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

NCT ID: NCT01910493

Last Updated: 2013-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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HIV-positive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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ART no SMS reminders

control group

Group Type ACTIVE_COMPARATOR

SMS reminders

Intervention Type BEHAVIORAL

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.

PMTCT no SMS reminders

control group

Group Type ACTIVE_COMPARATOR

SMS reminders

Intervention Type BEHAVIORAL

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.

SMS reminders to PMTCT cohort

experimental group

Group Type EXPERIMENTAL

SMS reminders

Intervention Type BEHAVIORAL

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.

SMS reminders to ART cohort

experimental group

Group Type EXPERIMENTAL

SMS reminders

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vodacom

UNKNOWN

Sponsor Role collaborator

United States Agency for International Development (USAID)

FED

Sponsor Role collaborator

Department for International Development, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Absolute Return for Kids

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cesar de Palha, MD

Role: PRINCIPAL_INVESTIGATOR

University of Eduardo Mondlane

Locations

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6 Health Facilities

Matola, Xinavane, Machava and Namaacha, Maputo, Mozambique

Site Status

Countries

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Mozambique

Other Identifiers

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SMSaude01

Identifier Type: -

Identifier Source: org_study_id

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