An interventional study of ARROW strategies and One-time education in Cervical Cancer, Kaposi Sarcoma and Non Hodgkin Lymphoma, sponsored by Implenomics. Recruiting at 1 site in Zambia. Open to participants aged 15 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Implenomics · Not applicable, Interventional, and Screening
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.
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 4,100 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Implenomics is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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.
Other: ARROW strategies
The comparator arm participants will receive one-time education and usual care services.
Other: One-time education
ARROW strategies are peer-to-peer support at the patient, provider and health system levels
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
Proportion who complete screening/physical examination
Number who complete screening/physician exams
Time frame: 12 months after study enrollment
Proportion who complete recommended cancer treatment modalities
Number who complete treatment
Time frame: 12 months after diagnosis
Proportion who complete recommended follow-up supplemental diagnostic procedures
Number who complete follow-up
Time frame: 3 months from receipt of follow-up referral
Proportion who initiate cancer treatment
Number who initiate treatment
Time frame: 3 months from diagnosis
Proportion alive at 12 months
Number alive at 12 months
Time frame: 12 months after diagnosis
Started May 2024 (actual). Primary completion is estimated for Dec 2026, 31 months after the start.
Of 445 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 71. This study's planned 31 months is close to that.
Counting every sponsor, half of 461 studies reached it within 33 months; a quarter within 15 and three quarters within 71.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: primary completion Aug 2026 → Dec 2026 and completion Jul 2027 → Aug 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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