HIV/AIDSNCT03916783
Suubi4Cancer: Improving Access to Pediatric Cancer Services and Treatment Adherence Among Children Living With HIV/AIDS
A study testing Combination intervention in people with HIV/AIDS and Cancer, run by Washington University School of Medicine at 1 site in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 24 years
- What is being tested?
- Combination intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUganda
- Study dates
- 15 Oct 2020to 20 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Suubi4Cancer: An Innovative Combination Intervention to Improve Access to Pediatric Cancer Services and Treatment Adherence Among Children Living With HIV/AIDS in Uganda
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.
Read the detailed description
While cancer studies among YLWHIV in sub-Saharan Africa (SSA) are rare, available literature demonstrates that HIV+ children have a greater risk for cancer (prior to antiretroviral therapy (ART)- >40-fold higher; post-ART- 4-14-fold higher) than their uninfected peers. Although ART is available to all Ugandan HIV+ children, only 47% were on ART in 2016. Additionally, some of the worst pediatric cancer survival rates worldwide are in SSA, with the majority dying from their disease. These dismal odds are influenced by several barriers to accessing cancer services and staying in treatment, including cultural misconceptions about cancer, and inadequate patient/family level resources. Based on our prior study findings among YLWHIV and informed by Asset theory, the investigators hypothesize that the main barriers to uptake of available cancer diagnostic testing, care and treatment adherence are financial and that through increased household and financial stability, the investigators can improve engagement with the health care system and seeking cancer care when confronted with a possible diagnosis.
Therefore this study is significant because the investigators will:
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.
Approach: We will identify lost to follow-up individuals who in consultation with clinics government guidelines, and our records. We will exclude those with a reported vital status of the dead where it can be determined that they died of a condition other than possible cancer. We will also exclude those identified as having transferred to another clinic (also referred to as transfer outs), although, if well-documented, efforts will be made to track them and find out whether they are visiting the clinics/health care centers where they may have transferred to.
2.2. Determine reasons for loss to follow-up or death.
Approach: From those identified as lost to follow-up in 2.1, we will extract names, sex, birth date, and contact information including addresses, phone numbers, caregiver information, and clinic id. We will engage an expert client at each clinic to assist us with tracing of these individuals or their caregiving families for those documented as deceased where cancer/suspected cancer for child/youth was reported or no cause for death was reported. We will conduct in-depth interviews to determine reasons for not returning to HIV care, if not available from existing records and/or clinic personnel.
For those with phone numbers, we will contact them by telephone to tell them about the study and to determine if they are interested in participating. We will invite them to the clinic to present the study and allow them adequate time to consider whether or not they want to participate. If they participate, we will arrange to meet them to interview them for the study following consent.
For those without phone numbers, we will contact via expert clients available at each clinic, who will assist us with tracing of the individuals and inviting them for an introductory meeting to take place either at the clinic/healthcare center, in ICHAD's private research field offices in Masaka; or at the participants' homes (if they request it and there is sufficient privacy to ensure confidentiality). Flexibility in location when re-engaging and interviewing participants has been critical to our ICHAD studies success to date, including Suubi+Adherence whose infrastructure the current studies builds on.
Traced participants will be asked whether they are interested in participating in the study. We will provide them with a consent form (for caregivers) and assent forms for any child below 18 years of age.
Interviews determining reasons for lost to follow-up will focus on 1) experiences around HIV care at the clinic where they were a patient; 2) multi-level facilitators and barriers to access care; and 3) multi-level facilitators and barriers to staying in treatment.
2.3. For those determined to have died of cancer or with a suspected cancer identified from lost to follow-up interviews and from medical record abstraction for Aim 1, we will conduct the same interview as in 2.2 with additional questions with them or their identified primary caregiver to determine barriers and facilitators to cancer care.
