ICCM of Common Childhood Diseases: Mozambique and Uganda

Malaria Clinical Trial

— inSCALE  

Official title:

Integrated Community Case Management of Common Childhood Diseases: Mozambique and Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01972321
• Other study ID #: ??OPP1002407
• Status: Completed
• Phase: N/A
• First received: April 22, 2013
• Last updated: January 7, 2016
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Malaria Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and TechnologyMozambique: Ministry of Health (MISAU)
• Study type: Interventional

Clinical Trial Summary

The aim of the inSCALE project is to test the effect of innovative approaches to increase coverage of integrated community case management, which provides community based-care for diarrhoea, pneumonia and malaria, resulting in more children receiving timely and appropriate care for these three most common childhood illnesses

Description:

The Innovations at Scale for Community Access and Lasting Effects (inSCALE) project is identifying and documenting limitations to national scale up of Integrated Community Case Management (ICCM) and aims to demonstrate that coverage and impact of government-led ICCM programmes can be extended if innovative solutions can be found for critical limitations. Based on research, three main constraints have been found to limit coverage of community based management of childhood diseases: supervision, motivation and information flow

Potential solutions to the identified constraints have been formulated based on current knowledge and experiences from Malaria Consortium ICCM implementation and other relevant community-based initiatives in both project countries and elsewhere. Extensive formative research was conducted to support the design of innovations aimed to improve motivation and performance of community health workers.

Innovations which have potential to address the project's aims but lack sufficient evidence of impact are being formally evaluated in a randomised control trial. In Mozambique, a technology based intervention is being tested where community health workers (CHWs) are provided with smart phones to programmed with a tool for decision support, immediate feedback and multimedia audio and images to improve adherence to protocols. The tool will also allow CHWs to send key indicators to a server and to keep a register of patients who can be tracked over time. The indicators submitted will be used for performance monitoring of the CHWs by providing automated timely, digestible reports with targeted follow-up actions for CHW supervisors. In Uganda, one technology and one community based intervention are being evaluated over a 12 month period. In the technology intervention, CHWs are given a Java enabled mobile phone through which they can send their weekly reports and drug stocks, receive immediate feedback based on data submission and monthly motivational messages. The phones in both countries also contain innovative tools such as a respiratory timers to support the CHWs in their work. CHWs and their supervisors are on closed user groups in order to increase communication and support. The community intervention is focused on the running of Village Health Clubs. These are designed to be highly participatory with the CHWs in the role of facilitator, aimed at increasing awareness about the CHW role and improving motivation through the support of the community.

Continuous Ministry of Health support for health facilities to provide referral care and equip community health workers with medicines, tools, supervision and training are critical for the success of the project.

Other known NCT identifiers

• NCT01810055

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2289
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

CHWs in districts with ICCM implementation

Exclusion Criteria:

CHWs in districts without ICCM implementation

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diarrhoea
• Malaria
• Pneumonia

Intervention

Other:
• Technology supported supervision
CHWs will be provided with mobile phones and solar chargers to carry out the following: Establish closed user groups (CUGs) to enable two-way communication between CHWs and their supervisors free of charge to the users. Data submission through mobile phones 2.1. receive motivational performance related feedback provided in response. 2.2. Automated messages to supervisors which 2.2.1. Flags problems and strengths/successes identified in CHWs data 2.2.2. Alerting supervisors as to which CHWs require targeted supervision. 2.3. CHWs data summarised in a user friendly format and made accessible to district statisticians Monthly motivational short message service (SMS) messages provided to CHWs that are locally relevant to CHW work and that are designed to impact positively on CHW performance.

Behavioral:
• Community supported supervision
CHWs will facilitate the clubs using a learning, planning and action cycle. Club members will rank child health challenges faced by their community using picture cards and decide which one to focus on for each cycle. They will discuss solutions, which include supporting CHWs services, and take actions to meet challenges. They will also promote group decision-making and ownership and through this process gain tangible results. Solutions to health challenges developed by club members are a key focus of the village health club approach. Village Health Clubs are based on 5 guiding principles: clubs are open to all, village owned, intended to support CHW work, strength based, and fun and focused.

Other:
• Integrated community case management
Implementation of integrated community case management, with provision of training and equipment to CHWs for diagnosis and treatment of malaria, pneumonia and diarrhoea in children less than 5 years of age. Supportive supervision of CHWs will be provided by assigned health facility supervisors.

