Clinical trial NCT02298140: Providers' Compliance to Malaria Treatment
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malaria
Keywords: SMS reminders
Provider's compliance
malaria
Lead sponsor: Ifakara Health Institute
Sponsor class: OTHER
Collaborators: name: Swiss Tropical & Public Health Institute
name: KEMRI-Wellcome Trust Collaborative Research Program
First posted: 2014-11-21
Enrollment: 712
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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:

1. To develop an automated text messaging system to send reminders to mobile phones of health workers based on Tanzanian malaria treatment guidelines;
2. To evaluate the impact of the intervention on providers' compliance to the National Guidelines for Malaria Diagnosis and Treatment (NGMDT);
3. To evaluate the impact of the intervention on patients adherence to malaria treatment with ACT
4. To evaluate the impact of the intervention on reducing baseline efficacy decay levels.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

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Primary outcomes:
measure: Provider Compliance
timeFrame: 10 months
Secondary outcomes:
measure: Number of fever patients who received diagnostic test
timeFrame: 10 months
measure: Number of confirmed malaria patients treated with recommended antimalaria
timeFrame: 10months
measure: Number of malaria patients who received correct dose of ACT
timeFrame: 10 months
measure: Number of patients with a negative malaria test who did not receive antimalaria
timeFrame: 10 months
measure: Number of afebrile patients who are tested for malaria
timeFrame: 10 months
measure: Number of patients who received counselling messages
timeFrame: 10 months
measure: Number of patients who completed antimalaria doses as instructed
timeFrame: 10 months
Other outcomes:
Locations:
city: Rufiji
country: Tanzania
facility: Ifakara Health Institute
state: Pwani
Study officials:
affiliation: Swiss Tropical & Public Health
name: Don de Savigny, PhD
role: PRINCIPAL_INVESTIGATOR
References: