Clinical trial NCT05131581: Strategies to Improve the Experience of Gynaecological Screening
Official title: The First Visit for Gynaecological Screening - How do we Make it as Valuable as Possible?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: Health promotion
Patient experience
Cervical screening test
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Sophiahemmet University
name: Sormland County Council, Sweden
First posted: 2021-11-23
Enrollment: 206
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim is to evaluate different strategies to improve the experience and effect of the first visit for a cervical screening test (CST).

1. How do the context and the allotted time for the first visit for a CST affect women's i) experience of CST ii) knowledge of and attitudes towards CST and cervical cancer and iii) attitude towards contacting a midwife regarding sexual and reproductive health in the future
2. What effects do the RLP have, when used as a starting point for counselling at the first visit for a CST, on women's i) experience of CST ii) knowledge of and attitudes towards CST and cervical cancer iii) attitude towards contacting a midwife regarding sexual and reproductive health in the future and iv) knowledge of and attitudes towards fertility and preconception health

Method: cluster randomised control trial evaluating the effect of different strategies, including RLP-based information, to improve the experience and effect of the first visit for a CST.

Detailed description: The aim is to evaluate different strategies to improve the experience and effect of the first visit for a cervical screening test (CST).

1. How do the context and the allotted time for the first visit for a CST affect women's i) experience of CST ii) knowledge of and attitudes towards CST and cervical cancer and iii) attitude towards contacting a midwife regarding sexual and reproductive health in the future
2. What effects do the RLP have, when used as a starting point for counselling at the first visit for a CST, on women's i) experience of CST ii) knowledge of and attitudes towards CST and cervical cancer iii) attitude towards contacting a midwife regarding sexual and reproductive health in the future and iv) knowledge of and attitudes towards fertility and preconception health

The study is a cluster randomized controlled trial evaluating different strategies, RLP-based information, to improve the experience and effect of the first visit for a cervical screening test (CST). The study will be conducted in a strategically chosen area which includes both rural and urban areas, high and low socioeconomic status and high and low percentage of immigrant visitors. The study is conducted in four steps: 1. Standard care for CST at the midwifery clinic (control group) 2. Standard care for CST at the youth clinic (intervention group 1) 3. Standard care for CST at the youth clinic with extra time allotted (intervention group 2) 4. Standard care for CST at the youth clinic with extra time allotted and the RLP-information (intervention group 3)

Step 2-4 will be conducted during different time periods at the same youth clinics. Recruitment for each step will be ongoing until the necessary number of participants are reached. All participating providers will be carefully instructed during educational sessions and provided with material on how to inform their visitors about the study. The providers at youth clinics will also receive oral information regarding how to execute the intervention and written materials (intervention guide, checklist) to ensure uniformity. During the project period, all providers will approach all adolescents visiting for CST and keep log over the visits to enable analysis of non-participants.

Participating adolescents in all groups will be asked to complete digital questionnaires after their visit. Primary outcomes: knowledge and awareness of CST, cervical cancer, fertility, and preconception health. Secondary outcomes: experience of the visit and likelihood to contact a midwife regarding questions about sexual or reproductive health in the future.

The power calculation is based on results by Stern et al. (2013) showing that university students increased knowledge by 40% after an RLP-intervention. The calculation assumed both greater variety in and lower increase in knowledge among adolescents than among university students. To detect a difference between the intervention and control group with 80% power and with a significance level of p\< 0.05, 50 adolescents are needed in each group. We expect high participation rate and plan to recruit 75 adolescents in each group, i.e. 300 adolescents.

Eligibility criteria: Inclusion Criteria:

* Persons with cervix
* 23 years of age
* Visiting midwife for their first cervical screening test

Exclusion Criteria:

* Non-Swedish-speaking

Primary outcomes:
measure: Experience of CST
timeFrame: Day 1. The patients receives a QR-code to the digital questionnaire at the end of the visit and can choose when and were to fill out the questionnaire, but are encouraged to do so in the waiting room
Secondary outcomes:
measure: Knowledge of and attitudes towards CST and cervical cancer
timeFrame: Day 1. The patients receives a QR-code to the digital questionnaire at the end of the visit and can choose when and were to fill out the questionnaire, but are encouraged to do so in the waiting room
measure: Attitude towards contacting a midwife regarding sexual and reproductive health in the future
timeFrame: Day 1. The patients receives a QR-code to the digital questionnaire at the end of the visit and can choose when and were to fill out the questionnaire, but are encouraged to do so in the waiting room
measure: Knowledge of and attitudes towards fertility and preconception health
timeFrame: Day 1. The patients receives a QR-code to the digital questionnaire at the end of the visit and can choose when and were to fill out the questionnaire, but are encouraged to do so in the waiting room
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Region Sörmland
Study officials:
affiliation: Uppsala University
name: Jenny Stern, PhD
role: PRINCIPAL_INVESTIGATOR
References: