Clinical trial NCT03916783: Suubi4Cancer: Improving Access to Pediatric Cancer Services and Treatment Adherence Among Children Living With HIV/AIDS
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: HIV/AIDS
Cancer
Keywords: Suubi
Youth
Poverty
Economic Empowerment Interventions
Epidemiology
Access to Treatment Services
Treatment Adherence
Uganda
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Uganda Cancer Institute
name: National Cancer Institute (NCI)
name: Reach the Youth Uganda
First posted: 2019-04-16
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Due to insufficient sample size, the intervention (Aim 3) was not implemented. The enrolment number specified is for Aim 2.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Cancer Treatment Access
timeFrame: Every assessment time point (Baseline and at 9-month post-intervention initiation)
measure: Cancer Treatment Adherence
timeFrame: Every assessment time point (Baseline and at 9-month post-intervention initiation)
measure: 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)
Secondary outcomes:
measure: Family and Social Support
timeFrame: Every assessment time point (Baseline and at 9-month post-intervention initiation)
measure: Child Vulnerability in the Household index
timeFrame: Every assessment time point (Baseline and at 9-month post-intervention initiation)
measure: Savings Deposits
timeFrame: Every assessment time point (Baseline and at 9-month post-intervention initiation)
measure: Financial Literacy
timeFrame: Every assessment time point (Baseline and at 9-month post-intervention initiation)
measure: Intervention Feedback
timeFrame: At 9-month time point post-intervention initiation
measure: Intervention Satisfaction
timeFrame: At 9-month time point post-intervention initiation
Other outcomes:
Locations:
city: Masaka
country: Uganda
facility: International Center for Child Health and Development
Study officials:
affiliation: Washington University School of Medicine
name: Fred M. Ssewamala, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Kimberly N Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Ozge Sensoy Bahar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.