Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment (PACT)

February 3, 2014 updated by: Günther Fink, Harvard School of Public Health (HSPH)

A randomized controlled trial was conducted to assess the effectiveness of text reminders sent to ACT users through an automated text messaging system short-message-system.

Study hypothesis: text message reminders increase adherence

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled trial was conducted to assess the effectiveness of text reminders sent to ACT users through an automated text messaging system short-message-system. Patients were enrolled at clinics and pharmacies upon receipt of ACTs and enrolled in the automated system for 3 days.

Study Type

Interventional

Enrollment (Actual)

1140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
    • Northern Region
      • Tamale, Northern Region, Ghana
        • Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

-subjects acquiring ACTs in Tamale, Ghana

Exclusion Criteria:

  • subjects acquiring ACTs for non household members
  • subjects under the age of 18
  • subjects without access to cell phones
  • subjects living more than 30 minutes from pickup location

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Patients in the control arm only got a generic health message at the end of the study.
Active Comparator: Short Message
Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
Behavioral: Text message reminders
Patients in the two treatment arms receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals to remind them to take their malaria medication as prescribed.
Active Comparator: Long message
Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
Behavioral: Text message reminders
Patients in the two treatment arms receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals to remind them to take their malaria medication as prescribed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported Adherence to Artemisinin-combination Therapy (ACT) Treatment
Time Frame: 70 hours
Percentage of participants completing full ACT treatment regimen 70 hours after treatment initiation. Subjects were visited at home, and asked to report when each of the prescribed six doses were taken. Adherence was defined as the (self-reported) completion of all six doses.
70 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard School of Public Health (HSPH)

Investigators

  • Principal Investigator: Gunther Fink, PhD, Harvard School of Public Health (HSPH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

November 2, 2012

First Submitted That Met QC Criteria

November 5, 2012

First Posted (Estimate)

November 7, 2012

Study Record Updates

Last Update Posted (Estimate)

March 21, 2014

Last Update Submitted That Met QC Criteria

February 3, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19850-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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