
Exclusion Criteria:
- Known virologic suppression (viral load <1000 copies/mL) within prior 3 months
- Cannot or unlikely to attend regular clinic visits
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：階乗代入
- 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：intervention(Enhanced package of care) Arm
The patients with advanced HIV disease that receive HIV care at the intervention clinics will receive the enhanced intervention package which will include: point of care CD4 testing with visitect, screening for TB and cryptococcal meningitis using Fujifilm LAM and semiquantitative crAg LFA respectively and pre-emptive treatment with isoniazid and rifapentine for one month.
Those with a high crAg titers will receive treatment for CNS cryptococcal disease.
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The intervention is an improved package of care for patients with advanced HIV disease with point of care CD4 testing, more sensitive screening tests for opportunistic infections and more intensive pre-emptive treatment for opportunistic infections
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介入なし：Standard of care Arm
The patients with advanced HIV disease that receive HIV care at the standard of care clinics will receive the usual routine HIV care as per the Uganda national guidelines.
That is CD4 testing with flowcytometry or other CD4 testing modalities available, screening for TB and cryptococcal meningitis using Alere LAM and crAg LFA respectively and pre-emptive treatment with isoniazid and rifapentine for 3-6 month.
Treatment of all asymptomatic crAG positives with fluconazole as per guidelines.
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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 |
|---|---|---|
|
24-week survival with retention in care
時間枠：24 weeks
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Comparison will be made between study arms of those who receive POC CD4 testing vs. those who receive standard flow cytometry, and those who receive the enhanced package of OI screening and prophylaxis, vs. those who receive the current WHO standard.
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24 weeks
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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 |
|---|---|---|
|
Evaluate sensitivity and specificity of the different TB point of care tests.
時間枠：24 weeks
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After a positive FujiFilm TB LAM test, incidence of Xpert-positive or culture positive TB, and clinical outcomes to distinguish between false positive vs. true positive urine tests
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24 weeks
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Incidence of OIs and associated hospitalization and mortality
時間枠：Six months
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Incidence of active TB within 6 months, Incidence of cryptococcal meningitis and associated mortality.
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Six months
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Tolerability and adherence to prophylaxis regimen and associated grade 3 to 5 adverse events
時間枠：24 weeks
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percentage completion of regimen and proportions that get grade 3 and above AEs.
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24 weeks
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
- IDIREC REF 007/2021
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
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
米国で製造され、米国から輸出された製品。
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。
Enhanced care packageの臨床試験
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