Study of Cell Phone SMS Messages for Prevention of Maternal to Child Transmission of HIV
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
HIV Infections |
Behavioral: cell phone sms text messaging |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Harnessing Mobile Phone Usage for HIV and Horizontal Health Systems Improvement: PMTCT |
- 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 ]
- 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 ]
| Estimated Enrollment: | 856 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01157442
| Contact: Joshua Kimani, MD | jkimani@csrtkenya.org | ||
| Contact: Lisa S Avery, MD | 1-204 272 3150 | avery@cc.umanitoba.ca |
| Kenya | |
| Pumwani Maternity Hospital | Recruiting |
| Nairobi, Kenya | |
| Contact: Mary Gichuhi gichuhimary@yahoo.com | |
| 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
| 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 |
| Study First Received: | July 2, 2010 |
| Last Updated: | March 22, 2011 |
| Health Authority: | Canada: Ethics Review Committee Kenya: Ethical Review Committee |
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 |
ClinicalTrials.gov processed this record on September 27, 2016