ザンビアのルサカとリビングストンでのCOVID-19パンデミック中に質の高い結核サービスの継続性を確保するための革新的なアプローチの採用。 （TBの遠隔医療） (Telemed TB)
Following the negative impact of public health program services including TB services by the COVID-19 Pandemic in 2020, CIDRZ conducted a program evaluation for remote patient follow up for TB treatment and prevention through a differentiated service delivery model (DSD), offering clinical monitoring and psychosocial support while minimizing contact with the health facilities. The project was implemented between February 2022 to March 2023 and was funded through Centers for Disease Control and Prevention's COVID-19 Response International Task Force - CARES funding. While DSD models have been widely adopted in HIV programs , DSD is a relatively new and exciting approach for TB treatment and prevention programs.
調査の概要
状態
詳細な説明
During the COVID-19 pandemic, government restrictions on movement decreased access to health care. Although DSD models have been widely adopted in HIV programs, this is a relatively new approach for TB programs. Zambia's NTLP has already changed policy to allow for such adaptations of service delivery, but these adaptations are not universally implemented and have not been evaluated at this time. This project aims to evaluate these DSD models for both TB treatment (Anti-TB Treatment ATT) and TPT using standardized indicators. To complement these DSD models, innovative approaches like digital (texting/SMS and phone) treatment support and remote monitoring of adverse events will be adopted using bi-directional SMS through use of the rapid pro system, a tool that allows medical information to be gathered and shared via a cell phone.
- To implement TPT in 6MMD and ATT DSD models at 5 sites in Lusaka and Livingstone districts
- To assess acceptability of TPT in 6MMD and ATT DSD models at implementation sties
- To assess trends in TPT coverage and completion rates from pre-implementation through implementation periods using aggregate program performance data
- To assess trends in ATT completion rates from pre-implementation through implementation periods using aggregate program performance data
- To inform the Ministry of Health on a systematic approach for digital follow up and screening for TB and TPT RoCs aligned to MMD models of care.
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
-
-
Lusaka Province
-
Lusaka、Lusaka Province、ザンビア、10101
- Lusaka and Livingstone districts
-
-
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:
TB ARM
- All ROCs presenting to chest clinic for TB treatment between February 2022 and September 2022 were considered for inclusion if:
Diagnosed with TB (new cases or retreatment cases) 18 years and above Willing and able to provide consent Not pregnant or breastfeeding No MDR TB
TPT ARM
All ROCs presenting to the ART clinic between February 2022 and September 2022 were considered for inclusion if they were:
18 years or above virally supressed with no symptoms or diagnosis suggestive of TB on ART for more than 6 months on 6MMD Consented to participate in the project did not receive TPT in the last 3 years not pregnant or breastfeeding women not incarcerated
Exclusion Criteria:
ATT ARM
- RoCs those TB diagnosis is not confirmed
- RoCs who are less than 18 years old
- RoCs not able to provide consent for program evaluation participation
- RoCs with MDR TB
TPT ARM
-
RoCs with symptoms suggestive of TB, diagnosed or confirmed with TB diagnosis
- RoCs who received TPT in the last 3 years
- RoCs who are less than 18 years old
- RoCs not able to provide consent for program evaluation participation
- Pregnant and breastfeeding women
- Incarcerated persons
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：防止
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
アクティブコンパレータ：TB treatment ARM
Beginning February 2022, we offered ATT via 2-month MMD during intensive and 4-month MMD during continuation phases. In-clinic visits during 6-months of ATT were reduced from 7 under standard of care to 3 visits in DSD, while ensuring robust adherence and adverse event screening. Remote monitoring consisted of structured SMS (months 1 to 5) and phone (week 2 and month 3) follow-up to assess adherence and screen for side effects. If SMS were not returned, a phone or home visit was triggered. |
Although DSD models have been widely adopted in HIV programs, DSD is a relatively new approach for TB programs because of an historical reliance on directly observed therapy (DOT) (6). DSD provides opportunities to improve health outcomes and reduce the burden of seeking care for people diagnosed with TB. |
|
アクティブコンパレータ：TPT DSD
Beginning February 2022, we offered TPT aligned to 6MMD ART model following standard of care processes with added support (See below). Remote monitoring consisted of structured SMS (months 1 to 5) and phone (week 2 and month 3) follow-up to assess adherence and screen for side effects. ROCs that did not respond to the SMS within 2 days were further contacted via phone and if not reachable a home visit was done. ROCs that reported at least one side effect or more were followed up with virtual reviews by clinicians. At enrollment ROCs reading language of preference was documented and the SMS was sent in their preferred language. |
Although DSD models have been widely adopted in HIV programs, DSD is a relatively new approach for TB programs because of an historical reliance on directly observed therapy (DOT) (6). DSD provides opportunities to improve health outcomes and reduce the burden of seeking care for people diagnosed with TB. |
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 and TPT Outcomes
時間枠：12 months
|
• The primary program evaluation outcomes of interest are the TPT and ATT completion rates in the prospective cohort, defined as the fraction of participants completing TPT or ATT among those who initiated TPT or ATT |
12 months
|
協力者と研究者
捜査官
- スタディディレクター：Mwanza Wa Mwanza, MD、Centre for Infectious Disease Research in Zambia
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 (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
- Telemedicine in TB
- NU2GGH002251 (その他の助成金/資金番号：U.S. Centers for Disease Control and Prevention's COVID-19 Response International Task Force)
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
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