Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06004011 |
| Other study ID # |
Imp001 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2024 |
| Est. completion date |
July 2027 |
Study information
| Verified date |
March 2024 |
| Source |
Implenomics |
| Contact |
Sujha Subramanian |
| Phone |
3022225034 |
| Email |
sujha.subramanian[@]implenomics.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
