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NCT Number: NCT06004011

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARROW strategies

Other

ARROW strategies are peer-to-peer support at the patient, provider and health system levels

One-time education

Other

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

Primary outcomes

  1. Proportion who complete screening/physical examination

    Time frame: 12 months after study enrollment

    Number who complete screening/physician exams

  2. Proportion who complete recommended cancer treatment modalities

    Time frame: 12 months after diagnosis

    Number who complete treatment

Secondary outcomes

  1. Proportion who complete recommended follow-up supplemental diagnostic procedures

    Time frame: 3 months from receipt of follow-up referral

    Number who complete follow-up

  2. Proportion who initiate cancer treatment

    Time frame: 3 months from diagnosis

    Number who initiate treatment

  3. Proportion alive at 12 months

    Time frame: 12 months after diagnosis

    Number alive at 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Sujha Subramanian

CONTACT

[email protected]

3022225034

Sponsors and collaborators

Lead sponsor

Implenomics

Other

Collaborators

  • Population Council
  • RTI International

Registry information

Official study title

Integrated Delivery of Cancer Control Interventions for Adolescents and Young Adults Living With HIV in Zambia

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 22, 2023
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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