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

HIV Infections Clinical Trial

Official title:

Harnessing Mobile Phone Usage for HIV and Horizontal Health Systems Improvement: PMTCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01157442
• Other study ID #: H2009:315
• Status: Recruiting
• Phase: N/A
• First received: July 2, 2010
• Last updated: March 22, 2011
• Start date: July 2010
• Est. completion date: March 2012

Study information

• Verified date: July 2010
• Source: University of Manitoba
• Contact: Joshua Kimani, MD
• Email: jkimani[@]csrtkenya.org
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeKenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

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.

Locations

Country	Name	City	State
Kenya	Pumwani Maternity Hospital	Nairobi

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	Canadian International Development Agency, University of Nairobi

Country where clinical trial is conducted

Kenya, 

Outcome

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