Storytelling Intervention to Promote Cervical Cancer Screening Uptakes Among Malawian Women Living With Human Immunodeficiency Virus
Primary Purpose
HIV/AIDS
Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Storytelling narrative videos on tablets
Sponsored by
About this trial
This is an interventional prevention trial for HIV/AIDS
Eligibility Criteria
Inclusion Criteria:
Women who:
- 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
Exclusion Criteria:
- are not able to speak Chichewa or English
- self-report currently receiving treatment of a serious mental illness (e.g., schizophrenia and bipolar disorder)
Sites / Locations
- Community organization
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
ST Narrative + mHealth: Storytelling narrative video on tablets
mHealth: a video with a voice over presenting didactic materials on tablets
Control: non-narrative educational materials will be read
Outcomes
Primary Outcome Measures
Number of Participant with Cervical Cancer Screening Uptakes
will be measured through self-report and health passport record review
Secondary Outcome Measures
Full Information
NCT ID
NCT04307433
First Posted
March 10, 2020
Last Updated
September 29, 2022
Sponsor
University of Massachusetts, Boston
1. Study Identification
Unique Protocol Identification Number
NCT04307433
Brief Title
Storytelling Intervention to Promote Cervical Cancer Screening Uptakes Among Malawian Women Living With Human Immunodeficiency Virus
Official Title
mHealth Delivered Narrative Intervention to Increase Cervical Cancer Screening Among Malawian Women Living With HIV
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Boston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The proposed study has two phases:
Phase 1. Development of Narrative Video: The investigators will first develop culturally-grounded and human-centered storytelling narrative intervention videos in Chichewa, the local language to address sociocultural and individual factors which influence cervical cancer prevention behaviors. The video will be filmed in person in community organizations in Malawi.
Phase 2: A Pilot Randomized Controlled Trial (RCT) of a Story Telling Narrative Intervention: The investigators will conduct a three-arm 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
Masking
Outcomes Assessor
Masking Description
The data collector who assesses the follow-up assessments will be blind to treatment condition
Allocation
Randomized
Enrollment
179 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
ST Narrative + mHealth: Storytelling narrative video on tablets
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
mHealth: a video with a voice over presenting didactic materials on tablets
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Description
Control: non-narrative educational materials will be read
Intervention Type
Behavioral
Intervention Name(s)
Storytelling narrative videos on tablets
Intervention Description
The storytelling narrative episodes in the application will feature video clips of the multiple stories of women living with HIV infection, HIV support group leaders, community leaders, and health care professionals and a Learn More video of physician discussing cervical cancer.
Primary Outcome Measure Information:
Title
Number of Participant with Cervical Cancer Screening Uptakes
Description
will be measured through self-report and health passport record review
Time Frame
six months post-intervention
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
females are biologically eligible because the research involves cervical cancer prevention. Inclusion of males in the study would be inappropriate due to lack of cervical cancer incidence.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women who:
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
Exclusion Criteria:
are not able to speak Chichewa or English
self-report currently receiving treatment of a serious mental illness (e.g., schizophrenia and bipolar disorder)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haeok Lee, PhD
Organizational Affiliation
University of Massachusetts, Boston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community organization
City
Lilongwe
Country
Malawi
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Storytelling Intervention to Promote Cervical Cancer Screening Uptakes Among Malawian Women Living With Human Immunodeficiency Virus
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