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Completed

NCT Number: NCT01433185

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text message

Other

Text messages sent to women before and after delivery

Other names: SMS, short message service, text messaging

Primary outcomes

  1. Proportion of women who attend postnatal clinic within 6-8 weeks postpartum

    Time frame: 6-8 weeks after delivery

  2. Proportion of infants tested for HIV by DNA PCR

    Time frame: 6-8 weeks after delivery

Secondary outcomes

  1. Infant adherence to antiretroviral prophylaxis

    Time frame: Up to 6 weeks after delivery

  2. Time to post-natal clinic return

    Time frame: Up to 8 weeks after delivery

  3. Maternal adherence to antiretroviral prophylaxis

    Time frame: Up to 8 weeks after delivery

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Official study title

Improving Uptake of Early Infant Diagnosis of HIV for PMTCT: a Randomized Trial of a Text Messaging Intervention

Acronym: SMS4PMTCT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 13, 2011
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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