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Brief education to increase uptake of influenza vaccine among pregnant women: a study protocol for a randomized controlled trial.

ABSTRACT: Pregnant women are the highest priority group for annual influenza vaccination. Studies have shown unacceptably low uptake of both seasonal and pandemic A/H1N1 influenza vaccination among pregnant women. This paper will describe the study protocol and methodology of a randomised controlled trial designed to assess the effectiveness of a brief educational intervention in improving the uptake of seasonal influenza vaccine among pregnant women in Hong Kong.A randomised controlled trial will be conducted with pregnant women in at least the second trimester of pregnancy from four publicly funded hospital antenatal clinics in Hong Kong. Participants will be randomly assigned to either one of the two treatment groups: standard care (control) or standard care plus brief education (intervention). Pregnant women in the standard care group will receive the usual antenatal care with an educational pamphlet developed by the Hong Kong Centre for Health Protection and those in the intervention group will be provided with usual care plus a brief ten-minute education intervention. Content of the education session will cover four core components recommended in the research literature. The primary study outcome will be the proportion of participants who have received influenza vaccine during their pregnancy. A total of 184 pregnant women (92 per group) will be required to give an 80% power to detect a treatment effect of 15%.Most intervention studies aimed at improving influenza vaccination rates in pregnant women have targeted obstetric-care providers and the results of the two patient-oriented RCT interventions are conflicting. The high priority for vaccination given to pregnant women and the low influenza vaccination rate among pregnant women worldwide strongly indicates a need for interventions to improve uptake.

SUBMITTER: Wong VW

PROVIDER: S-EPMC3898030 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

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Brief education to increase uptake of influenza vaccine among pregnant women: a study protocol for a randomized controlled trial.

Wong Valerie W Y VW Fong Daniel Y T DY Tarrant Marie M

BMC pregnancy and childbirth 20140114

<h4>Background</h4>Pregnant women are the highest priority group for annual influenza vaccination. Studies have shown unacceptably low uptake of both seasonal and pandemic A/H1N1 influenza vaccination among pregnant women. This paper will describe the study protocol and methodology of a randomised controlled trial designed to assess the effectiveness of a brief educational intervention in improving the uptake of seasonal influenza vaccine among pregnant women in Hong Kong.<h4>Methods</h4>A rando ...[more]

PMID: 24423245

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Project description:BackgroundPregnancy is strongly associated with increased risk for depression. Approximately 25% of pregnant women develop depression. Treatment for depression during pregnancy has several complexities: the use of psychiatric medications during pregnancy might result in developmental problems in the child and must be used with caution. Psychosocial interventions are effective, but they require specialized professionals. Low- and middle-income countries (LMIC) such as Brazil do not have enough mental health professionals needed to meet this demand. In this context, smartphone-based interventions show immense potential. We developed Motherly, a smartphone application (app) designed to treat maternal depression. We aim to test the efficacy of Motherly in addition to brief cognitive-behavioral therapies (CBT) to treat maternal depression.MethodsWe will conduct a 2-arm parallel-randomized controlled clinical trial in which 70 pregnant women aged between 16 and 40 years with depression will be randomized to intervention or active control. The intervention group will have access to Motherly, a smartphone app based on three concepts: psychoeducation, behavior monitoring, and gaming elements. Motherly is composed of a package of interventions composed of modules: mental health, sleep, nutrition, physical activity, social support, prenatal/postnatal support, and educational content. The main focus of Motherly is delivering behavioral activation (BA), a brief and structured psychological treatment. The app allows participants to schedule and engage in, and monitor activities according to a plan to avoid acting exclusively according to their mood. The active control group will have access to a simplified version of the app consisting of educational content about various aspects of pregnancy, maternal physical and mental health, and infant development (BA, activity scheduling, sleep hygiene, among other functionalities, will not be present in this version). Both groups will receive four sessions of brief CBT in 8 weeks. Participants will be evaluated by assessors blind to randomization and allocation status. Assessments will occur at baseline (T0), midpoint (T1, week 4-5), posttreatment (T2, week 8), and follow-up (T3, when the child is 2 months old). Maternal mental health (prenatal anxiety, psychological well-being, perceived stress, depression, depression severity, and sleep quality), quality of life, physical activity levels, and infant developmental milestones and social/emotional problems will be measured. Our primary outcome is the change in maternal prenatal depression from baseline to posttreatment (8 weeks).DiscussionThe potential of digital technology to deliver mental health interventions has been increasingly recognized worldwide. There is a growing literature on interventions using smartphone applications to promote mental health, both with or without the intermediation of a mental health professional. Our study adds to the literature by testing whether an app providing an intervention package, including CBT, psychoeducation, nutrition, physical activity, and social support, can promote maternal and child health and well-being. In particular, we aim to treat depression, for which the use of digital technologies is still scarce. Smartphone applications designed to treat maternal depression are especially relevant because of the potential to circumvent barriers that prevent pregnant women from accessing mental health care.Trial registrationClinicalTrials.gov NCT04495166 . Prospectively registered on July 29, 2020.

