Strategies to Improve the Experience of Gynaecological Screening
NCT ID: NCT05131581
Last Updated: 2025-01-14
Study Results
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Basic Information
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COMPLETED
NA
206 participants
INTERVENTIONAL
2021-11-01
2023-06-19
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Group 1
Standard care for cervical screening test (CST) at the midwifery clinic (control group)
No interventions assigned to this group
Group 2
Standard care for CST at the youth clinic (intervention group 1)
Changed clinical context
Changed clinical context: from midwifery clinic to youth clinic
Group 3
Standard care for CST at the youth clinic with extra time allotted (intervention group 2)
Changed clinical context
Changed clinical context: from midwifery clinic to youth clinic
Extra time allotted
Extra time allotted for each visit for CST
Group 4
Standard care for CST at the youth clinic with extra time allotted and the RLP-information (intervention group 3)
Changed clinical context
Changed clinical context: from midwifery clinic to youth clinic
Extra time allotted
Extra time allotted for each visit for CST
RLP-information
Midwife-initiated discussion of the Reproductive Life Plan
Interventions
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Changed clinical context
Changed clinical context: from midwifery clinic to youth clinic
Extra time allotted
Extra time allotted for each visit for CST
RLP-information
Midwife-initiated discussion of the Reproductive Life Plan
Eligibility Criteria
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Inclusion Criteria
* 23 years of age
* Visiting midwife for their first cervical screening test
Exclusion Criteria
23 Years
23 Years
FEMALE
No
Sponsors
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Sophiahemmet University
OTHER
Sormland County Council, Sweden
OTHER
Uppsala University
OTHER
Responsible Party
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Jenny Stern
PhD, Associate Professor
Principal Investigators
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Jenny Stern, PhD
Role: PRINCIPAL_INVESTIGATOR
Uppsala University
Locations
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Region Sörmland
Eskilstuna, , Sweden
Countries
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Other Identifiers
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UU-RLP-Cellprov-2021
Identifier Type: -
Identifier Source: org_study_id
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