- More specifically, the interviews will focus on1) experiences with their healthcare provider on communication around suspected cancer, and referral process; and 2) experiences with accessing services for further cancer testing, including barriers and facilitators to access
Aim 3. Conduct an open clinical trial to establish the feasibility and acceptability of the Suubi4Cancer intervention.
For cases identified with suspected cancers to date as a part of Aim 1 activities (n=7), those that are eligible will be invited to participate in an open clinical trial testing an economic empowerment intervention (Suubi4Cancer) to determine feasibility and acceptability.
We will conduct qualitative interviews to explore participants' experiences with the intervention, including feasibility and acceptability.
*Due to insufficient sample size, Aim 3 is not implemented.
- Being tested
- Combination intervention
- Keywords
- Suubi, Youth, Poverty, Economic Empowerment Interventions, Epidemiology, Access to Treatment Services, Treatment Adherence, Uganda
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Neoplasms, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination interventionBehavioural
Also called Family Development Account + Education Sessions
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.
| Study group | Role | What they receive |
|---|---|---|
| Combination intervention | Experimental | Selected 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. Receives: Behavioral: Combination intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Treatment Access
Change in mean count of cases accessing cancer services.
Measured: 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.
Measured: 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)).
Measured: At 3-month post-intervention initiation (before and after the cancer education sessions)
Secondary outcomes (6)
Family and Social Support
Change in family and social support. Family and social support will be assessed using the Social Support Behavior Scale (SS-B). The SS-B scale describes five central categories of supportive behaviors including emotional, socializing, practical, financial and advice/guidance which are assessed for both family and friends. The scale adapted for this study consists of 45 questions each with responses ranging from values of 1 (generally indicative of no support) to 5 (indicative of maximum support from both friends and family members). The theoretical range for this scale is 45-225, with higher scores indicating higher levels of social support from multiple sources.
Measured: Every assessment time point (Baseline and at 9-month post-intervention initiation)
Child Vulnerability in the Household index
Change in child vulnerability in the household. Child vulnerability will be assessed using the Uganda Orphans and Vulnerable Children (OVC) Vulnerability Index (VI). This tool is intended for the selection of vulnerable households into OVC programs. The tool helps to determine a household's level of vulnerability (slight, moderate, and critical) based on individual and household level questions. The scale includes a total of 14 questions including descriptive questions for example; "Have you experienced any form of the following abuse in the last 30 days?" as well as nominal and ordinal-type questions, for example, questions whose responses are Yes- (labeled 0) and No-(labeled 4) as well as those ranked from 0 to 4, where a scale of four represents a greater vulnerability. The theoretical range for this scale is from 0 (lowest score - no vulnerability) to 56 ( highest score - high vulnerability). The higher the total score, the greater the child's vulnerability.
Measured: Every assessment time point (Baseline and at 9-month post-intervention initiation)
Savings Deposits
Change in savings deposit.
Measured: Every assessment time point (Baseline and at 9-month post-intervention initiation)
Financial Literacy
Increase in Financial Literacy knowledge. Participant knowledge of financial literacy will be assessed pre- and post- financial literacy sessions. The participants will be requested to respond to a series of 6 comprehensive questions to evaluate their attitudes towards saving. These questions include both descriptive and scale-type questions where participants will provide responses on a scale of 1 (Not important at all) to 5 (Extremely important) to statements about savings.
Measured: Every assessment time point (Baseline and at 9-month post-intervention initiation)
Intervention Feedback
Semi-structured in-depth interviews will be utilized to obtain participants' feedback which will be utilized to inform future research with this population.
Measured: At 9-month time point post-intervention initiation
Intervention Satisfaction
Client satisfaction surveys. The client satisfaction surveys will be utilized to assess participants' experiences with the intervention. The surveys will include a total of 8 questions, each with responses on a scale of 1 (No, definitely not) to 4 (Yes, definitely).
