scholarly journals Conditional cash transfers to retain rural Kenyan women in the continuum of care during pregnancy, birth and the postnatal period: protocol for a cluster randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Caroline A. Ochieng ◽  
Hassan Haghparast-Bidgoli ◽  
Neha Batura ◽  
Aloyce Odhiambo ◽  
Geordan Shannon ◽  
...  
BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e032161
Author(s):  
Neha Batura ◽  
Jolene Skordis ◽  
Tom Palmer ◽  
Aloyce Odiambo ◽  
Andrew Copas ◽  
...  

IntroductionA wealth of evidence from a range of country settings indicates that antenatal care, facility delivery and postnatal care can reduce maternal and child mortality and morbidity in high-burden settings. However, the utilisation of these services by pregnant women, particularly in low/middle-income country settings, is well below that recommended by the WHO. The Afya trial aims to assess the impact, cost-effectiveness and scalability of conditional cash transfers to promote increased utilisation of these services in rural Kenya and thus retain women in the continuum of care during pregnancy, birth and the postnatal period. This protocol describes the planned economic evaluation of the Afya trial.Methods and analysisThe economic evaluation will be conducted from the provider perspective as a within-trial analysis to evaluate the incremental costs and health outcomes of the cash transfer programme compared with the status quo. Incremental cost-effectiveness ratios will be presented along with a cost-consequence analysis where the incremental costs and all statistically significant outcomes will be listed separately. Sensitivity analyses will be undertaken to explore uncertainty and to ensure that results are robust. A fiscal space assessment will explore the affordability of the intervention. In addition, an analysis of equity impact of the intervention will be conducted.Ethics and disseminationThe study has received ethics approval from the Maseno University Ethics Review Committee, REF MSU/DRPI/MUERC/00294/16. The results of the economic evaluation will be disseminated in a peer-reviewed journal and presented at a relevant international conference.Trial registration numberNCT03021070


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Laura Packel ◽  
Prosper Njau ◽  
Carolyn Fahey ◽  
Angela Ramadhani ◽  
William H. Dow ◽  
...  

Abstract Background Antiretroviral therapy (ART) for HIV, taken daily, is an effective strategy to clinically suppress the virus, providing the dual benefit of improved survival and vastly decreasing the risk of transmission. However, this highly effective intervention has not yet reached all who could benefit. Cash transfers are increasingly recognized as an effective strategy to motivate behavior change and improve HIV care and treatment outcomes, including engagement in HIV care and adherence to ART. Despite a growing evidence base and strong theoretical foundation for the cash transfer approach, key questions remain. To address these questions and begin to bridge the “know-do gap” with respect to cash transfers, our team is employing an implementation science approach to iterative development of an incentive-based intervention to promote ART uptake and adherence among people living with HIV (PLHIV) in the Lake Zone region, Tanzania. Methods We will conduct a type I hybrid implementation–effectiveness trial to test the effectiveness of a cash transfer intervention on the outcome of HIV viral suppression, and concurrently examine the potential for real-world implementation with a mobile health technology (mHealth) system. Specifically, our team will expand the intervention to 32 clinics and enroll 1984 PLHIV to (a) evaluate its effectiveness by conducting a cluster randomized controlled trial with clinics as the unit of randomization and 12-month viral suppression as the primary outcome and (b) evaluate the implementation challenges and successes at multiple levels (patient, provider, clinic). Discussion This trial will provide evidence not only about the real-world effectiveness of cash transfers for retention in HIV care and viral suppression, but also on the implementation challenges and successes that will facilitate or hinder wider scale-up within Tanzania and beyond. Trial registration ClinicalTrials.gov NCT04201353. Registered on December 17, 2019


2020 ◽  
Author(s):  
Dong (Roman) Xu ◽  
Rubee Dev ◽  
Abha Shrestha ◽  
Lingling Zhang ◽  
Archana Shrestha ◽  
...  

