Peer-delivered medications combined with health IT to help people with uncontrolled high blood pressure in western Kenya
Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 3 sites (Webuye, Bungoma County and 2 other locations) |
| Trial ID | NCT06485700 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Webuye, Bungoma County and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.