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Clinical Trials

MainTitle

Improving Uptake of Early Infant Diagnosis of HIV for the Prevention of Mother-to-child Transmission of HIV (SMS4PMTCT)

This study has been completed
Sponsor
University of Washington

Collaborator
Kenya Medical Research Institute
University of California, San Francisco

Information provided by (Responsible Party)
Thomas Odeny, University of Washington

ClinicalTrials.gov Identifier
NCT01433185

First received: September 12, 2011
Last updated: January 19, 2015
Last Verified: January 2015
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infections
Acquired Immunodeficiency Syndrome

Other : Text message

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Uptake of Early Infant Diagnosis of HIV for PMTCT: a Randomized Trial of a Text Messaging Intervention

Further study details as provided by Thomas Odeny, University of Washington:

Primary Outcome Measures

  • Proportion of women who attend postnatal clinic within 6-8 weeks postpartum [ Time Frame: 6-8 weeks after delivery ]
  • Proportion of infants tested for HIV by DNA PCR [ Time Frame: 6-8 weeks after delivery ]
Secondary Outcome Measures:
  • Infant adherence to antiretroviral prophylaxis [ Time Frame: Up to 6 weeks after delivery ]
  • Time to post-natal clinic return [ Time Frame: Up to 8 weeks after delivery ]
  • Maternal adherence to antiretroviral prophylaxis [ Time Frame: Up to 8 weeks after delivery ]

Enrollment: 388
Study Start Date: April 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Text message (SMS)
Text messages sent to women before and after delivery
Other: Text message

Text messages sent to women before and after delivery

Other Name: SMS, short message service, text messaging
No Intervention: Usual care (current standard of care)
Current standard of care for women enrolled in PMTCT programs
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: Yes  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433185

Locations

Kenya
Kenya Medical Research Institute, Family AIDS Care and Education Services
Kisumu, Nyanza, Kenya

Sponsors and Collaborators

University of Washington
Kenya Medical Research Institute
University of California, San Francisco

Investigators

Principal Investigator: Thomas A Odeny, MBChB, MPH University of Washington/Kenya Medical Research Institute
Study Chair: R Scott McClelland, MD, MPH University of Washington
Study Chair: Craig R Cohen, MD, MPH University of California, San Francisco
Study Chair: Carol Camlin, PhD University of California, San Francisco
Study Chair: Elizabeth A Bukusi, MBChB, MMed, MPH, PhD Kenya Medical Research Institute
More Information

More Information


Responsible Party: Thomas Odeny, Principal Investigator, University of Washington  
ClinicalTrials.gov Identifier: NCT01433185   History of Changes  
Other Study ID Numbers: 41186-E/G  
Study First Received: September 12, 2011  
Last Updated: January 19, 2015  

Keywords provided by Thomas Odeny, University of Washington:

PMTCT
SMS
HIV Infections
Acquired Immunodeficiency Syndrome
Prevention & Control
Patient Compliance
Cellular Phone
Randomized Controlled Trial

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.