Project description:BackgroundPregnant women are at increased risk of influenza-related complications. The World Health Organisation recommends influenza vaccination to this high-risk population as highest priority. However, achieving high influenza vaccine coverage among pregnant women remains challenging. We conducted a cross-sectional survey to estimate the coverage and determinants of influenza vaccination among pregnant women in Singapore.MethodsBetween September and November 2017, pregnant women aged ?21?years were recruited at two public hospitals in Singapore. Participants completed an anonymous, self-administered online questionnaire assessing participants' influenza vaccination uptake, knowledge of and attitudes towards influenza and the influenza vaccine, vaccination history, willingness to pay for the influenza vaccine, and external cues to vaccination. We estimated vaccine coverage and used multivariable Poisson models to identify factors associated with vaccine uptake.ResultsResponse rate was 61% (500/814). Only 49 women (9.8, 95% Confidence Interval (CI): 7.3-12.7%) reported receiving the vaccine during their current pregnancy. A few misconceptions were identified among participants, such as the belief that influenza can be treated with antibiotics. The most frequent reason for not being vaccinated was lack of recommendation. Women who were personally advised to get vaccinated against influenza during pregnancy were 7 times more likely to be vaccinated (prevalence ratio (PR)?=?7.11; 95% CI: 3.92-12.90). However, only 12% of women were personally advised to get vaccinated. Other factors associated with vaccine uptake were vaccination during a previous pregnancy (PR?=?2.51; 95% CI: 1.54-4.11), having insurance to cover the cost of the vaccine (PR?=?2.32; 95% CI: 1.43-3.76), and higher vaccine confidence (PR?=?1.62; 95% CI: 1.30-2.01).ConclusionsInfluenza vaccination uptake among pregnant women in Singapore is low. There is considerable scope for improving vaccination coverage in this high-risk population through vaccination recommendations from healthcare professionals, and public communication targeting common misconceptions about influenza and influenza vaccines.

