MalariainSCALENCT01972321
ICCM of Common Childhood Diseases: Mozambique and Uganda
A study testing Technology supported supervision, Community supported supervision and Integrated community case management in people with Malaria and Pneumonia, run by Malaria Consortium at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Technology supported supervision, Community supported supervision and Integrated community case management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,289 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- CHWs in districts with ICCM implementation
Who cannot join
- CHWs in districts without ICCM implementation
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Integrated Community Case Management of Common Childhood Diseases: Mozambique and Uganda
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
Read the detailed 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.
- Being tested
- Technology supported supervision, Community supported supervision, Integrated community case management
- Keywords
- Community health worker, Motivation, Performance, Quality of care, Africa
- Medical subject headings
- Malaria, Pneumonia, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology supported supervisionOther
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.
Community supported supervisionBehavioural
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.
Integrated community case managementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Technology supported supervision | Experimental | The technology supported supervision intervention will support the CHWs in providing quality case management for the under-fives who suffer from diarrhea, pneumonia and malaria through unlimited communication with their health facility supervisors and colleagues through closed-user-groups. It will enhance timely reporting of patient data and targeted support supervision on the CHWs who need support from their supervisors. With the CHWs receiving the above support and feedback messages, this will potentially increase CHW motivation, performance and retention. Data reported by CHWs can be used by the district planners to forecasting of medicine procurements and react to drug stock-outs or unusual data trends (e.g. disease outbreaks). Receives: Other: Technology supported supervision; Other: Integrated community case management |
| Community supported supervision | Experimental | The community supported supervision intervention will set up village health clubs with the aim to improve child health through a community led forum with the CHW as the main focus point. Village health club meetings will provide a forum where CHWs and community members who are part of the club can work together to identify child health and CHW challenges. They will use village networks, knowledge, creativity and other assets. Receives: Behavioral: Community supported supervision; Other: Integrated community case management |
| Control arm | Active comparator | The CHWs in the control arm will be receiving the standard Ministry of Health designed package to integrated community case management support and supervision. Receives: Other: Integrated community case management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaria Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, University College, London, Karolinska Institutet, Makerere University
- Responsible party
- Principal investigator, Karin Källander, Malaria Consortium
- Investigators
- Sylvia Meek, PhD, Study director, Malaria Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972321
- Sponsor's protocol ID
- OPP1002407
- Acronym
- inSCALE
- Status last verified
- Jan 2016
- First submitted
- 22 Apr 2013
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thondoo M, Strachan DL, Nakirunda M, Ndima S, Muiambo A, Kallander 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.
PubMed 26206419Kasteng F, Settumba S, Kallander 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.
PubMed 26001813Strachan DL, Kallander 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.
PubMed 25925007Kallander 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.
PubMed 25873093Hill Z, Dumbaugh M, Benton L, Kallander 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.
PubMed 24815075Nanyonjo A, Makumbi F, Etou P, Tomson G, Kallander 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.
PubMed 24244581Kallander 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.
PubMed 23353680Nanyonjo A, Nakirunda M, Makumbi F, Tomson G, Kallander K, The 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.
PubMed 23136284Strachan DL, Kallander K, Ten Asbroek AHA, 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):111-119. doi: 10.4269/ajtmh.2012.12-0030.
PubMed 23136286Nanyonjo A, Ssekitooleko J, Counihan H, Makumbi F, Tomson G, Kallander 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.
PubMed 26337975Nanyonjo A, Bagorogoza B, Kasteng F, Ayebale G, Makumbi F, Tomson G, Kallander 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 case management programme in Uganda. BMC Health Serv Res. 2015 Aug 28;15:347. doi: 10.1186/s12913-015-1019-5.
PubMed 26315661Kallander K, Soremekun S, Strachan DL, Hill Z, Kasteng F, Kertho E, Nanyonjo A, Ten Asbroek G, Nakirunda M, Lumumba P, Ayebale G, Bagorogoza B, Vassall A, Meek S, Tibenderana J, Lingam R, Kirkwood B. Improving community health worker treatment for malaria, diarrhoea, and pneumonia in Uganda through inSCALE community and mHealth innovations: A cluster randomised controlled trial. PLOS Digit Health. 2023 Jun 12;2(6):e0000217. doi: 10.1371/journal.pdig.0000217. eCollection 2023 Jun.
PubMed 37307519Batura N, Kasteng F, Condoane J, Bagorogosa B, Castel-Branco AC, Kertho E, Kallander K, Soremekun S, Lingam R, Vassall A; inSCALE study group. Costs of treating childhood malaria, diarrhoea and pneumonia in rural Mozambique and Uganda. Malar J. 2022 Aug 20;21(1):239. doi: 10.1186/s12936-022-04254-y.