Measured: At 9-month time point post-intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start15 Oct 2020 (estimated)
- Primary completion20 Sep 2021 (estimated)
- Study completion20 Sep 2021 (estimated)
Why it stopped: We implemented Aims 1 and 2, but did not have a sufficient sample size to carry out the clinical trial portion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Due to insufficient sample size, the intervention (Aim 3) was not implemented. The enrolment number specified is for Aim 2.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Uganda Cancer Institute, National Cancer Institute (NCI), Reach the Youth Uganda
- Responsible party
- Sponsor
- Investigators
- Fred M. Ssewamala, PhD, Principal investigator, Washington University School of MedicineKimberly N Johnson, PhD, Principal investigator, Washington University School of MedicineOzge Sensoy Bahar, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916783
- Sponsor's protocol ID
- R21CA236531
- Other IDs
- 1R21CA236531-01
- Status last verified
- Feb 2025
- First submitted
- 9 Apr 2019
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 31650077
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suubi4Cancer: An Innovative Combination Intervention to Improve Access to Pediatric Cancer Services and Treatment Adherence Among Children Living With HIV/AIDS in Uganda
- ClinicalTrials.gov ID
- NCT03916783
- Acronym / sponsor ID
- R21CA236531
- Keywords
- Suubi, Youth, Poverty, Economic Empowerment Interventions, Epidemiology, Access to Treatment Services, Treatment Adherence, Uganda
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We implemented Aims 1 and 2, but did not have a sufficient sample size to carry out the clinical trial portion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Uganda Cancer Institute, National Cancer Institute (NCI), Reach the Youth Uganda
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 20 Sep 2021 (estimated)
- Study completion
- 20 Sep 2021 (estimated)
- First posted
- 16 Apr 2019 (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.
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.
Detailed description
While cancer studies among YLWHIV in sub-Saharan Africa (SSA) are rare, available literature demonstrates that HIV+ children have a greater risk for cancer (prior to antiretroviral therapy (ART)- >40-fold higher; post-ART- 4-14-fold higher) than their uninfected peers. Although ART is available to all Ugandan HIV+ children, only 47% were on ART in 2016. Additionally, some of the worst pediatric cancer survival rates worldwide are in SSA, with the majority dying from their disease. These dismal odds are influenced by several barriers to accessing cancer services and staying in treatment, including cultural misconceptions about cancer, and inadequate patient/family level resources. Based on our prior study findings among YLWHIV and informed by Asset theory, the investigators hypothesize that the main barriers to uptake of available cancer diagnostic testing, care and treatment adherence are financial and that through increased household and financial stability, the investigators can improve engagement with the health care system and seeking cancer care when confronted with a possible diagnosis.
Therefore this study is significant because the investigators will:
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.
Approach: We will identify lost to follow-up individuals who in consultation with clinics government guidelines, and our records. We will exclude those with a reported vital status of the dead where it can be determined that they died of a condition other than possible cancer. We will also exclude those identified as having transferred to another clinic (also referred to as transfer outs), although, if well-documented, efforts will be made to track them and find out whether they are visiting the clinics/health care centers where they may have transferred to.
2.2. Determine reasons for loss to follow-up or death.
Approach: From those identified as lost to follow-up in 2.1, we will extract names, sex, birth date, and contact information including addresses, phone numbers, caregiver information, and clinic id. We will engage an expert client at each clinic to assist us with tracing of these individuals or their caregiving families for those documented as deceased where cancer/suspected cancer for child/youth was reported or no cause for death was reported. We will conduct in-depth interviews to determine reasons for not returning to HIV care, if not available from existing records and/or clinic personnel.
For those with phone numbers, we will contact them by telephone to tell them about the study and to determine if they are interested in participating. We will invite them to the clinic to present the study and allow them adequate time to consider whether or not they want to participate. If they participate, we will arrange to meet them to interview them for the study following consent.
