Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05531448 |
| Other study ID # |
STUDY00010106 |
| Secondary ID |
4R33TW011658 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 16, 2022 |
| Est. completion date |
August 1, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
University of Washington |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
In sub-Saharan Africa (SSA), antiretroviral therapy (ART) retention challenges threatens both
individual health and HIV epidemic control. With significant healthcare system constraints
and formidable healthcare worker (HCW) shortages, ART services in SSA are struggling to keep
up with demand for, and continuity in, ART care. Within large-volume public ART clinics in
SSA, mobile health (mHealth) innovations may prove critical to support retention of more
patients on ART with reduced workload and lower cost.
Lighthouse Trust (LT) is a national ART Centre of Excellence in Lilongwe, Malawi, that
operates with the Malawi Ministry of Health (MoH) to provide HIV care, treatment, and support
across Malawi. In its two Lilongwe flagship clinics, 35,000 patients are on ART: 24,000 at
Martin Preuse Centre (MPC) and 11,000 at Lighthouse (LH). Patients at both are managed via a
real-time, point-of-care, electronic medical records system (EMRS). Despite its prominence,
retention at MPC and LH clinics falls short: an average of 67% of ART patients are retained
at 12-months, well below the 90% threshold needed for epidemic control. Since 2006, LH and
MPC implemented a patient retention program, "Back-To-Care" (B2C), that traces ART patients
by phone or home visit who miss a clinic visit by >14 days. B2C has been well-recognized for
its success returning patients to care . Although early patient tracing increases likelihood
of patient reengagement, tracing-based retention efforts are reactive -- waiting for clients
to miss visits before intervention. B2C and other tracing programs are highly resource
intensive, limiting scale. At MPC, there are over 7800 scheduled ART visits each month: of
these, over 800 clients are presumed lost to follow up (LTFU) and referred to the 8 full-time
B2C tracers. Program resource constraints cause B2C delays and tracing gaps, greatly
diminishing B2C effectiveness and retention success. In July, 2019 only 33% of eligible
clients were traced at MPC, a tracing gap found in other ART programs in SSA. Additional
proactive retention efforts, within the existing limited resources, are needed to reduce LTFU
before it happens.
Therefore, the University of Washington's International Training and Education Center for
Health (I-TECH) and LT, with support from MoH and Medic Mobile implemented an innovative,
proactive, patient retention system using two-way texting (2wT) between new ART patients and
staff. 2wT aims to resolve potential retention issues before they occur and improve data
quality (e.g. identifying transfers), reducing B2C workload. A comparison of retention (ART
outcomes, visit adherence, VL) and B2C referrals among new MPC ART clients showed improved
retention with possible lower costs.
The Malawi Ministry of Health Department of HIV/AIDS (DHA) requested a small-scale randomized
control trial (RCT) to provide more rigorous evidence of the 2wT benefit for ART retention.
Study arms:
ARM 1: Routine new ART client and B2C care procedures (control):
At ART enrollment, the vast majority of clients (>90%) consent to potential B2C patient
tracing and complete B2C patient locater forms with phones numbers, household map, and next
of kin contacts. All new initiates receive augmented adherence counseling as part of ART
initiation. New ART patient visits are scheduled monthly during the first six months on ART
and every two or three months thereafter if the patient is stable and adherent to therapy.
Those clients randomized to routine care will follow routine B2C processes. For routine B2C,
patients with any ART drug dispensing record (including initiation) who missed a scheduled
appointment by 14 days or more are identified using the electronic medical record system
(EMRS) and considered LTFU. A team of B2C tracers manually verifies the LTFU list to rule out
EMRS data errors and creates a paper-based B2C tracing list. Then, patients with completed
locator forms are first traced by phone (SMS or call) up to five phone attempts and/or then
up to three home visit attempts. The EMRS at ART patient registration is used daily to
determine if/when a client returns to care and to stop B2C client follow-up for that specific
event/month. For all patients reached, B2C interviews clients to ascertain ART outcomes and
records data on paper B2C forms; data clerks enter it into the EMRS.
Arm 2:
Intervention (2wT):
Same new ART initiation and care as described above. New ART patients who are consented and
randomized to 2wT will receive additional texting information and response instruction at 2wT
enrollment. 2wT paper clients files will be marked to alert reception of participation. 2WT
data clerk will manually enter client unique identification (ID), client phone number and
scheduled visit dates into 2WT system. The 2WT system will automatically send varying, weekly
adherence support texts and visit reminders (3 and 1 day before) for 12 months, with opt-out
at any time. Clients will be asked to respond to visit reminder messages with a "1=will
attend" or "0=no." A "yes" will trigger, "See you soon!" A "no" will trigger hybrid automated
and interactive SMS follow-up where clients can request an appointment date change, report
transfers, note other outcome, or request a call. These modifiable, scripted texts between
2wT staff and the client will complete ART outcome data (transfer, stop, etc.) or determine
the next steps. To support visit verification, the 2wT system will produce a set of daily
"tasks" (IDs of client with expected visits) for 2WT clerks to monitor visit attendance.
Using these daily lists of presumed visits, a clerk will confirm visits using the EMRS,
recording attended visits in the 2WT system, updating subsequent visit dates if needed.
Confirmed attendance stops visit reminders for that specific instance; completion of other
ART outcomes ascertained via 2WT (stop, transfer, dead) also stops all messaging. If an
expected client visit was not confirmed, and outcome otherwise not updated, the 2wT system
will create another alert after 5 days, triggering 2wT staff to launch an automated a series
of "missed visit" SMS with similar 2WT response options every 3 days until day 14. If no
visit, no text, or otherwise updated ART outcome by day 14, the 2wT system will create
another alert for referral to routine B2C. B2C referrals will be compiled weekly. The
2WT-based generation of the B2C list with reported transfers removed and visits verified,
will reduce delays in identification and tracing of those presumed LTFU. The system is free
for clients.
