AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)

Trial Title: AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)

NCT ID: NCT06004011

Condition: Cervical Cancer
Kaposi Sarcoma
Non Hodgkin Lymphoma

Conditions: Official terms:
Sarcoma, Kaposi

Conditions: Keywords:
cancer screening
Implementation trial

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Screening

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: ARROW strategies
Description: ARROW strategies are peer-to-peer support at the patient, provider and health system levels
Arm group label: ARROW strategies

Intervention type: Other
Intervention name: One-time education
Description: 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
Arm group label: One-time education

Summary: 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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 15 Years

Maximum age: 39 Years

Healthy volunteers: No

Locations:

Facility:
Name: Public Health Facilities

Address:
City: Lusaka
Country: Zambia

Status: Recruiting

Contact:
Last name: Ronald Mungoni

Start date: May 1, 2024

Completion date: July 31, 2027

Lead sponsor:
Agency: Implenomics
Agency class: Other

Collaborator:
Agency: Population Council
Agency class: Other

Collaborator:
Agency: RTI International
Agency class: Other

Source: Implenomics

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06004011