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

Sponsor
Elizabeth Glaser Pediatric AIDS Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT01645865
Collaborator
World Health Organization, Alliance for Health Policy and Systems Research (Other), Kenya National AIDS & STI Control Programme (Other)
600
1
35
17.1

Study Details

Study Description

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 Phase
  • Behavioral: Control
  • Behavioral: Intervention

Study Design

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 1, 2011
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. The proportion of women who successfully complete key PMTCT transition points from antenatal to six weeks postpartum. [~ 6 months]

  2. Initiation of Infant prophylaxis, Facility delivery and receipt of results of 6 weeks early infant diagnosis by DNA PCR [~ 6 months]

Secondary Outcome Measures

  1. Uptake ARV prophylaxis/ART during labor, delivery, and postpartum [~ 6 months]

  2. Self-reported maternal adherence to ARV prophylaxis/ART during pregnancy [~ 4 months]

  3. Time to initiation of ARV prophylaxis/ART uptake after initial identification of HIV seropositivity within ANC [~ 1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier:
NCT01645865
Other Study ID Numbers:
  • RPC441
First Posted:
Jul 20, 2012
Last Update Posted:
Nov 13, 2014
Last Verified:
Nov 1, 2014
Keywords provided by Elizabeth Glaser Pediatric AIDS Foundation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2014