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PrEP Implementation for Mothers in Antenatal Care (PrIMA): study protocol of a cluster randomised trial.

ABSTRACT: INTRODUCTION:Women in regions with high HIV prevalence are at high risk of HIV acquisition during pregnancy and postpartum, and acute maternal HIV contributes a substantial proportion of infant HIV infections. Pre-exposure prophylaxis (PrEP) could prevent HIV during pregnancy/postpartum; however, identifying women who would most benefit from PrEP in this period is challenging. Women may not perceive risk, may not know partner HIV status and partners may have external partners during this period. PrEP offer in pregnancy could be universal or risk guided. METHODS AND ANALYSIS:The PrEP Implementation for Mothers in Antenatal Care (PrIMA) study is a cluster randomised trial that aims to determine the best model for PrEP implementation in pregnancy, among women attending public sector maternal child health clinics in Western Kenya (HIV prevalence >25%). Twenty clinics are randomised to either universal PrEP offer following standardised counselling ('Universal arm' 10 clinics) or risk screening with partner self-test option ('Targeted arm' 10 clinics). Four thousand women will be enrolled and followed through 9-month postpartum. The primary analysis will be intention to treat. Outcomes reflect the balance between HIV preventive effectiveness and avoiding unnecessary PrEP exposure to women at low risk and include: maternal HIV incidence, PrEP uptake, PrEP adherence, PrEP duration, 'appropriate' PrEP use (among women with objective evidence of potential risk), infant birth outcomes, infant growth and partner self-testing uptake. To better understand the feasibility and acceptability of the provision of PrEP in these settings, qualitative interviews and cost-effectiveness analyses will be conducted. ETHICS AND DISSEMINATION:The protocol was approved by the institutional review boards at Kenyatta National Hospital and the University of Washington. An external advisory panel monitors adverse and social harm events. Results will be disseminated through peer-reviewed journals, presentations at local and international conferences to national and global policy makers, community and participants. TRIAL REGISTRATION NUMBER:NCT03070600.

SUBMITTER: Dettinger JC

PROVIDER: S-EPMC6430021 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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PrEP Implementation for Mothers in Antenatal Care (PrIMA): study protocol of a cluster randomised trial.

Dettinger Julia C JC Kinuthia John J Pintye Jillian J Mwongeli Nancy N Gómez Laurén L Richardson Barbra A BA Barnabas Ruanne R Wagner Anjuli D AD O'Malley Gabrielle G Baeten Jared M JM John-Stewart Grace G

BMJ open 20190307 3

<h4>Introduction</h4>Women in regions with high HIV prevalence are at high risk of HIV acquisition during pregnancy and postpartum, and acute maternal HIV contributes a substantial proportion of infant HIV infections. Pre-exposure prophylaxis (PrEP) could prevent HIV during pregnancy/postpartum; however, identifying women who would most benefit from PrEP in this period is challenging. Women may not perceive risk, may not know partner HIV status and partners may have external partners during this ...[more]

PMID: 30850409

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Project description:Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting.A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients' experiences, and stakeholders' experiences of implementation, including influences. ANOVA was used to test differences over time and interventions.Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility.This was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions' impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance.ISRCTN18046709--Peri-operative Implementation Study Evaluation (POISE).

Project description:Background:Antenatal care is an important public health priority. Women from socially disadvantaged, and culturally and linguistically diverse groups often have difficulties with accessing antenatal care and report more negative experiences with care. Although group antenatal care has been shown in some settings to be effective for improving women's experiences of care and for improving other maternal as well as newborn health outcomes, these outcomes have not been rigorously assessed in the UK. A pilot trial will be conducted to determine the feasibility of, and optimum methods for, testing the effectiveness of group antenatal care in an NHS setting serving populations with high levels of social deprivation and cultural, linguistic and ethnic diversity. Outcomes will inform the protocol for a future full trial. Methods:This protocol outlines an individual-level randomised controlled external pilot trial with integrated process and economic evaluations. The two trial arms will be group care and standard antenatal care. The trial will involve the recruitment of 72 pregnant women across three maternity services within one large NHS Acute Trust. Baseline, outcomes and economic data will be collected via questionnaires completed by the participants at three time points, with the final scheduled for 4 months postnatal. Routine maternity service data will also be collected for outcomes assessment and economic evaluation purposes. Stakeholder interviews will provide insights into the acceptability of research and intervention processes, including the use of interpreters to support women who do not speak English. Pre-agreed criteria have been selected to guide the decision about whether or not to progress to a full trial. Discussion:This pilot trial will determine if it is appropriate to proceed to a full trial of group antenatal care in this setting. If progression is supported, the pilot will provide authoritative high-quality evidence to inform the design and conduct of a trial in this important area that holds significant potential to influence maternity care, outcomes and experience. Trial registration:ISRCTN ISRCTN66925258. Registered 03 April 2017. Retrospectively registered.