For those without phone numbers, we will contact via expert clients available at each clinic, who will assist us with tracing of the individuals and inviting them for an introductory meeting to take place either at the clinic/healthcare center, in ICHAD's private research field offices in Masaka; or at the participants' homes (if they request it and there is sufficient privacy to ensure confidentiality). Flexibility in location when re-engaging and interviewing participants has been critical to our ICHAD studies success to date, including Suubi+Adherence whose infrastructure the current studies builds on.
Traced participants will be asked whether they are interested in participating in the study. We will provide them with a consent form (for caregivers) and assent forms for any child below 18 years of age.
Interviews determining reasons for lost to follow-up will focus on 1) experiences around HIV care at the clinic where they were a patient; 2) multi-level facilitators and barriers to access care; and 3) multi-level facilitators and barriers to staying in treatment.
2.3. For those determined to have died of cancer or with a suspected cancer identified from lost to follow-up interviews and from medical record abstraction for Aim 1, we will conduct the same interview as in 2.2 with additional questions with them or their identified primary caregiver to determine barriers and facilitators to cancer care.
- More specifically, the interviews will focus on1) experiences with their healthcare provider on communication around suspected cancer, and referral process; and 2) experiences with accessing services for further cancer testing, including barriers and facilitators to access
Aim 3. Conduct an open clinical trial to establish the feasibility and acceptability of the Suubi4Cancer intervention.
For cases identified with suspected cancers to date as a part of Aim 1 activities (n=7), those that are eligible will be invited to participate in an open clinical trial testing an economic empowerment intervention (Suubi4Cancer) to determine feasibility and acceptability.
We will conduct qualitative interviews to explore participants' experiences with the intervention, including feasibility and acceptability.
*Due to insufficient sample size, Aim 3 is not implemented.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Due to insufficient sample size, the intervention (Aim 3) was not implemented. The enrolment number specified is for Aim 2.
| Arm | Type | Receives |
|---|---|---|
| Combination intervention | Experimental | Behavioral: Combination interventionSelected 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. |
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Combination interventionAlso: Family Development Account + Education SessionsThe 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. | Behavioural | Combination intervention |
Primary outcome
Cancer Treatment Access
Time frame: Every assessment time point (Baseline and at 9-month post-intervention initiation)
Change in mean count of cases accessing cancer services.
Cancer Treatment Adherence
Time frame: Every assessment time point (Baseline and at 9-month post-intervention initiation)
Change in mean count of youth reporting adherence to prescribed cancer treatment.
Knowledge, Attitudes and Beliefs about Cancer and Cancer Treatment Services Composite measure
Time frame: At 3-month post-intervention initiation (before and after the cancer education sessions)
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)).
6 secondary outcomes
Family and Social Support
Time frame: Every assessment time point (Baseline and at 9-month post-intervention initiation)
Child Vulnerability in the Household index
Time frame: Every assessment time point (Baseline and at 9-month post-intervention initiation)
Savings Deposits
Time frame: Every assessment time point (Baseline and at 9-month post-intervention initiation)
Financial Literacy
Time frame: Every assessment time point (Baseline and at 9-month post-intervention initiation)
Intervention Feedback
Time frame: At 9-month time point post-intervention initiation
Intervention Satisfaction
Time frame: At 9-month time point post-intervention initiation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Derived from this study: PubMed 31650077Ssewamala 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.
- Individual participant dataSharing planned: Yes. 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.
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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. This study is not recruiting at the moment.
Fred M. Ssewamala, PhD principal investigator
Washington University School of Medicine
Kimberly N Johnson, PhD principal investigator
Washington University School of Medicine
Ozge Sensoy Bahar, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination intervention in people with HIV/AIDS and Cancer, run by Washington University School of Medicine at 1 site in Uganda.
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 9 inclusion and 3 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: withdrawn, as of the sponsor's last update on 27 Feb 2025. 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 Uganda. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer Treatment Access (time frame: Every assessment time point (Baseline and at 9-month post-intervention initiation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03916783, which also lists 1 linked publication.
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 27 Feb 2025.