HIVNCT01645865
Mobile Phone Technology for Prevention of Mother-to-Child Transmission of HIV: Acceptability, Effectiveness, and Cost (Kenya)
An observational study of HIV and HIV Infections, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV, HIV Infections, AIDS
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 1 siteKenya
- Study dates
- May 2011to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Potential participants are recruited from participating study sites.
Who may be able to join
- 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
Who cannot join
- HIV-positive pregnant women who have already initiated antiretroviral treatment
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Control, Intervention
- Keywords
- HIV, AIDS, PMTCT, Mobile Phone, SMS
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
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.
InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described Receives: Behavioral: Control | |
| Intervention | Not described Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of women who successfully complete key PMTCT transition points from antenatal to six weeks postpartum.
Measured: ~ 6 months
Initiation of Infant prophylaxis, Facility delivery and receipt of results of 6 weeks early infant diagnosis by DNA PCR
Measured: ~ 6 months
Secondary outcomes (3)
Uptake ARV prophylaxis/ART during labor, delivery, and postpartum
Measured: ~ 6 months
Self-reported maternal adherence to ARV prophylaxis/ART during pregnancy
Measured: ~ 4 months
Time to initiation of ARV prophylaxis/ART uptake after initial identification of HIV seropositivity within ANC
Measured: ~ 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startMay 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Alliance for Health Policy and Systems Research, Kenya National AIDS & STI Control Programme
- Responsible party
- Sponsor
- Investigators
- John Ong'ech, MBChB, MMed, MPH, Principal investigator, Elizabeth Glaser Pediatric AIDS Foundation, UON/KNHSeble Kassaye, MD, MS, Principal investigator, Elizabeth Glaser Pediatric AIDS Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645865
- Sponsor's protocol ID
- EG0080
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2012
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phone Technology for Prevention of Mother-to-Child Transmission of HIV: Acceptability, Effectiveness, and Cost (Kenya)
- ClinicalTrials.gov ID
- NCT01645865
- Acronym / sponsor ID
- EG0080
- Conditions
- HIV, HIV Infections, AIDS, Antiretroviral Therapy
- Keywords
- HIV, AIDS, PMTCT, Mobile Phone, SMS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Collaborators
- World Health Organization, Alliance for Health Policy and Systems Research, Kenya National AIDS & STI Control Programme
- Study start
- May 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Behavioral: Control |
| Intervention | – | Behavioral: Intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Potential participants are recruited from participating study sites.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- HIV-positive pregnant women who have already initiated antiretroviral treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlHealth facilities where PMTCT services are available in the traditional clinical setting with HIV testing and counseling, PMTCT support, and enrollment in care and treatment. | Behavioural | Control |
| InterventionIn 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. | Behavioural | Intervention |
Primary outcome
The proportion of women who successfully complete key PMTCT transition points from antenatal to six weeks postpartum.
Time frame: ~ 6 months
Initiation of Infant prophylaxis, Facility delivery and receipt of results of 6 weeks early infant diagnosis by DNA PCR
Time frame: ~ 6 months
3 secondary outcomes
Uptake ARV prophylaxis/ART during labor, delivery, and postpartum
Time frame: ~ 6 months
Self-reported maternal adherence to ARV prophylaxis/ART during pregnancy
Time frame: ~ 4 months
Time to initiation of ARV prophylaxis/ART uptake after initial identification of HIV seropositivity within ANC
Time frame: ~ 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Derived from this study: PubMed 28053784Kassaye 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and HIV Infections, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of women who successfully complete key PMTCT transition points from antenatal to six weeks postpartum. (time frame: ~ 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01645865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.