Trial Outcomes & Findings for Peers and Technology for Adherence, Access, Accountability, and Analytics (NCT NCT05051124)

NCT ID: NCT05051124

Last Updated: 2025-03-19

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

101 participants

Primary outcome timeframe

Baseline, Month 12

Results posted on

2025-03-19

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Enrolled in the AMPATH CDM Program Peer Delivery of Medications: The study team will adopt a novel approach of extending beyond the use of peer support in the clinical setting and implement door-to-door peer delivery of medications within patients' communities Health Information Technology (HIT) Platform: To support peer delivery, the study team will use a HIT platform that performs 4 core functions: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) tracking medication refills to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data. This is an innovative use of HIT to accomplish these functions to support medication adherence.
Overall Study STARTED	101
Overall Study COMPLETED	95
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients Enrolled in the AMPATH CDM Program Peer Delivery of Medications: The study team will adopt a novel approach of extending beyond the use of peer support in the clinical setting and implement door-to-door peer delivery of medications within patients' communities Health Information Technology (HIT) Platform: To support peer delivery, the study team will use a HIT platform that performs 4 core functions: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) tracking medication refills to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data. This is an innovative use of HIT to accomplish these functions to support medication adherence.
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	1
Overall Study Residential relocation	2
Overall Study Death	1

Baseline Characteristics

Peers and Technology for Adherence, Access, Accountability, and Analytics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Enrolled in the AMPATH CDM Program n=95 Participants Peer Delivery of Medications: The study team will adopt a novel approach of extending beyond the use of peer support in the clinical setting and implement door-to-door peer delivery of medications within patients' communities Health Information Technology (HIT) Platform: To support peer delivery, the study team will use a HIT platform that performs 4 core functions: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) tracking medication refills to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data. This is an innovative use of HIT to accomplish these functions to support medication adherence.
Age, Continuous	62.6 years STANDARD_DEVIATION 10.92 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	95 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	95 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Kenya	95 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 12

Outcome measures

Outcome measures
Measure	Patients Enrolled in the AMPATH CDM Program n=95 Participants Peer Delivery of Medications: The study team will adopt a novel approach of extending beyond the use of peer support in the clinical setting and implement door-to-door peer delivery of medications within patients' communities Health Information Technology (HIT) Platform: To support peer delivery, the study team will use a HIT platform that performs 4 core functions: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) tracking medication refills to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data. This is an innovative use of HIT to accomplish these functions to support medication adherence.
Absolute Mean Change in Systolic Blood Pressure (SBP)	11.5 millimeters of mercury (mmHg) Standard Deviation 23.9

PRIMARY outcome

Timeframe: Month 12

Proportion of prescribed doses taken over a 1-month time period.

Outcome measures

Outcome measures
Measure	Patients Enrolled in the AMPATH CDM Program n=95 Participants Peer Delivery of Medications: The study team will adopt a novel approach of extending beyond the use of peer support in the clinical setting and implement door-to-door peer delivery of medications within patients' communities Health Information Technology (HIT) Platform: To support peer delivery, the study team will use a HIT platform that performs 4 core functions: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) tracking medication refills to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data. This is an innovative use of HIT to accomplish these functions to support medication adherence.
Pill Count Adherence Ratio	0.99 Proportion of prescribed doses Standard Deviation 0.08

PRIMARY outcome

Timeframe: Month 12

Confirmed medication delivery will be documented by patient e-signature.

Outcome measures

Outcome measures
Measure	Patients Enrolled in the AMPATH CDM Program n=101 Participants Peer Delivery of Medications: The study team will adopt a novel approach of extending beyond the use of peer support in the clinical setting and implement door-to-door peer delivery of medications within patients' communities Health Information Technology (HIT) Platform: To support peer delivery, the study team will use a HIT platform that performs 4 core functions: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) tracking medication refills to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data. This is an innovative use of HIT to accomplish these functions to support medication adherence.
Number of Confirmed Medication Deliveries	992 Deliveries

PRIMARY outcome

Timeframe: Month 12

Outcome measures

Outcome measures
Measure	Patients Enrolled in the AMPATH CDM Program n=101 Participants Peer Delivery of Medications: The study team will adopt a novel approach of extending beyond the use of peer support in the clinical setting and implement door-to-door peer delivery of medications within patients' communities Health Information Technology (HIT) Platform: To support peer delivery, the study team will use a HIT platform that performs 4 core functions: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) tracking medication refills to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data. This is an innovative use of HIT to accomplish these functions to support medication adherence.
Number of Peer Completions of HIT Form	999 Completed forms

Adverse Events

Patients Enrolled in the AMPATH CDM Program

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Patients Enrolled in the AMPATH CDM Program n=101 participants at risk Peer Delivery of Medications: The study team will adopt a novel approach of extending beyond the use of peer support in the clinical setting and implement door-to-door peer delivery of medications within patients' communities Health Information Technology (HIT) Platform: To support peer delivery, the study team will use a HIT platform that performs 4 core functions: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) tracking medication refills to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data. This is an innovative use of HIT to accomplish these functions to support medication adherence.
General disorders Death	0.99% 1/101 • 12 months

Other adverse events

Adverse event data not reported

Additional Information

Jessica Gjonaj

NYU Langone Health

Phone: 646-501-3663

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place