Suubi4Cancer: An Innovative Combination Intervention to Improve Access to Pediatric Cancer Services and Treatment Adherence Among Children Living With HIV/AIDS in Uganda
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Cancer Treatment Access
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Cancer Treatment Access
时间窗: Every assessment time point (Baseline and at 9-month post-intervention initiation)
Change in mean count of cases accessing cancer services.
Cancer Treatment Adherence
时间窗: 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
时间窗: 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)).
次要结局
- Family and Social Support(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 Satisfaction(At 9-month time point post-intervention initiation)
- Child Vulnerability in the Household index(Every assessment time point (Baseline and at 9-month post-intervention initiation))
- Intervention Feedback(At 9-month time point post-intervention initiation)
- Savings Deposits(Every assessment time point (Baseline and at 9-month post-intervention initiation))