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Trial record 6 of 31 for:    " July 17, 2013":" August 16, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

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ClinicalTrials.gov Identifier: NCT01910493
Recruitment Status : Completed
First Posted : July 29, 2013
Last Update Posted : July 29, 2013
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

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
HIV-positive Behavioral: SMS reminders Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : November 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. Retention in ART care [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Retention in PMTCT care [ Time Frame: until 8 weeks post partum ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Absolute Return for Kids
ClinicalTrials.gov Identifier: NCT01910493     History of Changes
Other Study ID Numbers: SMSaude01
First Posted: July 29, 2013    Key Record Dates
Last Update Posted: July 29, 2013
Last Verified: July 2013

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