Clinical trial NCT01645865: Mobile Phone Technology for Prevention of Mother-to-Child Transmission of HIV: Acceptability, Effectiveness, and Cost
Official title: Mobile Phone Technology for Prevention of Mother-to-Child Transmission of HIV: Acceptability, Effectiveness, and Cost
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
HIV Infections
AIDS
Antiretroviral Therapy
Keywords: HIV
AIDS
PMTCT
Mobile Phone
SMS
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: World Health Organization, Alliance for Health Policy and Systems Research
name: Kenya National AIDS & STI Control Programme
First posted: 2012-07-20
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants are recruited from participating study sites.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The proportion of women who successfully complete key PMTCT transition points from antenatal to six weeks postpartum.
timeFrame: ~ 6 months
measure: Initiation of Infant prophylaxis, Facility delivery and receipt of results of 6 weeks early infant diagnosis by DNA PCR
timeFrame: ~ 6 months
Secondary outcomes:
measure: Uptake ARV prophylaxis/ART during labor, delivery, and postpartum
timeFrame: ~ 6 months
measure: Self-reported maternal adherence to ARV prophylaxis/ART during pregnancy
timeFrame: ~ 4 months
measure: Time to initiation of ARV prophylaxis/ART uptake after initial identification of HIV seropositivity within ANC
timeFrame: ~ 1 month
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Elizabeth Glaser Pediatric AIDS Foundation
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation, UON/KNH
name: John Ong'ech, MBChB, MMed, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Seble Kassaye, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.