Cervical CancerNCT06004011
AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)
A study testing ARROW strategies and One-time education in people with Cervical Cancer and Kaposi Sarcoma, run by Implenomics at 1 site in Zambia.
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. Read more about this study
- Who is it for?
- Ages 15 to 39 years
- Conditions the study is for
- Cervical Cancer, Kaposi Sarcoma, Non Hodgkin Lymphoma
- What is being tested?
- ARROW strategies and One-time education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,100 participants
- Where
- 1 siteZambia
- Study dates
- 1 May 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- pregnant at study enrolment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zambia1 site, 1 recruiting
- Recruiting
Public Health Facilities
Lusaka
Ronald Mungoni
About this study
Official title: Integrated Delivery of Cancer Control Interventions for Adolescents and Young Adults Living With HIV in Zambia
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.
Read the 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.
- Conditions
- Cervical Cancer, Kaposi Sarcoma, Non Hodgkin Lymphoma
- Being tested
- ARROW strategies, One-time education
- Keywords
- cancer screening, Implementation trial
- Medical subject headings
- Uterine Cervical Neoplasms, Sarcoma, Kaposi, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARROW strategiesOther
ARROW strategies are peer-to-peer support at the patient, provider and health system levels
One-time educationOther
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
| Study group | Role | What they receive |
|---|---|---|
| ARROW strategies | Experimental | 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. Receives: Other: ARROW strategies |
| One-time education | Active comparator | The comparator arm participants will receive one-time education and usual care services. Receives: Other: One-time education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion who complete screening/physical examination
Number who complete screening/physician exams
Measured: 12 months after study enrollment
Proportion who complete recommended cancer treatment modalities
Number who complete treatment
Measured: 12 months after diagnosis
Secondary outcomes (3)
Proportion who complete recommended follow-up supplemental diagnostic procedures
Number who complete follow-up
Measured: 3 months from receipt of follow-up referral
Proportion who initiate cancer treatment
Number who initiate treatment
Measured: 3 months from diagnosis
Proportion alive at 12 months
Number alive at 12 months
Measured: 12 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 May 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implenomics
- Sponsor type
- University, hospital or other
- Collaborators
- Population Council, RTI International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004011
- Sponsor's protocol ID
- Imp001
- Status last verified
- Jan 2026
- First submitted
- 15 Aug 2023
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Delivery of Cancer Control Interventions for Adolescents and Young Adults Living With HIV in Zambia
- ClinicalTrials.gov ID
- NCT06004011
- Acronym / sponsor ID
- Imp001
- Conditions
- Cervical Cancer, Kaposi Sarcoma, Non Hodgkin Lymphoma
- Keywords
- cancer screening, Implementation trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,100 participants (estimated)
- Lead sponsor
- ImplenomicsUniversity, hospital or other
- Collaborators
- Population Council, RTI International
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARROW strategies | Experimental | Other: ARROW strategiesThe 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. |
| One-time education | Active comparator | Other: One-time educationThe comparator arm participants will receive one-time education and usual care services. |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- pregnant at study enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARROW strategiesARROW strategies are peer-to-peer support at the patient, provider and health system levels | Other | ARROW strategies |
| One-time educationThe 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 | Other | One-time education |
Primary outcome
Proportion who complete screening/physical examination
Time frame: 12 months after study enrollment
Number who complete screening/physician exams
Proportion who complete recommended cancer treatment modalities
Time frame: 12 months after diagnosis
Number who complete treatment
3 secondary outcomes
Proportion who complete recommended follow-up supplemental diagnostic procedures
Time frame: 3 months from receipt of follow-up referral
Proportion who initiate cancer treatment
Time frame: 3 months from diagnosis
Proportion alive at 12 months
Time frame: 12 months after diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARROW strategies and One-time education in people with Cervical Cancer and Kaposi Sarcoma, run by Implenomics at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sujha Subramanian (3022225034, sujha.subramanian@implenomics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion who complete screening/physical examination (time frame: 12 months after study enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.