Malaria(PCMT)NCT02298140
Providers' Compliance to Malaria Treatment
A study testing SMS reminders in people with Malaria, run by Ifakara Health Institute at 1 site in Tanzania.
Trial summary
INDEPTH Network Effectiveness and Safety Studies in Africa (INESS) have demonstrated a substantial efficacy decay of Artemisinin based combination therapy (ACT) in Tanzania in 2012 (from efficacy of 98% to effectiveness of 18%). Hence system readiness for control and elimination strategies is severely compromised. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malaria
- What is being tested?
- SMS reminders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 712 participants
- Where
- 1 siteTanzania
- Study dates
- Nov 2014to 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Dispensaries and health centers; public and private; operating in Rufiji district that provided outpatient services will be eligible for the study. In the intervention arm facility, all health workers who see and take care of patients at the outpatient department (OPD) will be registered to receive automated SMS as the intervention in this study.
- During the evaluation phase, all patients attending the surveyed facilities for initial illness consultation will be eligible for inclusion in the study. Assessment of adherence will be performed to malaria patients (who tested positive) and received ACT for treatment.
Who cannot join
- Due to logistical difficulties, health facilities within the Delta region will be excluded in this study. As well, two hospitals in the district will be excluded in the study since they mostly receive referral patients. Also, hospitals have specialized clinic sections with highly trained staff and their nurses or clinicians may be rotating in different departments, hence there may not be health provider's whose primary duties are on OPD patients alone. In addition, health workers in eligible facilities who do not own a mobile phone will be excluded to receive "SMS" reminders.
- During evaluation, all severe cases and hospitalized patients will not be included in the surveys. Assessment of adherence study will exclude non residents of the study area.
- -
Trial locations and contacts
1 site in 1 country.
Tanzania1 site, 1 recruiting
- Recruiting
Ifakara Health Institute
Rufiji, Pwani Region
Neema Thomas, Nursing, +255787139961, tneema80@yahoo.com
Asteria Massawe, Nursing, +255754869939
About this study
Official title: Responding to Efficacy Decay Analysis of Artemisinin Based Combination Therapy (ACTs) in Rural Tanzania: Intervening on Provider Compliance and Patient Adherence to Correct Malaria Treatment
INDEPTH Network Effectiveness and Safety Studies in Africa (INESS) have demonstrated a substantial efficacy decay of Artemisinin based combination therapy (ACT) in Tanzania in 2012 (from efficacy of 98% to effectiveness of 18%). Hence system readiness for control and elimination strategies is severely compromised. Sub-optimal health workers' performance in treating malaria cases was a major contributor to the decay, effecting both treatment and patient adherence. If these quantified system failures remain unchecked it will pose major barrier in achieving malaria control and elimination goals. There is growing evidence that mobile phone text message reminders can improve health workers' compliance and patients' adherence to malaria treatment guidelines. Tanzania has recently harnessed all public sector health worker phones into Short Message System (SMS) platform. The investigators intend to exploit this opportunity in a randomized trial of messages to substantially reduce the decay documented by the INESS platform.
The null hypothesis: Sending automated text message reminders to health workers on malaria diagnosis and treatment recommendations, will not have any effects in the quality of malaria case management.
Read the detailed description
The baseline assessment of systems effectiveness performed by this team, have done a comprehensive quantitative documentation of efficacy decay for ACTs in real world settings; showing how community and provider's contribute to efficacy decay. The proposed text messages reminder intervention builds up from the recent findings of the Kenyan study which demonstrated an improvement in malaria case management by 24%. This level of improvement in malaria case management, if coupled with other systems interventions to improve timely access to ACT providers, should at least double systems effectiveness. This being the case, health systems in developing countries will be able to address these significant challenges hindering taking the diseases eradication agenda forward. Inappropriate care and untimely access to treatment has been identified as one of important elements for ACTs efficacy decay that in turn continues to pose a serious challenge to achieving malaria eradication.
Goal: The study aim to evaluate using cluster randomized control trial whether mobile phone text messages reminders can improve the quality of malaria case management.
Specific objectives:
- To develop an automated text messaging system to send reminders to mobile phones of health workers based on Tanzanian malaria treatment guidelines;
- To evaluate the impact of the intervention on providers' compliance to the National Guidelines for Malaria Diagnosis and Treatment (NGMDT);
- To evaluate the impact of the intervention on patients adherence to malaria treatment with ACT
- To evaluate the impact of the intervention on reducing baseline efficacy decay levels.
