search
Back to results

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

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
cell phone sms text messaging
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring prevention of maternal to child transmission of HIV, mhealth, access to antenatal care, pregnancy

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Pumwani Maternity HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cell phone sms messages

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

increased nevirapine uptake in labour in pregnant HIV positive women from 60% to 70%

Secondary Outcome Measures

HIV positive rates in infants born to mothers in the study
number of antenatal care visits
earlier identification and treatment of HIV positive infants
acceptability fo smsm messages for PMTCT related care

Full Information

First Posted
July 2, 2010
Last Updated
March 22, 2011
Sponsor
University of Manitoba
Collaborators
University of Nairobi, Canadian International Development Agency
search

1. Study Identification

Unique Protocol Identification Number
NCT01157442
Brief Title
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

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Manitoba
Collaborators
University of Nairobi, Canadian International Development Agency

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
prevention of maternal to child transmission of HIV, mhealth, access to antenatal care, pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
856 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cell phone sms messages
Arm Type
Experimental
Arm Description
The experimental arm will receive the cell phone SMS text messaging intervention.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will receive the standard of care but no SMS text messages.
Intervention Type
Behavioral
Intervention Name(s)
cell phone sms text messaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
increased nevirapine uptake in labour in pregnant HIV positive women from 60% to 70%
Time Frame
At time of delivery and/or postpartum visit
Secondary Outcome Measure Information:
Title
HIV positive rates in infants born to mothers in the study
Time Frame
assessed at birth, 6 weeks and 3 months of age
Title
number of antenatal care visits
Time Frame
assessed at time of 6 week postpartum visit
Title
earlier identification and treatment of HIV positive infants
Time Frame
at 6 week infant visit
Title
acceptability fo smsm messages for PMTCT related care
Time Frame
at 6 week postpartum visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Kimani, MD
Email
jkimani@csrtkenya.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa S Avery, MD
Phone
1-204 272 3150
Email
avery@cc.umanitoba.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Kimani, MD
Organizational Affiliation
University of Manitoba and University of Nairobi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Cherutich, MD
Organizational Affiliation
Ministry of Health, NASCOP Kenya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary Gichuihi, Masters
Organizational Affiliation
University of Nairobi
Official's Role
Study Director
Facility Information:
Facility Name
Pumwani Maternity Hospital
City
Nairobi
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Gichuhi
Email
gichuhimary@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs