Your search found 512 Results

  1. 1
    394218
    Peer Reviewed

    A Prospective Study of Causes of Illness and Death in Preterm Infants in Ethiopia: The SIP Study Protocol.

    Muhe LM; McClure EM; Mekasha A; Worku B; Worku A; Dimtse A; Gebreyesus G; Tigabu Z; Abayneh M; Workneh N; Eshetu B; Girma A; Asefa M; Portales R; Arayaselassie M; Gebrehiwot Y; Bekele T; Bezabih M; Metaferia G; Gashaw M; Abebe B; Geleta A; Shehibo A; Hailu Y; Berta H; Alemu A; Desta T; Hailu R; Patterson J; Nigussie AK; Goldenberg RL

    Reproductive Health. 2018 Jun 27; 15(1):116.

    BACKGROUND: With nearly 15 million annual preterm births globally, preterm birth is the most common cause of neonatal death. Forty to 60 % of neonatal deaths are directly or indirectly associated with preterm mortality. As countries aim to meet the Sustainable Development Goals to reduce neonatal mortality, significant reductions in preterm mortality are needed. This study aims to identify the common causes of preterm illness and their contribution to preterm mortality in low-resource settings. This article will describe the methods used to undertake the study. METHODS: This is a prospective, multi-centre, descriptive clinical study. Socio-demographic, obstetric, and maternal factors, and clinical and laboratory findings will be documented. The major causes of preterm mortality will be identified using clinical, laboratory, imaging, and autopsy methods and use the national Ethiopian guidelines on management of preterm infants including required investigations to reach final diagnoses. The study will document the clinical and management protocols followed in these settings. The approach consists of clinical examinations and monitoring, laboratory investigations, and determination of primary and contributory causes of mortality through both clinical means and by post-mortem examinations. An independent panel of experts will validate the primary and contributory causes of mortality. To obtain the estimated sample size of 5000 preterm births, the study will be undertaken in five hospitals in three regions of Ethiopia, which are geographically distributed across the country. All preterm infants who are either born or transferred to these hospitals will be eligible for the study. Three methods (last menstrual period, physical examination using the New Ballard Score, and ultrasound) will be used to determine gestational age. All clinical procedures will be conducted per hospital protocol and informed consent will be taken from parents or caretakers prior to their participation in the study as well as for autopsy if the infant dies. DISCUSSION: This study will determine the major causes of death and illness among hospitalized preterm infants in a low-resource setting. The result will inform policy makers and implementers of areas that can be prioritized in order to contribute to a significant reduction in neonatal mortality.
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  2. 2
    394091
    Peer Reviewed

    Effect of life skills building education and micronutrient supplements provided from preconception versus the standard of care on low birth weight births among adolescent and young Pakistani women (15-24 years): a prospective, population-based cluster-randomized trial.

    Baxter JB; Wasan Y; Soofi SB; Suhag Z; Bhutta ZA

    Reproductive Health. 2018 May 31; 15(1):104.

    BACKGROUND: Risk factors known to impact maternal and newborn nutrition and health can exist from adolescence. If an undernourished adolescent girl becomes pregnant, her own health and pregnancy are at an increased risk for adverse outcomes. Offering preconception care from adolescence could provide an opportunity for health and nutrition promotion to improve one's own well-being, as well as future pregnancy outcomes and the health of the next generation. METHODS: The Matiari emPowerment and Preconception Supplementation (MaPPS) Trial is a population-based two-arm, cluster-randomized, controlled trial of life skills building education and multiple micronutrient supplementation provided in a programmatic context to evaluate the impact on pre-identified nutrition and health outcomes among adolescent and young women (15-24 years) in Matiari district Pakistan, and the infants born to them within the context of the trial. The primary aim is to assess the effect of the intervention on the prevalence of low birth weight births (< 2500 g). The intervention includes bi-monthly life skills building education provided from preconception, and supplementation with multiple micronutrients during preconception (twice-weekly), pregnancy (daily), and post-partum (daily to 6 months). The standard of care includes non-regulated community-based health sessions and daily iron and folic acid supplementation during pregnancy. Additional outcome information will also be collected at set time periods. Among participants, these relate to nutrition (anthropometry, nutritional status), morbidity, and mortality. Among infants, these include birth outcomes (stillbirth, preterm birth, length of gestation, small for gestational age, birth defects), anthropometry, morbidity, and mortality. DISCUSSION: Preconception care from adolescence that includes interventions targeting life skills development and nutrition is suggested to be important to improving the health and nutrition of adolescent and young women and their future offspring. This study is expected to offer insight into providing such an intervention both within a programmatic context and with an extended exposure period prior to conception. TRIAL REGISTRATION: The MaPPS Trial was registered retrospectively on clinicaltrials.gov (Identifier: NCT03287882 ) on September 19, 2017.
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  3. 3
    393915
    Peer Reviewed

    Protocol for a scoping review to identify and map the global health personnel considered skilled attendants at birth in low and middle-income countries between 2000 and 2015.