- Conditions
- Malaria
- Being tested
- SMS reminders
- Keywords
- SMS reminders, Provider's compliance, malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS remindersOther
Also called Post training reinforcement
Text-message reminders about malaria case management will be prepared and distributed to all health workers seeing outpatients in the selected health facilities through their personal mobile phones and facility phones. These messages will reflect ACT recommendations from Tanzania's national guidelines for the diagnosis and treatment of malaria and training manuals. The intervention will run for three months, two text message a day will be send to all identified health workers during regular working hours (i.e. between 8 am to 3 pm), three times a week. To avoid health worker's fatigue of receiving these messages, the messages will also contain some non-malaria humorous, inspirational, motivational and educative contents.
| Study group | Role | What they receive |
|---|---|---|
| SMS reminders | Experimental | This arm will receive automated mobile phone text message reminders for health workers in outpatient departments of public and private health facilities on issues related to care of malaria patients and suspected patients. Receives: Other: SMS reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider Compliance
Proportion of patients presenting to health provider for initial illness consultation with fever (documented fever or history of fever within 48 hours); who are tested for malaria and prescribed ACT for test positive results or not prescribed any antimalarial for test negative results.
Measured: 10 months
Secondary outcomes (7)
Number of fever patients who received diagnostic test
- Proportion of fever patients receiving a diagnostic test to rule out/in malaria as per national guidelines.
Measured: 10 months
Number of confirmed malaria patients treated with recommended antimalaria
Proportion of malaria patients (fever with a positive test routine and gold standard) treated according to malaria treatment guidelines.
Measured: 10months
Number of malaria patients who received correct dose of ACT
Proportion of patients who receive a correct dose of ACT based on age and/or body weight for malaria treatment
Measured: 10 months
Number of patients with a negative malaria test who did not receive antimalaria
Proportion of negative tested patients who did not receive antimalarials
Measured: 10 months
Number of afebrile patients who are tested for malaria
Proportion of non-febrile (no fever or no history of fever within 48 hours) patients who are tested for malaria
Measured: 10 months
Number of patients who received counselling messages
Proportion of patients who received recommended counseling messages
Measured: 10 months
Number of patients who completed antimalaria doses as instructed
Proportion of complete and incomplete adherent patients, as prescribed by health worker.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 712 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ifakara Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute, KEMRI-Wellcome Trust Collaborative Research Program
- Responsible party
- Sponsor
- Investigators
- Don de Savigny, PhD, Principal investigator, Swiss Tropical & Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298140
- Sponsor's protocol ID
- 3245
- Acronym
- (PCMT)
- Status last verified
- Jul 2015
- First submitted
- 1 Jul 2014
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responding to Efficacy Decay Analysis of Artemisinin Based Combination Therapy (ACTs) in Rural Tanzania: Intervening on Provider Compliance and Patient Adherence to Correct Malaria Treatment
- ClinicalTrials.gov ID
- NCT02298140
- Acronym / sponsor ID
- (PCMT) / 3245
- Conditions
- Malaria
- Keywords
- SMS reminders, Provider's compliance, malaria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 712 participants (estimated)
- Lead sponsor
- Ifakara Health InstituteUniversity, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute, KEMRI-Wellcome Trust Collaborative Research Program
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 21 Nov 2014 (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.
INDEPTH Network Effectiveness and Safety Studies in Africa (INESS) have demonstrated a substantial efficacy decay of Artemisinin based combination therapy (ACT) in Tanzania in 2012 (from efficacy of 98% to effectiveness of 18%). Hence system readiness for control and elimination strategies is severely compromised. Sub-optimal health workers' performance in treating malaria cases was a major contributor to the decay, effecting both treatment and patient adherence. If these quantified system failures remain unchecked it will pose major barrier in achieving malaria control and elimination goals. There is growing evidence that mobile phone text message reminders can improve health workers' compliance and patients' adherence to malaria treatment guidelines. Tanzania has recently harnessed all public sector health worker phones into Short Message System (SMS) platform. The investigators intend to exploit this opportunity in a randomized trial of messages to substantially reduce the decay documented by the INESS platform.
