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

Primary Purpose

HIV-positive

Status

Completed

Phase

Not Applicable

Locations

Mozambique

Study Type

Interventional

Intervention

SMS reminders

About this trial

This is an interventional treatment trial for HIV-positive focused on measuring mhealth, mobile health, SMS, SMS reminders, ART retention in care, PMTCT, PMTCT cascade, retention in care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

Sites / Locations

6 Health Facilities

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

ART no SMS reminders

PMTCT no SMS reminders

SMS reminders to PMTCT cohort

SMS reminders to ART cohort

Arm Description

control group

experimental group

Outcomes

Primary Outcome Measures

Retention in ART care

Secondary Outcome Measures

Retention in PMTCT care

Full Information

NCT ID

NCT01910493

First Posted

July 25, 2013

Last Updated

July 25, 2013

Sponsor

Absolute Return for Kids

Collaborators

Vodacom, United States Agency for International Development (USAID), Department for International Development, United Kingdom

1. Study Identification

Unique Protocol Identification Number

NCT01910493

Brief Title

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

Acronym

SMSaude

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Absolute Return for Kids

Collaborators

Vodacom, United States Agency for International Development (USAID), Department for International Development, United Kingdom

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV-positive

Keywords

mhealth, mobile health, SMS, SMS reminders, ART retention in care, PMTCT, PMTCT cascade, retention in care

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1352 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ART no SMS reminders

Arm Type

Active Comparator

Arm Description

control group

Arm Title

PMTCT no SMS reminders

Arm Type

Active Comparator

Arm Description

control group

Arm Title

SMS reminders to PMTCT cohort

Arm Type

Experimental

Arm Description

experimental group

Arm Title

SMS reminders to ART cohort

Arm Type

Experimental

Arm Description

experimental group

Intervention Type

Behavioral

Intervention Name(s)

SMS reminders

Intervention Description

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.

Primary Outcome Measure Information:

Title

Retention in ART care

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Retention in PMTCT care

Time Frame

until 8 weeks post partum

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cesar de Palha, MD

Organizational Affiliation

University of Eduardo Mondlane

Official's Role

Principal Investigator

Facility Information:

Facility Name

6 Health Facilities

City

Matola, Xinavane, Machava and Namaacha

State/Province

Maputo

Country

Mozambique

12. IPD Sharing Statement

Learn more about this trial

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

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