Clinical Trials

MainTitle

Storytelling Intervention to Promote Cervical Cancer Screening Uptakes Among Malawian Women Living With Human Immunodeficiency Virus

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified March 2020 by Haeok Lee, University of Massachusetts, Boston

Sponsor
University of Massachusetts, Boston


Information provided by (Responsible Party)
Haeok Lee, University of Massachusetts, Boston

ClinicalTrials.gov Identifier
NCT04307433

First received: March 10, 2020
Last updated: March 12, 2020
Last Verified: March 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV/AIDS

Behavioral : Storytelling narrative videos on tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 120 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: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: mHealth Delivered Narrative Intervention to Increase Cervical Cancer Screening Among Malawian Women Living With HIV

Further study details as provided by Haeok Lee, University of Massachusetts, Boston:

Primary Outcome Measures

  • Number of Participant with Cervical Cancer Screening Uptakes [ Time Frame: six months post-intervention ]
    will be measured through self-report and health passport record review

Estimated Enrollment: 120
Study Start Date: May 2020
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Arm 1
ST Narrative + mHealth: Storytelling narrative video on tablets
Behavioral: Storytelling narrative videos on tablets

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.

Active Comparator: Arm 2
mHealth: a video with a voice over presenting didactic materials on tablets
Behavioral: Storytelling narrative videos on tablets

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.

Placebo Comparator: Arm 3
Control: non-narrative educational materials will be read
Behavioral: Storytelling narrative videos on tablets

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.

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 120 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.

Eligibility

Eligibility

Ages Eligible for Study: 20 Years to 50 Years  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:
Women who:

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


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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04307433

Contacts

Contact:   haeok lee, PhD 7202204018 ext 7202204018 haeok.lee@umb.edu
Contact:   Deogwoon kim, PhDc 7202204018 ext 7202204018 deogwoon.kim001@umb.edu

Sponsors and Collaborators

University of Massachusetts, Boston

Investigators

Principal Investigator: Haeok Lee, PhD University of Massachusetts, Boston
More Information

More Information


Responsible Party: Haeok Lee, Professor, University of Massachusetts, Boston  
ClinicalTrials.gov Identifier: NCT04307433   History of Changes  
Other Study ID Numbers: 2019250  
Study First Received: March 10, 2020  
Last Updated: March 12, 2020  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Uterine Cervical Neoplasms

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.