    Hobbs AJ; Moller AB; Carvajal-Aguirre L; Amouzou A; Chou D; Say L

    BMJ Open. 2017 Oct 15; 7(10):e017229.

    INTRODUCTION: Despite progress towards the Millennium Development Goals (MDG), maternal mortality remains high in countries where there are shortages of skilled personnel able to manage and provide quality care during pregnancy and childbirth. The 'percentage of births attended by skilled health personnel' (SAB, skilled attendants at birth) was a key indicator for tracking progress since the MDGs and is part of the Sustainable Development Goal agenda. However, due to contextual differences between and within countries on the definition of SAB, a lack of clarity exists around the training, competencies, and skills they are qualified to perform. In this paper, we outline a scoping review protocol that poses to identify and map the health personnel considered SAB in low and middle-income countries (LMIC). METHODS AND ANALYSIS: A search will be conducted for the years 2000-2015 in PubMed/MEDLINE, EMBASE, CINAHL Complete, Cochrane Database of Systematic Reviews, POPLINE and the WHO Global Health Library. A manual search of reference lists from identified studies or systematic reviews and a hand search of the literature from international partner organisations will be done. Original studies conducted in LMIC that assessed health personnel (paid or voluntary) providing interventions during the intrapartum period will be considered for inclusion. ETHICS AND DISSEMINATION: A scoping review is a secondary analysis of published literature and does not require ethics approval. This scoping review proposes to synthesise data on the training, competency and skills of identified SAB and expands on other efforts to describe this global health workforce. The results will inform recommendations around improved coverage measurement and reporting of SAB moving forward, allowing for more accurate, consistent and timely data able to guide decisions and action around planning and implementation of maternal and newborn health programme globally. Data will be disseminated through a peer-reviewed manuscript, conferences and to key stakeholders within international organisations. (c) World Health Organization 2017. Licensee BMJ Publishing Group Limited. This is an open access article distributed under the terms of the Creative Commons Attribution IGO License (https://creativecommons.org/licenses/by/3.0/igo), which permits use, distribution, and reproduction for non-commercial purposes in any medium, provided the original work is properly cited. In any reproduction of this article there should not be any suggestion that WHO or this article endorse any specific organization or products. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL.
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  4. 4
    393906
    Peer Reviewed

    Equity and intrapartum care by skilled birth attendant globally: protocol for a systematic review.

    Kachikis A; Moller AB; Allen T; Say L; Chou D

    BMJ Open. 2018 May 26; 8(5):e019922.

    INTRODUCTION: Equity is a cross-cutting theme within the Sustainable Development Goals (SDGs) and central to the effort to improve maternal and child health globally. One key strategy to prevent maternal death set out in SDG 3 is assistance by a skilled birth attendant (SBA) at childbirth (indicator 3.1.2). However, the increased coverage of SBAs globally has not been reflected by the same degree of decrease in maternal mortality and has been reported to have higher levels of inequality than other maternal health interventions. There is a need to evaluate the extent of inequity in intrapartum care by SBAs and evaluate themes in determinants of inequity across regions and specific country characteristics. METHODS AND ANALYSIS: The protocol for this review follows The Cochrane Handbook for Systematic Reviews and Preferred Reporting Items for Systematic Reviews and Meta-Analyses with equity extension 2012 guidelines. Studies of all languages and from all countries from 2004, the year when the WHO/ICM/FIGO joint statement on SBAs was published, and onwards will be included. PubMed/MEDLINE, CINAHL Complete, the Cochrane Library, POPLINE, the World Health Organization (WHO) Global Index Medicus, and grey literature will be searched. Our primary outcome is intrapartum care by SBA. Studies will be included if they evaluate equity and its determinants adapted from the Progress-Plus grouping of characteristics affecting health outcomes. Results will be stratified based on WHO, World Bank Group income and SDG regional groupings. ETHICS AND DISSEMINATION: This review is a secondary analysis of published literature and does not require ethics review. Results will provide information regarding equity in intrapartum care by SBAs globally and will inform development of indicators for monitoring of inequity as well as global policy related to intrapartum care and maternal mortality. Results will be disseminated via peer-reviewed manuscript, international conferences and stakeholder websites. PROSPERO REGISTRATION NUMBER: CRD42017069021. (c) Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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  5. 5
    393854
    Peer Reviewed

    'MATRI-SUMAN' a capacity building and text messaging intervention to enhance maternal and child health service utilization among pregnant women from rural Nepal: study protocol for a cluster randomised controlled trial.

    Singh JK; Kadel R; Acharya D; Lombard D; Khanal S; Singh SP

    BMC Health Services Research. 2018 Jun 14; 18(1):447.

