Clinical trial NCT01157442: Study of Cell Phone SMS Messages for Prevention of Maternal to Child Transmission of HIV
Official title: Harnessing Mobile Phone Usage for HIV and Horizontal Health Systems Improvement: PMTCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Keywords: prevention of maternal to child transmission of HIV
mhealth
access to antenatal care
pregnancy
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: University of Nairobi
name: Canadian International Development Agency
First posted: 2010-07-07
Enrollment: 856
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility 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.

Primary outcomes:
measure: increased nevirapine uptake in labour in pregnant HIV positive women from 60% to 70%
timeFrame: At time of delivery and/or postpartum visit
Secondary outcomes:
measure: HIV positive rates in infants born to mothers in the study
timeFrame: assessed at birth, 6 weeks and 3 months of age
measure: number of antenatal care visits
timeFrame: assessed at time of 6 week postpartum visit
measure: earlier identification and treatment of HIV positive infants
timeFrame: at 6 week infant visit
measure: acceptability fo smsm messages for PMTCT related care
timeFrame: at 6 week postpartum visit
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Pumwani Maternity Hospital
Study officials:
affiliation: University of Manitoba and University of Nairobi
name: Joshua Kimani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Health, NASCOP Kenya
name: Peter Cherutich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nairobi
name: Mary Gichuihi, Masters
role: STUDY_DIRECTOR
References: