Trial record 1 of 39 for:    " August 15, 2011":" September 14, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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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
  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: 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

Resource links provided by NLM:


Further study details as provided by 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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
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

No publications provided

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: October 22, 2013
Health Authority: United States: Institutional Review Board
Kenya: Ethical Review Committee

Keywords provided by University of Washington:
PMTCT
SMS
HIV Infections
Acquired Immunodeficiency Syndrome
Prevention & Control
Patient Compliance
Cellular Phone
Randomized Controlled Trial

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014