ClinicalTrials.gg
CompletedNCT01645865Updated Sep 10, 2026

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

An observational study in HIV, HIV Infections and AIDS, sponsored by Elizabeth Glaser Pediatric AIDS Foundation. Completed at 1 site in Kenya. Per ClinicalTrials.gov, last updated 2026-09-10.

Primary conditionAcquired Immunodeficiency SyndromeRegistry: HIV InfectionsReclassifiedWhy we changed it
Registry
HIV Infections — the first condition term the registry derived for this study.
ClinicalTrials.gg
Acquired Immunodeficiency Syndrome
Why
  1. The study's listed conditions name Acquired Immunodeficiency Syndrome, a narrower term within HIV Infections.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Elizabeth Glaser Pediatric AIDS Foundation · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Sex
All
01

Study 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.

02

Conditions studied

  • HIV
  • HIV Infections
  • AIDS
  • Antiretroviral Therapy

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Keywords

  • HIV
  • AIDS
  • PMTCT
  • Mobile Phone
  • SMS
03

In context

Acquired Immunodeficiency Syndrome Reclassified

3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.

This study's enrollment of 600 is above the median of 287 across 503 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Elizabeth Glaser Pediatric AIDS Foundation is the lead sponsor of 30 studies on the registry; none are open to participants now.

Compared within Acquired Immunodeficiency Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is HIV Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Potential participants are recruited from participating study sites.

Eligibility criteria

Inclusion Criteria (female):

  • -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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (actual)

Groups and cohorts

  • Control

    Behavioral: Control

  • Intervention

    Behavioral: Intervention

Interventions

  • BehavioralControl

    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.

  • BehavioralIntervention

    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.

06

What researchers measure

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

07

Study locations

1 site
  • Elizabeth Glaser Pediatric AIDS Foundation
    Nairobi, Kenya
08

References and documents

Publications

  • 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. PubMed 28053784 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01645865
Lead sponsor
Elizabeth Glaser Pediatric AIDS Foundation
Collaborators
World Health Organization, Alliance for Health Policy and Systems Research, Kenya National AIDS & STI Control Programme
Responsible party
Sponsor
First posted
Jul 20, 2012
Start date
May 2011
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Sep 10, 2026

Study contacts

John Ong'ech, MBChB, MMed, MPH
principal investigator · Elizabeth Glaser Pediatric AIDS Foundation, UON/KNH
Seble Kassaye, MD, MS
principal investigator · Elizabeth Glaser Pediatric AIDS Foundation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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