    BACKGROUND: Capacity development of health volunteers and text messaging to pregnant women through mobile phones have shown improved maternal and child health (MCH) outcomes and is associated with increased utilisation of MCH services. However, such interventions are uncommon in Nepal. We aim to carry out an intervention with the hypothesis that capacity building and text messaging intervention will increase the MCH service utilisation. METHOD/DESIGN: MATRI-SUMAN is a 12-month cluster randomized controlled trial (RCT). The trial involves pregnant women from 52 clusters of six village development committees (VDCs) covering 66,000 populations of Dhanusha district of Nepal. In the intervention clusters, Female Community Health Volunteers (FCHVs) will receive capacity development skills through reinforcement training, supervision and monitoring skills for the promotion of health seeking behaviour among pregnant women and study participants will receive periodic promotional text messaging service about MCH components through mobile phones. A sample of 354with equal numbers in each study arm is estimated using power calculation formula. The primary outcomes of this study are the rate of utilization of skilled birth attendants and consumption of a specified diversified meal. The secondary outcomes are: four antenatal (ANC) visits, weight gain of women during pregnancy, delivery of a baby at the health facility, postnatal care (PNC) visits, positive changes in child feeding practices among mothers, performance of FCHVs in MCH service utilization. DISCUSSION: The intervention is designed to enhance the capacity of health volunteers for the promotion of health seeking behaviour among pregnant women and text messaging through a mobile phone to expecting mothers to increase MCH service utilization. The trial if proven effective will have policy implications in poor resource settings. TRIAL REGISTRATION: ISRCTN60684155, ( https://doi.org/10.1186/ISRCTN60684155 ). The trial was registered retrospectively.
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  6. 6
    372632
    Peer Reviewed

    Effectiveness of a package of postpartum family planning interventions on the uptake of contraceptive methods until twelve months postpartum in Burkina Faso and the Democratic Republic of Congo: the YAM DAABO study protocol.

    Tran NT; Gaffield ME; Seuc A; Landoulsi S; Yamaego WM; Cuzin-Kihl A; Kouanda S; Thieba B5; Mashinda D; Yodi R; Kiarie J; Reier S

    BMC Health Services Research. 2018 Jun 11; 18(1):12 p.

    BACKGROUND: Postpartum family planning (PPFP) information and services can prevent maternal and child morbidity and mortality in low-resource countries, where high unmet need for PPFP remains despite opportunities offered by routine postnatal care visits. This study aims to identify a package of PPFP interventions and determine its effectiveness on the uptake of contraceptive methods during the first year postpartum. We hypothesize that implementing a PPFP intervention package that is designed to strengthen existing antenatal and postnatal care services will result in an increase in contraceptive use. METHODS: This is an operational research project using a complex intervention design with three interacting phases. The pre-formative phase aims to map study sites to establish a sampling frame. The formative phase employs a participatory approach using qualitative methodology to identify barriers and catalysts to PPFP uptake to inform the design of a PPFP intervention package. The intervention phase applies a cluster randomized-controlled trial design based at the primary healthcare level, with the experimental group implementing the PPFP package, and the control group implementing usual care. The primary outcome is modern contraceptive method uptake at twelve months postpartum. Qualitative research is embedded in the intervention phase to understand the operational reasons for success or failure of PPFP services. DISCUSSION: Designing, testing, and scaling-up effective, affordable, and sustainable health interventions in low-resource countries is critical to address the high unmet need for PPFP. Due to socio-cultural complexities surrounding contraceptive use, this research assumes that this is more effectively accomplished by engaging key stakeholders, including adolescents, women, men, key community members, service providers, and policy-makers. At the individual level, knowledge, attitudes, and behaviors of women and couples toward PPFP will likely be influenced by a set of low-cost interventions. At the health service delivery level, the implementation of this trial will probably require a shift in behavior and accountability of providers regarding the systematic integration of PPFP into their clinical practice, as well as the optimization of health service organization to ensure the availability of competent staff and contraceptive supplies.
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  7. 7
    393138
    Peer Reviewed

    Mobile Link - a theory-based messaging intervention for improving sexual and reproductive health of female entertainment workers in Cambodia: study protocol of a randomized controlled trial.

    Brody C; Tuot S; Chhoun P; Swendenman D; Kaplan KC; Yi S

    Trials. 2018 Apr 19; 19(1):235.

    BACKGROUND: In Cambodia, HIV prevalence is concentrated in key populations including among female entertainment workers (FEWs) who may engage in direct or indirect sex work. Reaching FEWs with sexual and reproductive health (SRH) services has been difficult because of their hidden and stigmatized nature. Mobile-phone-based interventions may be an effective way to reach this population and connect them with the existing services. This article describes study design and implementation of a randomized controlled trial (RCT) of a mobile health intervention (the Mobile Link) aiming to improve SRH and related outcomes among FEWs in Cambodia. METHODS: A two-arm RCT will be used to determine the effectiveness of a mobile-phone-based text/voice messaging intervention. The intervention will be developed through a participatory process. Focus group discussions and in-depth interviews have been conducted to inform and tailor behavior change theory-based text and voice messages. During the implementation phase, 600 FEWs will be recruited and randomly assigned into one of the two arms: (1) a control group and (2) a mobile phone message group (either text messages [SMS] or voice messages [VM], a delivery method chosen by participants). Participants in the control group will also receive a weekly monitoring survey, which will provide real-time information to implementing partners to streamline outreach efforts and be able to quickly identify geographic trends. The primary outcome measures will include self-reported HIV and sexually transmitted infections (STI) testing and treatment, condom use, contraceptive use, and gender-based violence (GBV). DISCUSSION: If the Mobile Link trial is successful, participants will report an increase in condom use, linkages to screening and treatment for HIV and STI, and contraception use as well as a reduction in GBV. This trial is unique in a number of ways. First, the option of participation mode (SMS or VM) allows participants to choose the message medium that best links them to services. Second, this is the first RCT of a mobile-phone-based behavior change intervention using SMS/VMs to support linkage to SRH services in Cambodia. Lastly, we are working with a hidden, hard-to-reach, and dynamic population with which existing methods of outreach have not been fully successful. TRIAL REGISTRATION: Clinical trials.gov, NCT03117842 . Registered on 31 March 2017.
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  8. 8
    393048

