AYAHIV 腫瘍学に焦点を当てた従業員に対する役割に基づく責任 (ARROW)
ザンビアで HIV とともに生きる青少年および若年成人に対するがん制御介入の統合的提供
Adolescents and young adults living with HIV experience higher premature mortality from cancer than their uninfected peers. In Zambia, because of multilevel barriers, interventions for early diagnosis and optimized treatment to reduce this cancer mortality are underutilized for this disproportionally impacted cohort. In this study, the investigators will test peer-to-peer education and support strategies to increase use of early diagnosis services in HIV treatment facilities and improve compliance with cancer treatment in the cancer center.
調査の概要
詳細な説明
Zambia is a global epicenter for HIV with a large number of adolescents and young adults living with HIV (AYAHIV). Compared with their uninfected peers, AYAHIV are at increased risk of developing cancer, most frequently Kaposi sarcoma (KS), non-Hodgkin's lymphoma (NHL), and cervical cancer (CC). To reduce this premature mortality, evidence-based strategies should be implemented to both diagnose cancers at an earlier stage and help AYAHIV complete recommended cancer treatment. The investigators will use theory-informed multilevel strategies to create the AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW) program to increase uptake of services for early diagnosis and improve compliance with cancer treatment for KS, NHL, and CC. Our overall approach is based on the evidence-based strategy of peer support for engagement and learning. At the individual level, the investigators will address barriers by embedding peer counselors to support AYAHIV. At the provider level, the investigators will create a peer-to-peer learning network to build linkages between those specializing in pediatric and adult HIV treatment and cancer care. At the health care system level, the investigators will bring together health care administrators and Zambian Ministry of Health policy makers to review barriers and to develop and implement collaborative solutions. The investigators will use implementation science methods to evaluate effectiveness, implementation outcomes, and cost-effectiveness of the ARROW program compared with a one-time education campaign by pursuing the following aims:
Aim 1. Conduct randomized trials to compare the ARROW program with the one-time education campaign in increasing services received by AYAHIV to facilitate early diagnosis (physical exam for KS and NHL, CC screening, and timely diagnostic testing) and in improving adherence to cancer treatment.
Aim 2. Use mixed methods to assess implementation outcomes of the ARROW program compared with one-time education based on acceptability, feasibility, appropriateness, fidelity, and sustainability.
Aim 3. Perform economic evaluations to assess cost-effectiveness and return-on-investment scenarios.
Successful completion of these aims will yield a set of data-driven strategies that can be scaled up to reduce premature cancer mortality among AYAHIV. To support future implementation efforts, the investigators will generate incremental cost-effectiveness estimates, conduct policy simulations, evaluate implementation outcomes, and assess challenges and facilitators to optimize the ARROW program. The model tested in Zambia can serve as a blueprint for other Sub-Saharan African countries to ensure AYAHIV receive optimal services to facilitate early diagnosis and ensure completion of guideline-recommended treatments. The ARROW program will also provide a framework for implementing expanded services, such as preventive services and survivorship care, to further reduce the burden of cancer AYAHIV face.
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:Sujha Subramanian
- 電話番号:3022225034
- メール:sujha.subramanian@implenomics.com
研究場所
-
-
-
Lusaka、ザンビア
- 募集
- Public Health Facilities
-
コンタクト:
- Ronald Mungoni
-
-
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:
- 15 to 39 years of age at the time of study enrolment, on antiretroviral medication (ART) for at least 6 months and with no pending plans to move from current residence during the 3-year study duration
Exclusion Criteria:
- pregnant at study enrolment
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:ふるい分け
- 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:ARROW strategies
The ARROW strategies which use peer-peer support at the patient level (through peer counselors), at the provider level (through peer lead education sessions) and at the health system level (through a health collaborative forum) to deliver high quality screenings and ensure cancer treatment completion. |
ARROW strategies are peer-to-peer support at the patient, provider and health system levels |
|
アクティブコンパレータ:One-time education
The comparator arm participants will receive one-time education and usual care services. |
The comparison group will receive a one-time education campaign that will provide informational brochures to adolescents and young adults living with HIV and HIV providers |
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 |
|---|---|---|
|
Proportion who complete screening/physical examination
時間枠:12 months after study enrollment
|
Number who complete screening/physician exams |
12 months after study enrollment
|
|
Proportion who complete recommended cancer treatment modalities
時間枠:12 months after diagnosis
|
Number who complete treatment |
12 months after diagnosis
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion who complete recommended follow-up supplemental diagnostic procedures
時間枠:3 months from receipt of follow-up referral
|
Number who complete follow-up |
3 months from receipt of follow-up referral
|
|
Proportion who initiate cancer treatment
時間枠:3 months from diagnosis
|
Number who initiate treatment |
3 months from diagnosis
|
|
Proportion alive at 12 months
時間枠:12 months after diagnosis
|
Number alive at 12 months |
12 months after diagnosis
|
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 (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
- Imp001
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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