WelTel PMTCT Project
What we do
We employ information and communication technology (ICT) using mobile health (mhealth) within a randomized controlled trial to assess if effective in improving completion of HIV management services particularly prevention of mother to child transmission (PMTCT) program. Using an interactive short message service we hypothesize that a weekly mobile phone short messaging service (WelTel SMS) is an effective as well as cost-effective method to improve HIV positive women and their newborns’ patient retention in a PMTCT program
To analyze the effect of the WelTel SMS intervention on retention in PMTCT care in urban and rural Kenya, by way of a randomized controlled trial.
- To assess the acceptability of the WelTel SMS intervention, reasons for non-acceptance or dropout as well as satisfaction of care among HIV-positive pregnant women and newly delivered mothers.
- To assess the effect of the WelTel SMS intervention compared to standard care on single component interventions of PMTCT.
- To assess provider costs against effectiveness and utility of the WelTel SMS interventions on retention in PMTCT.
A five facility two-arms open randomized controlled trial in which the intervention is allocated in a 1:1 ratio.
Figure 1. Trial design
The study is set in four zones in western Kenya. Our study population will be drawn from HIV-infected pregnant women attending antenatal care (ANC) at 5 facilities. These five facilities follow similar procedures in regard to PMTCT program
The study population consists of pregnant HIV infected women aged 18 and above presenting for PMTCT at the selected facilities and their subsequent babies. Women who test positive for both pregnancy (based on a urine test) and HIV (based on two rapid HIV tests for women newly diagnosed during the current pregnancy and based on referral from the comprehensive care clinic for those with known HIV infection and on ART or pre-ART)
- Woman aged 18 and above
- Evidence of pregnancy as confirmed by urine test
- Evidence of HIV infection (confirmed by a rapid test if newly detected and those known to be infected and referred from comprehensive care clinic) whether on ARVs or not
- Resident of the PMTCT clinic catchment area and plans to remain residents from recruitment until 20 months after delivery
- Willing to be followed-up from recruitment until 20 months after delivery
- Own a mobile phone and/or have a phone in possession at the time of enrollment /or have access to a phone
- Able or have someone in close contact that they trust to read and send/respond to a text message in Kiswahili
- Willing to receive text messages from the PMTCT clinic
- Able and willing to provide informed consent
Participants in the intervention group will receive an automated weekly short text message in Kiswahili asking about their health-related wellbeing and provided with an opportunity to request assistance. The message Mambo? (Kiswahili for “How are you?”) is sent on a fixed day of the week and allows the patient to respond within 24 hours as either that they are well for example ok or sawa or that they have a problem for example problem or shida. A female study coordinator will be in charge of monitoring the WelTel SMS platform, which automatically registers responses from the participants. All participants who respond “problem” or “ non-response” will be directly linked to a male or female nurse experienced in PMTCT at her specific clinic to follow up and triage their problems. Problems that cannot be immediately solved by the nurse will be referred to the PMTCT clinical officer / doctor at the respective facilities who will then decide if the patient needs to visit the facility or to receive an answer through the phone. The study coordinator will follow up with the respective PMTCT nurses to record action taken. This recording is performed directly into the platform. Patients who do not respond within 24 hours are traced within the defaulter tracing outreach program in routine PMTCT care. At enrollment the participants will be informed that the weekly SMS support service does not replace appointments for routine services such as counseling or clinical services and that all emergencies should be handled by usual means.
Figure 2. WelTel SMS intervention
Research ethics approval
The original study protocol, consent form and data collection tools were approved by AMREF Health Africa in Kenya Ethics and Scientific Review Committee (P95/13) and Moi University institutional Research and Ethics Committee (IREC 1292).
This trial provides the opportunity to test whether the WelTel SMS intervention is effective in PMTCT care, during pregnancy and after delivery for both HIV positive mothers and their newborns. Further, we will be able to determine whether the interactive WelTel text-messaging intervention, by engaging patients with the PMTCT clinic on a weekly basis, is a cost-effective way to help promote retention in this critical stage of eliminating pediatric HIV infections.
Who we are
International and national collaboration
This collaboration involves four partners: Karolinska Institutet, WelTel International, AMREF Health in Africa and Moi University.
We have multidisciplinary technical and clinic expertise in the field of HIV/AIDS, maternal and child health, sexual and reproductive health, public health, statistics and health economics as well as research methods including trials. We are further strengthened with research structures that include long-term collaboration and networking, leadership and involvement with MoH in Kenya, clinical service and community linkages as well as community participation during research planning and dissemination.
The Global Health, HIV/AIDS and Sexual and Reproductive Health research group (leading this project) at KI has longstanding research bonds with AMREF Health in Africa (Kenya country office) since 2006, and has produced three PhDs, one post-doc and over 15 published articles in peer-reviewed journals in the areas of HIV care, PMTCT and sexual behaviors in the urban slum of Nairobi, Kibera.
The Partners in Prevention team at Moi University has implemented clinical trials on discordant couples in collaboration with the University of Washington, Seattle, USA. The Partners in Prevention team therefore has both capacity and experience to work with HIV infected women with the overall strive to eliminate MTCT.
WelTel International Kenya office is a non-profit organization that developed and owns the WelTel SMS platform. Led by Dr Richard Lester (a co-investigator in this trial) who has wide experience in performing randomized trials for mHealth in Kenya, WelTel provides the platform and technical support at a very subsidized rate.
Patricia Awiti (KI & MU), firstname.lastname@example.org
Anna Mia Ekström (KI)
Edwin Were (MU & MTRH)
Anna Thorson (KI)
Richard Lester (WelTel International)
Katrine De Ángeles