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:
Collaborators:
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: October 22, 2013
Last verified: October 2013

September 12, 2011
October 22, 2013
April 2012
July 2013   (final data collection date for primary outcome measure)
  • Proportion of women who attend postnatal clinic within 6-8 weeks postpartum [ Time Frame: 6-8 weeks after delivery ] [ Designated as safety issue: No ]
  • Proportion of infants tested for HIV by DNA PCR [ Time Frame: 6-8 weeks after delivery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01433185 on ClinicalTrials.gov Archive Site
  • Infant adherence to antiretroviral prophylaxis [ Time Frame: Up to 6 weeks after delivery ] [ Designated as safety issue: No ]
  • Time to post-natal clinic return [ Time Frame: Up to 8 weeks after delivery ] [ Designated as safety issue: No ]
  • Maternal adherence to antiretroviral prophylaxis [ Time Frame: Up to 8 weeks after delivery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Improving Uptake of Early Infant Diagnosis of HIV for the Prevention of Mother-to-child Transmission of HIV
Improving Uptake of Early Infant Diagnosis of HIV for PMTCT: a Randomized Trial of a Text Messaging Intervention

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
Other: Text message
Text messages sent to women before and after delivery
Other Name: SMS, short message service, text messaging
  • Experimental: Text message (SMS)
    Text messages sent to women before and after delivery
    Intervention: Other: Text message
  • No Intervention: Usual care (current standard of care)
    Current standard of care for women enrolled in PMTCT programs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
388
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01433185
41186-E/G
No
Thomas Odeny, University of Washington
University of Washington
  • Kenya Medical Research Institute
  • University of California, San Francisco
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
University of Washington
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP