Clinical trial NCT06485700: Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A)
Official title: Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Disease
Hypertension
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 1140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Peer-based medication delivery decreases the cost of transportation and the opportunity cost of travel while HIT can support peer activities by facilitating targeted adherence counseling, teleconsultation, synchronization of clinical care, and pharmacy activities. The investigators have implemented a pilot program of door-to-door peer-based medication delivery and HIT in western Kenya, and preliminary data indicate improved adherence and blood pressure. However, the effectiveness of this implementation strategy is not fully established. Therefore, the objective of the study is to use the PRECEDE-PROCEED framework to conduct transdisciplinary implementation research to test the hypothesis that integrating peer delivery of medications with HIT (PT4A) improves medication adherence and reduces blood pressure among patients with uncontrolled hypertension in western Kenya.

Detailed description: 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.

Primary outcomes:
measure: Mean Change in SBP from Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Pill Count Adherence Ratio (PCAR) at Month 12
timeFrame: Month 12
measure: Number of Patient E-Signatures
timeFrame: Up to Month 12
measure: Number of Completed HIT Forms
timeFrame: Up to Month 12
Secondary outcomes:
measure: Mean Change in SBP from Baseline to Month 6
timeFrame: Baseline, Month 6
measure: Percentage of Participants with Controlled Blood Pressure (BP) at Month 6
timeFrame: Month 6
measure: Percentage of Participants with Controlled BP at Month 12
timeFrame: Month 12
Other outcomes:
Locations:
city: Webuye
country: Kenya
facility: Study Site
state: Bungoma County
city: Kitale
country: Kenya
facility: Study Site
state: Trans Nzoia County
city: Eldoret
country: Kenya
facility: Study Site
state: Uasin Gishu County
Study officials:
affiliation: NYU Langone Health
name: Rajesh Vedanthan
role: PRINCIPAL_INVESTIGATOR
References: