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

NCT04307433 | Completed

• 1 other identifier: 2019250
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• Number of Participant with Cervical Cancer Screening Uptakes

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

  six months post-intervention

Study Arms (3)

Arm 1

EXPERIMENTAL

ST Narrative + mHealth: Storytelling narrative video on tablets

Behavioral: Storytelling narrative videos on tablets

Arm 2

ACTIVE COMPARATOR

mHealth: a video with a voice over presenting didactic materials on tablets

Behavioral: Storytelling narrative videos on tablets

Arm 3

PLACEBO COMPARATOR

Control: non-narrative educational materials will be read

Behavioral: Storytelling narrative videos on tablets

Interventions

Storytelling narrative videos on tablets BEHAVIORAL

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.

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Massachusetts, Boston: lead

Study Sites (1)

Community organization

Lilongwe, Malawi

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Haeok Lee, PhD

  University of Massachusetts, Boston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data collector who assesses the follow-up assessments will be blind to treatment condition
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 13, 2020
• Study Start: October 21, 2021
• Primary Completion: June 30, 2022
• Study Completion: August 31, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)