NCT06503991

Brief Summary

To adapt and assess the implementation and preliminary effectiveness of an integrated COBRA and CHAMP multi-component community health worker-delivered hypertension intervention in improving blood pressure control among PLWH in northern Tanzania.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

December 13, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
4 months until next milestone

Results Posted

Study results publicly available

February 2, 2026

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

July 10, 2024

Results QC Date

January 12, 2026

Last Update Submit

January 12, 2026

Conditions

HypertensionHIV

Outcome Measures

Primary Outcomes (1)

  • Feasibility as Measured by the Number of Total Scheduled Intervention Sessions (CHW Counseling Sessions, Doctor's Visits, Phone Calls) Attended

    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.

    6 months

Secondary Outcomes (3)

  • Number of Participants Reporting Adherence to an Anti-hypertensive Medication at 6-month Follow-up

    6 months

  • Number of Participants With Controlled Blood Pressure at 6-month Follow-up

    6 months

  • Hypertension Knowledge-Level Scale (HK-LS) Scores at 6-month Follow-up

    6 months

Study Arms (1)

COBRA and CHAMP (COACH) adapted intervention

EXPERIMENTAL

Persons living with HIV (PLWH) and receiving routine HIV care in northern Tanzania will receive an integrated COBRA (Control of Blood Pressure and Risk Attenuation) and CHAMP (Community Health Worker-delivered Hypertension Management Pilot) multi-component hypertension intervention.

Behavioral: Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP)Behavioral: Control of Blood Pressure and Risk Attenuation (COBRA)

Interventions

Control of Blood Pressure and Risk Attenuation (COBRA)BEHAVIORAL

Multi-component counseling program addressing patient education, provider training, coordination of care, and subsidizing care costs.

COBRA and CHAMP (COACH) adapted intervention
Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP)BEHAVIORAL

Clinic-based hypertension educational intervention delivered by a Community Health Worker.

COBRA and CHAMP (COACH) adapted intervention

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Known HIV
  • Hypertension with single reading of SBP=\>160 mm Hg and /or DBP=\>100mm Hg
  • Two separate measurements of SBP =\> 140 mmHg and/or DBP=\> 90 mmHg

You may not qualify if:

  • No documented elevated blood pressure
  • No HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KCMC

Moshi, Tanzania

Location

Related Publications (1)

  • Min Htike WY, Manavalan P, Wanda L, Haukila K, Mmbaga BT, Sakita FM, Zebedayo R, Gwasma F, Jafar T, Bosworth HB, Thielman NM, Hertz JT. Community Health Worker Optimization of Antihypertensive Care in HIV (COACH): Study protocol for a pilot trial of an intervention to improve hypertension care among Tanzanians with HIV. PLoS One. 2024 Dec 17;19(12):e0315027. doi: 10.1371/journal.pone.0315027. eCollection 2024.

    PMID: 39689146DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Allied Health PersonnelHealth PersonnelHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Julian Hertz, MD, MSc
Organization
Duke University
julian.hertz@duke.edu
919-681-0196

Study Officials

  • Julian Hertz, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 16, 2024

Study Start

December 13, 2024

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

February 2, 2026

Results First Posted

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TA(1)