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Trial Outcomes & Findings for Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment (NCT NCT01722734)

NCT ID: NCT01722734

Last Updated: 2014-03-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1140 participants

Primary outcome timeframe

70 hours

Results posted on

2014-03-21

Participant Flow

Subjects were recruited at all private and public facilities distributing Artemisinin-combination Therapies (ACTs).

Only subjects from the Tamale area with cell phones were included.

Participant milestones

Participant milestones
Measure
Control
Control group participants received only a message after five days informing them about the importance of using bed nets for malaria. No reminders to take ACTs were sent.
Short Message
Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
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.
Overall Study
STARTED
554
277
309
Overall Study
COMPLETED
552
276
307
Overall Study
NOT COMPLETED
2
1
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control
n=554 Participants
Patients in this group received only a generic malaria information message (use bed nets) at the end of the study.
Short Message
n=277 Participants
Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
Long Message
n=309 Participants
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.
Total
n=1140 Participants
Total of all reporting groups
Age, Categorical
<=18 years
166 Participants
n=5 Participants
105 Participants
n=7 Participants
111 Participants
n=5 Participants
382 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
342 Participants
n=5 Participants
158 Participants
n=7 Participants
166 Participants
n=5 Participants
666 Participants
n=4 Participants
Age, Categorical
>=65 years
46 Participants
n=5 Participants
14 Participants
n=7 Participants
32 Participants
n=5 Participants
92 Participants
n=4 Participants
Age, Continuous
25.3 years
STANDARD_DEVIATION 17.7 • n=5 Participants
23 years
STANDARD_DEVIATION 17.1 • n=7 Participants
23.8 years
STANDARD_DEVIATION 17.8 • n=5 Participants
24.3 years
STANDARD_DEVIATION 17.6 • n=4 Participants
Sex: Female, Male
Female
302 Participants
n=5 Participants
152 Participants
n=7 Participants
180 Participants
n=5 Participants
634 Participants
n=4 Participants
Sex: Female, Male
Male
252 Participants
n=5 Participants
125 Participants
n=7 Participants
129 Participants
n=5 Participants
506 Participants
n=4 Participants
Region of Enrollment
Ghana
554 participants
n=5 Participants
277 participants
n=7 Participants
309 participants
n=5 Participants
1140 participants
n=4 Participants

PRIMARY outcome

Timeframe: 70 hours

Population: The number of subjects analyzed is smaller than the number of subjects enrolled due to missing data on adherence. A total of 30 observations were lost due to missing information on adherence - 16 in the control group, 9 in the short message group, and 5 in the long message group.

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.

Outcome measures

Outcome measures
Measure
Control
n=538 Participants
Subjects in this group received only one generic malaria message (use bed nets) at the end of the study.
Short Message
n=268 Participants
Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
Long Message
n=304 Participants
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.
Self-reported Adherence to Artemisinin-combination Therapy (ACT) Treatment
61.5 percentage of participants
Interval 57.39 to 65.648
69.0 percentage of participants
Interval 63.45 to 74.6
64.1 percentage of participants
Interval 58.72 to 69.56

Adverse Events

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Short Message

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Long Message

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Günther Fink

Harvard School of Public Health

Phone: 6174327389

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place