Two-way Texting (2wT) to Improve Antiretroviral (ART) Patient Retention in Malawi

NCT05531448 | Active Not Recruiting

• 2 other identifiers: STUDY000101064R33TW011658
• Study Type: interventional
• Target: 467
• Locations: 1 country
• Sites: 2

Brief Summary

Investigators aim to demonstrate that interactive, two-way texting (2WT) to remind patients about their clinic visits and engage patients in their health can increase antiretroviral therapy (ART) retention in a routine setting in Lilongwe Malawi.

Conditions

Retention in Care

Outcome Measures

Primary Outcomes (2)

• Retention

  ART retention at 6 months post initiation (e.g., alive on ART, transferred out, dead, ART disruption)

  6 months

• Referrals to tracing

  Cumulative B2C referrals at 6 months as a measure of patients referred to tracing after missing scheduled ART drug dispensing visits.

  6 months

Study Arms (2)

2wT (2-way texting)

EXPERIMENTAL

2wT participants will receive weekly motivational messages without any HIV-related information. They will receive visit reminders with an option to respond they will attend, they transfered, or they need scheduling help. If they do not attend their visit, they will be traced at 14 days.

Other: two way texting

Routine retention

NO INTERVENTION

Control participants will have routine Back to Care retention support services and tracing at 14 days after a visit it missed.

Interventions

two way texting OTHER

Automated 2WT-based adherence support messages combined with scheduled visit reminders focus on preventing visit default will be implemented. One-way "blast" motivational support messages will be sent to all new ART patients who opt-into 2WT. ART visit reminders 3- and 1- day before visits will ask clients to respond with 1=attend and 0=no, triggering 2wT responses to clients to reschedule visits, record transfers, etc. 2WT clerks proactively communicate with clients before a visit to prevent default or ascertain true outcomes for those who don't return. Those who miss visits receive additional 2wT reminders. On day 14 post visit, 2wT patients who missed visits, did not respond to text or did not have outcomes updated (transfer, stop, etc.), are identified by the 2WT system and referred to B2C for tracing, days or months earlier than routine B2C. The 2wT-generated tracing list is more timely and accurate, reducing workload and increasing B2C effectiveness

2wT (2-way texting)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- new ART initiates (0-6 months on ART) at LH (including transfer in) aged 18 years and above has mobile phone at enrollment written consent confirmed SMS enrollment receipt willing to receive/send SMS

You may not qualify if:

• \- No cell phone

Sponsors & Collaborators

• University of Washington: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (2)

Lighthouse Trust

Lilongwe, Malawi

Location

Martin Preuss Centre

Lilongwe, Malawi

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: patients eligible for 2wT who consent will be randomized 1:1 into routine retention care an 2wT-based retention care. At 6 months, control arm participants will receive also receive 2wT and continue in 2wT as part of routine Lighthouse retention activities under the umbrella R33 NIH-funded quasi-experimental study.

Study Record Dates

• First Submitted: September 3, 2022
• First Posted: September 8, 2022
• Study Start: December 16, 2022
• Primary Completion: December 28, 2023
• Study Completion: August 1, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After results are finalized and will be published in an open access journal.
• Access Criteria: de-identified data will be available in Dryad

Locations

MA (2)