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

November 12, 2014 updated by: Elizabeth Glaser Pediatric AIDS Foundation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Nairobi, Kenya
        • Elizabeth Glaser Pediatric AIDS Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Potential participants are recruited from participating study sites.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of women who successfully complete key PMTCT transition points from antenatal to six weeks postpartum.
Time Frame: ~ 6 months
~ 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
~ 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Collaborators

Kenya National AIDS & STI Control Programme
World Health Organization, Alliance for Health Policy and Systems Research

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

July 18, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (Estimate)

July 20, 2012

Study Record Updates

Last Update Posted (Estimate)

November 13, 2014

Last Update Submitted That Met QC Criteria

November 12, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RPC441

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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