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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01910493
First received: July 25, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  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: Double Blind (Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Retention in PMTCT care [ Time Frame: until 8 weeks post partum ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Absolute Return for Kids
ClinicalTrials.gov Identifier: NCT01910493     History of Changes
Other Study ID Numbers: SMSaude01
Study First Received: July 25, 2013
Last Updated: July 25, 2013
Health Authority: University of Eduardo Mondlane: Mozambique
Ministry of Health: Mozambique

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

ClinicalTrials.gov processed this record on October 16, 2014