Integrated Model of Cancer Control for Early Detection and Treatment in Adolescents and Young Adults Living With HIV: Protocol for a Cluster Randomized Controlled Trial.
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BACKGROUND: Zambia has one of the highest prevalence rates of HIV among adolescents and young adults (AYA) living with HIV in sub-Saharan Africa, which accounts for half of all new HIV cases as of 2023. Compared to their peers who are not living with HIV, AYA living with HIV are more likely to develop cancer. The most frequently diagnosed cancers among AYA living with HIV in Zambia are cervical cancer, Kaposi sarcoma, and non-Hodgkin lymphoma. Premature cancer mortality among AYA living with HIV is driven by late-stage presentation and poor treatment adherence. OBJECTIVE: We aim to develop and test an integrated model of cancer control for AYA living with HIV that can be delivered as an embedded component in existing HIV treatment programs in primary care facilities and linked with specialized treatment at cancer centers. METHODS: We propose a cluster randomized controlled trial to compare the AYAHIV Role-Based Responsibilities for Oncology-Focused Workforce (ARROW) program with a one-time education campaign. The ARROW program consists of interventions at the individual, health care provider, and health system levels. Peer counselors will educate AYA living with HIV through one-on-one and group education sessions and offer care coordination and linkages with clinicians. The HIV and oncology workforce will receive collaborative education and training. The ARROW Health Care Collaborative will connect administrators and policy makers to address system-level barriers. The study will recruit AYA living with HIV between the ages of 15 and 39 years who have been on antiretroviral therapy for at least 6 months and are not pregnant; the cancer treatment cohort will enroll AYA living with HIV who have been diagnosed with cervical cancer, Kaposi sarcoma, or non-Hodgkin lymphoma in Lusaka, Zambia. Half of the 18 HIV facilities have been randomly assigned to a one-time educational campaign and the other half to the ARROW intervention. Participants in the cancer treatment cohort will be randomized into 1 of the 2 study arms. We will conduct economic evaluations to assess the cost-effectiveness of the ARROW program. We will use an intent-to-treat approach to test the hypothesis that AYA living with HIV in the ARROW program will have higher uptake of diagnostic services, increased adherence to treatment, and improved outcomes compared to those receiving one-time education. RESULTS: As of March 2025, early detection cohort recruitment concluded with 3442 participants and cancer treatment cohort enrollment is ongoing, with 105 participants thus far. Results pertaining to the 12-month end points will be available in early 2026. CONCLUSIONS: If successful, the ARROW program will offer a model to improve cancer prevention, early diagnosis, and treatment through improved integration between HIV and cancer services. Furthermore, ARROW can provide a framework for implementing expanded services, such as survivorship care, for AYA living with HIV. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/68254.