Project description:Background: Group antenatal care has demonstrated promise as a service delivery model that may result in improved outcomes compared to standard antenatal care in socio-demographic populations at disparately high risk for poor perinatal outcomes. Intrigued by results from the United States showing lower preterm birth rates among high-risk women who participate in group antenatal care, partners working together as the Preterm Birth Initiative - Rwanda designed a trial to assess the impact of group antenatal care on gestational age at birth. Methods: This study is a pair-matched cluster randomized controlled trial with four arms. Pairs randomized to group or standard care were further matched with other pairs into quadruples, within which one pair was assigned to implement basic obstetric ultrasound at the health center and early pregnancy testing at the community. At facilities randomized to group care, this will follow the opt-out model of service delivery and individual visits will always be available for those who need or prefer them. The primary outcome of interest is mean gestational age at birth among women who presented for antenatal care before 24 completed weeks of pregnancy and attended more than one antenatal care visit. Secondary outcomes of interest include attendance at antenatal and postnatal care, preterm birth rates, satisfaction of mothers and providers, and feasibility. A convenience sample of women will be recruited to participate in a longitudinal survey in which they will report such indicators as self-reported health-related behaviors and depressive symptoms. Providers will be surveyed about satisfaction and stress. Discussion: This is the largest cluster randomized controlled trial of group antenatal and postnatal care ever conducted, and the first in a low- or middle-income country to examine the effect of this model on gestational age at birth. Trial registration: This study is registered on ClinicalTrials.gov as NCT03154177 May 16, 2017.

Project description:ObjectiveTo evaluate the effectiveness of offering antenatal screening for sickle cell disease and thalassaemia in primary care as a way of facilitating earlier uptake of screening.DesignPartial factorial cluster randomised controlled trial.Setting25 UK general practices from deprived inner city areas.ParticipantsAnonymised data on all pregnant women attending participating practices during a six month period before randomisation and a seven month period after randomisation. This included 1708 eligible women.InterventionPractices were randomised to three groups for seven months: parallel testing in general practice (tests for sickle cell disease and thalassaemia offered to both parents when pregnancy was first reported); sequential testing in general practice (tests offered to mothers when pregnancy was first reported, and subsequently to the partners of women who were found to be carriers); and midwife care (tests offered to mothers at first consultation with a midwife).Main outcome measuresThe primary outcome (available for all women) was the proportion of eligible women screened before 10 weeks' (70 days') gestation. Secondary outcomes were an offer of screening to women before 10 weeks' gestation, gestational age at testing, mean interval from first visit to the general practice visit to screening, and women's knowledge of the carrier status of their baby's father before 77 days' (11 weeks') gestation. The study was designed to detect a 20% absolute increase in screening uptake. Cluster level analyses were adjusted for age group, parity, ethnic group, primary care organisation, and number of general practitioners per practice.ResultsData were analysed for 1708 eligible women. In the midwife care arm, 2% (9/441) of women were screened before 10 weeks' gestation compared with 24% (161/677) in the GP parallel testing arm and 28% (167/590) in the GP sequential testing arm. The estimated adjusted difference between the midwife care and GP parallel testing arms was 16.5% (95% confidence interval 7.1% to 25.8%; P=0.002) and between the midwife care and GP sequential testing arms was 27.8% (14.8% to 40.7%; P<0.001). By 26 weeks' gestation the proportion of women screened across the three trial arms was similar (81%). The proportion of women who knew the carrier status of the baby's father by 11 weeks' gestation was 0% (0/441) in the midwife care arm, 2% (13/677) in the GP parallel testing arm (P=0.003), and 1% (3/590) in the GP sequential testing arm (P=0.374).ConclusionOffering antenatal screening for sickle cell disease and thalassaemia as part of consultations for pregnancy confirmation in primary care increases the proportion of women screened before 10 weeks' gestation. Even with intervention, however, only a minority of women were screened before 10 weeks. Additional interventions should be considered to achieve testing early in pregnancy for most women wanting such tests so that couples with affected pregnancies have less time pressure to choose options, which may include termination of the pregnancy.Trial registrationCurrent Controlled Trials ISRCTN00677850.

