WithdrawnNot Applicable

Suubi4Cancer: Improving Access to Pediatric Cancer Services and Treatment Adherence Among Children Living With HIV/AIDS

Stopped: We implemented Aims 1 and 2, but did not have a sufficient sample size to carry out the clinical trial portion

Uganda0Started 2020-10-15

Plain-language summary

This study will tailor and explore the short-term preliminary outcomes of an existing evidence-based Economic Empowerment (EE) Intervention, Suubi (Hope in Luganda -local Ugandan language), on access to pediatric cancer diagnosis, care, and treatment adherence among youth living with HIV (YLWHIV) with suspected cancers. The study will specifically address the following aims/research questions: Aim 1. Identify confirmed and suspected cancer cases in a cohort of \>3000 HIV+ youth (ages 10-24) seen at 39 clinics in 5 districts heavily affected by HIV/AIDS in southern Uganda. Aim 2. Identify those lost to follow-up from the cohort in Aim 1 and determine reasons for loss to follow-up through qualitative interviews. 2.1. Identify those who have not returned to the clinic in ≥ 60 days (\~2 months) from their expected return visit date. 2.2. Determine reasons for loss to follow-up or death. Aim 3. Conduct an open clinical trial to establish the feasibility and acceptability of the Suubi4Cancer intervention. \*Due to insufficient sample size, Aim 3 is not implemented.

Who can participate

Age range

10 Years – 24 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Youth inclusion criteria are: * HIV+ (confirmation by medical report) * Must be living within a family (defined broadly, not necessarily with biological parents); * Must be between 10-24 years old * Attending one of the 39 clinics * Did not access services or expressed unwillingness and/or inability to do so. * For Aim 1, inclusion criteria only includes 1) and 3). Caregiver inclusion criteria: * Have a YLWHIV (with suspected cancer) under their care who attends one of the 39 study-affiliated clinics. Exclusion Criteria: Potential participants will be excluded from the study if the research team determines that the participant: * Cannot comprehend the study and participant rights * Is unwilling to participate.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cancer Treatment Access

Timeframe: Every assessment time point (Baseline and at 9-month post-intervention initiation)

Cancer Treatment Adherence

Timeframe: Every assessment time point (Baseline and at 9-month post-intervention initiation)

Knowledge, Attitudes and Beliefs about Cancer and Cancer Treatment Services Composite measure

Timeframe: At 3-month post-intervention initiation (before and after the cancer education sessions)

Trial details

NCT IDNCT03916783

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-20

View on ClinicalTrials.gov More HIV/AIDS trials

Plain-language summary

Who can participate

Age range

10 Years – 24 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Cancer Treatment Access

Timeframe: Every assessment time point (Baseline and at 9-month post-intervention initiation)

Cancer Treatment Adherence

Timeframe: Every assessment time point (Baseline and at 9-month post-intervention initiation)

Knowledge, Attitudes and Beliefs about Cancer and Cancer Treatment Services Composite measure

Timeframe: At 3-month post-intervention initiation (before and after the cancer education sessions)