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
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: August 13, 2013
Last verified: August 2013
  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

Resource links provided by NLM:


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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Genders Eligible for Study:   Both
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
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

No publications provided

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: August 13, 2013
Health Authority: United Nations: World Health Organization
Kenya: Kenyatta National Hospital - University of Nairobi Ethical Review Committee

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

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

ClinicalTrials.gov processed this record on August 27, 2014