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Evaluation of the Impact of Mobile Phone Messages on ART and PMTCT Adherence in Mozambique (SMSaude)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01910493
First Posted: July 29, 2013
Last Update Posted: July 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Vodacom
United States Agency for International Development (USAID)
Department for International Development, United Kingdom
Information provided by (Responsible Party):
Absolute Return for Kids
  Purpose
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.

Condition Intervention
HIV-positive Behavioral: SMS reminders

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Impact of Mobile Phone Messages on ART and PMTCT Adherence in Mozambique: A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Absolute Return for Kids:

Primary Outcome Measures:
  • Retention in ART care [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Retention in PMTCT care [ Time Frame: until 8 weeks post partum ]

Enrollment: 1352
Study Start Date: November 2011
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ART no SMS reminders
control group
Behavioral: SMS reminders
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.
Active Comparator: PMTCT no SMS reminders
control group
Behavioral: SMS reminders
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.
Experimental: SMS reminders to PMTCT cohort
experimental group
Behavioral: SMS reminders
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.
Experimental: SMS reminders to ART cohort
experimental group
Behavioral: SMS reminders
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910493


Locations
Mozambique
6 Health Facilities
Matola, Xinavane, Machava and Namaacha, Maputo, Mozambique
Sponsors and Collaborators
Absolute Return for Kids
Vodacom
United States Agency for International Development (USAID)
Department for International Development, United Kingdom
Investigators
Principal Investigator: Cesar de Palha, MD University of Eduardo Mondlane
  More Information

Responsible Party: Absolute Return for Kids
ClinicalTrials.gov Identifier: NCT01910493     History of Changes
Other Study ID Numbers: SMSaude01
First Submitted: July 25, 2013
First Posted: July 29, 2013
Last Update Posted: July 29, 2013
Last Verified: July 2013

Keywords provided by Absolute Return for Kids:
mhealth
mobile health
SMS
SMS reminders
ART retention in care
PMTCT
PMTCT cascade
retention in care

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases