Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05684081
Other study ID # MaKSPH_BMGF_INV03047_2022
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date December 30, 2023

Study information

Verified date February 2023
Source Makerere University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction: Good quality OPV campaigns can interrupt and possibly prevent transmission of the polio virus. Health care worker performance and motivation are prerequisites for the success of such campaigns. Complete, transparent and timely payments are, in turn, prerequisites for the sustenance of health care worker motivation and thereby efforts. To date, most such health care workers have been paid in cash, with chronic payment issues that have negatively affected campaign quality and vaccination coverage. Cash-based payments are often plagued with multiple delays in funds disbursements, cash leakages, and a lack of accountability and financial transparency. These difficulties have prompted a transition to digitized payments that are perceived to be faster, more convenient, traceable, reliable, easier and more reasonable to set up. The roll-out phase of these digital payment interventions has not been quantitatively evaluated and the effect of digital payments on the motivation, satisfaction and performance of health workers is not known. Therefore, this study will compare digitized payment of polio vaccination campaign health care workers with cash-based payment with regards to health care worker motivation, satisfaction and performance. Findings from this study may inform the operationalization of digital financial systems, and the transition towards cross-campaign digital payments. Primary Objectives: 1. To compare the motivation, satisfaction and performance of vaccination health care workers in areas where they are paid using mobile money versus in cash, 2. To explore how gender norms and relations influence health workers' response to payment systems (mobile money versus cash payments) and how these affect the health workers' performance and motivation in polio vaccination campaigns and Secondary objectives: 1. To compare vaccination campaign quality in areas where health care workers are paid using mobile money versus in cash 2. To compare vaccination coverage in areas where campaign health care workers are paid using mobile money versus in cash. 3. To estimate the incremental cost of the intervention. Methods: This will be a mixed methods study including a cluster-randomized controlled implementation trial and a qualitative study. A total of 60 districts be randomized to implement either a digital payment system for polio campaign vaccinators during the polio campaign or the traditional cash-based payment system.


Description:

Problem statement and justification A motivated health workforce is essential for the success of critical health campaigns and programmes such as the recently concluded and upcoming polio campaigns. This is even more critical particularly in periods during and following disruptions in health services such as the Covid-19 pandemic and the resultant restrictions. Remuneration, which has been traditionally cash based is a key factor for health care worker motivation, satisfaction and performance. However, traditional cash-based modes of payment are fraught with numerous problems like delays in funds requisitions and disbursements, cash leakages, exposure to risk of theft while in transit, and a lack of accountability data and financial transparency. These chronic problems associated with cash-based payments have led to a gradual transition to digital (mobile money) payments in several countries including Uganda. While digital payments are seen as fast, convenient, traceable, reliable, and easy to set up, they are not themselves free of challenges. Also, their effect on health outcomes has not been evaluated with robust scientific methods. Few studies have particularly paid attention to the role of digital payments in influencing gender relations (power relations, access to resources and gender roles) and also how gender relations affect the adoption and use of digital payments particularly in relation to health worker's motivation and performance that is essential for increasing coverage and quality of vaccination campaigns. Furthermore, the investigators are cognizant of the intersections between gender and other social identities of both female and male health workers such as gender, age, education, cadre of health worker, income bracket, location, disability, ethnicity) that could have a bearing on how they interact and respond to digital payments-and their implications on the motivation and performance of health workers. This study therefore, will evaluate an intervention that seeks solutions to the current challenges faced by payment systems by providing a verified national database of health care workers and processing payments directly to those health care workers digitally, through mobile money platforms. Set within the context of the upcoming polio vaccination campaign, this study will examine the effect of this intervention on health outcomes such as polio vaccination coverage as well as health worker related outcomes like motivation, satisfaction and performance. This study will also examine the effect of gender norms/gender relations on health workers' response to payment systems employed during polio vaccination. While maintaining Uganda free of polio is in itself a very important goal, lessons learned from this cluster randomized implementation trial can be extended to other health campaigns and programmes.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2700
Est. completion date December 30, 2023
Est. primary completion date October 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adults aged 18 and above 2. History of participation in the most recent polio vaccination campaign in Uganda 3. Member of the district leadership team Exclusion Criteria: 1) Non-consenting adults

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Digital payment
The proposed intervention is designed to support the implementation of polio campaigns through digital payments

Locations

Country Name City State
Uganda Ministry of Health Facilities in 54 districts/municipalities in Uganda Kampala

Sponsors (2)

Lead Sponsor Collaborator
Makerere University Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vaccination campaign health care worker motivation, performance and satisfaction based on self reports on a scale of 1-5 Assessing the health workers motivation, performance and satisfaction based on self report on a scale of 1-5. At least one week post payment of immunization health workers
Secondary Vaccination coverage Proportion of children 0-59 vaccinated against polio during the campaign At least one week post payment of immunization health workers
See also
  Status Clinical Trial Phase
Completed NCT00772369 - Retrospective Survey of Safety of Fourth Dose Pentacel® in Children Phase 4
Completed NCT00401531 - Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants Phase 3
Completed NCT00254917 - Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines Phase 4
Completed NCT00772928 - Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™ Phase 3
Completed NCT04576910 - Immunogenicity and Safety of the Booster Dose of Polio Vaccine With Different Primary Sequential Schedules in China Phase 4
Completed NCT04264546 - Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Phase Ib) Phase 1/Phase 2
Not yet recruiting NCT06114810 - Immunogenicity of Novel Oral Poliovirus Vaccine Type 2 (nOPV2), bOPV and IPV Phase 4
Completed NCT01475539 - Sequential Inactivated Poliomyelitis Vaccine Followed by Oral Poliomyelitis Vaccine Versus Oral Poliomyelitis Vaccine Phase 4
Completed NCT01244464 - A Study of the Safety of IMOVAX Polio™ in China Phase 4
Completed NCT00255047 - Safety and Immune Response of Different Pediatric Combination Vaccines. Phase 3
Recruiting NCT05850364 - A Multi-center, Open-labelled, Randomized, Controlled, Extended Phase Ⅲ Clinical Trial of sIPV Vaccine Phase 3
Completed NCT00662870 - Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine Phase 3
Completed NCT03147560 - Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants Phase 4
Completed NCT05083039 - Observational Program, Study the Preventive Efficacy of the BiVac Polio Vaccine Against the Incidence of Acute Respiratory Infections, Including COVID-19
Active, not recruiting NCT00932269 - Seroimmunity 2007 and Sub Study of the Swedish Population Regarding Vaccine Preventable Disease Phase 0
Completed NCT03922061 - Evaluation of Safety, Reactogenicity and Immunogenicity of Fractional-dose Inactivated Polio Vaccine (fIPV) Given Intradermally With Double Mutant Enterotoxigenic Escherichia Coli Heat Labile Toxin (dmLT) Adjuvant Phase 1
Enrolling by invitation NCT03818477 - Environmental Surveillance (ES) for Polio and AMR Using the TaqMan Array Card
Completed NCT00348387 - Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV Phase 3
Not yet recruiting NCT06460545 - Phase IV Study of Concomitant Administration of the sIPV and HepA Phase 4
Active, not recruiting NCT01908114 - To Develop, Implement and Evaluate the Polio Demonstration Project Comprising of a Community Based Intervention Package for Polio Eradication in Pakistan Phase 4