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

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ClinicalTrials.gov Identifier: NCT01910493
Recruitment Status : Completed
First Posted : July 29, 2013
Last Update Posted : July 29, 2013
Sponsor:
Collaborators:
Vodacom
United States Agency for International Development (USAID)
Department for International Development, United Kingdom
Information provided by (Responsible Party):
Absolute Return for Kids

Tracking Information
First Submitted Date  ICMJE July 25, 2013
First Posted Date  ICMJE July 29, 2013
Last Update Posted Date July 29, 2013
Study Start Date  ICMJE November 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2013)
Retention in ART care [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2013)
Retention in PMTCT care [ Time Frame: until 8 weeks post partum ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Impact of Mobile Phone Messages on ART and PMTCT Adherence in Mozambique
Official Title  ICMJE Evaluation of the Impact of Mobile Phone Messages on ART and PMTCT Adherence in Mozambique: A Randomized Control Trial
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV-positive
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: ART no SMS reminders
    control group
    Intervention: Behavioral: SMS reminders
  • Active Comparator: PMTCT no SMS reminders
    control group
    Intervention: Behavioral: SMS reminders
  • Experimental: SMS reminders to PMTCT cohort
    experimental group
    Intervention: Behavioral: SMS reminders
  • Experimental: SMS reminders to ART cohort
    experimental group
    Intervention: Behavioral: SMS reminders
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2013)
1352
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mozambique
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01910493
Other Study ID Numbers  ICMJE SMSaude01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Absolute Return for Kids
Study Sponsor  ICMJE Absolute Return for Kids
Collaborators  ICMJE
  • Vodacom
  • United States Agency for International Development (USAID)
  • Department for International Development, United Kingdom
Investigators  ICMJE
Principal Investigator: Cesar de Palha, MD University of Eduardo Mondlane
PRS Account Absolute Return for Kids
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP