Study Stopped
We implemented Aims 1 and 2, but did not have a sufficient sample size to carry out the clinical trial portion
Suubi4Cancer: Improving Access to Pediatric Cancer Services and Treatment Adherence Among Children Living With HIV/AIDS
Suubi4Cancer: An Innovative Combination Intervention to Improve Access to Pediatric Cancer Services and Treatment Adherence Among Children Living With HIV/AIDS in Uganda
2 other identifiers
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedStudy Start
First participant enrolled
October 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2021
CompletedFebruary 27, 2025
February 1, 2025
11 months
April 9, 2019
February 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Cancer Treatment Access
Change in mean count of cases accessing cancer services.
Every assessment time point (Baseline and at 9-month post-intervention initiation)
Cancer Treatment Adherence
Change in mean count of youth reporting adherence to prescribed cancer treatment.
Every assessment time point (Baseline and at 9-month post-intervention initiation)
Knowledge, Attitudes and Beliefs about Cancer and Cancer Treatment Services Composite measure
Change in knowledge, attitudes, and beliefs about cancer and cancer treatment services will be assessed by comparing pre- and post-study assessment questionnaire scores for participants in the intervention group. The assessment questionnaire is a composite measure developed for this study and adapted from several knowledge, attitudes and beliefs about cancer questionnaires including Attitudes and Beliefs about Cancer (ABC), Cancer Awareness Measure (CAM), Cancer Stigma Scale (CASS), and the Family CARE Project Baseline Questionnaire. The measure has a total of 13 questions ( including Yes- and No-types, questions on a scale of 1 (strongly agree) to 5 (strongly disagree) and descriptive questions such as health care provider preferences coded from 1 (medical doctor) to 4 (other)).
At 3-month post-intervention initiation (before and after the cancer education sessions)
Secondary Outcomes (6)
Family and Social Support
Every assessment time point (Baseline and at 9-month post-intervention initiation)
Child Vulnerability in the Household index
Every assessment time point (Baseline and at 9-month post-intervention initiation)
Savings Deposits
Every assessment time point (Baseline and at 9-month post-intervention initiation)
Financial Literacy
Every assessment time point (Baseline and at 9-month post-intervention initiation)
Intervention Feedback
At 9-month time point post-intervention initiation
- +1 more secondary outcomes
Study Arms (1)
Combination intervention
EXPERIMENTALSelected families will be assigned to the treatment condition (delivered over 9 months) to receive BSC plus a family EE intervention comprising of a matched family development account (FDA) for health-related expenses, including transport to UCI, food/nutrition, and health insurance. Combined with the Family EE will be four sessions of Financial Literacy and Management (FL\&M) and two sessions of cancer education. The sessions will be conducted over a 4-week period. The two cancer-specific education sessions will use UCI materials to address: 1) definitions of cancer, potential causes, signs and symptoms, and importance of cancer testing; 2) debunking cultural explanations for the causes of cancer and misconceptions (beliefs, values, norms and prevailing attitudes)regarding cancer that largely impede service use. \*Due to insufficient sample size, the open clinical trial is not being conducted.
Interventions
The FDA will be a matched savings account held in the child's name with the parent or caregiver as the co-signer, in a financial institution registered by the Central Bank (Bank of Uganda). The account opened will be matched with money from the program up to a match cap of 72,000 Uganda shillings (an equivalent of $20) a month per family for the 9-month intervention period. The FDAs will be complemented with four sessions of Financial Literacy and Management (FL\&M) and two sessions of cancer education conducted over a 4-week period. The two cancer-specific education sessions will use UCI materials to address: 1) definitions of cancer, potential causes, signs and symptoms, and importance of cancer testing; 2) debunking cultural explanations for the causes of cancer and misconceptions (beliefs, values, norms and prevailing attitudes)regarding cancer that largely impede service use.
Eligibility Criteria
You may qualify if:
- 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.
- Have a YLWHIV (with suspected cancer) under their care who attends one of the 39 study-affiliated clinics.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- Uganda Cancer Institutecollaborator
- National Cancer Institute (NCI)collaborator
- Reach the Youth Ugandacollaborator
Study Sites (1)
International Center for Child Health and Development
Masaka, Uganda
Related Publications (1)
Ssewamala FM, Sensoy Bahar O, Johnson KJ, Katumba RGN. Suubi4Cancer: A protocol for an innovative combination intervention to improve access to pediatric cancer services and treatment adherence among children living with HIV/AIDS in Uganda. Contemp Clin Trials Commun. 2019 Oct 1;16:100459. doi: 10.1016/j.conctc.2019.100459. eCollection 2019 Dec.
PMID: 31650077DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fred M. Ssewamala, PhD
Washington University School of Medicine
- PRINCIPAL INVESTIGATOR
Kimberly N Johnson, PhD
Washington University School of Medicine
- PRINCIPAL INVESTIGATOR
Ozge Sensoy Bahar, PhD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2019
First Posted
April 16, 2019
Study Start
October 15, 2020
Primary Completion
September 20, 2021
Study Completion
September 20, 2021
Last Updated
February 27, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Will be determined on a case by case basis
- Access Criteria
- Will be determined on a case by case basis
Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PI and indicates the data will be used for the purposes of research (per CFR Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."). In sharing participant data, the team will follow Brown School at Washington University's Office of Sponsored Projects' data sharing agreements.