Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Elizabeth Glaser Pediatric AIDS Foundation

Collaborator
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
ClinicalTrials.gov Identifier
NCT01645865

First received: July 18, 2012
Last updated: November 12, 2014
Last Verified: November 2014
History of Changes
Purpose

Purpose

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 Intervention
HIV
HIV Infections
AIDS
Antiretroviral Therapy

Behavioral : Control
Behavioral : Intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mobile Phone Technology for Prevention of Mother-to-Child Transmission of HIV: Acceptability, Effectiveness, and Cost

Further study details as provided by Elizabeth Glaser Pediatric AIDS Foundation:

Primary Outcome Measures

  • The proportion of women who successfully complete key PMTCT transition points from antenatal to six weeks postpartum. [ Time Frame: ~ 6 months ]
  • 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:
  • Uptake ARV prophylaxis/ART during labor, delivery, and postpartum [ Time Frame: ~ 6 months ]
  • Self-reported maternal adherence to ARV prophylaxis/ART during pregnancy [ Time Frame: ~ 4 months ]
  • Time to initiation of ARV prophylaxis/ART uptake after initial identification of HIV seropositivity within ANC [ Time Frame: ~ 1 month ]

Enrollment: 600
Study Start Date: May 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.

Eligibility

Eligibility

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

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: 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

More Information


Responsible Party: Elizabeth Glaser Pediatric AIDS Foundation  
ClinicalTrials.gov Identifier: NCT01645865   History of Changes  
Other Study ID Numbers: RPC441  
Study First Received: July 18, 2012  
Last Updated: November 12, 2014  

Keywords provided by Elizabeth Glaser Pediatric AIDS Foundation:

HIV
AIDS
PMTCT
Mobile Phone
SMS

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.