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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
World Health Organization, Alliance for Health Policy and Systems Research
National AIDS and STD Control Programme (NASCOP), Ministry of Health, Kenya
Information provided by (Responsible Party):
Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier:
NCT01645865
First received: July 18, 2012
Last updated: August 13, 2013
Last verified: August 2013

July 18, 2012
August 13, 2013
May 2011
April 2014   (final data collection date for primary outcome measure)
  • The proportion of women who successfully complete key PMTCT transition points from antenatal to six weeks postpartum. [ Time Frame: ~ 6 months ] [ Designated as safety issue: No ]
  • Initiation of Infant prophylaxis, Facility delivery and receipt of results of 6 weeks early infant diagnosis by DNA PCR [ Time Frame: ~ 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01645865 on ClinicalTrials.gov Archive Site
  • Uptake ARV prophylaxis/ART during labor, delivery, and postpartum [ Time Frame: ~ 6 months ] [ Designated as safety issue: No ]
  • Self-reported maternal adherence to ARV prophylaxis/ART during pregnancy [ Time Frame: ~ 4 months ] [ Designated as safety issue: No ]
  • Time to initiation of ARV prophylaxis/ART uptake after initial identification of HIV seropositivity within ANC [ Time Frame: ~ 1 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Mobile Phone Technology for Prevention of Mother-to-Child Transmission of HIV: Acceptability, Effectiveness, and Cost
Mobile Phone Technology for Prevention of Mother-to-Child Transmission of HIV: Acceptability, Effectiveness, and Cost

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Potential participants are recruited from participating study sites.

  • HIV
  • HIV Infections
  • AIDS
  • Antiretroviral Therapy
  • 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.
  • 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.
  • Control
    Intervention: Behavioral: Control
  • Intervention
    Intervention: Behavioral: Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01645865
RPC441
No
Elizabeth Glaser Pediatric AIDS Foundation
Elizabeth Glaser Pediatric AIDS Foundation
  • World Health Organization, Alliance for Health Policy and Systems Research
  • National AIDS and STD Control Programme (NASCOP), Ministry of Health, Kenya
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
Elizabeth Glaser Pediatric AIDS Foundation
August 2013

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