Clinical Trials

MainTitle

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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified April 2019 by Fred Ssewamala, Washington University School of Medicine

Sponsor
Washington University School of Medicine

Collaborator
Uganda Cancer Institute
Reach the Youth Uganda
National Cancer Institute (NCI)

Information provided by (Responsible Party)
Fred Ssewamala, Washington University School of Medicine

ClinicalTrials.gov Identifier
NCT03916783

First received: April 9, 2019
Last updated: April 18, 2019
Last Verified: April 2019
History of Changes
Purpose

Purpose

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 (ages10-24) seen at approximately 39 clinics in seven districts heavily affected by HIV/AIDS in southern Uganda. Aim 2. Enhance the Suubi EE intervention by including an educational component addressing misconceptions about cancer (Suubi4Cancer) and explore the acceptability and preliminary impact of Suubi4Cancer on short-term outcomes. Aim 3. Explore multi-level factors (individual, family, cultural) impacting participants' participation in and experiences withSuubi4Cancer.

Condition Intervention
HIV/AIDS
Cancer

Behavioral : Combination intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel 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

Further study details as provided by Fred Ssewamala, Washington University School of Medicine:

Primary Outcome Measures

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

Estimated Enrollment: 78
Study Start Date: June 2019
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
No Intervention: Control Condition: Bolstered care
All selected families in 19 clinics (n=~38 families) will be placed in a control condition receiving bolstered standard of care (BSC) comprising of psychosocial counseling bolstered with literature addressing cultural misconceptions (beliefs, values, norms and attitudes) regarding cancer that largely impede service use and overall pediatric cancer education (using materials available at Uganda Cancer Institute-UCI).
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

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 potential pediatric cancer cases in an HIV-infected cohort (~3000 HIV+ youth) in the poor SSA country of Uganda through Medical Record (MR) abstraction. Participant charts will be abstracted from approximately 39 health clinics to retrospectively identify known and suspected cancer cases using a structured chart abstraction form developed in REDCap software. Youth with known cancers will be included in the registry initiated as part of the study for the estimation of prevalence and future pediatric cancer incidence and etiology research in HIV-infected youth and contribute to sparse data on pediatric cancer burden. Youth with suspected malignancies (not yet diagnosed at UCI) in the last six months and their families identified through this process and prospective suspected malignancy cases identified by clinic staff while our study is underway will be eligible for Aim 2.
Aim 2). Enhance and test the acceptability and preliminary impact of a combination EE intervention targeting barriers influencing access to pediatric cancer services, including diagnosis, care and treatment adherence. To do this, the investigators will identify youth and caregivers for the participants who were referred to UCI with a suspicion of cancer within up to past 6 months but did not seek UCI services and randomize at the clinic level (39 clinics). All selected families in 19 clinics (n=~38 families) will be placed in a control condition receiving bolstered standard of care (BSC) comprising of psychosocial counseling bolstered with literature addressing cultural misconceptions (beliefs, values, norms and attitudes) regarding cancer that largely impede service use and overall pediatric cancer education (using materials available at UCI). 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. Youth in the same clinic will be assigned to the same study condition to avoid contamination.
Aim 3) Conduct semi-structured in-depth interviews with caregivers and youth (separately) upon intervention completion for intervention acceptability and relevance. The interview will focus on 1) Experiences with the intervention and its specific components (i.e., savings, financial literacy, and cancer education—including beliefs, values, norms, and attitudes about cancer) and 2) Key multi-level (individual, family, contextual, and programmatic) influences that affected their participation and their decision to treatment adherence. All participants in the treatment arm (n=40) will be invited to participate in the interviews.

Eligibility

Eligibility

Ages Eligible for Study: 10 Years to 24 Years  
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.

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03916783

Contacts

Contact:   Fred M. Ssewamala, PhD 3149358521 fms1@wustl.edu
Contact:   Ozge Sensoy Bahar, PhD 3149359403 ozge.sensoybahar@wustl.edu

Locations

Uganda
International Center for Child Health and Development Not yet recruiting
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

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
More Information

More Information


Responsible Party: Fred Ssewamala, William E. Gordon Distinguished Professor, Washington University School of Medicine  
ClinicalTrials.gov Identifier: NCT03916783   History of Changes  
Other Study ID Numbers: R21CA236531  
  1R21CA236531-01  
Study First Received: April 9, 2019  
Last Updated: April 18, 2019  
Individual Participant Data    
Plan to Share IPD: Yes  

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

ClinicalTrials.gov processed this data on August 16, 2019
This information is provided by ClinicalTrials.gov.