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

NCT ID: NCT01157442

Last Updated: 2011-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 856 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-03-31

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

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

cell phone sms messages

The experimental arm will receive the cell phone SMS text messaging intervention.

Group Type: EXPERIMENTAL

cell phone sms text messaging

Intervention Type: BEHAVIORAL

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.

Control

The control group will receive the standard of care but no SMS text messages.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nairobi

OTHER

Sponsor Role: collaborator

Canadian International Development Agency

OTHER_GOV

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

University of Manitoba and UNiversity of Nairobi

Principal Investigators

Joshua Kimani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba and University of Nairobi

Peter Cherutich, MD

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, NASCOP Kenya

Mary Gichuihi, Masters

Role: STUDY_DIRECTOR

University of Nairobi

Locations

Pumwani Maternity Hospital

Nairobi, , Kenya

Site Status: RECRUITING

Countries

Kenya

Central Contacts

Joshua Kimani, MD

Role: CONTACT

jkimani@csrtkenya.org

Lisa S Avery, MD

Role: CONTACT

avery@cc.umanitoba.ca

1-204 272 3150

Facility Contacts

Mary Gichuhi

Role: primary

gichuhimary@yahoo.com

Other Identifiers

H2009:315

Identifier Type: -

Identifier Source: org_study_id