Improving Uptake of Early Infant Diagnosis of HIV for the Prevention of Mother-to-child Transmission of HIV (SMS4PMTCT)
Primary Purpose
HIV Infections, Acquired Immunodeficiency Syndrome
Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Text message
Sponsored by
About this trial
This is an interventional supportive care trial for HIV Infections focused on measuring PMTCT, SMS, HIV Infections, Acquired Immunodeficiency Syndrome, Prevention & Control, Patient Compliance, Cellular Phone, Randomized Controlled Trial
Eligibility Criteria
Inclusion Criteria:
- age at least 18 years
- report ability to read SMS
- ≥ 28 weeks gestation or delivery at study clinic on day of enrollment
- HIV positive women enrolled in the PMTCT program
- have access to a mobile phone (personal or partner's if HIV serostatus disclosed to partner)
- willing to receive SMS messages from the study
- planning to remain in the study area (Nyanza province) for the duration of the study
Exclusion Criteria:
- age less than 18 years old
- women who share phones with partners but HIV status not disclosed to partners
- intention to deliver at a non-study hospital
Sites / Locations
- Kenya Medical Research Institute, Family AIDS Care and Education Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Text message (SMS)
Usual care (current standard of care)
Arm Description
Text messages sent to women before and after delivery
Current standard of care for women enrolled in PMTCT programs
Outcomes
Primary Outcome Measures
Proportion of women who attend postnatal clinic within 6-8 weeks postpartum
Proportion of infants tested for HIV by DNA PCR
Secondary Outcome Measures
Infant adherence to antiretroviral prophylaxis
Time to post-natal clinic return
Maternal adherence to antiretroviral prophylaxis
Full Information
NCT ID
NCT01433185
First Posted
September 12, 2011
Last Updated
January 19, 2015
Sponsor
University of Washington
Collaborators
Kenya Medical Research Institute, University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01433185
Brief Title
Improving Uptake of Early Infant Diagnosis of HIV for the Prevention of Mother-to-child Transmission of HIV
Acronym
SMS4PMTCT
Official Title
Improving Uptake of Early Infant Diagnosis of HIV for PMTCT: a Randomized Trial of a Text Messaging Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Kenya Medical Research Institute, University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Early accurate diagnosis is one of the first crucial steps in care for infants born to HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early diagnosis and results in significant reductions in infant morbidity and mortality. There is little information on evidence-based interventions that specifically target improved attendance of postpartum clinic visits and subsequent infant HIV testing in the context of prevention of mother-to-child transmission of HIV (PMTCT) programs. The investigators propose a randomized controlled trial to examine the effect of text messages sent to women enrolled in PMTCT programs on adherence to postpartum clinic visits and uptake of early infant diagnosis by DNA polymerase chain reaction (PCR). This study seeks to test the hypotheses that (a) text messages sent to women enrolled in PMTCT will improve their attendance at the postnatal clinic within the first 6-8 weeks after childbirth; and (b) text messages sent to women enrolled in PMTCT programs will increase uptake of DNA PCR HIV testing at 6-8 weeks among infants exposed to HIV. This study will evaluate a novel strategy to improve adherence to postnatal clinic visits and increase the uptake of infant HIV testing. If proven superior to standard care, the proposed intervention can be easily scaled-up and integrated into existing healthcare systems in resource-limited settings. Findings from this study will provide randomized trial evidence to inform HIV prevention program planners and implementers. This study will also provide further information on the feasibility of using mobile phone-based technology for public health interventions in resource-limited settings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Acquired Immunodeficiency Syndrome
Keywords
PMTCT, SMS, HIV Infections, Acquired Immunodeficiency Syndrome, Prevention & Control, Patient Compliance, Cellular Phone, Randomized Controlled Trial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
388 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Text message (SMS)
Arm Type
Experimental
Arm Description
Text messages sent to women before and after delivery
Arm Title
Usual care (current standard of care)
Arm Type
No Intervention
Arm Description
Current standard of care for women enrolled in PMTCT programs
Intervention Type
Other
Intervention Name(s)
Text message
Other Intervention Name(s)
SMS, short message service, text messaging
Intervention Description
Text messages sent to women before and after delivery
Primary Outcome Measure Information:
Title
Proportion of women who attend postnatal clinic within 6-8 weeks postpartum
Time Frame
6-8 weeks after delivery
Title
Proportion of infants tested for HIV by DNA PCR
Time Frame
6-8 weeks after delivery
Secondary Outcome Measure Information:
Title
Infant adherence to antiretroviral prophylaxis
Time Frame
Up to 6 weeks after delivery
Title
Time to post-natal clinic return
Time Frame
Up to 8 weeks after delivery
Title
Maternal adherence to antiretroviral prophylaxis
Time Frame
Up to 8 weeks after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age at least 18 years
report ability to read SMS
≥ 28 weeks gestation or delivery at study clinic on day of enrollment
HIV positive women enrolled in the PMTCT program
have access to a mobile phone (personal or partner's if HIV serostatus disclosed to partner)
willing to receive SMS messages from the study
planning to remain in the study area (Nyanza province) for the duration of the study
Exclusion Criteria:
age less than 18 years old
women who share phones with partners but HIV status not disclosed to partners
intention to deliver at a non-study hospital
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas A Odeny, MBChB, MPH
Organizational Affiliation
University of Washington/Kenya Medical Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
R Scott McClelland, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Craig R Cohen, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carol Camlin, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elizabeth A Bukusi, MBChB, MMed, MPH, PhD
Organizational Affiliation
Kenya Medical Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Kenya Medical Research Institute, Family AIDS Care and Education Services
City
Kisumu
State/Province
Nyanza
Country
Kenya
12. IPD Sharing Statement
Citations:
PubMed Identifier
25313586
Citation
Odeny TA, Bukusi EA, Cohen CR, Yuhas K, Camlin CS, McClelland RS. Texting improves testing: a randomized trial of two-way SMS to increase postpartum prevention of mother-to-child transmission retention and infant HIV testing. AIDS. 2014 Sep 24;28(15):2307-12. doi: 10.1097/QAD.0000000000000409.
Results Reference
result
PubMed Identifier
25181408
Citation
Odeny TA, Newman M, Bukusi EA, McClelland RS, Cohen CR, Camlin CS. Developing content for a mHealth intervention to promote postpartum retention in prevention of mother-to-child HIV transmission programs and early infant diagnosis of HIV: a qualitative study. PLoS One. 2014 Sep 2;9(9):e106383. doi: 10.1371/journal.pone.0106383. eCollection 2014.
Results Reference
result
Learn more about this trial
Improving Uptake of Early Infant Diagnosis of HIV for the Prevention of Mother-to-child Transmission of HIV
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