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临床试验/NCT07728370
NCT07728370尚未招募不适用

RISE: Reducing Cancer and HIV Stigma Through Empowerment

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
440
试验地点
1
主要终点
Quality of Life (Cancer)

研究概览

简要总结

This multilevel randomized behavioral study evaluates participant- and provider-level stigma-reduction interventions in Zambia. Participant-level intervention: Women living with cervical cancer and HIV (WLC+H ) are randomized in a 2×2 factorial design of storytelling versus neutral videos and storytelling versus neutral disclosure interventions to assess effects on quality of life, anxiety, and depressive symptoms. Provider-level intervention: Healthcare workers are randomized to storytelling or neutral videos to assess changes in stigma and compassion. The study also evaluates participant -reported stigma and satisfaction with care before and after implementation of the provider intervention.

详细描述

People living with HIV face a substantially elevated risk of developing cancers due to compromised immunity. Among women, HIV significantly increases vulnerability to oncogenic human papillomavirus (HPV) infection, the primary cause of cervical cancer. This dual burden of cervical cancer and HIV disproportionately impacts low- and middle-income countries (LMICs), with Zambia exemplifying this crisis. Outcomes for affected individuals living with cervical cancer and HIV in LMICs are poor, with a one-year survival rate of just 65%. Addressing this intertwined public health challenge in LMICs is critical to advancing global efforts against cancer and HIV. This study uses a multilevel approach to address intersectional stigma at the patient and provider level.

In the participant -level component of the study, WLC+H (N=240) are randomly assigned to one of four conditions in a two (storytelling video vs. neutral video) by two (storytelling disclosure vs. neutral disclosure) factorial design. The primary outcome is quality of life (QOL), and the secondary outcomes are anxiety and depressive symptoms.

In the provider-level component of the study, healthcare workers (n=100) are randomly assigned to watch either storytelling or neutral videos. Outcomes (social and enacted stigma and compassion) among healthcare workers will be assessed pre-and post-intervention. An anonymous participant survey will also be administered to women living with cervical cancer and HIV (WLC+H) to compare outcomes between those treated before (control cohort, N=50) and after (intervention cohort, N=50) the implementation of the provider intervention. The anonymous patient survey will assess perceived stigma and satisfaction with care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants and outcomes assessors

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient-level intervention
  • Women diagnosed with cervical cancer and HIV (stage I-IV)
  • Receiving cancer treatment at the Cancer Disease Hospital in Zambia
  • Aged 18 or above
  • Able to speak in English (the official language in Zambia) or one of four local languages (Bemba, Nyanja, Tonga, Lozi) for cultural inclusivity
  • Provider-level intervention
  • 1. Employment at the Cancer Disease Hospital in Lusaka, Zambia

排除标准

  • Patient-level intervention
  • 1.Inability to provide informed consent and presence of a major mental health disorder (e.g., schizophrenia or bipolar disorder), as determined by participant records or self-report.
  • Provider-level intervention
  • 1. Inability to provide informed consent

结局指标

主要结局

Quality of Life (Cancer)

时间窗: Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up

Quality of life (cancer) will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G). The FACT-G contains 27 items that assess perceived quality of life of patients living with cancer over the past week.

Patient-level: Quality of Life (HIV)

时间窗: Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up

Quality of life (HIV) will be assessed using a shortened version of the Patient-Reported Outcomes Quality of Life-HIV (PROQOL-HIV). The shortened PROQOL-HIV scale has four factors: physical health and symptoms; health concerns and mental distress, social and intimate relationships, and treatment impact.

次要结局

  • Patient-level: Depressive Symptoms(Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up)
  • Patient-level: Anxiety Symptoms(Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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