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临床试验/NCT04307433
NCT04307433已完成不适用

mHealth Delivered Narrative Intervention to Increase Cervical Cancer Screening Among Malawian Women Living With HIV

University of Massachusetts, Boston1 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2021年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
179
试验地点
1
主要终点
Number of Participant with Cervical Cancer Screening Uptakes

研究概览

简要总结

To develop a theory-based culturally-grounded storytelling-based intervention to increase cervical cancer screening among Malawian women living with HIV infection. Secondary objectives: To conduct a pilot randomized clinical trial (RCT) to examine the acceptability, feasibility and preliminary effectiveness of narrative intervention on cervical cancer screening prevention behavior.

详细描述

Design

This two year project will employ a holistic community-based approach for recruitment. The project will involve two phases: Phase 1: The investigators will produce culturally-grounded and human-centered storytelling narrative intervention videos to address sociocultural and individual factors which influence cervical cancer prevention behaviors. Phase 2: The investigator will conduct a pilot RCT using the storytelling-based intervention delivered by mHealth (tablets) with 180 women residing in a rural community in Malawi. The intervention groups (Arm 1: storytelling narrative video on tablets [n=60] & Arm 2: a video with a voice over presenting didactic materials on tablets [n=60]) will watch approximately 30 minutes of video intervention and the comparison group (Arm 3 [n=60]) will be read non-narrative educational materials. Study measures of attitudes, knowledge, and cervical cancer screening intention will be assessed by pre-test and immediate post-test interviews, then again at 2 and 6-months following the intervention.

Selection and Enrollment

Inclusion criteria are: 1) being confirmed HIV positive based on medical records, 2) women living with HIV infection (WLHIV) support group members, 3) ages 20-50 years, 4) no prior cervical cancer screening, 5) no history of invasive cervical cancer, and 6) willingness to participate in the study. The age range to 20-50 years for cervical cancer screening because there is limited evidence that this is the optimal upper age for cervical cancer screening of HIV-infected women (World Health Organization [WHO] 2013).

This study will use a sequential-stratified sampling method. Of the eligible support groups and among those expressing interest, the investigators will select 15 support groups from rural areas within the Lilongwe district and then randomly assign the selected groups into intervention and comparison arms. The computer-generated assignments will be stratified by support group size and the distance between intervention and control arms (at least 4 miles). Within each selected support group, 12 women who are eligible will be invited to participate in the study. The investigators have satisfactorily used these methods for recruitment of WLHIV by working with HIV support group leaders in our previous studies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The data collector who assesses the follow-up assessments will be blind to treatment condition

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • are confirmed HIV positive based on medical records
  • are women living with HIV infection support group members
  • are ages 20-50 years
  • are no prior cervical cancer screening
  • are no history of invasive cervical cancer
  • are willingness to participate in the study

排除标准

  • are not able to speak Chichewa or English
  • self-report currently receiving treatment of a serious mental illness (e.g., schizophrenia and bipolar disorder)

结局指标

主要结局

Number of Participant with Cervical Cancer Screening Uptakes

时间窗: six months post-intervention

will be measured through self-report and health passport record review

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Haeok Lee

Professor

University of Massachusetts, Boston

研究点 (1)

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