Reducing Acquisition of CMV Through Antenatal Education

Study Overview
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Brief Summary
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The evidence to date indicates that educational strategies may be effective at reducing antenatal CMV infection, however these have not been tested in the UK. In phase 1 of the study, the investigators will co-design an educational intervention with pregnant women and families affected by congenital CMV with the aim of reducing the risk of acquisition of CMV in pregnancy. In phase 2 of the study, the investigators will use this educational intervention in a randomised controlled trial (RCT) as part of a feasibility study to generate the data required for the design of a future main RCT. Should the future main RCT show that the educational intervention is effective in reducing the risk of primary CMV infection in pregnancy, the intervention could be rolled out in the National Health Service (NHS). This would have significant benefits to patients and the NHS. No other single cause of congenital defects and long-term developmental disability currently provides greater opportunity for improved outcomes than the prevention of congenital CMV, therefore trials designed to test prevention strategies should be a research priority for the NHS.

Detailed Description
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Cytomegalovirus (CMV) is the most common infection to be contracted before birth (a congenital infection); overall, about 20% of babies infected in this way have permanent health problems, such as hearing loss, learning delay or physical impairments. CMV is not a well-known infection, despite the health problems it can cause. It is actually more common than Down's syndrome or spina bifida. Simple hygiene measures may reduce the risk of catching CMV infection whilst pregnant and therefore also the risk of congenital infection in the infant. In the UK, pregnant women are not routinely counselled about these hygiene measures. Before a large-scale study can be performed in the UK to determine the effectiveness of an educational intervention in reducing CMV infection in pregnancy, educational materials need to be developed and tested to ensure the feasibility of such a large study. In this feasibility study, the investigators will work with pregnant women and families affected by CMV to design and produce a short film appropriate for use in the NHS to educate women about these simple hygiene measures (phase 1 of the study). Working in partnership with members of the public will help us ensure the content is relevant, clear and sensitive.The film will subsequently be tested in a study where women are assigned by chance to the educational intervention or to continue with treatment as usual with information about vaccines already recommended within the NHS. This ensures both groups will get some benefit from the study. This study will enable the investigators to work out the number of pregnant women who are at risk of contracting CMV, how many of these women would agree to take part and to calculate the number of people needed in a future main trial in order to come to a reliable answer. This feasibility study is therefore essential to the design of a large-scale future trial.

Official Title
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Reducing Acquisition of CMV Through Antenatal Education: A Feasibility Study to Assess an Educational Intervention to Prevent Cytomegalovirus Infection in Pregnancy

Conditions
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Cytomegalovirus Congenital

Intervention / Treatment
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* Behavioral: Hygiene based educational film


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: • Pregnant women who have children less than 3 years of age booking to St George's Hospital antenatal clinics Exclusion Criteria: Unwilling or unable to give informed consent Unwilling or unable to commit to study procedures Less than 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: CMV seronegative pregnant women will be randomised to one of two study arms: treatment as usual or the education intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hygiene based educational film<br>Women randomised to receive the CMV educational intervention will fill in a questionnaire and view the film. The website will also contain interactive information about CMV and how to prevent it. After watching the film and reading the information, women will be asked to fill in a post-intervention questionnaire. The website will be accessible via the participants' own mobile device or computer or dedicated study tablets or computers on-site. Using a web-based intervention, we will be able to monitor use of the educational intervention and also collect data in real time. | Behavioral: Hygiene based educational film<br>* Pregnant women will watch an educational film to increase the awareness of CMV, encourage the adoption of risk reduction behaviours and preventative strategies. The film will include women's views of the risks of CMV infection in pregnancy and how they adopted the preventative strategies.<br>|
| No Intervention: Treatment as usual (TAU)<br>Women who are randomised to the TAU group will also be asked to log-on the website. Instead of receiving specific information about prevention of CMV in pregnancy, they will receive information about routine antenatal immunisation. In the UK, the Department of Health recommends that all pregnant women should be offer immunisation against pertussis (whooping cough) and influenza (if pregnant during the influenza session). This will ensure that participants in the TAU arm of the study also derive benefit from the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Educational intervention development | Develop and refinement of a film-based educational intervention in partnership with pregnant women and families affected by CMV | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women willing to be screened for CMV | Proportion of women approached who are willing to have antenatal booking blood tested for CMV antibodies to determine serostatus | 1 year | 
| Proportion of women seronegative at antenatal booking | Proportion of women who have no evidence of previous CMV infection at the time of antenatal booking | 1 year | 
| Proportion of women with primary CMV infection in the first trimester of pregnancy | Proportion of women who have evidence of primary CMV infection within the first trimester of pregnancy | 1 year | 
| Proportion of seronegative willing to be randomised to receive educational intervention or treatment as usual | Proportion of seronegative pregnant women willing to participate in feasibility study, which includes randomisation to the educational intervention or treatment as usual | 1 year | 
| Seroconversion rate | Women will have a second blood sample tested at the end of pregnancy (between 34 weeks and delivery) to determine whether seroconversion has occurred. Seroconversion is the appearance of anti-CMV IgG antibodies in the serum of a person who did not have such antibodies previously. This will be the gold standard evidence for acquisition of primary infection and is the main outcome measure of the future main trial. | 18 months | 
| Proportion of infants with congenital CMV | The proportion of infants with a positive test for CMV in the first 21 days of life | 2 years | 
| Measures of adherence | Women in the treatment arm will be asked to a questionnaire to assess their perceptions of adherence to the advice given | 2 years | 
| Change in knowledge | Women will complete questionnaires before and after the intervention to assess changes in knowledge about CMV | 2 years | 
| Knowledge of CMV risk reduction measures | Women will complete questionnaires before and after the intervention to assess changes in knowledge about risk reduction measures and self-efficacy towards these | 2 years | 
| Acceptability of prevention measures | Women will complete questionnaires before and after the intervention to assess the acceptability of prevention measures and to identify barriers to adherence. Interviews will also be carried out to explore these in more depth. | 2 years | 
| Acceptability of the educational intervention (film) | Perceptions Perceptions and acceptability of the educational intervention will be explored in questionnaires and interviews | 2 years | 
| Anxiety level | Women in the treatment arm will complete the Perinatal Anxiety Screening Scale and Edinburgh Depression Scale to ensure that study participation does not increase anxiety. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cytomegalovirus Congenital, CMV, Cytomegalovirus infections