    Analysis of selected policies towards universal health coverage in Uganda: the policy implementation barometer protocol.

    Hongoro C; Rutebemberwa E; Twalo T; Mwendera C; Douglas M; Mukuru M; Kasasa S; Ssengooba F

    Archives of Public Health. 2018; 76:12.

    Background: Policy implementation remains an under researched area in most low and middle income countries and it is not surprising that several policies are implemented without a systematic follow up of why and how they are working or failing. This study is part of a larger project called Supporting Policy Engagement for Evidence-based Decisions (SPEED) for Universal Health Coverage in Uganda. It seeks to support policymakers monitor the implementation of vital programmes for the realisation of policy goals for Universal Health Coverage. A Policy Implementation Barometer (PIB) is proposed as a mechanism to provide feedback to the decision makers about the implementation of a selected set of policy programmes at various implementation levels (macro, meso and micro level). The main objective is to establish the extent of implementation of malaria, family planning and emergency obstetric care policies in Uganda and use these results to support stakeholder engagements for corrective action. This is the first PIB survey of the three planned surveys and its specific objectives include: assessment of the perceived appropriateness of implementation programmes to the identified policy problems; determination of enablers and constraints to implementation of the policies; comparison of on-line and face-to-face administration of the PIB questionnaire among target respondents; and documentation of stakeholder responses to PIB findings with regard to corrective actions for implementation. Methods/Design: The PIB will be a descriptive and analytical study employing mixed methods in which both quantitative and qualitative data will be systematically collected and analysed. The first wave will focus on 10 districts and primary data will be collected through interviews. The study seeks to interview 570 respondents of which 120 will be selected at national level with 40 based on each of the three policy domains, 200 from 10 randomly selected districts, and 250 from 50 facilities. Half of the respondents at each level will be randomly assigned to either face-to-face or on-line interviews. An integrated questionnaire for these interviews will collect both quantitative data through Likert scale-type questions, and qualitative data through open-ended questions. And finally focused dialogues will be conducted with selected stakeholders for feedback on the PIB findings. Secondary data will be collected using data extraction tools for performance statistics. Discussion: It is anticipated that the PIB findings and more importantly, the focused dialogues with relevant stakeholders, that will be convened to discuss the findings and establish corrective actions, will enhance uptake of results and effective health policy implementation towards universal health coverage in Uganda.
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  9. 9
    393023
    Peer Reviewed

    The effect of a clinical decision-making mHealth support system on maternal and neonatal mortality and morbidity in Ghana: study protocol for a cluster randomized controlled trial.

    Amoakoh HB; Klipstein-Grobusch K; Amoakoh-Coleman M; Agyepong IA; Kayode GA; Sarpong C; Grobbee DE; Ansah EK

    Trials. 2017 Apr 4; 18(1):157.

    BACKGROUND: Mobile health (mHealth) presents one of the potential solutions to maximize health worker impact and efficiency in an effort to reach the Sustainable Development Goals 3.1 and 3.2, particularly in sub-Saharan African countries. Poor-quality clinical decision-making is known to be associated with poor pregnancy and birth outcomes. This study aims to assess the effect of a clinical decision-making support system (CDMSS) directed at frontline health care providers on neonatal and maternal health outcomes. METHODS/DESIGN: A cluster randomized controlled trial will be conducted in 16 eligible districts (clusters) in the Eastern Region of Ghana to assess the effect of an mHealth CDMSS for maternal and neonatal health care services on maternal and neonatal outcomes. The CDMSS intervention consists of an Unstructured Supplementary Service Data (USSD)-based text messaging of standard emergency obstetric and neonatal protocols to providers on their request. The primary outcome of the intervention is the incidence of institutional neonatal mortality. Outcomes will be assessed through an analysis of data on maternal and neonatal morbidity and mortality extracted from the District Health Information Management System-2 (DHIMS-2) and health facility-based records. The quality of maternal and neonatal health care will be assessed in two purposively selected clusters from each study arm. DISCUSSION: In this trial the effect of a mobile CDMSS on institutional maternal and neonatal health outcomes will be evaluated to generate evidence-based recommendations for the use of mobile CDMSS in Ghana and other West African countries. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02468310 . Registered on 7 September 2015; Pan African Clinical Trials Registry, identifier: PACTR20151200109073 . Registered on 9 December 2015 retrospectively from trial start date.
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  10. 10
    375893

    Changing the Way We Care.