The null hypothesis: Sending automated text message reminders to health workers on malaria diagnosis and treatment recommendations, will not have any effects in the quality of malaria case management.
Detailed description
The baseline assessment of systems effectiveness performed by this team, have done a comprehensive quantitative documentation of efficacy decay for ACTs in real world settings; showing how community and provider's contribute to efficacy decay. The proposed text messages reminder intervention builds up from the recent findings of the Kenyan study which demonstrated an improvement in malaria case management by 24%. This level of improvement in malaria case management, if coupled with other systems interventions to improve timely access to ACT providers, should at least double systems effectiveness. This being the case, health systems in developing countries will be able to address these significant challenges hindering taking the diseases eradication agenda forward. Inappropriate care and untimely access to treatment has been identified as one of important elements for ACTs efficacy decay that in turn continues to pose a serious challenge to achieving malaria eradication.
Goal: The study aim to evaluate using cluster randomized control trial whether mobile phone text messages reminders can improve the quality of malaria case management.
Specific objectives:
- To develop an automated text messaging system to send reminders to mobile phones of health workers based on Tanzanian malaria treatment guidelines;
- To evaluate the impact of the intervention on providers' compliance to the National Guidelines for Malaria Diagnosis and Treatment (NGMDT);
- To evaluate the impact of the intervention on patients adherence to malaria treatment with ACT
- To evaluate the impact of the intervention on reducing baseline efficacy decay levels.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMS reminders | Experimental | Other: SMS remindersThis arm will receive automated mobile phone text message reminders for health workers in outpatient departments of public and private health facilities on issues related to care of malaria patients and suspected patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Dispensaries and health centers; public and private; operating in Rufiji district that provided outpatient services will be eligible for the study. In the intervention arm facility, all health workers who see and take care of patients at the outpatient department (OPD) will be registered to receive automated SMS as the intervention in this study.
- During the evaluation phase, all patients attending the surveyed facilities for initial illness consultation will be eligible for inclusion in the study. Assessment of adherence will be performed to malaria patients (who tested positive) and received ACT for treatment.
Key exclusion criteria (3 listed)
- Due to logistical difficulties, health facilities within the Delta region will be excluded in this study. As well, two hospitals in the district will be excluded in the study since they mostly receive referral patients. Also, hospitals have specialized clinic sections with highly trained staff and their nurses or clinicians may be rotating in different departments, hence there may not be health provider's whose primary duties are on OPD patients alone. In addition, health workers in eligible facilities who do not own a mobile phone will be excluded to receive "SMS" reminders.
- During evaluation, all severe cases and hospitalized patients will not be included in the surveys. Assessment of adherence study will exclude non residents of the study area.
- -
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 |
|---|---|---|
| SMS remindersAlso: Post training reinforcementText-message reminders about malaria case management will be prepared and distributed to all health workers seeing outpatients in the selected health facilities through their personal mobile phones and facility phones. These messages will reflect ACT recommendations from Tanzania's national guidelines for the diagnosis and treatment of malaria and training manuals. The intervention will run for three months, two text message a day will be send to all identified health workers during regular working hours (i.e. between 8 am to 3 pm), three times a week. To avoid health worker's fatigue of receiving these messages, the messages will also contain some non-malaria humorous, inspirational, motivational and educative contents. | Other | SMS reminders |
Primary outcome
Provider Compliance
Time frame: 10 months
Proportion of patients presenting to health provider for initial illness consultation with fever (documented fever or history of fever within 48 hours); who are tested for malaria and prescribed ACT for test positive results or not prescribed any antimalarial for test negative results.
7 secondary outcomes
Number of fever patients who received diagnostic test
Time frame: 10 months
Number of confirmed malaria patients treated with recommended antimalaria
Time frame: 10months
Number of malaria patients who received correct dose of ACT
Time frame: 10 months
Number of patients with a negative malaria test who did not receive antimalaria
Time frame: 10 months
Number of afebrile patients who are tested for malaria
Time frame: 10 months
Number of patients who received counselling messages
Time frame: 10 months
Number of patients who completed antimalaria doses as instructed
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
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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.
Don de Savigny, PhD principal investigator
Swiss Tropical & Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS reminders in people with Malaria, run by Ifakara Health Institute at 1 site in Tanzania.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene M Masanja, PhD (+255786371240, imasanja@ihi.or.tz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provider Compliance (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2015.