The effect of weekly text messaging to improve retention across the prevention of mother to child transmission of HIV program

• Register: ISRCTN
• Last refreshed on: 26 June 2023
• Main ID: ISRCTN98818734
• Date of registration: 09/12/2014
• Prospective Registration: Yes
• Primary sponsor: Karolinska Institute (Sweden)
• Public title: The effect of weekly text messaging to improve retention across the prevention of mother to child transmission of HIV program
• Scientific title: The effect of weekly text messaging to improve retention across the PMTCT cascade for pregnant HIV- infected women: a randomized controlled trial
• Date of first enrolment: 12/01/2015
• Target sample size: 600
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN98818734
• Study type: Interventional
• Study design: Multi-center two-arm open randomized controlled trial (Other)
• Phase: Not Applicable

Countries of recruitment

Kenya

Contacts

• Name: Patricia Awiti

• Name: Anna Mia Ekstrom

Key inclusion & exclusion criteria

Inclusion criteria: 1. Woman aged 18 and above
2. Evidence of pregnancy as confirmed by urine test
3. 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
4. Resident of the PMTCT clinic catchment area (in urban and rural Kenya) and plans to remain residents from recruitment until 20 months after delivery
5. Willing to be followed-up from recruitment until 20 months after delivery
6. Own a mobile phone and/or have a phone in possession at the time of enrollment /or have access to a phone
7. Able or have someone in close contact that they trust to read and send/respond to a text message in Kiswahili
8. Willing to receive text messages from the PMTCT clinic
9. Able and willing to provide informed consent
Exclusion criteria: Those not fulfilling the inclusion criteria

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Retention in PMTCT program
Not Applicable

Intervention(s)

1. 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 48 hours as either that they are well for example ok or sawa or that they have a problem for example problem or shida. A male or female nurse experienced in PMTCT will be in charge of monitoring the WelTel SMS platform that automatically registers responses from the participants. The nurse will call participants who respond “problem” 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 come to the facility or an answer given through the phone. Patients who do not respond within 24 hours are traced within the defaulter tracing outreach program that includes mentor mothers where available, community health extension workers (CHEWs) as linkage between facility and community and community health workers (CHWs) at the household level. 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. All cell phone communication resulting from the SMS queries will be recorded by the technological platform, and the research assistant will be able to enter any actions taken directly into this system.
2. Participants in the control group attend a PMTCT clinic but do not receive the weekly short text messages.

Primary Outcome(s)

Retention in PMTCT care defined as the proportion of HIV-exposed infants whose HIV status are confirmed at 18 months of age, measured as whether the infant was tested for HIV at 20- 24 months after birth (at or outside the selected clinics).

Secondary Outcome(s)

1. Feasibility and Acceptability of WelTel SMS intervention on PMTCT participants
2. Effects of WelTel SMS on single PMTCT components
3. Cost against (i) effectiveness from a providers perspective and (ii) cost against the utility (differences in QUALYs between the 2 arms with the intervention arm having an improvement of 30%) from a patients perspective
4. A model framework for estimating cost-effectiveness of an m-health intervention to improve PMTCT outcomes, generalizable to other settings

Secondary ID(s)

N/A

Source(s) of Monetary Support

Vetenskapsrådet

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; 1. Amref Ethics and Scientific Review Committee, 21/01/2014, ref. P95/2013 2. Moi University Institutional Research and Ethics Committee, 06/10/2014, ref. IREC 1292

Results

• Results available: Yes
• Date Completed: 30/12/2017