    Catholic Relief Services [CRS]. Changing the Way We Care

    [Baltimore, Maryland], CRS, 2018. 2 p.

    Between 80-90% of children in orphanages have a living parent, most of whom would care for their children if they had the resources they need. CRS' "Changing the Way We Care" project is establishing a framework for a regional and global advocacy and behavior change campaign, which is critical to long-term change in the way the world cares for orphans.
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  11. 11
    392382
    Peer Reviewed

    Efficacy of vitamin D3 supplementation in reducing incidence of pulmonary tuberculosis and mortality among HIV-infected Tanzanian adults initiating antiretroviral therapy: study protocol for a randomized controlled trial.

    Sudfeld CR; Mugusi F; Aboud S; Nagu TJ; Wang M; Fawzi WW

    Trials. 2017 Feb 10; 18(1):66.

    BACKGROUND: HIV-infected adults initiating antiretroviral therapy (ART) in sub-Saharan Africa continue to experience high rates of morbidity and mortality during the initial months of treatment. Observational studies in high-income and resource-limited settings indicate that HIV-infected adults with low vitamin D levels may be at increased risk of mortality, HIV disease progression, and incidence of pulmonary tuberculosis (TB). As a result, vitamin D3 supplementation may improve survival and treatment outcomes for HIV-infected adults initiating ART. METHODS/DESIGN: The Trial of Vitamins-4 (ToV4) is an individually randomized, double-blind, placebo-controlled trial of vitamin D3 (cholecalciferol) supplementation conducted among 4000 HIV-infected adults with low vitamin D levels [25-hydroxyvitamin D (25(OH)D) <30 ng/mL] initiating ART in Dar es Salaam, Tanzania. The two primary aims of the trial are to determine the effect of a vitamin D3 supplementation regimen on incidence of (1) mortality and (2) pulmonary TB as compared to a matching placebo regimen. The primary safety outcome of the study is incident hypercalcemia. The investigational vitamin D3 regimen consists of oral supplements containing 50,000 IU vitamin D3 taken under direct observation at randomization and once a week for 3 weeks (four doses) followed by daily oral supplements containing 2000 IU vitamin D3 taken at home from the fourth week until trial discharge at 1 year post ART initiation. Trial participants are followed up at weekly clinic visits during the first month of ART and at monthly clinic visits thereafter until trial discharge at 1 year post ART initiation. Secondary aims of the trial are to examine the effect of the vitamin D3 regimen on CD4 T cell reconstitution, incidence of non-TB comorbidities, body mass index (BMI), depression and anxiety, physical activity, bone health, and immunologic biomarkers. DISCUSSION: The ToV4 will provide causal evidence on the effect of vitamin D3 supplementation on incidence of pulmonary TB and mortality among HIV-infected Tanzanian adults initiating ART. The trial will also give insight to whether vitamin D3 supplementation trials for the prevention of pulmonary TB should be pursued in HIV-uninfected populations. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01798680 . Registered on 21 February 2013.
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  12. 12
    392379
    Peer Reviewed

    Evaluation of mHealth strategies to optimize adherence and efficacy of Option B+ prevention of mother-to-child HIV transmission: Rationale, design and methods of a 3-armed randomized controlled trial.

    Drake AL; Unger JA; Ronen K; Matemo D; Perrier T; DeRenzi B; Richardson BA; Kinuthia J; John-Stewart G

    Contemporary Clinical Trials. 2017 Jun; 57:44-50.

    BACKGROUND: Lifelong antiretroviral therapy (ART) (Option B+) is recommended for all HIV-infected pregnant/postpartum women, but high adherence is required to maximize HIV prevention potential and maintain maternal health. Mobile health (mHealth) interventions may provide treatment adherence support for women during, and beyond, the pregnancy and postpartum periods. METHODS AND DESIGN: We are conducting an unblinded, triple-arm randomized clinical trial (Mobile WACh X) of one-way short message service (SMS) vs. two-way SMS vs. control (no SMS) to improve maternal ART adherence and retention in care by 2years postpartum. We will enroll 825 women from Nairobi and Western Kenya. Women in the intervention arms receive weekly, semi-automated motivational and educational SMS and visit reminders via an interactive, human-computer hybrid communication system. Participants in the two-way SMS arm are also asked to respond to a question related to the message. SMS are based in behavioral theory, are tailored to participant characteristics through SMS tracks, and are timed along the pregnancy/postpartum continuum. After enrollment, follow-up visits are scheduled at 6weeks; 6, 12, 18, and 24months postpartum. The primary outcomes, virological failure (HIV viral load >/=1000copies/mL), maternal retention in care, and infant HIV infection or death, will be compared in an intent to treat analysis. We will also measure ART adherence and drug resistance. DISCUSSION: Personalized and tailored SMS to support HIV-infected women during and after pregnancy may be an effective strategy to motivate women to adhere to ART and remain in care and improve maternal and infant outcomes. Copyright (c) 2017 Elsevier Inc. All rights reserved.
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  13. 13
    392165

    Safety, Quality, and Acceptability of Contraceptive Subdermal Implant Provision by Community Health Extension Workers Versus Nurses and Midwives in Nigeria: Protocol for a Quasi-Experimental, Noninferiority Study.