Project description:INTRODUCTION:Among preterm infants, mother's own milk feeding reduces neonatal morbidity and decreases the length of hospital stay. However, breastfeeding rates and duration are lower than among term infants. It is reported that peer counselling is effective in increasing breast feeding in term infants in low-income and middle-income countries, but results are mixed in high-income countries. We aim to investigate herein whether peer counselling may be a feasible and effective breastfeeding support among preterm infants in French-speaking high-income countries. METHODS AND ANALYSIS:Eight European centres will participate in this stepped-wedge cluster randomised controlled trial. We plan to include 2400 hospitalised neonates born before 35 gestational weeks. Each centre will begin with an observational period. Every 3?months, a randomised cluster (centre) will begin the interventional period with peer counsellors until the end of the study. The counsellors will be trained and supervised by the trained nurses. They will have a weekly contact with participating mothers, with a face-to-face meeting at least once every fortnight. During these meetings, peer counsellors will listen to mothers' concerns, share experiences and help the mother with their own knowledge of breast feeding. The main outcome is breastfeeding rate at 2 months corrected age. Secondary outcomes are breastfeeding rates at hospital discharge and at 6 months, breastfeeding duration and severe neonatal morbidity and mortality. The mental health of the mother, mother-infant bonding and infant behaviour will be assessed using self-report questionnaires. A neurodevelopmental follow-up, a cost-effectiveness analysis and a cost-consequence at 2 years corrected age will be performed among infants in a French subgroup. ETHICS AND DISSEMINATION:French, Belgian and Swiss ethics committees gave their agreement. Publications in peer-reviewed journals are planned on breast feeding, mental health and economic outcomes. TRIAL REGISTRATION NUMBER:NCT03156946.

Project description:The protection and promotion of breastfeeding is considered a priority in Europe where only 22% of infants less than 6 months old are exclusively breastfed. In Spain this percentage reaches 24.8% but in our city it falls to 18.26%. Various studies emphasise that the improvement of these results should be based upon the training of health professionals. Following the recommendations of a breastfeeding guide can modify the practice of health professionals and improve results with respect to exclusively or predominatly breastfed children at 6 months of age.This study involves a community based cluster randomized trial in primary healthcare centres in Leganés (Madrid, Spain). The project aims to determine whether the use of an implementation strategy (including training session, information distribution, opinion leader) of a breastfeeding guideline in primary care is more effective than usual diffusion. The number of patients required will be 240 (120 in each arm). It will be included all the mothers of infants born during the study period (6 months) who come to the health centre on the first visit of the child care programme and who give their consent to participate. The main outcome variable is the exclusive o predominant breastfeeding at 6 moths of age..Main effectiveness will be analyzed by comparing the percentage of infants with exclusive or predominant breastfeeding at 6 months between the intervention group and the control group. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.Strategies need to be found which facilitate the giving of effective advice on breastfeeding by professionals and which provide support to women during the breastfeeding period. By applying the guide's recommendations, clinical variability can be reduced and the care received by patients can be improved.The trial was registered with ClinicalTrials.gov, number NCT01474096.

Project description:Introduction: Successfully transitioning adolescents to adult HIV care is critical for optimising outcomes. Disclosure of HIV status, a prerequisite to transition, remains suboptimal in sub-Saharan Africa. Few interventions have addressed both disclosure and transition. An adolescent transition package (ATP) that combines disclosure and transition tools could support transition and improve outcomes.Methods and analysis: In this hybrid type 1 effectiveness-implementation cluster randomised controlled trial, 10 HIV clinics with an estimated ?100 adolescents and young adults age 10-24 living with HIV (ALWHIV) in Kenya will be randomised to implement the ATP and compared with 10 clinics receiving standard of care. The ATP includes provider tools to assist disclosure and transition. Healthcare providers at intervention clinics will receive training on ATP use and support to adapt it through continuous quality improvement cycles over the initial 6 months of the study, with continued implementation for 1?year. The primary outcome is transition readiness among ALWHIV ages 15-24 years, assessed 6 monthly using a 22-item readiness score. Secondary outcomes including retention and viral suppression among ALWHIV at the end of the intervention period (month 18), implementation outcomes (acceptability, feasibility, fidelity, coverage and penetration) and programme costs complement effectiveness outcomes. The primary analysis will be intent to treat, using mixed-effects linear regression models to compare transition readiness scores (overall and by domain (HIV literacy, self-management, communication, support)) over time in control and intervention sites with adjustment for multiple testing, accounting for clustering by clinic and repeated assessments. We will estimate the coefficients and 95% CIs with a two- sided ?=0.05.Ethics and dissemination: The study was approved by the University of Washington Institutional Review Board and the Kenyatta National Hospital Ethics and Research Committee. Study results will be shared with participating facilities, county and national policy-makers.Trials registration number: NCT03574129; Pre-results.

Dataset Information

PrEP Implementation for Mothers in Antenatal Care (PrIMA): study protocol of a cluster randomised trial.

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PrEP Implementation for Mothers in Antenatal Care (PrIMA): study protocol of a cluster randomised trial.

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