MalariaNCT02561624
Hati Salama (Secure Voucher)
A study testing Behaviour change communication via text message in people with Malaria, run by Queen's University at 1 site in Tanzania.
Trial summary
The use of long-lasting insecticide treated nets (LLINs) is shown to reduce malaria prevalence. The Tanzania Net Voucher Scheme has been an active component of bed net distribution to pregnant women in Tanzania since 2004. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Behaviour change communication via text message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,219 participants
- Where
- 1 siteTanzania
- Study dates
- Jul 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women capable of providing informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expanding the Successful E-voucher System to Improve Malaria Prevention and Fight New Global Health Threats Through Innovative Health Partnerships and Mobile Phone Technology in Tanzania
The use of long-lasting insecticide treated nets (LLINs) is shown to reduce malaria prevalence. The Tanzania Net Voucher Scheme has been an active component of bed net distribution to pregnant women in Tanzania since 2004. The transition from paper vouchers to electronic vouchers in this program has increased efficiency and the ability to track and distribute nets since 2007. Although the program has been successful, to date, electronic voucher redemption varies widely across the country and it has not been clearly established as to what barriers exist for women who receive electronic vouchers in the program. This cluster-randomized trial was designed to examine perceived barriers to electronic voucher redemption among pregnant women and to evaluate if educational and personalized text messages around electronic voucher redemption and bed net usage will increase electronic voucher redemption when directed at pregnant women who receive electronic vouchers in the currently existing program.
- Conditions
- Malaria
- Being tested
- Behaviour change communication via text message
- Keywords
- mHealth, Text message
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behaviour change communication via text messageBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Use of behaviour change communication via text messages to pregnant women receiving an electronic voucher for long lasting insecticide treated nets redemption through antenatal clinics. Receives: Behavioral: Behaviour change communication via text message |
| Control | No intervention | Control group receives no behaviour change communication via text message, but receives an electronic voucher for long lasting insecticide treated nets redemption through antenatal clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased uptake of long-lasting insecticide treated nets from retailers using an electronic voucher through text messaging.
The outcome measure will be assessed by LLIN evoucher redemption.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5,219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Mennonite Economic Development Associates
- Responsible party
- Principal investigator, Dr. Karen Yeates, Queen's University
- Investigators
- Karen Yeates, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561624
- Sponsor's protocol ID
- DMED-1712-14
- Status last verified
- Apr 2016
- First submitted
- 20 Jul 2015
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Vey T, Kinnicutt E, Day AG, West N, Sleeth J, Nchimbi KB, Yeates K. Targeted Behavior Change Communication Using a Mobile Health Platform to Increase Uptake of Long-Lasting Insecticidal Nets Among Pregnant Women in Tanzania: Hati Salama "Secure Voucher" Study Cluster Randomized Controlled Trial. J Med Internet Res. 2025 Mar 19;27:e51524. doi: 10.2196/51524.
PubMed 40106816Vey T, Kinnicutt E, West N, Sleeth J, Nchimbi KB, Yeates K. Implementation of a Mobile Health Approach to a Long-Lasting Insecticidal Net Uptake Intervention for Malaria Prevention Among Pregnant Women in Tanzania: Process Evaluation of the Hati Salama (HASA) Randomized Controlled Trial Study. J Med Internet Res. 2024 Nov 5;26:e51527. doi: 10.2196/51527.
PubMed 39499551
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding the Successful E-voucher System to Improve Malaria Prevention and Fight New Global Health Threats Through Innovative Health Partnerships and Mobile Phone Technology in Tanzania
- ClinicalTrials.gov ID
- NCT02561624
- Acronym / sponsor ID
- DMED-1712-14
- Conditions
- Malaria
- Keywords
- mHealth, Text message
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,219 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Mennonite Economic Development Associates
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of long-lasting insecticide treated nets (LLINs) is shown to reduce malaria prevalence. The Tanzania Net Voucher Scheme has been an active component of bed net distribution to pregnant women in Tanzania since 2004. The transition from paper vouchers to electronic vouchers in this program has increased efficiency and the ability to track and distribute nets since 2007. Although the program has been successful, to date, electronic voucher redemption varies widely across the country and it has not been clearly established as to what barriers exist for women who receive electronic vouchers in the program. This cluster-randomized trial was designed to examine perceived barriers to electronic voucher redemption among pregnant women and to evaluate if educational and personalized text messages around electronic voucher redemption and bed net usage will increase electronic voucher redemption when directed at pregnant women who receive electronic vouchers in the currently existing program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Behaviour change communication via text messageUse of behaviour change communication via text messages to pregnant women receiving an electronic voucher for long lasting insecticide treated nets redemption through antenatal clinics. |
| Control | No intervention | –Control group receives no behaviour change communication via text message, but receives an electronic voucher for long lasting insecticide treated nets redemption through antenatal clinics. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women capable of providing informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Behaviour change communication via text message | Behavioural | Intervention |
Primary outcome
Increased uptake of long-lasting insecticide treated nets from retailers using an electronic voucher through text messaging.
Time frame: 12 weeks
The outcome measure will be assessed by LLIN evoucher redemption.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Derived from this study: PubMed 40106816Vey T, Kinnicutt E, Day AG, West N, Sleeth J, Nchimbi KB, Yeates K. Targeted Behavior Change Communication Using a Mobile Health Platform to Increase Uptake of Long-Lasting Insecticidal Nets Among Pregnant Women in Tanzania: Hati Salama "Secure Voucher" Study Cluster Randomized Controlled Trial. J Med Internet Res. 2025 Mar 19;27:e51524. doi: 10.2196/51524.
- Derived from this study: PubMed 39499551Vey T, Kinnicutt E, West N, Sleeth J, Nchimbi KB, Yeates K. Implementation of a Mobile Health Approach to a Long-Lasting Insecticidal Net Uptake Intervention for Malaria Prevention Among Pregnant Women in Tanzania: Process Evaluation of the Hati Salama (HASA) Randomized Controlled Trial Study. J Med Internet Res. 2024 Nov 5;26:e51527. doi: 10.2196/51527.
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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.
Karen Yeates, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behaviour change communication via text message in people with Malaria, run by Queen's University at 1 site in Tanzania.
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 0 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 13 Apr 2016. 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 Tanzania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Increased uptake of long-lasting insecticide treated nets from retailers using an electronic voucher through text messaging. (time frame: 12 weeks). 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 NCT02561624, which also lists 2 linked publications.
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 13 Apr 2016.