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Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A)

NCT06485700 · NYU Langone Health
In plain English

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About this study
Aim 1 will evaluate the effectiveness of PT4A by conducting a two-arm cluster randomized controlled implementation research hybrid type 2 trial, comparing PT4A to control. The primary biological outcome is one-year change in systolic blood pressure. The primary adherence outcome is the pill count adherence ratio. The primary implementation outcome is fidelity. Secondary outcomes are blood pressure control, self-reported adherence, and RE-AIM metrics. Aim 2 will evaluate potential mechanistic relationships between implementation measures and outcomes. Sub Aim 2.1 will evaluate if trust in the health system and patient activation mediate the relationship between PT4A and the outcomes. Aim 3 will consist of cost-effectiveness, budget impact, and qualitative analyses to help inform adaptation of PT4A to other settings. The research will be conducted by a transdisciplinary team with diverse and complementary expertise. The investigators intend to add to existing knowledge of innovative and scalable strategies to improve medication adherence for global hypertension control.
Eligibility 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.
Study design
Enrollment target: 1140 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-18
Estimated completion: 2028-04-20
Last updated: 2026-02-27
Interventions
Other: Peer Delivery of MedicationsOther: Health Information Technology (HIT) Platform
Primary outcomes
  • Mean Change in SBP from Baseline to Month 12 (Baseline, Month 12)
  • Pill Count Adherence Ratio (PCAR) at Month 12 (Month 12)
  • Number of Patient E-Signatures (Up to Month 12)
Sponsor
NYU Langone Health · other
Contacts & investigators
ContactRajesh Vedanthan · contact · Rajesh.vedanthan@nyulangone.org · 1-646-501-3890
ContactJessica Gjonaj · contact · Jessica.gjonaj@nyulangone.org · 1-646-501-3663
InvestigatorRajesh Vedanthan · principal_investigator, NYU Langone Health
All locations (3)
Study SiteRecruiting
Webuye, Bungoma County, Kenya
Study SiteRecruiting
Kitale, Trans Nzoia County, Kenya
Study SiteRecruiting
Eldoret, Uasin Gishu County, Kenya
Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A) · TrialPath