NCT01722734

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,140

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 21, 2014

Completed
Last Updated

March 21, 2014

Status Verified

February 1, 2014

Enrollment Period

6 months

First QC Date

November 2, 2012

Results QC Date

October 23, 2013

Last Update Submit

February 3, 2014

Conditions

Keywords

MalariaACTs

Outcome Measures

Primary Outcomes (1)

  • 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.

    70 hours

Study Arms (3)

Control

NO INTERVENTION

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

Short Message

ACTIVE COMPARATOR

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

Behavioral: Text message reminders

Long message

ACTIVE COMPARATOR

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

Interventions

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.

Long messageShort Message

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects acquiring ACTs in Tamale, Ghana

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Study site

Tamale, Northern Region, Ghana

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Limitations and Caveats

Main outcome is self-reported adherence. Study was restricted to urban population with mobile phone ownership.

Results Point of Contact

Title
Dr Günther Fink
Organization
Harvard School of Public Health

Study Officials

  • Gunther Fink, PhD

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of International Health Economics

Study Record Dates

First Submitted

November 2, 2012

First Posted

November 7, 2012

Study Start

June 1, 2011

Primary Completion

December 1, 2011

Study Completion

January 1, 2013

Last Updated

March 21, 2014

Results First Posted

March 21, 2014

Record last verified: 2014-02

Locations