- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT06004011
Responsabilités basées sur les rôles d'AYAHIV pour la main-d'œuvre axée sur l'oncologie (ARROW)
Prestation intégrée d'interventions de lutte contre le cancer pour les adolescents et les jeunes adultes vivant avec le VIH en Zambie
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sujha Subramanian
- Numéro de téléphone: 3022225034
- E-mail: sujha.subramanian@implenomics.com
Lieux d'étude
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Lusaka, Zambie
- Recrutement
- Public Health Facilities
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Contact:
- Ronald Mungoni
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Comparateur actif: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion who complete screening/physical examination
Délai: 12 months after study enrollment
|
Number who complete screening/physician exams |
12 months after study enrollment
|
|
Proportion who complete recommended cancer treatment modalities
Délai: 12 months after diagnosis
|
Number who complete treatment |
12 months after diagnosis
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion who complete recommended follow-up supplemental diagnostic procedures
Délai: 3 months from receipt of follow-up referral
|
Number who complete follow-up |
3 months from receipt of follow-up referral
|
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Proportion who initiate cancer treatment
Délai: 3 months from diagnosis
|
Number who initiate treatment |
3 months from diagnosis
|
|
Proportion alive at 12 months
Délai: 12 months after diagnosis
|
Number alive at 12 months |
12 months after diagnosis
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladies du système immunitaire
- Infections
- Maladies virales
- Tumeurs par type histologique
- Maladies utérines
- Maladies génitales, femme
- Infections par le virus de l'ADN
- Tumeurs génitales, femme
- Maladies lymphatiques
- Troubles lymphoprolifératifs
- Troubles immunoprolifératifs
- Maladies du col de l'utérus
- Lymphome
- Tumeurs utérines
- Sarcome
- Tumeurs, tissus conjonctifs et mous
- Infections à Herpesviridae
- Tumeurs, tissu vasculaire
- Maladies hémiques et lymphatiques
- Tumeurs du col de l'utérus
- Lymphome non hodgkinien
- Sarcome, Kaposi
Autres numéros d'identification d'étude
- Imp001
Informations sur les médicaments et les dispositifs, documents d'étude
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