    Reiss K; Penfold S; Alabi O; Ali M; Hopkins K; Ngo TD; Odogwu K; Douthwaite M; Ezire O; Udoh U; Effiom E; Munroe ES

    JMIR Research Protocols. 2018 Mar 2; 7(3):e67.

    BACKGROUND: As part of its Family Planning 2020 commitment, the Nigerian government is aiming for a contraceptive prevalence rate of 36% by 2018, and in 2014, approved a policy to allow community health extension workers (CHEWs), in addition to doctors, nurses, and midwives, to provide contraceptive subdermal implants. There is a lack of rigorous evidence on the safety of long-acting reversible contraceptive provision, such as implants, among lower cadres of health providers. OBJECTIVE: This study aimed to compare implant provision by CHEWs versus nurses and midwives up to 14 days post insertion. METHODS: The quasi-experimental, noninferiority study will take place in public sector facilities in Kaduna and Ondo States. In each state, we will select 60 facilities, and from these, we will select a total of 30 nurses and midwives and 30 CHEWs to participate. Selected providers will be trained to provide implant services. Once trained, providers will recruit a minimum of 8125 women aged between 18 and 49 years who request and are eligible for an implant, following comprehensive family planning counseling. During implant insertion, providers will record data about the process and any adverse events, and 14 days post insertion, providers will ask 4410 clients about adverse events arising from the implant. Supervisors will observe 792 implant insertions to assess service provision quality and ask clients about their satisfaction with the procedure. We will conclude noninferiority if the CI for the difference in the proportion of adverse events between CHEWs and nurses and midwives on the day of insertion or 14 days post insertion lies to the right of -2%. RESULTS: In September and October 2015, we trained 60 CHEWs and a total of 60 nurses and midwives from 12 local government areas (LGAs) in Kaduna and 23 LGAs in Ondo. Recruitment took place between November 2015 and December 2016. Data analysis is being finalized, and results are expected in March 2018. CONCLUSIONS: The strength of this study is having a standard care (nurse and midwife provision) group with which CHEW provision can be compared. The intervention builds on existing training and supervision procedures, which increases the sustainability and scalability of CHEW implant provision. Important limitations include the lack of randomization due to nurses and midwives in Nigeria working in separate types of health care facilities compared with CHEWs, and that providers self-assess their own practices. It is unfeasible to observe all procedures independently, and observation may change practice. Although providers will be trained to conduct implant removals, the study time will be too short to reach the sample size required to make noninferiority comparisons for removals. TRIAL REGISTRATION: ClinicalTrials.gov NCT03088722; https://clinicaltrials.gov/ct2/show/NCT03088722 (Archived by WebCite at http://www.webcitation.org/6xIHImWvu).
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  14. 14
    375841

    Ending eclampsia: Nigeria. Assessing quality of care and health outcomes after pre-eclampsia / eclampsia.

    Population Council

    Abuja, Nigeria, Population Council, 2017. 2 p. (Ending Eclampsia: Nigeria Country Brief)

    Guidelines that direct care for women with PE / E in the postpartum period are not locally available. The World Health Organization guidelines for pre-eclampsia prevention and management even stopped short of the postpartum period. This study aims to ascertain service delivery gaps and patterns of morbidities associated with PE / E within one year of delivery.
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  15. 15
    375840

    Ending eclampsia: Nigeria. Engaging community women's groups for improved antenatal and postnatal care services.

    Population Council

    Abuja, Nigeria, Population Council, 2018. 2 p. (Ending Eclampsia: Nigeria Country Brief)

    In Nigeria's Cross River State, this study aims to test the feasibility of women leaders to deliver health education on PE / E, referral, and other antenatal care (ANC) and postnatal care (PNC) services to their peers; to increase access to ANC / PNC services; to improve the ability of women to request specific services during ANC / PNC consultations and ask for results / feedback about their health examinations; and to test the effectiveness of women’s group interventions on ANC / PNC service uptake.
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  16. 16
    375839

    Ending eclampsia: Nigeria. Assessing feasibility and acceptability of CHEWS treating hypertension in pregnancy.

    Population Council

    Abuja, Nigeria, Population Council, 2017. 2 p. (Ending Eclampsia: Nigeria Country Brief)

    This study intends to test the feasibility of CHEWs (Community Health Extension Workers) detecting and managing hypertension, and administering alpha methyldopa at PHC facilities as part of package of care for women with PE / E. In Ebonyi State, CHEWs received training on accurate measurement and categorization of hypertension in pregnancy as normal, mild, moderate, or severe hypertension, and received training on how to manage hypertension using alpha methyldopa. An endline evaluation will measure improvements in knowledge retention and early detection, prevention, and management of PE / E using antihypertensive drugs.
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  17. 17
    375838

    Ending eclampsia: Bangladesh. Feasibility of PHC providers prescribing antihypertensive drugs to pregnant women.

