Skip to main content
OpenTrials
Completed

NCT Number: NCT01645865

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV AIDS Acquired Immunodeficiency Syndrome Antiretroviral Therapy Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Elizabeth Glaser Pediatric AIDS Foundation

Nairobi, Kenya

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Behavioral

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

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.

Primary outcomes

  1. The proportion of women who successfully complete key PMTCT transition points from antenatal to six weeks postpartum.

    Time frame: ~ 6 months

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

    Time frame: ~ 6 months

Secondary outcomes

  1. Uptake ARV prophylaxis/ART during labor, delivery, and postpartum

    Time frame: ~ 6 months

  2. Self-reported maternal adherence to ARV prophylaxis/ART during pregnancy

    Time frame: ~ 4 months

  3. Time to initiation of ARV prophylaxis/ART uptake after initial identification of HIV seropositivity within ANC

    Time frame: ~ 1 month

Sponsors and collaborators

Lead sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Other

Collaborators

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

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 20, 2012
Registry last updated
Nov 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.