- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06004011
AYAHIV rollbaserade ansvarsområden för onkologifokuserad arbetskraft (ARROW)
Integrerad leverans av cancerkontrollinsatser för ungdomar och unga vuxna som lever med hiv i Zambia
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Sujha Subramanian
- Telefonnummer: 3022225034
- E-post: sujha.subramanian@implenomics.com
Studieorter
-
-
-
Lusaka, Zambia
- Rekrytering
- Public Health Facilities
-
Kontakt:
- Ronald Mungoni
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
|
Aktiv komparator: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion who complete screening/physical examination
Tidsram: 12 months after study enrollment
|
Number who complete screening/physician exams |
12 months after study enrollment
|
|
Proportion who complete recommended cancer treatment modalities
Tidsram: 12 months after diagnosis
|
Number who complete treatment |
12 months after diagnosis
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion who complete recommended follow-up supplemental diagnostic procedures
Tidsram: 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
Tidsram: 3 months from diagnosis
|
Number who initiate treatment |
3 months from diagnosis
|
|
Proportion alive at 12 months
Tidsram: 12 months after diagnosis
|
Number alive at 12 months |
12 months after diagnosis
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Immunsystemets sjukdomar
- Infektioner
- Virussjukdomar
- Neoplasmer efter histologisk typ
- Livmodersjukdomar
- Genitala sjukdomar, kvinnor
- DNA-virusinfektioner
- Genitala neoplasmer, hona
- Lymfatiska sjukdomar
- Lymfoproliferativa störningar
- Immunproliferativa störningar
- Livmoderhalssjukdomar
- Lymfom
- Uterina neoplasmer
- Sarkom
- Neoplasmer, bindväv och mjukvävnad
- Herpesviridae-infektioner
- Neoplasmer, vaskulär vävnad
- Hemiska och lymfsjukdomar
- Uterina cervikala neoplasmer
- Lymfom, icke-Hodgkin
- Sarkom, Kaposi
Andra studie-ID-nummer
- Imp001
Läkemedels- och apparatinformation, studiedokument
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