Abstract Background: The purpose of this study will be to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing standard diabetes program in Nepal. Methods: We will conduct a two-arm, open-masked stratified cluster randomized controlled trial of a NU rse-led CO ntinuum of care for people with D iabetes (N1=200) and pre-diabetes (N2=1036) (NUCOD) , with primary care centers (9 Outreach Centers and 17 Government Health Posts) as a unit of randomization. NUCOD will be delivered through the trained diabetes nurses in the community to the intervention group and the outcomes will be compared to the enhanced usual-treatment group at 6 and 12 months of the intervention. The primary outcome will be change in glycated hemoglobin (HbA1c) level among diabetes and progression to type 2 diabetes among prediabetes, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. Outcomes will be analyzed on an intention to treat basis. Discussion: The results of this trial will provide information about the effectiveness of the NUCOD program in improving clinical outcomes for diabetes and prediabetes individuals, and implementation outcomes for the organization. Trial registration: This study was registered in a clinical trials registry via ClinicalTrials.gov (NCT04131257) on 18 October 2019. https://bit.ly/34qwIAd


BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e055921
Author(s):  
Fedra Vanhuyse ◽  
Oliver Stirrup ◽  
Aloyce Odhiambo ◽  
Tom Palmer ◽  
Sarah Dickin ◽  
...  

ObjectivesGiven high maternal and child mortality rates, we assessed the impact of conditional cash transfers (CCTs) to retain women in the continuum of care (antenatal care (ANC), delivery at facility, postnatal care (PNC) and child immunisation).DesignWe conducted an unblinded 1:1 cluster-randomised controlled trial.Setting48 health facilities in Siaya County, Kenya were randomised. The trial ran from May 2017 to December 2019.Participants2922 women were recruited to the control and 2522 to the intervention arm.InterventionsAn electronic system recorded attendance and triggered payments to the participant’s mobile for the intervention arm (US$4.5), and phone credit for the control arm (US$0.5). Eligibility criteria were resident in the catchment area and access to a mobile phone.Primary outcomesPrimary outcomes were any ANC, delivery, any PNC between 4 and 12 months after delivery, childhood immunisation and referral attendance to other facilities for ANC or PNC. Given problems with the electronic system, primary outcomes were obtained from maternal clinic books if participants brought them to data extraction meetings (1257 (50%) of intervention and 1053 (36%) control arm participants). Attendance at referrals to other facilities is not reported because of limited data.ResultsWe found a significantly higher proportion of appointments attended for ANC (67% vs 60%, adjusted OR (aOR) 1.90; 95% CI 1.36 to 2.66) and child immunisation (88% vs 85%; aOR 1.74; 95% CI 1.10 to 2.77) in intervention than control arm. No intervention effect was seen considering delivery at the facility (90% vs 92%; aOR 0.58; 95% CI 0.25 to 1.33) and any PNC attendance (82% vs 81%; aOR 1.25; 95% CI 0.74 to 2.10) separately. The pooled OR across all attendance types was 1.64 (1.28 to 2.10).ConclusionsDemand-side financing incentives, such as CCTs, can improve attendance for appointments. However, attention needs to be paid to the technology, the barriers that remain for delivery at facility and PNC visits and encouraging women to attend ANC visits within the recommended WHO timeframe.Trial registrationNCT03021070.


2020 ◽  
Author(s):  
Dong (Roman) Xu ◽  
Rubee Dev ◽  
Abha Shrestha ◽  
Lingling Zhang ◽  
Archana Shrestha ◽  
...  

Abstract Background: The purpose of this study will be to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing standard diabetes program in Nepal.Methods: We will conduct a two-arm, parallel group, stratified cluster randomized controlled trial of a NUrse-led COntinuum of care for people with Diabetes (N1=200) and pre-diabetes (N2=1036) (NUCOD), with primary care centers (9 Outreach Centers and 17 Government Health Posts) as a unit of randomization. NUCOD will be delivered through the trained diabetes nurses in the community to the intervention group and the outcomes will be compared to the usual treatment group at 6 and 12 months of the intervention. The primary outcome will be change in glycated hemoglobin (HbA1c) level among diabetes and progression to type 2 diabetes among prediabetes, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. Outcomes will be analyzed on an intention to treat basis.Discussion: The results of this trial will provide information about the effectiveness of the NUCOD program in improving clinical outcomes for diabetes and prediabetes individuals, and implementation outcomes for the organization. The continuum of care model can be used for the prevention and management of diabetes and other non-communicable diseases within and beyond Nepal with similar context.Trial registration: This study was registered in a clinical trials registry via ClinicalTrials.gov (NCT04131257) on 18 October 2019. URL: https://bit.ly/34qwIAd


2020 ◽  
Author(s):  
Gul Nawaz Khan ◽  
Sumra Kureishy ◽  
Shabina Ariff ◽  
Muhammad Atif Habib ◽  
Asra Abeer Usmani ◽  
...  

