Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916783
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : August 5, 2020
Sponsor:
Collaborators:
Uganda Cancer Institute
Reach the Youth Uganda
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Ssewamala, Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Cancer Behavioral: Combination intervention Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : September 15, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Combination intervention
Selected families in the other 20 clinics (n=~40 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.
Behavioral: Combination intervention

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.

Other Name: Family Development Account + Education Sessions




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)).


Secondary Outcome Measures :
  1. Family and Social Support [ Time Frame: Every assessment time point (Baseline and at 9-month post-intervention initiation) ]
    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.

  2. Child Vulnerability in the Household index [ Time Frame: Every assessment time point (Baseline and at 9-month post-intervention initiation) ]
    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.

  3. Savings Deposits [ Time Frame: Every assessment time point (Baseline and at 9-month post-intervention initiation) ]
    Change in savings deposit.

  4. Financial Literacy [ Time Frame: Every assessment time point (Baseline and at 9-month post-intervention initiation) ]
    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.

  5. Intervention Feedback [ Time Frame: At 9-month time point post-intervention initiation ]
    Semi-structured in-depth interviews will be utilized to obtain participants' feedback which will be utilized to inform future research with this population.

  6. Intervention Satisfaction [ Time Frame: At 9-month time point post-intervention initiation ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916783


Contacts
Layout table for location contacts
Contact: Fred M. Ssewamala, PhD 3149358521 fms1@wustl.edu
Contact: Ozge Sensoy Bahar, PhD 3149359403 ozge.sensoybahar@wustl.edu

Locations
Layout table for location information
Uganda
International Center for Child Health and Development
Masaka, Uganda
Contact: Flavia Namuwonge       flavia.namuwonge9@gmail.com   
Contact: Jennifer Nattabi, MSW       jnattabi13@gmail.com   
Sponsors and Collaborators
Washington University School of Medicine
Uganda Cancer Institute
Reach the Youth Uganda
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Fred Ssewamala, William E. Gordon Distinguished Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03916783    
Other Study ID Numbers: R21CA236531 ( U.S. NIH Grant/Contract )
1R21CA236531-01 ( U.S. NIH Grant/Contract )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Time Frame: Will be determined on a case by case basis
Access Criteria: Will be determined on a case by case basis

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fred Ssewamala, Washington University School of Medicine:
Suubi
Youth
Poverty
Economic Empowerment Interventions
Epidemiology
Access to Treatment Services
Treatment Adherence
Uganda
Additional relevant MeSH terms:
Layout table for MeSH terms
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases