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

NCT ID: NCT01645865

Last Updated: 2014-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV HIV Infections AIDS Antiretroviral Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Control

Intervention Type 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

Intervention

Intervention Type 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.

Interventions

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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 Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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


* Referral by pregnant female partner

Exclusion Criteria

* HIV-positive pregnant women who have already initiated antiretroviral treatment
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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World Health Organization, Alliance for Health Policy and Systems Research

UNKNOWN

Sponsor Role collaborator

Kenya National AIDS & STI Control Programme

OTHER

Sponsor Role collaborator

Elizabeth Glaser Pediatric AIDS Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Ong'ech, MBChB, MMed, MPH

Role: PRINCIPAL_INVESTIGATOR

Elizabeth Glaser Pediatric AIDS Foundation, UON/KNH

Seble Kassaye, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Elizabeth Glaser Pediatric AIDS Foundation

Locations

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Elizabeth Glaser Pediatric AIDS Foundation

Nairobi, , Kenya

Site Status

Countries

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Kenya

References

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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.

Reference Type DERIVED
PMID: 28053784 (View on PubMed)

Other Identifiers

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RPC441

Identifier Type: -

Identifier Source: org_study_id