Storytelling Intervention to Promote Cervical Cancer Screening Uptakes Among Malawian Women Living With Human Immunodeficiency Virus
Condition: HIV/AIDS
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Storytelling narrative videos on tablets
Intervention type(s): Behavioral
Intervention description(s): 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.
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 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: Single (Outcomes Assessor)
Primary purpose: Prevention