BACKGROUND In Pakistan, the prevalence of stunting in children younger than 5 years has remained above global critical levels over the past two decades, with the stunting rate being 40.2% in 2018. Children living in rural areas and in the poorest households suffer the most from stunting across the country—43.2% in rural areas and 51.4% in the lowest wealth quintile. As a continuing public health concern, it is essential that stunting prevention is a national priority in order to ensure human capital development, especially among the poorest households. OBJECTIVE The primary objective of this study is to determine the effect of a medium quantity of a lipid-based nutrient supplement (LNS) combined with unconditional cash transfers and social and behavior change communication (SBCC) on reduction of stunting in children aged 6 to 23 months. METHODS A 5-arm cluster randomized controlled trial will be conducted in the district of Rahim Yar Khan in Punjab, Pakistan. The intervention packages will be (1) cash only, (2) cash with LNS, (3) cash with SBCC, and (4) cash with SBCC and LNS. The control arm will receive routine standard of care. We will enroll children at 6 months of age and follow up on a monthly basis up to 24 months of age. A total of 2000 children, 400 in each arm, will be enrolled to detect a 20% reduction in the prevalence of stunting among children aged 24 months. Length, weight, food intake, compliance to interventions, morbidities, and other relevant data will be collected at enrollment and on a monthly basis over the period of 18 months. The process evaluation will assess acceptability of the interventions and potential barriers to implementation through focus group discussions and in-depth interviews with the target population and relevant stakeholders. Furthermore, a cost analysis will be conducted to assess the cost-effectiveness of each intervention package. RESULTS The study protocol was approved by the Ethics Review Committee of Aga Khan University in Pakistan on January 4, 2017. Data collection began in May 2017 and was completed in July 2019. Data analyses are yet to be completed. This study will explore the effectiveness of intervention packages comprised of cash transfers from Benazir Income Support Programme with or without additional LNS and SBCC in preventing childhood stunting. We expect the results to be published in peer-reviewed journals by autumn of 2020. CONCLUSIONS The findings of this trial will provide robust evidence as to which intervention packages can have significant effects on linear growth of children and design effective intervention packages to prevent stunting in children aged 6 to 23 months. CLINICALTRIAL ClinicalTrials.gov NCT03299218; https://clinicaltrials.gov/ct2/show/NCT03299218 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19001


2020 ◽  
Author(s):  
Laura Packel ◽  
Prosper Njau ◽  
Carolyn Fahey ◽  
Angela Ramadhani ◽  
William H Dow ◽  
...  

Abstract Background: Antiretroviral therapy (ART) for HIV, taken daily, is an effective strategy to clinically suppress the virus, providing the dual benefit of improved survival and vastly decreasing the risk of transmission. However, this highly effective intervention has not yet reached all who could benefit. Cash transfers are increasingly recognized as an effective strategy to motivate behavior change and improve HIV care and treatment outcomes, including engagement in HIV care and adherence to ART. Despite a growing evidence base and strong theoretical foundation for the cash transfer approach, key questions remain. To address these questions and begin to bridge the “know-do gap” with respect to cash transfers, our team is employing an implementation science approach to iterative development of an incentive-based intervention to promote ART uptake and adherence among people living with HIV (PLHIV) in the Lake Zone Region, Tanzania.Methods: We will conduct a type I hybrid implementation – effectiveness trial to test the effectiveness of a cash transfer intervention on the outcome of HIV viral suppression, and concurrently examine the potential for real-world implementation with an mobile health technology (mHealth) system. Specifically, our team will expand the intervention to 32 clinics and enroll 1,984 PLHIV to (a) evaluate its effectiveness by conducting a cluster randomized controlled trial with clinics as the unit of randomization and 12-month viral suppression as the primary outcome; and (b) evaluate the implementation challenges and successes at multiple levels (patient, provider, clinic).Discussion: This trial will provide evidence about not only the real-world effectiveness of cash transfers for retention in HIV care and viral suppression, but also on the implementation challenges and successes that will facilitate or hinder wider scale-up within Tanzania and beyond.


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