Providers' Compliance to Malaria Treatment

Malaria Clinical Trial

— (PCMT)  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02298140
• Other study ID #: 3245
• Status: Recruiting
• Phase: N/A
• First received: July 1, 2014
• Last updated: July 31, 2015
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: Ifakara Health Institute
• Contact: Irene M Masanja, PhD
• Phone: +255786371240
• Email: imasanja[@]ihi.or.tz
• Is FDA regulated: No
• Health authority: Tanzania: National Institute for Medical Research
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 712
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Malaria

Intervention

Other:
• SMS reminders
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.

Locations

Country	Name	City	State
Tanzania	Ifakara Health Institute	Rufiji	Pwani

Sponsors (3)

Lead Sponsor	Collaborator
Ifakara Health Institute	KEMRI-Wellcome Trust Collaborative Research Program, Swiss Tropical & Public Health Institute

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 months	No
Secondary	Number of fever patients who received diagnostic test	1) Proportion of fever patients receiving a diagnostic test to rule out/in malaria as per national guidelines.	10 months	No
Secondary	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.	10months	No
Secondary	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	10 months	No
Secondary	Number of patients with a negative malaria test who did not receive antimalaria	Proportion of negative tested patients who did not receive antimalarials	10 months	No
Secondary	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	10 months	No
Secondary	Number of patients who received counselling messages	Proportion of patients who received recommended counseling messages	10 months	No
Secondary	Number of patients who completed antimalaria doses as instructed	Proportion of complete and incomplete adherent patients, as prescribed by health worker.	10 months	No