    Population Council

    [Dhaka], Bangladesh, Population Council, 2017. 2 p. (Ending Eclampsia: Bangladesh Country Brief)

    The primary objective of this study is to assess the feasibility of PHC providers in identifying pregnant women with high BP and prescribing alpha methyldopa for moderate to severe hypertension and refer women to secondary facilities.
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  18. 18
    375837

    Ending eclampsia: Bangladesh. Assessing quality of care and outcomes after pre-eclampsia / eclampsia.

    Population Council

    [Dhaka], Bangladesh, Population Council, 2017. 2 p. (Ending Eclampsia: Bangladesh Country Brief)

    Guidelines that direct care for women with PE / E in the postpartum period are not locally available in Bangladesh. The World Health Organization guidelines for pre-eclampsia prevention and management even stopped short of the postpartum period. This study aims to ascertain service delivery gaps and patterns of morbidities associated with PE / E within one year of delivery.
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  19. 19
    375836

    Ending eclampsia: Ethiopia. Exploring opportunities for preventing and managing pre-eclampsia / eclampsia.

    Population Council

    [Addis Ababa], Ethiopia, Population Council, 2017. 2 p. (Ending Eclampsia: Ethiopia Country Brief)

    This cross sectional qualitative study explores the gaps in antenatal care in Ethiopia and with a focus on PE / E at multiple levels. The study will take place in peri-urban and rural areas of the Southern Nations, Nationalities, and Peoples Region, and seeks to understand the nuanced relationships of women, communities, and health systems that shape experience and burden of PE / E. It builds upon this knowledge and specifically aims to assess the policy and health systems environment related to PE / E diagnosis, referral, and treatment, and identifying bottlenecks in the supply chain. It investigates knowledge and perceptions of PE / E and aims to describe barriers for provision / utilization of PE / E prevention and management, including antenatal and postnatal care during service delivery and within communities.
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  20. 20
    375835

    Ending eclampsia: Kenya. Exploring opportunities for preventing and managing pre-eclampsia / eclampsia.

    Population Council

    [Nairobi], Kenya, Population Council, 2017. 2 p. (Ending Eclampsia: Kenya Country Brief)

    This qualitative study explores health system barriers that prevent access to quality maternal care in Kenya -- including essential supplies and drugs -- and focuses on pre-eclampsia / eclampsia. The study explores the policy implementation context and relationships of women, communities, and health systems that shape experiences and burden of PE / E.
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  21. 21
    375834

    Ending eclampsia: Kenya. Clinical outcomes of pre-eclampsia / eclampsia at Kenyatta National Hospital.

    Population Council

    [Nairobi], Kenya, Population Council, 2017. 2 p. (Ending Eclampsia: Kenya Country Brief)

    The goal of this study is to determine the characteristics, treatment patterns, and outcomes of pregnant and postpartum women of patients with HDP, especially PE / E, over a two-year period at the national referral hospital in Kenya. Researchers examine the clinical spectrum, including presentation at admission, management of complications, and maternal and newborn health outcomes in a busy maternity unit to ascertain whether there is a difference between health outcomes of early and late onset pre-eclampsia.
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  22. 22
    390710
    Peer Reviewed

    Preferences for ARV-based HIV prevention methods among men and women, adolescent girls and female sex workers in Gauteng Province, South Africa: a protocol for a discrete choice experiment.

    Quaife M; Eakle R; Cabrera M; Vickerman P; Tsepe M; Cianci F; Delany-Moretlwe S; Terris-Prestholt F

    BMJ Open. 2016 Jun 27; 6(6):e010682.

    INTRODUCTION: For the past few decades, condoms have been the main method of HIV prevention. Recent advances in antiretroviral (ARV)-based prevention products have substantially changed the prevention landscape, yet little is known about how popular these products will be among potential users, or whether new methods might be used in conjunction with, or instead of, condoms. This study will use a discrete choice experiment (DCE) to (1) explore potential users' preferences regarding HIV prevention products, (2) quantify the importance of product attributes and (3) predict the uptake of products to inform estimates of their potential impact on the HIV epidemic in South Africa. We consider preferences for oral pre-exposure prophylaxis; a vaginal microbicide gel; a long-acting vaginal ring; a SILCS diaphragm used in concert with gel; and a long-acting ARV-based injectable. METHODS AND ANALYSIS: This study will gather data from 4 populations: 200 women, 200 men, 200 adolescent girls (aged 16-17 years) and 200 female sex workers. The DCE attributes and design will be developed through a literature review, supplemented by a thematic analysis of qualitative focus group discussions. Extensive piloting will be carried out in each population through semistructured interviews. The final survey will be conducted using computer tablets via a household sample (for women, men and adolescents) and respondent-driven sampling (for female sex workers), and DCE data analysed using a range of multinomial logit models. ETHICS AND DISSEMINATION: This study has been approved by the University of the Witwatersrand Human Research Ethics Committee and the Research Ethics Committee at the London School of Hygiene and Tropical Medicine. Findings will be presented to international conferences and peer-reviewed journals. Meetings will be held with opinion leaders in South Africa, while results will be disseminated to participants in Ekurhuleni through a public meeting or newsletter. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
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  23. 23
    390617

    Prevalence, predictors and adverse outcomes of adolescent pregnancy in sub-Saharan Africa: a protocol of a systematic review.

