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

Sponsor
Absolute Return for Kids (Other)
Overall Status
Completed
CT.gov ID
NCT01910493
Collaborator
Vodacom (Other), United States Agency for International Development (USAID) (U.S. Fed), Department for International Development, United Kingdom (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SMS reminders
N/A

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

Study Type:
Interventional
Actual Enrollment :
1352 participants
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
Study Start Date :
Nov 1, 2011
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Retention in ART care [12 months]

Secondary Outcome Measures

  1. Retention in PMTCT care [until 8 weeks post partum]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Absolute Return for Kids
ClinicalTrials.gov Identifier:
NCT01910493
Other Study ID Numbers:
  • SMSaude01
First Posted:
Jul 29, 2013
Last Update Posted:
Jul 29, 2013
Last Verified:
Jul 1, 2013
Keywords provided by Absolute Return for Kids
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2013