Peer-delivered medications combined with health IT to help people with uncontrolled high blood pressure in western Kenya
Official title: Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A)
Run by NYU Langone Health · NCT06485700 · Data updated 2026-11-12
This project will test whether combining door-to-door peer medication delivery with a health information platform helps adults with uncontrolled hypertension in western Kenya take their medicines and lower their blood pressure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1140 (estimated) |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 3 sites (Webuye, Bungoma County and 2 other locations) |
| Status | Recruiting |
| Started | November 18, 2025 |
| Main results expected | March 31, 2028 |
| Study ends | April 20, 2028 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT06485700 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults enrolled in the AMPATH Chronic Disease Management program with uncontrolled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) who can provide informed consent and live in the study catchment areas are ideal candidates.
✕Probably not a fit
Patients with a hypertensive emergency requiring immediate medical attention, those with a terminal illness, people unable to provide informed consent, or those whose blood pressure is already controlled are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a two-arm cluster randomized implementation hybrid type 2 trial comparing an integrated peer medication delivery plus health information technology program (PT4A) to usual care among adults with uncontrolled hypertension enrolled in AMPATH. The primary biological outcome is one-year change in systolic blood pressure, the primary adherence outcome is the pill count adherence ratio, and the primary implementation outcome is fidelity; secondary outcomes include blood pressure control, self-reported adherence, and RE-AIM implementation metrics. The study will also examine whether trust in the health system and patient activation mediate effects on adherence and blood pressure, and will include cost-effectiveness, budget impact, and qualitative analyses to inform adaptation to other settings. The trial is conducted across several clinical sites in western Kenya using a transdisciplinary team with prior pilot data suggesting benefit.
Why it matters
Potential benefit: If successful, the approach could increase medication adherence, reduce travel burdens and costs, and lower blood pressure for people with uncontrolled hypertension.
How similar studies have gone: Preliminary pilot data from the same program in western Kenya indicate improved adherence and blood pressure, and other peer-delivery and health IT approaches in low-resource settings have shown promise, but full effectiveness of this integrated implementation strategy is not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: • Adult participants enrolled in AMPATH's CDM Program with uncontrolled hypertension (SBP ≥ 140 or diastolic BP (DBP) ≥ 90) Exclusion Criteria: * hypertensive emergency requiring immediate medical attention, * terminal illness, and * inability to provide informed consent.
Where it's running
-
Study Site
Webuye, Bungoma County, Kenya Recruiting -
Study Site
Kitale, Trans Nzoia County, Kenya Recruiting -
Study Site
Eldoret, Uasin Gishu County, Kenya Recruiting
Study contacts
- Principal investigator: Rajesh Vedanthan — NYU Langone Health
- Study coordinator: Rajesh Vedanthan
- Email: Rajesh.vedanthan@nyulangone.org
- Phone: 1-646-501-3890
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.