    Sama CB; Ngasa SN; Dzekem BS; Choukem SP

    Systematic Reviews. 2017 Dec 6; 6(1):247.

    BACKGROUND: Several studies have reported on factors influencing adolescent pregnancies and the associated outcomes, but evidence from a systematic review is limited, especially in sub-Saharan Africa where the greater burden lies. Establishment of accurate epidemiological data on the rates of adolescent pregnancy, its predictors, and adverse outcomes (maternal and neonatal) may have important implications towards attainment of the Sustainable Development Goals. METHODS: This will be a systematic review of studies reporting predictors of adolescent pregnancy and adverse outcomes in sub-Saharan Africa published between January 2000 and December 2017. The following databases will be searched: PubMed/MEDLINE, Excerpta Medica Database (EMBASE), SCOPUS, Popline, Africa Wide Information, African Index Medicus, Google scholar and the Cochrane library. Three authors will independently screen all potential articles for eligibility as guided by the selection criteria. The Stata statistical software will be used in analysing the data. Appropriate meta-analytic techniques will be used to pool prevalence estimates from studies with similar features, overall and by major subgroups as warranted. Heterogeneity of studies will be evaluated by the chi (2) test on Cochrane's Q statistic. Publication bias will be sorted for using funnel plot analysis and Egger's test. Qualitative synthesis will be used where data are insufficient to produce a quantitative synthesis. This protocol is reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P) 2015 guidelines. DISCUSSION: This systematic review and meta-analysis is expected to serve as a template for designing adolescent-friendly preventive and control programmes to help curb the ever-growing burden of adolescent pregnancies, and as a guide for future research. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017070773.
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  24. 24
    390598

    Impact of male partner involvement on modern contraceptive use among married or partnered women in developing countries: a protocol for systematic review.

    Gebrie SA; Abraha YG; Garoma DA; Deribe FM; Tefera MH; Morankar S

    JBI Database of Systematic Reviews and Implementation Reports. 2017 Dec; 15(12):2837-2841.

    REVIEW QUESTION/OBJECTIVE:: The objective of this systematic review is to explore the impact of male partner involvement on modern contraceptive use among married or partnered women of reproductive age in developing countries. Specifically, does male partner involvement.
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  25. 25
    368695
    Peer Reviewed

    Safety of tubal ligation by minilaparotomy provided by clinical officers versus assistant medical officers: study protocol for a noninferiority randomized controlled trial in Tanzanian women.

    Barone MA; Mbuguni Z; Achola JO; Cordero C; Kanama J; Muganyizi PS; Mwanga J; Shannon C; Tibyehabwa L

    Trials. 2017 Oct 26; 18(1):499.

    BACKGROUND: Female sterilization by tubal ligation is a safe, extremely effective, and permanent way to limit childbearing. It is the most popular modern contraceptive method worldwide. The simplest way to provide tubal ligation is by a procedure called minilaparotomy, generally performed with the client under local anesthesia with systemic sedation and analgesia. In Tanzania, unmet need for family planning is high and has declined little in the past decade. Access to tubal ligation is limited throughout the country, in large part because of a lack of trained providers. Clinical officers (COs) are midlevel health workers who provide diagnosis, treatment, and minor surgeries. They are more prevalent than physicians in poorer and rural communities. Task shifting-the delegation of some tasks to less-specialized health workers, including task shifting of surgical procedures to midlevel cadres-has improved access to lifesaving interventions in resource-limited settings. It is a cost-effective way to address shortages of physicians, increasing access to services. The primary objective of this trial is to establish whether the safety of tubal ligation by minilaparotomy provided by COs is noninferior to the safety of tubal ligation by minilaparotomy provided by physicians (assistant medical officers [AMOs]), as measured by rates of major adverse events (AEs) during the procedure and through 42 days of follow-up. METHODS/DESIGN: In this facility-based, multicenter, noninferiority randomized controlled trial, we are comparing the safety of tubal ligation by minilaparotomy performed by trained COs versus by trained AMOs. The primary outcome is safety, defined by the overall rate of major AEs occurring during the minilaparotomy procedure and through 42 days of follow-up. The trial will be conducted among 1970 women 18 years of age or older presenting for tubal ligation at 7 study sites in northern Tanzania. DISCUSSION: If no major safety issues are identified, the data from this trial may facilitate changes in the Tanzanian government's regulations, allowing appropriately trained COs to provide tubal ligation by minilaparotomy. Positive findings may have broader implications. Task shifting to provide long-acting contraceptives, if proven safe, may be an effective approach to increasing contraceptive access in low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02944149 . Registered on 14 October 2016.
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