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

HIV-positive Clinical Trial

— SMSaude  

Official title:

Evaluation of the Impact of Mobile Phone Messages on ART and PMTCT Adherence in Mozambique: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01910493
• Other study ID #: SMSaude01
• Status: Completed
• Phase: N/A
• First received: July 25, 2013
• Last updated: July 25, 2013
• Start date: November 2011
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Absolute Return for Kids
• Contact: n/a
• Is FDA regulated: No
• Health authority: University of Eduardo Mondlane: MozambiqueMinistry of Health: Mozambique
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1352
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Seropositivity
• HIV-positive

Intervention

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.

Locations

Country	Name	City	State
Mozambique	6 Health Facilities	Matola, Xinavane, Machava and Namaacha	Maputo

Sponsors (4)

Lead Sponsor	Collaborator
Absolute Return for Kids	Department for International Development, United Kingdom, United States Agency for International Development (USAID), Vodacom

Country where clinical trial is conducted

Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention in ART care		12 months	No
Secondary	Retention in PMTCT care		until 8 weeks post partum	No