MalariaPACTNCT01722734

Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment

A study testing Text message reminders in people with Malaria, run by Harvard School of Public Health (HSPH) at 1 site in Ghana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Malaria
What is being tested?: Text message reminders
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,140 participants
Where: 1 siteGhana
Study dates: Jun 2011to Jan 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

-subjects acquiring ACTs in Tamale, Ghana

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Ghana1 site

Study site
Tamale, Northern Region

Other trials in Ghana

About this study

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

Read the 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.

Conditions: Malaria
Being tested: Text message reminders
Keywords: Malaria, ACTs
Medical subject headings: Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Text message remindersBehavioural
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.

Study groups in NCT01722734
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Text message reminders

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 70 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Jan 2013

First posted7 Nov 2012 (estimated)
Study startJun 2011
Primary completionDec 2011
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MalariaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01722734
Sponsor's protocol ID: 19850-101
Acronym: PACT
Status last verified: Feb 2014
First submitted: 2 Nov 2012
Last updated: 21 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 25350546

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment
ClinicalTrials.gov ID: NCT01722734
Acronym / sponsor ID: PACT / 19850-101
Conditions: Malaria
Keywords: Malaria, ACTs
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,140 participants (actual)
Lead sponsor: Harvard School of Public Health (HSPH)University, hospital or other
Study start: Jun 2011
Primary completion: Dec 2011 (actual)
Study completion: Jan 2013 (actual)
First posted: 7 Nov 2012 (estimated)
Results: Posted 21 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Control	No intervention	–Patients in the control arm only got a generic health message at the end of the study.
Short Message	Active comparator	Behavioral: Text message remindersPatients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
Long message	Active comparator	Behavioral: Text message remindersPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

-subjects acquiring ACTs in Tamale, Ghana

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Text message remindersPatients 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.	Behavioural	Long message, Short Message

Primary outcome

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.

Results and safety

Results posted to the registry on 21 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	554	552
Short Message	277	276
Long Message	309	307

Primary outcome: Self-reported Adherence to Artemisinin-combination Therapy (ACT) Treatment

Time frame: 70 hours. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Control n = 538	Short Message n = 268	Long Message n = 304
Value	61.5 (57.39 to 65.648)	69.0 (63.45 to 74.60)	64.1 (58.72 to 69.56)

Population analysed: 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.

Adverse events

Time frame: Adverse effects were restricted to the 3 days monitoring period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 554 (0%)	0 of 554 (0%)	Not reported
Short Message	0 of 277 (0%)	0 of 277 (0%)	Not reported
Long Message	0 of 309 (0%)	0 of 309 (0%)	Not reported

Limitations and caveats (from the sponsor): Main outcome is self-reported adherence. Study was restricted to urban population with mobile phone ownership.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25350546Raifman 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gunther Fink, PhD principal investigator

Harvard School of Public Health (HSPH)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Text message reminders in people with Malaria, run by Harvard School of Public Health (HSPH) at 1 site in Ghana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-reported Adherence to Artemisinin-combination Therapy (ACT) Treatment (time frame: 70 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01722734, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2014.