Clinical trial NCT05489978: Effectiveness of a Cervical Cancer Stigma Reduction Intervention Program on Cancer Stigma Score and Cervical Cancer Screening Uptake in Nepal
Official title: Effectiveness of a Cervical Cancer Stigma Reduction Intervention Program on Cancer Stigma Score and Cervical Cancer Screening Uptake in Nepal- A Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Stigma
Screening
Lead sponsor: Kathmandu University School of Medical Sciences
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 310
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: It is a cluster randomized control trial to assess the effectiveness of the cervical cancer stigma reduction intervention on cancer stigma score and cervical cancer screening uptake in Nepal

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean stigma score
timeFrame: Measured at baseline and endline (after 2 months gap from baseline)
Secondary outcomes:
measure: Cervical cancer screening uptake
timeFrame: Measured within a month after endline
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Budanilkantha Municipality
state: Province-3
Study officials:
References: