HIV Infections Clinical Trial
Official title:
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
Status | Recruiting |
Enrollment | 856 |
Est. completion date | March 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Kenya | Pumwani Maternity Hospital | Nairobi |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Canadian International Development Agency, University of Nairobi |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | increased nevirapine uptake in labour in pregnant HIV positive women from 60% to 70% | At time of delivery and/or postpartum visit | No | |
Secondary | HIV positive rates in infants born to mothers in the study | assessed at birth, 6 weeks and 3 months of age | No | |
Secondary | number of antenatal care visits | assessed at time of 6 week postpartum visit | No | |
Secondary | earlier identification and treatment of HIV positive infants | at 6 week infant visit | No | |
Secondary | acceptability fo smsm messages for PMTCT related care | at 6 week postpartum visit | No |
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