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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04307433
• Other study ID #: 2019250
• Status: Completed
• Phase: N/A
• Start date: October 21, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2022
• Source: University of Massachusetts, Boston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: August 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• HIV/AIDS
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Malawi	Community organization	Lilongwe

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Boston

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participant with Cervical Cancer Screening Uptakes	will be measured through self-report and health passport record review	six months post-intervention