Cardiovascular DiseasePT4ANCT06485700
Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A)
A study testing Peer Delivery of Medications and Health Information Technology (HIT) Platform in people with Cardiovascular Disease and Hypertension, run by NYU Langone Health at 3 sites in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Hypertension
- What is being tested?
- Peer Delivery of Medications and Health Information Technology (HIT) Platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,140 participants
- Where
- 3 sitesKenya
- Study dates
- 18 Nov 2025to 20 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants enrolled in AMPATH's CDM Program with uncontrolled hypertension (SBP ≥ 140 or diastolic BP (DBP) ≥ 90)
Who cannot join
- hypertensive emergency requiring immediate medical attention,
- terminal illness, and
- inability to provide informed consent.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya3 sites, 3 recruiting
- Recruiting
Study Site
Eldoret, Uasin Gishu County
- Recruiting
Study Site
Kitale, Trans Nzoia County
- Recruiting
Study Site
Webuye, Bungoma County
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Disease, Hypertension
- Being tested
- Peer Delivery of Medications, Health Information Technology (HIT) Platform
- Medical subject headings
- Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Delivery of MedicationsOther
Door-to-door peer delivery of medications within patients' communities will be implemented.
Health Information Technology (HIT) PlatformOther
The HIT platform provides: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) medication refill tracking to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data.
| Study group | Role | What they receive |
|---|---|---|
| PT4A | Experimental | Peer delivery of medications supported by Health Information Technology (HIT) platform. Receives: Other: Peer Delivery of Medications; Other: Health Information Technology (HIT) Platform |
| Control | No intervention | Participants in the control arm will receive the standard of care for hypertension or the standard of care including peer-delivery of medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in SBP from Baseline to Month 12
Measured: Baseline, Month 12
Pill Count Adherence Ratio (PCAR) at Month 12
PCAR is calculated as the percentage of pills taken over the previous month and is measured over a 30-day time period.
Measured: Month 12
Number of Patient E-Signatures
Measure of fidelity.
Measured: Up to Month 12
Number of Completed HIT Forms
Measure of fidelity.
Measured: Up to Month 12
Secondary outcomes (3)
Mean Change in SBP from Baseline to Month 6
Measured: Baseline, Month 6
Percentage of Participants with Controlled Blood Pressure (BP) at Month 6
BP measured using automatic BP monitor.
Measured: Month 6
Percentage of Participants with Controlled BP at Month 12
BP measured using automatic BP monitor.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start18 Nov 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion20 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rajesh Vedanthan, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485700
- Sponsor's protocol ID
- 24-00277
- Acronym
- PT4A
- Status last verified
- Feb 2026
- First submitted
- 27 Jun 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Rajesh.vedanthan@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A)
- ClinicalTrials.gov ID
- NCT06485700
- Acronym / sponsor ID
- PT4A / 24-00277
- Conditions
- Cardiovascular Disease, Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,140 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 20 Apr 2028 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PT4A | Experimental | Other: Peer Delivery of Medications, Other: Health Information Technology (HIT) PlatformPeer delivery of medications supported by Health Information Technology (HIT) platform. |
| Control | No intervention | –Participants in the control arm will receive the standard of care for hypertension or the standard of care including peer-delivery of medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult participants enrolled in AMPATH's CDM Program with uncontrolled hypertension (SBP ≥ 140 or diastolic BP (DBP) ≥ 90)
Key exclusion criteria (3 listed)
- hypertensive emergency requiring immediate medical attention,
- terminal illness, and
- inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Delivery of MedicationsDoor-to-door peer delivery of medications within patients' communities will be implemented. | Other | PT4A |
| Health Information Technology (HIT) PlatformThe HIT platform provides: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) medication refill tracking to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data. | Other | PT4A |
Primary outcome
Mean Change in SBP from Baseline to Month 12
Time frame: Baseline, Month 12
Pill Count Adherence Ratio (PCAR) at Month 12
Time frame: Month 12
PCAR is calculated as the percentage of pills taken over the previous month and is measured over a 30-day time period.
Number of Patient E-Signatures
Time frame: Up to Month 12
Measure of fidelity.
Number of Completed HIT Forms
Time frame: Up to Month 12
Measure of fidelity.
3 secondary outcomes
Mean Change in SBP from Baseline to Month 6
Time frame: Baseline, Month 6
Percentage of Participants with Controlled Blood Pressure (BP) at Month 6
Time frame: Month 6
Percentage of Participants with Controlled BP at Month 12
Time frame: Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Rajesh.vedanthan@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rajesh Vedanthan principal investigator
NYU Langone Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Delivery of Medications and Health Information Technology (HIT) Platform in people with Cardiovascular Disease and Hypertension, run by NYU Langone Health at 3 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rajesh Vedanthan (1-646-501-3890, Rajesh.vedanthan@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in SBP from Baseline to Month 12 (time frame: Baseline, Month 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.