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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: Storytelling narrative videos on tablets

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.

• Study Type: Interventional
• Enrollment (Actual): 179
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Lilongwe, Malawi
    • Community organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participant with Cervical Cancer Screening Uptakes	will be measured through self-report and health passport record review	six months post-intervention

Collaborators and Investigators

• Sponsor: University of Massachusetts, Boston
• Investigators: Principal Investigator: Haeok Lee, PhD, University of Massachusetts, Boston

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: 2019250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No