PubMed 35987625
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Community Case Management of Common Childhood Diseases: Mozambique and Uganda
- ClinicalTrials.gov ID
- NCT01972321
- Acronym / sponsor ID
- inSCALE / OPP1002407
- Keywords
- Community health worker, Motivation, Performance, Quality of care, Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,289 participants (actual)
- Lead sponsor
- Malaria ConsortiumUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, University College, London, Karolinska Institutet, Makerere University
- Study start
- Apr 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Technology supported supervision | Experimental | Other: Technology supported supervision, Other: Integrated community case managementThe technology supported supervision intervention will support the CHWs in providing quality case management for the under-fives who suffer from diarrhea, pneumonia and malaria through unlimited communication with their health facility supervisors and colleagues through closed-user-groups. It will enhance timely reporting of patient data and targeted support supervision on the CHWs who need support from their supervisors. With the CHWs receiving the above support and feedback messages, this will potentially increase CHW motivation, performance and retention. Data reported by CHWs can be used by the district planners to forecasting of medicine procurements and react to drug stock-outs or unusual data trends (e.g. disease outbreaks). |
| Community supported supervision | Experimental | Behavioral: Community supported supervision, Other: Integrated community case managementThe community supported supervision intervention will set up village health clubs with the aim to improve child health through a community led forum with the CHW as the main focus point. Village health club meetings will provide a forum where CHWs and community members who are part of the club can work together to identify child health and CHW challenges. They will use village networks, knowledge, creativity and other assets. |
| Control arm | Active comparator | Other: Integrated community case managementThe CHWs in the control arm will be receiving the standard Ministry of Health designed package to integrated community case management support and supervision. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- CHWs in districts with ICCM implementation
Key exclusion criteria (1 listed)
- CHWs in districts without ICCM implementation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology supported supervisionCHWs will be provided with mobile phones and solar chargers to carry out the following: 1. Establish closed user groups (CUGs) to enable two-way communication between CHWs and their supervisors free of charge to the users. 2. 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 3. 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. | Other | Technology supported supervision |
| Community supported supervisionCHWs 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. | Behavioural | Community supported supervision |
| Integrated community case managementImplementation 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. | Other | Community supported supervision, Control arm, Technology supported supervision |
Primary outcome
Appropriate treatment of malaria, pneumonia and diarrhoea in children under five years of age
Time frame: 1 year
Proportion of children under five years of age with symptoms of malaria, pneumonia and diarrhoea who received appropriate treatment
1 secondary outcome
Community health workers with medicine stock-out <1 week each quarter
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Background: PubMed 26206419Thondoo M, Strachan DL, Nakirunda M, Ndima S, Muiambo A, Kallander 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.
- Background: PubMed 26001813Kasteng F, Settumba S, Kallander 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.
- Background: PubMed 25925007Strachan DL, Kallander 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.
- Background: PubMed 25873093Kallander 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.
- Background: PubMed 24815075Hill Z, Dumbaugh M, Benton L, Kallander 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.
- Background: PubMed 24244581Nanyonjo A, Makumbi F, Etou P, Tomson G, Kallander 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.
- Background: PubMed 23353680Kallander 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.
- Background: PubMed 23136284Nanyonjo A, Nakirunda M, Makumbi F, Tomson G, Kallander K, The 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.
- Background: PubMed 23136286Strachan DL, Kallander K, Ten Asbroek AHA, 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):111-119. doi: 10.4269/ajtmh.2012.12-0030.
- Background: PubMed 26337975Nanyonjo A, Ssekitooleko J, Counihan H, Makumbi F, Tomson G, Kallander 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.
- Results publication: PubMed 26315661Nanyonjo A, Bagorogoza B, Kasteng F, Ayebale G, Makumbi F, Tomson G, Kallander 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 case management programme in Uganda. BMC Health Serv Res. 2015 Aug 28;15:347. doi: 10.1186/s12913-015-1019-5.
- Derived from this study: PubMed 37307519Kallander K, Soremekun S, Strachan DL, Hill Z, Kasteng F, Kertho E, Nanyonjo A, Ten Asbroek G, Nakirunda M, Lumumba P, Ayebale G, Bagorogoza B, Vassall A, Meek S, Tibenderana J, Lingam R, Kirkwood B. Improving community health worker treatment for malaria, diarrhoea, and pneumonia in Uganda through inSCALE community and mHealth innovations: A cluster randomised controlled trial. PLOS Digit Health. 2023 Jun 12;2(6):e0000217. doi: 10.1371/journal.pdig.0000217. eCollection 2023 Jun.
- Project websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvia Meek, PhD study director
Malaria Consortium
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology supported supervision, Community supported supervision and Integrated community case management in people with Malaria and Pneumonia, run by Malaria Consortium at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mozambique, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appropriate treatment of malaria, pneumonia and diarrhoea in children under five years of age (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01972321, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.