Trial Outcomes & Findings for Acute Coronary Syndrome KCMC_1 (NCT NCT06503991)

Last Updated: 2026-02-02

Results Overview

The primary measure of feasibility for this study will be the number of total scheduled intervention sessions (CHW counseling sessions, doctor's visits, phone calls) attended by the 100 study participants over the course of the 6-month intervention.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

6 months

Results posted on

2026-02-02

Participant Flow

Participant milestones

Participant milestones
Measure	COACH Intervention Persons living with HIV (PLWH) and receiving routine HIV care in northern Tanzania will receive an integrated multi-component hypertension intervention, Community Health Worker Optimization of Antihypertensive Care in HIV (COACH). COACH consists of clinic-based hypertension educational counseling delivered by a Community Health Worker, provider training, coordination of care, and subsidizing care costs.
Overall Study STARTED	100
Overall Study COMPLETED	96
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	COACH Intervention Persons living with HIV (PLWH) and receiving routine HIV care in northern Tanzania will receive an integrated multi-component hypertension intervention, Community Health Worker Optimization of Antihypertensive Care in HIV (COACH). COACH consists of clinic-based hypertension educational counseling delivered by a Community Health Worker, provider training, coordination of care, and subsidizing care costs.
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Acute Coronary Syndrome KCMC_1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CHAMP Intervention n=100 Participants Persons living with HIV (PLWH) and receiving routine HIV care in northern Tanzania will receive an integrated multi-component hypertension intervention, Community Health Worker Optimization of Antihypertensive Care in HIV (COACH). COACH consists of clinic-based hypertension educational counseling delivered by a Community Health Worker, provider training, coordination of care, and subsidizing care costs.
Age, Continuous	53.4 years STANDARD_DEVIATION 9.2 • n=13 Participants
Sex: Female, Male Female	77 Participants n=13 Participants
Sex: Female, Male Male	23 Participants n=13 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=13 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	100 Participants n=13 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants
Race (NIH/OMB) Asian	0 Participants n=13 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants
Race (NIH/OMB) Black or African American	100 Participants n=13 Participants
Race (NIH/OMB) White	0 Participants n=13 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants
Region of Enrollment Tanzania	100 Participants n=13 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	COACH Intervention n=600 Scheduled sessions Persons living with HIV (PLWH) and receiving routine HIV care in northern Tanzania will receive an integrated multi-component hypertension intervention, Community Health Worker Optimization of Antihypertensive Care in HIV (COACH). COACH consists of clinic-based hypertension educational counseling delivered by a Community Health Worker, provider training, coordination of care, and subsidizing care costs.
Feasibility as Measured by the Number of Total Scheduled Intervention Sessions (CHW Counseling Sessions, Doctor's Visits, Phone Calls) Attended	589 Scheduled sessions

SECONDARY outcome

Timeframe: 6 months

Population: Participants who completed the study.

Outcome measures

Outcome measures
Measure	COACH Intervention n=96 Participants Persons living with HIV (PLWH) and receiving routine HIV care in northern Tanzania will receive an integrated multi-component hypertension intervention, Community Health Worker Optimization of Antihypertensive Care in HIV (COACH). COACH consists of clinic-based hypertension educational counseling delivered by a Community Health Worker, provider training, coordination of care, and subsidizing care costs.
Number of Participants Reporting Adherence to an Anti-hypertensive Medication at 6-month Follow-up	91 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants who completed the study.

Controlled blood pressure (BP) is defined as systolic BP\<140 mmHg and diastolic BP \<90 mmHg.

Outcome measures

Outcome measures
Measure	COACH Intervention n=96 Participants Persons living with HIV (PLWH) and receiving routine HIV care in northern Tanzania will receive an integrated multi-component hypertension intervention, Community Health Worker Optimization of Antihypertensive Care in HIV (COACH). COACH consists of clinic-based hypertension educational counseling delivered by a Community Health Worker, provider training, coordination of care, and subsidizing care costs.
Number of Participants With Controlled Blood Pressure at 6-month Follow-up	73 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants who completed the study.

The HK-LS is used to measure knowledge about hypertension among adults. It has 22 items with six sub-dimensions. The maximum score is 22 for the entire scale, 2 for "definition", 4 for "medical treatment", 4 for "drug compliance", 5 for "lifestyle", 2 for "diet", and 5 for "complications" sub-dimensions. A higher score indicates greater hypertension knowledge.

Outcome measures

Outcome measures
Measure	COACH Intervention n=96 Participants Persons living with HIV (PLWH) and receiving routine HIV care in northern Tanzania will receive an integrated multi-component hypertension intervention, Community Health Worker Optimization of Antihypertensive Care in HIV (COACH). COACH consists of clinic-based hypertension educational counseling delivered by a Community Health Worker, provider training, coordination of care, and subsidizing care costs.
Hypertension Knowledge-Level Scale (HK-LS) Scores at 6-month Follow-up	20.4 score on a scale Standard Deviation 2.0

Adverse Events

COBRA and CHAMP (COACH) Adapted Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julian Hertz, MD, MSc

Duke University

Phone: 919-681-0196

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place