NCT02298140

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
712

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 3, 2015

Status Verified

July 1, 2015

Enrollment Period

1.1 years

First QC Date

July 1, 2014

Last Update Submit

July 31, 2015

Conditions

Keywords

SMS remindersProvider's compliancemalaria

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Number of fever patients who received diagnostic test

    10 months

  • Number of confirmed malaria patients treated with recommended antimalaria

    10months

  • Number of malaria patients who received correct dose of ACT

    10 months

  • Number of patients with a negative malaria test who did not receive antimalaria

    10 months

  • Number of afebrile patients who are tested for malaria

    10 months

  • +2 more secondary outcomes

Study Arms (1)

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.

Other: SMS reminders

Interventions

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.

Also known as: Post training reinforcement
SMS reminders

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ifakara Health Institute

Rufiji, Coast Region, Tanzania

RECRUITING

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Don de Savigny, PhD

    Swiss Tropical & Public Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene M Masanja, PhD

CONTACT

Rashid A Khatib, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2014

First Posted

November 21, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 3, 2015

Record last verified: 2015-07

Locations