Providers' Compliance to Malaria Treatment — (PCMT)  

Malaria Clinical Trial

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

Status Recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Malaria

• NCT number: NCT02298140
• Study type: Interventional
• Source: Ifakara Health Institute
• Contact: Irene M Masanja, PhD
• Phone: +255786371240
• Email: imasanja@ihi.or.tz
• Status: Recruiting
• Phase: N/A
• Start date: November 2014
• Completion date: December 2015