Locations

Country	Name	City	State
Mozambique	6 Districts	Inhambane
Uganda	26 Sub-Counties	Hoima	Please Select

Sponsors (5)

Lead Sponsor	Collaborator
Malaria Consortium	Karolinska Institutet, London School of Hygiene and Tropical Medicine, Makerere University, University College, London

Countries where clinical trial is conducted

Mozambique,  Uganda, 

References & Publications (11)

Hill Z, Dumbaugh M, Benton L, Källander K, Strachan D, ten Asbroek A, Tibenderana J, Kirkwood B, Meek S. Supervising community health workers in low-income countries--a review of impact and implementation issues. Glob Health Action. 2014 May 8;7:24085. doi: 10.3402/gha.v7.24085. eCollection 2014. Review. — View Citation

Källander K, Strachan D, Soremekun S, Hill Z, Lingam R, Tibenderana J, Kasteng F, Vassall A, Meek S, Kirkwood B. Evaluating the effect of innovative motivation and supervision approaches on community health worker performance and retention in Uganda and Mozambique: study protocol for a randomised controlled trial. Trials. 2015 Apr 12;16:157. doi: 10.1186/s13063-015-0657-6. — View Citation

Källander K, Tibenderana JK, Akpogheneta OJ, Strachan DL, Hill Z, ten Asbroek AH, Conteh L, Kirkwood BR, Meek SR. Mobile health (mHealth) approaches and lessons for increased performance and retention of community health workers in low- and middle-income countries: a review. J Med Internet Res. 2013 Jan 25;15(1):e17. doi: 10.2196/jmir.2130. Review. — View Citation

Kasteng F, Settumba S, Källander K, Vassall A; inSCALE Study Group. Valuing the work of unpaid community health workers and exploring the incentives to volunteering in rural Africa. Health Policy Plan. 2016 Mar;31(2):205-16. doi: 10.1093/heapol/czv042. Epub 2015 May 22. — View Citation

Nanyonjo A, Bagorogoza B, Kasteng F, Ayebale G, Makumbi F, Tomson G, Källander K; inSCALE study group. Estimating the cost of referral and willingness to pay for referral to higher-level health facilities: a case series study from an integrated community — View Citation

Nanyonjo A, Makumbi F, Etou P, Tomson G, Källander K; inSCALE Study Group. Perceived quality of care for common childhood illnesses: facility versus community based providers in Uganda. PLoS One. 2013 Nov 7;8(11):e79943. doi: 10.1371/journal.pone.0079943. eCollection 2013. — View Citation

Nanyonjo A, Nakirunda M, Makumbi F, Tomson G, Källander K; inSCALE Study Group. Community acceptability and adoption of integrated community case management in Uganda. Am J Trop Med Hyg. 2012 Nov;87(5 Suppl):97-104. doi: 10.4269/ajtmh.2012.11-0763. — View Citation

Nanyonjo A, Ssekitooleko J, Counihan H, Makumbi F, Tomson G, Källander K. Impact of an integrated community case management programme on uptake of appropriate diarrhoea and pneumonia treatments in Uganda: A propensity score matching and equity analysis study. Int J Equity Health. 2015 Sep 4;14:74. doi: 10.1186/s12939-015-0202-y. — View Citation

Strachan DL, Källander K, Nakirunda M, Ndima S, Muiambo A, Hill Z; inSCALE study group. Using theory and formative research to design interventions to improve community health worker motivation, retention and performance in Mozambique and Uganda. Hum Resour Health. 2015 Apr 30;13:25. doi: 10.1186/s12960-015-0020-8. — View Citation

Strachan DL, Källander K, ten Asbroek AH, Kirkwood B, Meek SR, Benton L, Conteh L, Tibenderana J, Hill Z. Interventions to improve motivation and retention of community health workers delivering integrated community case management (iCCM): stakeholder perceptions and priorities. Am J Trop Med Hyg. 2012 Nov;87(5 Suppl):111-9. doi: 10.4269/ajtmh.2012.12-0030. Review. — View Citation

Thondoo M, Strachan DL, Nakirunda M, Ndima S, Muiambo A, Källander K, Hill Z; InSCALE Study Group. Potential Roles of Mhealth for Community Health Workers: Formative Research With End Users in Uganda and Mozambique. JMIR Mhealth Uhealth. 2015 Jul 23;3(3):e76. doi: 10.2196/mhealth.4208. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Community health worker retention	Proportion of community health workers staying in post after 1 year of implementation of the intervention	1 year	No
Primary	Appropriate treatment of malaria, pneumonia and diarrhoea in children under five years of age	Proportion of children under five years of age with symptoms of malaria, pneumonia and diarrhoea who received appropriate treatment	1 year	No
Secondary	Community health workers with medicine stock-out <1 week each quarter	The proportion of community health workers with medicine stock-out <1 week each quarter	1 year	No

External Links

•   Project website