Project description:BACKGROUND:Maternal immunization is an effective strategy to protect pregnant women and their infants from vaccine-preventable diseases. Despite the recommendation of maternal influenza and more recently pertussis immunization in Australia, uptake of these vaccines has been suboptimal. A midwife delivered immunization program for pregnant women at the Women's and Children's Hospital in South Australia commenced in April 2015. Monitoring the uptake of the current funded vaccine programs for pregnant women is limited. The study aimed to estimate maternal vaccine uptake and assess factors associated with influenza and pertussis vaccine uptake among pregnant women. METHODS:This prospective study was undertaken between November 2014 and July 2016 at the Women's and Children's Hospital. Following consent, demographic details and vaccination history for South Australian pregnant women who attended the antenatal clinic were collected. A standardised self-reported survey was completed during pregnancy with a follow up telephone interview at 8-10 weeks post-delivery. RESULTS:205 women consented and completed the self-reported survey. Of the 180 pregnant women who completed the study, 76% and 81% received maternal influenza and pertussis vaccines respectively. The adjusted odds of women receiving maternal vaccines during pregnancy were significantly higher for women delivering after the implementation of the midwife delivered program compared with women who delivered babies prior to the program for both pertussis vaccination (AOR 21.17, 95% CI 6.14-72.95; p<0.001) and influenza vaccination (AOR 5.95, 95% CI 2.13-16.61, p<0.001). Women receiving a recommendation from a health care provider and first time mothers were significantly more likely to receive influenza vaccination during pregnancy. CONCLUSIONS:High uptake of influenza and pertussis vaccines during pregnancy can be attained with health care provider recommendation and inclusion of maternal immunization as part of standard antenatal care. A midwife delivered maternal immunization program is a promising approach to improve maternal vaccine uptake by pregnant women.

Project description:BACKGROUND:Standard-dose, seasonal, trivalent, inactivated influenza vaccine induces moderate-to-low haemagglutination-inhibition antibody responses in people living with HIV. This study assessed the immunogenicity and safety of different dosing schedules of inactivated influenza vaccine in pregnant women living with HIV in South Africa. METHODS:In this double-blind, randomised, controlled trial, we recruited pregnant women with HIV from seven antenatal clinics in Soweto, South Africa. Pregnant women were eligible if they were aged 18-38 years, infected with HIV, and had an estimated gestational age of 12-36 weeks. Women were randomly assigned (1:1:1), using a computer-generated randomisation list, to receive inactivated influenza vaccine containing 15 μg of each of the three seasonal influenza strains for that year, as a single dose, a double dose, or two single doses 1 month apart. Participants and study personnel were masked to group allocation. Haemagglutination-inhibition antibody responses were measured for all groups in the mothers at enrolment and at 1 month after each vaccine dose, and in the single-dose and double-dose groups within 7 days of birth in the neonates. Immunogenicity analyses only included women with visits 28-35 days apart and infants who were born at least 28 days after maternal immunisation. The primary was seroconversion rate to each of the vaccine strains in the mothers 1 month after completion of the dosing schedule, and the primary safety outcomes were frequency of local and systemic reactions. Safety was assessed in mothers and infants until 24 weeks post partum and analysed in all participants who received at least one dose of vaccine. This study is registered with ClinicalTrials.gov, NCT01527825, and is closed to accrual. FINDINGS:Between Feb 11, and June 6, 2013, 800 pregnant women living with HIV were enrolled and randomly assigned to the single-dose (n=266), double-dose (n=265), or two-single-doses (n=269) group. In the analysable population, seroconversion rates in mothers 1 month after the final vaccine dose were significantly higher in the double-dose group (n=230; ranging from 29% to 65% for the three vaccine strains) than in the single-dose group (n=230; ranging from 18% to 49%; p≤0·019 for the three vaccine strains), but were similar between the two-single-doses group (n=220; ranging from 23% to 52%) and the single-dose group (p≥0·20 for the three vaccine strains). Safety outcomes were similar in the three groups, except for more injection-site reactions in recipients in the double-dose group. INTERPRETATION:A regimen of double-dose inactivated influenza vaccine gave slightly greater immunogenicity than did a single-dose regimen in pregnant women living with HIV. However, immunogenicity in the double-dose group was still lower than historical data from the same setting in pregnant women without HIV. More immunogenic vaccines are needed for pregnant women living with HIV to enhance transplacental transfer of vaccine-induced protective antibodies to their newborn infants. FUNDING:Bill & Melinda Gates Foundation.

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Brief education to increase uptake of influenza vaccine among pregnant women: a study protocol for a randomized controlled trial.

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Brief education to increase uptake of influenza vaccine among pregnant women: a study protocol for a randomized controlled trial.

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