NCT05489978

Brief Summary

It is an interventional study to assess the effectiveness of the cervical cancer stigma reduction intervention on cancer stigma score and cervical cancer screening uptake in Nepal

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 5, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

May 24, 2022

Last Update Submit

April 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean stigma score

    Change in mean stigma score using Cancer Stigma Scale at baseline and follow up

    Measured at baseline and endline (after 2 months gap from baseline)

Secondary Outcomes (1)

  • Cervical cancer screening uptake

    Measured within a month after endline

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Randomization will allocate women to intervention and control arm in 1:1 ratio; with 6 wards in each group. The intervention arm will consist of 153 women who will receive "Cervical Cancer Stigma Reduction Intervention".

Behavioral: "Cervical Cancer Stigma Reduction Intervention"

Control Arm

NO INTERVENTION

The control arm will consist of 153 women who would not be given any intervention.

Interventions

Change in knowledge: Cervical cancer burden in Nepal, signs and symptoms, preventive measures available, lifestyle modifications, HPV vaccination, early diagnosis, screening, and treatment. Change in Stigma 1. Para-social contact * Video of a person facing cervical cancer what symptoms she got, how she dealt with it, and how she overcame it. * Experiences of a cervical cancer survivor so that women personalize the information by relating it to their own life experiences by changing their attitude and behavior. 2. Participatory learning techniques * Personal stories: Voluntary self-reflection of any stigma they perceive on cervical cancer or their community perceives cervical cancer. * Group Discussion: Discuss the drivers of stigma, facilitators of sigma, types of stigma prevalent in your community, and consequences of stigma. 3. Myths vs facts: Negative attitudes, myths, and misconceptions about cervical cancer will be contraindicated by factual information.

Intervention Arm

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study population will be women aged 30-60 years which is the recommended age group by National Guideline for Cervical Cancer Screening and Prevention in Nepal
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 30-60 years (the age range recommended for VIA screening in Nepal
  • Married women
  • Residents of Budanilkantha Municipality

You may not qualify if:

  • Women who have already undergone screening within 5 years.
  • Women with hearing or mental disorders
  • Pregnant women
  • Less than 6 weeks postpartum
  • Mothers who had lived in the community for less than 6 months to perform seasonal work (e.g. in brick kilns) or visitors in the family.
  • Women who are already diagnosed with cervical pre-cancer and cancer and have undergone hysterectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Budanilkantha Municipality

Kathmandu, Province-3, Nepal

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsSocial Stigma

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

May 24, 2022

First Posted

August 5, 2022

Study Start

June 15, 2022

Primary Completion

December 15, 2022

Study Completion

February 15, 2023

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations