Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment

Malaria Clinical Trial

— PACT  

Official title:

Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722734
• Other study ID #: 19850-101
• Status: Completed
• Phase: N/A
• First received: November 2, 2012
• Last updated: February 3, 2014
• Start date: June 2011
• Est. completion date: January 2013

Study information

• Verified date: February 2014
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ghana: Committee on Human Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1140
• Est. completion date: January 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malaria

Intervention

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.

Locations

Country	Name	City	State
Ghana	Study site	Tamale	Northern Region

Sponsors (1)

Lead Sponsor	Collaborator
Harvard School of Public Health

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No