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
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||856 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- increased nevirapine uptake in labour in pregnant HIV positive women from 60% to 70% [ Time Frame: At time of delivery and/or postpartum visit ]
- HIV positive rates in infants born to mothers in the study [ Time Frame: 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 ]
- earlier identification and treatment of HIV positive infants [ Time Frame: at 6 week infant visit ]
- acceptability fo smsm messages for PMTCT related care [ Time Frame: at 6 week postpartum visit ]
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
|Contact: Joshua Kimani, MDfirstname.lastname@example.org|
|Contact: Lisa S Avery, MD||1-204 272 email@example.com|
|Pumwani Maternity Hospital||Recruiting|
|Contact: Mary Gichuhi firstname.lastname@example.org|
|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|