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

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ClinicalTrials.gov Identifier: NCT01157442
Recruitment Status : Unknown
Verified July 2010 by University of Manitoba.
Recruitment status was:  Recruiting
First Posted : July 7, 2010
Last Update Posted : March 23, 2011
Sponsor:
Collaborators:
University of Nairobi
Canadian International Development Agency
Information provided by:
University of Manitoba

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: cell phone sms text messaging Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 856 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Harnessing Mobile Phone Usage for HIV and Horizontal Health Systems Improvement: PMTCT
Study Start Date : July 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. increased nevirapine uptake in labour in pregnant HIV positive women from 60% to 70% [ Time Frame: At time of delivery and/or postpartum visit ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01157442


Contacts
Contact: Joshua Kimani, MD jkimani@csrtkenya.org
Contact: Lisa S Avery, MD 1-204 272 3150 avery@cc.umanitoba.ca

Locations
Kenya
Pumwani Maternity Hospital Recruiting
Nairobi, Kenya
Contact: Mary Gichuhi       gichuhimary@yahoo.com   
Sponsors and Collaborators
University of Manitoba
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dr. Joshua Kimani, University of Manitoba and UNiversity of Nairobi
ClinicalTrials.gov Identifier: NCT01157442     History of Changes
Other Study ID Numbers: H2009:315
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: March 23, 2011
Last Verified: July 2010

Keywords provided by University of Manitoba:
prevention of maternal to child transmission of HIV
mhealth
access to antenatal care
pregnancy

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases