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

NCT01645865 | Completed

• 1 other identifier: RPC441
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; HIV Infections; AIDS; Antiretroviral Therapy

Keywords

HIV; AIDS; PMTCT; Mobile Phone; SMS

Outcome Measures

Primary Outcomes (2)

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

  ~ 6 months

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

  ~ 6 months

Secondary Outcomes (3)

• Uptake ARV prophylaxis/ART during labor, delivery, and postpartum

  ~ 6 months

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

  ~ 4 months

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

  ~ 1 month

Study Arms (2)

Control

Behavioral: Control

Intervention

Behavioral: Intervention

Interventions

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.

Control

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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants are recruited from participating study sites.

You may qualify if:

• 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

You may not qualify if:

• HIV-positive pregnant women who have already initiated antiretroviral treatment
• Referral by pregnant female partner

Sponsors & Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation: lead
• World Health Organization, Alliance for Health Policy and Systems Research: collaborator
• Kenya National AIDS & STI Control Programme: collaborator

Study Sites (1)

Elizabeth Glaser Pediatric AIDS Foundation

Nairobi, Kenya

Location

Related Publications (1)

• Kassaye SG, Ong'ech J, Sirengo M, Kose J, Matu L, McOdida P, Simiyu R, Syengo T, Muthama D, Machekano R. Cluster-Randomized Controlled Study of SMS Text Messages for Prevention of Mother-to-Child Transmission of HIV in Rural Kenya. AIDS Res Treat. 2016;2016:1289328. doi: 10.1155/2016/1289328. Epub 2016 Dec 8.

  PMID: 28053784 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Methods

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• John Ong'ech, MBChB, MMed, MPH

  Elizabeth Glaser Pediatric AIDS Foundation, UON/KNH

  PRINCIPAL INVESTIGATOR

• Seble Kassaye, MD, MS

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: July 20, 2012
• Study Start: May 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

KE (1)