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

Primary Purpose

Malaria

Status
Completed
Phase
Not Applicable
Locations
Ghana
Study Type
Interventional
Intervention
Text message reminders
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malaria focused on measuring Malaria, ACTs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Study site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Control

Short Message

Long message

Arm Description

Patients in the control arm only got a generic health message at the end of the study.

Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.

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.

Outcomes

Primary Outcome Measures

Self-reported Adherence to Artemisinin-combination Therapy (ACT) Treatment
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.

Secondary Outcome Measures

Full Information

First Posted
November 2, 2012
Last Updated
February 3, 2014
Sponsor
Harvard School of Public Health (HSPH)
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1. Study Identification

Unique Protocol Identification Number
NCT01722734
Brief Title
Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment
Acronym
PACT
Official Title
Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malaria, ACTs

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in the control arm only got a generic health message at the end of the study.
Arm Title
Short Message
Arm Type
Active Comparator
Arm Description
Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
Arm Title
Long message
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text message reminders
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported Adherence to Artemisinin-combination Therapy (ACT) Treatment
Description
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.
Time Frame
70 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunther Fink, PhD
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Study site
City
Tamale
State/Province
Northern Region
Country
Ghana

12. IPD Sharing Statement

Citations:
PubMed Identifier
25350546
Citation
Raifman JR, Lanthorn HE, Rokicki S, Fink G. The impact of text message reminders on adherence to antimalarial treatment in northern Ghana: a randomized trial. PLoS One. 2014 Oct 28;9(10):e109032. doi: 10.1371/journal.pone.0109032. eCollection 2014.
Results Reference
derived

Learn more about this trial

Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment

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