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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01645865
• Other study ID #: RPC441
• Status: Completed
• Phase: N/A
• First received: July 18, 2012
• Last updated: November 12, 2014
• Start date: May 2011
• Est. completion date: April 2014

Study information

• Verified date: November 2014
• Source: Elizabeth Glaser Pediatric AIDS Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Nations: World Health OrganizationKenya: Kenyatta National Hospital - University of Nairobi Ethical Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• AIDS
• Antiretroviral Therapy
• HIV
• HIV Infections

Intervention

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
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.

Locations

Country	Name	City	State
Kenya	Elizabeth Glaser Pediatric AIDS Foundation	Nairobi

Sponsors (3)

Lead Sponsor	Collaborator
Elizabeth Glaser Pediatric AIDS Foundation	Kenya National AIDS & STI Control Programme, World Health Organization, Alliance for Health Policy and Systems Research

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of women who successfully complete key PMTCT transition points from antenatal to six weeks postpartum.		~ 6 months	No
Primary	Initiation of Infant prophylaxis, Facility delivery and receipt of results of 6 weeks early infant diagnosis by DNA PCR		~ 6 months	No
Secondary	Uptake ARV prophylaxis/ART during labor, delivery, and postpartum		~ 6 months	No
Secondary	Self-reported maternal adherence to ARV prophylaxis/ART during pregnancy		~ 4 months	No
Secondary	Time to initiation of ARV prophylaxis/ART uptake after initial identification of HIV seropositivity within ANC		~ 1 month	No