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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Manitoba.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Nairobi
Canadian International Development Agency
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01157442
First received: July 2, 2010
Last updated: March 22, 2011
Last verified: July 2010

July 2, 2010
March 22, 2011
July 2010
December 2011   (final data collection date for primary outcome measure)
increased nevirapine uptake in labour in pregnant HIV positive women from 60% to 70% [ Time Frame: At time of delivery and/or postpartum visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01157442 on ClinicalTrials.gov Archive Site
  • HIV positive rates in infants born to mothers in the study [ Time Frame: assessed at birth, 6 weeks and 3 months of age ] [ Designated as safety issue: No ]
  • number of antenatal care visits [ Time Frame: assessed at time of 6 week postpartum visit ] [ Designated as safety issue: No ]
  • earlier identification and treatment of HIV positive infants [ Time Frame: at 6 week infant visit ] [ Designated as safety issue: No ]
  • acceptability fo smsm messages for PMTCT related care [ Time Frame: at 6 week postpartum visit ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Cell Phone SMS Messages for Prevention of Maternal to Child Transmission of HIV
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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
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.
  • Experimental: cell phone sms messages
    The experimental arm will receive the cell phone SMS text messaging intervention.
    Intervention: Behavioral: cell phone sms text messaging
  • No Intervention: Control
    The control group will receive the standard of care but no SMS text messages.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
856
March 2012
December 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years to 49 Years
Yes
Contact: Joshua Kimani, MD jkimani@csrtkenya.org
Contact: Lisa S Avery, MD 1-204 272 3150 avery@cc.umanitoba.ca
Kenya
 
NCT01157442
H2009:315
No
Dr. Joshua Kimani, University of Manitoba and UNiversity of Nairobi
University of Manitoba
  • University of Nairobi
  • Canadian International Development Agency
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
University of Manitoba
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP