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Mobile Phone Technology for Prevention of Mother-to-Child Transmission of HIV: Acceptability, Effectiveness, and Cost

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ClinicalTrials.gov Identifier: NCT01645865
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : November 13, 2014
Sponsor:
Collaborators:
World Health Organization, Alliance for Health Policy and Systems Research
Kenya National AIDS & STI Control Programme
Information provided by (Responsible Party):
Elizabeth Glaser Pediatric AIDS Foundation

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Although gains have been made in achieving the health-related Millennium Development Goals (MDG), much is still needed in countries affected by high levels of HIV/AIDS. Prevention of mother-to-child transmission (PMTCT) is a cornerstone strategy in reducing infant mortality from HIV. The study will employ a cluster randomized control trial (cRCT) with 26 health facilities randomized to two arms (intervention or control) to determine the effect of mobile phone technology on completion of key PMTCT milestones from antenatal to six weeks postpartum. The study will examine the acceptability, effectiveness, and cost of implementing a PMTCT-focused mHealth strategy among HIV-infected pregnant women, health workers, and male partners.

Condition or disease Intervention/treatment
HIV HIV Infections AIDS Antiretroviral Therapy Behavioral: Control Behavioral: Intervention

Study Design
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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mobile Phone Technology for Prevention of Mother-to-Child Transmission of HIV: Acceptability, Effectiveness, and Cost
Study Start Date : May 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Control Behavioral: Control
Health facilities where PMTCT services are available in the traditional clinical setting with HIV testing and counseling, PMTCT support, and enrollment in care and treatment.
Intervention Behavioral: Intervention
In addition to the 'Standard of Care', HIV-infected pregnant women and male partners within the PMTCT program are engaged in multi-directional mobile communication for PMTCT promotion with health care providers.


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The proportion of women who successfully complete key PMTCT transition points from antenatal to six weeks postpartum. [ Time Frame: ~ 6 months ]
  2. Initiation of Infant prophylaxis, Facility delivery and receipt of results of 6 weeks early infant diagnosis by DNA PCR [ Time Frame: ~ 6 months ]

Secondary Outcome Measures :
  1. Uptake ARV prophylaxis/ART during labor, delivery, and postpartum [ Time Frame: ~ 6 months ]
  2. Self-reported maternal adherence to ARV prophylaxis/ART during pregnancy [ Time Frame: ~ 4 months ]
  3. Time to initiation of ARV prophylaxis/ART uptake after initial identification of HIV seropositivity within ANC [ Time Frame: ~ 1 month ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potential participants are recruited from participating study sites.
Criteria

Inclusion Criteria (female):

  • HIV-positive pregnant women seeking ANC at a study site
  • Up to 32 weeks gestation
  • Own or have access to a mobile phone on which they can receive calls and SMS messages

Exclusion Criteria (female):

  • HIV-positive pregnant women who have already initiated antiretroviral treatment

Inclusion Criteria (male):

  • Referral by pregnant female partner
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01645865


Locations
Kenya
Elizabeth Glaser Pediatric AIDS Foundation
Nairobi, Kenya
Sponsors and Collaborators
Elizabeth Glaser Pediatric AIDS Foundation
World Health Organization, Alliance for Health Policy and Systems Research
Kenya National AIDS & STI Control Programme
Investigators
Principal Investigator: John Ong'ech, MBChB, MMed, MPH Elizabeth Glaser Pediatric AIDS Foundation, UON/KNH
Principal Investigator: Seble Kassaye, MD, MS Elizabeth Glaser Pediatric AIDS Foundation
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier: NCT01645865     History of Changes
Other Study ID Numbers: RPC441
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014

Keywords provided by Elizabeth Glaser Pediatric AIDS Foundation:
HIV
AIDS
PMTCT
Mobile Phone
SMS

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