HIV-positiveSMSaudeNCT01910493
Evaluation of the Impact of Mobile Phone Messages on ART and PMTCT Adherence in Mozambique
A study testing SMS reminders in people with HIV-positive, run by Absolute Return for Kids at 1 site in Mozambique.
Trial summary
Mobile phone SMS are increasingly used to promote positive health behaviour with an aim to improve health outcomes. However, robust data on the efficacy of SMS on health seeking behaviour and patient outcomes in resource-limited settings is sparse. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-positive
- What is being tested?
- SMS reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,352 participants
- Where
- 1 siteMozambique
- Study dates
- Nov 2011to Jun 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- On ART for >15 days (for ART only)
- Live in province and plan to stay for 12+ months
- Have cell phone
- Literate
- For PMTCT (in addition to above criteria):
- pregnant between 8-28 weeks
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Mozambique1 site
6 Health Facilities
Matola, Xinavane, Machava and Namaacha, Maputo
About this study
Official title: Evaluation of the Impact of Mobile Phone Messages on ART and PMTCT Adherence in Mozambique: A Randomized Control Trial
Mobile phone SMS are increasingly used to promote positive health behaviour with an aim to improve health outcomes. However, robust data on the efficacy of SMS on health seeking behaviour and patient outcomes in resource-limited settings is sparse. The SMSaude study aims to assess whether regular SMS-reminders improve retention on antiretroviral therapy (ART) and prevention of mother to child transmission of HIV (PMTCT) programmes in Mozambique.
Read the detailed description
SMSaúde is a multisite randomised clinical trial of HIV-infected adults on ART and HIV-infected pregnant women in six clinics in Maputo Province, Mozambique. Eligibility criteria include: currently residing in the province; no plans to move for 12+ months; have own cell-phone; literate; 8-28 weeks pregnant (PMTCT cohort); on first line ART and on ART for >15 days (ART cohort). Patients were interviewed for eligibility, and then randomized (1:1). SMS reminders are sent to the intervention group using software that picks up the patient's next appointment from the electronic patient database. Primary outcomes tested were improved retention in ART care and uptake of all PMTCT services.
- Conditions
- HIV-positive
- Being tested
- SMS reminders
- Keywords
- mhealth, mobile health, SMS, SMS reminders, ART retention in care, PMTCT, PMTCT cascade, retention in care
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS remindersBehavioural
Intervention participants only will be sent text messages to their phones. The content of text messages will have a maximum of 160 characters and not mention HIV and will state the dates for the forthcoming consultations, visits to the pharmacy, lab results, time to take medication and reminders for patients who miss appointments.
| Study group | Role | What they receive |
|---|---|---|
| ART no SMS reminders | Active comparator | control group Receives: Behavioral: SMS reminders |
| PMTCT no SMS reminders | Active comparator | control group Receives: Behavioral: SMS reminders |
| SMS reminders to PMTCT cohort | Experimental | experimental group Receives: Behavioral: SMS reminders |
| SMS reminders to ART cohort | Experimental | experimental group Receives: Behavioral: SMS reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in ART care
Measured: 12 months
Secondary outcomes (1)
Retention in PMTCT care
Measured: until 8 weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-positiveStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Absolute Return for Kids
- Sponsor type
- University, hospital or other
- Collaborators
- Vodacom, United States Agency for International Development (USAID), Department for International Development, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Cesar de Palha, MD, Principal investigator, University of Eduardo Mondlane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910493
- Sponsor's protocol ID
- SMSaude01
- Acronym
- SMSaude
- Status last verified
- Jul 2013
- First submitted
- 25 Jul 2013
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Mobile Phone Messages on ART and PMTCT Adherence in Mozambique: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01910493
- Acronym / sponsor ID
- SMSaude / SMSaude01
- Conditions
- HIV-positive
- Keywords
- mhealth, mobile health, SMS, SMS reminders, ART retention in care, PMTCT, PMTCT cascade, retention in care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,352 participants (actual)
- Lead sponsor
- Absolute Return for KidsUniversity, hospital or other
- Collaborators
- Vodacom, United States Agency for International Development (USAID), Department for International Development, United Kingdom
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Jul 2013 (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.
Mobile phone SMS are increasingly used to promote positive health behaviour with an aim to improve health outcomes. However, robust data on the efficacy of SMS on health seeking behaviour and patient outcomes in resource-limited settings is sparse. The SMSaude study aims to assess whether regular SMS-reminders improve retention on antiretroviral therapy (ART) and prevention of mother to child transmission of HIV (PMTCT) programmes in Mozambique.
Detailed description
SMSaúde is a multisite randomised clinical trial of HIV-infected adults on ART and HIV-infected pregnant women in six clinics in Maputo Province, Mozambique. Eligibility criteria include: currently residing in the province; no plans to move for 12+ months; have own cell-phone; literate; 8-28 weeks pregnant (PMTCT cohort); on first line ART and on ART for >15 days (ART cohort). Patients were interviewed for eligibility, and then randomized (1:1). SMS reminders are sent to the intervention group using software that picks up the patient's next appointment from the electronic patient database. Primary outcomes tested were improved retention in ART care and uptake of all PMTCT services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ART no SMS reminders | Active comparator | Behavioral: SMS reminderscontrol group |
| PMTCT no SMS reminders | Active comparator | Behavioral: SMS reminderscontrol group |
| SMS reminders to PMTCT cohort | Experimental | Behavioral: SMS remindersexperimental group |
| SMS reminders to ART cohort | Experimental | Behavioral: SMS remindersexperimental group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- On ART for >15 days (for ART only)
- Live in province and plan to stay for 12+ months
- Have cell phone
- Literate
- pregnant between 8-28 weeks
Key exclusion criteria (1 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 |
|---|---|---|
| SMS remindersIntervention participants only will be sent text messages to their phones. The content of text messages will have a maximum of 160 characters and not mention HIV and will state the dates for the forthcoming consultations, visits to the pharmacy, lab results, time to take medication and reminders for patients who miss appointments. | Behavioural | ART no SMS reminders, PMTCT no SMS reminders, SMS reminders to ART cohort, SMS reminders to PMTCT cohort |
Primary outcome
Retention in ART care
Time frame: 12 months
1 secondary outcome
Retention in PMTCT care
Time frame: until 8 weeks post partum
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 29 Jul 2013.
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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.
Cesar de Palha, MD principal investigator
University of Eduardo Mondlane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS reminders in people with HIV-positive, run by Absolute Return for Kids at 1 site in Mozambique.
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 6 inclusion and 1 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 29 Jul 2013. 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 Mozambique. 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?
Retention in ART care (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2013.