Study of Cell Phone SMS Messages for Prevention of Maternal to Child Transmission of HIV

March 22, 2011 updated by: University of Manitoba

Harnessing Mobile Phone Usage for HIV and Horizontal Health Systems Improvement: PMTCT

Optimal development of sustainable health systems must use locally relevant infrastructure. Mobile phone technology, driven primarily by local market forces rather than foreign assistance, is spreading rapidly through African communities to improve people's personal and business communications. Here, the investigators propose using a structured mobile phone communications system for prevention of mother to child transmission of HIV (PMTCT). The system is designed to improve antenatal linkage to care, provide reminders to take PMTCT medications, and improve post-natal support and follow-up, even when mothers deliver at home. In addition to benefits in PMTCT related outcomes, this model allows evaluation of the intervention in a public health setting with the ultimate goal of advancing regional health systems development. The overall goal of of the study is to assess if mobile phones and SMS text messages can be used to help improve prevention of maternal to child transmission (PMTCT) of HIV services by strengthening health systems.

Specific objectives are:

1. To determine if mobile phone SMS text messages can demonstrate an improvement in compliance with a known intervention ( use of nevirapine) for PMTCT, demonstrated by:

1a) improved antenatal care attendance (greater than 4 visits)

1b) increased usage of nevirapine in labour (from 60% to at least 70%)

1c) earlier identification and treatment of HIV positive infants

1d) increased postpartum care for HIV positive mothers

1e) acceptability of cell phone SMS text messages transmission of information among HIV positive women

2. To demonstrate that mobile phone technology can be used as an effective tool to strengthen PMTCT health information systems at the facility level by: 2a) determining factors that constrain or promote the use of cell phone technology to strengthen PMTCT health information systems from the perspective of patients, health care providers and policy makers 2b) determining how cell phones can be used as a tool to generate equity statistics for PMTCT programs and formulate equity orientated PMTCT policies 2c) determine if early involvement of policy makers in the study improves knowledge translation

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

856

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Women will be eligible to participate if they:

  • are pregnant with a singleton pregnancy,
  • attend care at Pumwani Maternity Hospital,
  • are HIV positive,
  • have never had a preterm birth (before 37 weeks),
  • are planning to reside in Nairobi for at least 6 months post delivery,
  • live within 15 km of PMH,
  • have basic literacy skills in Kiswahili or English,
  • are willing to be contacted for follow up and have their own cell phone or regular access to their partners' cell phone (partners must be aware of their HIV status).

Exclusion Criteria:

  • Women who are pregnant and attend care at Pumwani Maternity Hospital who are not HIV positive,
  • Women who have had a preterm birth,
  • Women who are not planning to reside in Nairobi for at least 6 months post delivery,
  • Women who do not live within 15 km of PMH,
  • Women who do not have basic literacy skills in English or Kiswahili
  • Women who are not willing to be contacted for follow up,
  • Women who do not have their own cell phone or regular access to their partner's cell phone and
  • Women whose partner's are not aware of their HIV status.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cell phone sms messages
The experimental arm will receive the cell phone SMS text messaging intervention.
Behavioral: cell phone sms text messaging
At enrollment a study nurse will send the intervention group a weekly SMS message reminding them to attend antenatal care. Starting at 36 weeks gestational age, an automated bulk SMS management system, will send the intervention group 3 SMS text messages (using non descript slogans) each week by proxy reminding them to take their nevirapine in labor. From time of delivery to 6 weeks postpartum the women will aslo receive 3 SMS messages per week reminding them to attend their 6 week checkup and 6 week infant visit.Upon receiving these messages women in the intervention group can text back if they have any concerns or questions. These women would then receive phone calls from the study nurse triaged according to the women's needs.
No Intervention: Control
The control group will receive the standard of care but no SMS text messages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
increased nevirapine uptake in labour in pregnant HIV positive women from 60% to 70%
Time Frame: At time of delivery and/or postpartum visit
At time of delivery and/or postpartum visit

Secondary Outcome Measures

Outcome Measure
Time Frame
HIV positive rates in infants born to mothers in the study
Time Frame: assessed at birth, 6 weeks and 3 months of age
assessed at birth, 6 weeks and 3 months of age
number of antenatal care visits
Time Frame: assessed at time of 6 week postpartum visit
assessed at time of 6 week postpartum visit
earlier identification and treatment of HIV positive infants
Time Frame: at 6 week infant visit
at 6 week infant visit
acceptability fo smsm messages for PMTCT related care
Time Frame: at 6 week postpartum visit
at 6 week postpartum visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

University of Nairobi
Canadian International Development Agency

Investigators

  • Principal Investigator: Joshua Kimani, MD, University of Manitoba and University of Nairobi
  • Principal Investigator: Peter Cherutich, MD, Ministry of Health, NASCOP Kenya
  • Study Director: Mary Gichuihi, Masters, University of Nairobi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

July 2, 2010

First Submitted That Met QC Criteria

July 6, 2010

First Posted (Estimate)

July 7, 2010

Study Record Updates

Last Update Posted (Estimate)

March 23, 2011

Last Update Submitted That Met QC Criteria

March 22, 2011

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2009:315

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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