Community organization
Lilongwe, Malawi
NCT Number: NCT04307433
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.
Looking for future studies?
Notify Me20 year–50 year
Female
Interventional
Not applicable
Lilongwe, Malawi
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Women who:
Exclusion criteria
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.
Time frame: six months post-intervention
will be measured through self-report and health passport record review
University of Massachusetts, Boston
Other
mHealth Delivered Narrative Intervention to Increase Cervical Cancer Screening Among Malawian Women Living With HIV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05609513
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Kampala, Uganda
View Trial DetailsNCT06739915
Acquired Immunodeficiency Syndrome, Actinomycetales Infections
Soweto, Gauteng, South Africa
View Trial DetailsNCT04446611
Acquired Immunodeficiency Syndrome, Antenatal Care
East London, Eastern Cape, South Africa
View Trial DetailsNCT05121064
Acquired Immunodeficiency Syndrome, Alcohol-Related Disorders
Lusaka, Zambia
View Trial Details