Effectiveness of a Stigma Reduction Education Program on Stigma Score and Cervical Cancer Screening Uptake in Nepal

Sponsor

Kathmandu University School of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05489978

Collaborator

(none)

306

Enrollment

Location

Arms

8.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It is a cluster randomised control trial to assess the effectiveness of the stigma reduction education program cancer on cancer stigma score and cervical cancer screening uptake in Nepal

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Stigma Screening	Behavioral: "Stigma Reduction Education Program"	N/A

Detailed Description

Despite the presence of ample evidence, that stigma is one of the major reasons for low screening coverage, Nepal does not have a single stigma reduction intervention targeted among women to increase cervical cancer screening coverage. Therefore, we aim to assess the effectiveness of a stigma reduction education program on stigma score and cervical cancer screening uptake in Nepal. We will conduct a two-arm open-label cluster-interventional study in Budanilkhantha Municipality. A computer-based program will randomly allocate the 12 wards of Budanilkhantha Municipality with an allocation ratio 1:1; 6 wards in intervention group and 6 wards in control group. We will conduct a "stigma reduction education program" in the intervention group. After that we will follow up the participants for2 months to see the effectiveness of a stigma reduction education program on stigma score and cervical cancer screening uptake in Nepal. We will analyze data using STATA 14. We will use independent tests to find the mean difference between cervical cancer screening uptake and cervical cancer stigma score. The difference in mean among the two groups will actually be the difference due to intervention given. Findings from this study will help managers and stakeholders to formulate and improve strategies on screening programs and develop programs to reduce stigma on cervical cancer among women in Nepal.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

306 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Effectiveness of a Stigma Reduction Education Program on Stigma Score and Cervical Cancer Screening Uptake in Nepal- A Cluster Randomised Controlled Trial

Actual Study Start Date :

Jun 15, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Arm Randomization will allocate women to intervention or usual care in a 1:1 ratio which is 6 wards In each group. There should be 153 women in the intervention group who will receive "Stigma Reduction Intervention package".	Behavioral: "Stigma Reduction Education Program" Change in knowledge: 20 minutes presentation slide cervical cancer, its burden, signs and symptoms, preventive measures ;lifestyle modifications, HPV vaccination, early diagnosis, screening and treatment services available in Nepal. 2. Change in Stigma Video on cervical cancer: Video of a person facing cervical cancer what symptoms she got, how she dealt with it and how she overcame it, highlights on importance of screening if any unusual symptoms are found and not to be embarrassed to seek help. Participatory learning techniques Personal stories and group discussion on drivers of stigma, facilitators of sigma, types of stigma prevalent in your community, consequences of stigma and present it by themselves. Myths vs facts Flash card will be used to show myths which includes negative attitudes, myths and misconceptions which will be contraindicated by the factual information on cervical cancer
No Intervention: Control Arm The control arm will consist of 153 women who would not be given any intervention.

Arm

Intervention/Treatment

Experimental: Intervention Arm

Randomization will allocate women to intervention or usual care in a 1:1 ratio which is 6 wards In each group. There should be 153 women in the intervention group who will receive "Stigma Reduction Intervention package".

Behavioral: "Stigma Reduction Education Program"

Change in knowledge: 20 minutes presentation slide cervical cancer, its burden, signs and symptoms, preventive measures ;lifestyle modifications, HPV vaccination, early diagnosis, screening and treatment services available in Nepal. 2. Change in Stigma Video on cervical cancer: Video of a person facing cervical cancer what symptoms she got, how she dealt with it and how she overcame it, highlights on importance of screening if any unusual symptoms are found and not to be embarrassed to seek help. Participatory learning techniques Personal stories and group discussion on drivers of stigma, facilitators of sigma, types of stigma prevalent in your community, consequences of stigma and present it by themselves. Myths vs facts Flash card will be used to show myths which includes negative attitudes, myths and misconceptions which will be contraindicated by the factual information on cervical cancer

No Intervention: Control Arm

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

Outcome Measures

Primary Outcome Measures

Mean stigma score [Measured at baseline and endline (after 2 months gap from baseline)]
Change in mean stigma score using Cancer Stigma Scale at baseline and follow up

Secondary Outcome Measures

Cervical cancer screening uptake [Measured within a month after endline]
Number of women attending cervical cancer screening program in intervention and control groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Budanilkantha Municipality	Kathmandu	Province-3	Nepal

Sponsors and Collaborators

Kathmandu University School of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Priyanka Timsina, Student, Kathmandu University School of Medical Sciences

ClinicalTrials.gov Identifier:

NCT05489978

Other Study ID Numbers:

CC2022

First Posted:

Aug 5, 2022

Last Update Posted:

Aug 5, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Aug 5, 2022