Acute Coronary Syndrome KCMC_1

NCT ID: NCT06503991

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-13
• Study Completion Date: 2025-09-30

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.

Detailed Description

Adapt and assess feasibility and preliminary effectiveness of an adapted community health worker-delivered hypertension intervention (Specific Objective 6): Using the ADAPT-ITT model, an interdisciplinary team of stakeholders will help adapt the COBRA intervention for integration within the HIV clinic to improve hypertension care among person living with HIV(PLWH) in Tanzania. The adapted, multicomponent, intervention (COACH) will integrate key components from our previous pilot intervention CHAMP with COBRA. The investigators anticipate the adapted intervention will include community health worker (CHW)-delivered hypertension counseling and blood pressure monitoring, integrated within existing HIV clinic appointments, referral to a prescribing provider within the HIV clinic for persistently elevated blood pressure, CHW-coordination and tracking of these referrals, provider training on use of an algorithmic protocol for blood pressure management, and subsidies to cover the unmet costs of antihypertensive agents. In the first 8 months, intervention content will be adapted using ADAPT-ITT. ADAPT-ITT is a pragmatic framework utilizing iterative, experiential processes to adapt evidence-based interventions. The investigators will assemble an inter-disciplinary Design Consultation Team (DCT) composed of key stakeholders who will participate in the intervention adaptation and design process which will occur iteratively through twice-monthly meetings between the study team and DCT. The DCT will include purposively selected patients with HIV and hypertension, clinicians and scientists from the US and Tanzania, clinic administrators, and community health workers. The investigators will document adaptation using the ADAPT-ITT framework.

Key staff, including community health workers, nurses, and physicians working at Majengo Care and Treatment Center (MCTC) and Pasua Care and Treatment Center (PCTC), will be trained with the final adapted COACH intervention, and this team will be responsible for implementing COACH in MCTC and PCTC. The investigators will then conduct a single arm pre-post feasibility study of COACH with 100 hypertensive participants recruited from MCTC and PCTC to determine implementation (reach, adoptability, implementation, and maintenance) and preliminary effectiveness outcomes (blood pressure, antihypertensive adherence, body mass index, waist circumference, CVD risk score, and hypertension knowledge) of the adapted intervention. Community health workers will measure blood pressure at initial enrollment and at monthly follow-up at HIV clinic and also participants with persistently elevated blood pressure at monthly follow-up. Any participant with SBP>=160mmHg and DBP>=100mmHg at enrollment will be referred to the hypertension coordinator and physician to be prescribed anti-hypertensives according to the COACH treatment algorithm. Participants with persistently elevated blood pressure (SBP ³140mmHg or DBP ³90mmHg) at 3- or 6- month follow-up will also be referred for pharmacotherapy. The investigators will compare participant blood pressure, antihypertensive adherence, body mass index, waist circumference, NHANES CVD risk score20 and hypertension knowledge (via the Hypertension Knowledge Level Scale21) at baseline and after six months of the intervention. The investigators will use quantitative and qualitative methods guided by the RE-AIM framework22to understand contexts of implementation of the adapted intervention. The investigators will use simple descriptive statistics to assess measures of reach and feasibility (i.e. the percentage of eligible MCTC and PCTC patients who enroll and the percentage of enrolled participants who 1) attend scheduled CHW visits; 2) are referred to a prescribing provider; 3) attend a referral appointment; 4) are prescribed anti-hypertensives; 5) report adherence to anti-hypertensives at 6-month follow up, and 6) the proportion of prescribed anti-hypertensives that conform to the COACH treatment algorithm. To assess adoption and acceptability of the intervention the investigators will conduct approximately 18 exit in-depth interviews with a subset of participants enrolled in COACH and also conduct approximately one - two focus group discussion with physicians, nurses, CHWS, and administrators to determine barriers and facilitators of intervention adoption and also resources, strategies and policies needed for intervention sustainability. To assess fidelity (i.e. the proportion of intervention components successfully delivered as designed) the investigators will audio record and review approximately 20% of CHW-delivered counseling to assess session completion and CHWs will complete a COACH fidelity checklist for each session.

Conditions

Hypertension; HIV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

COBRA and CHAMP (COACH) adapted intervention

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.

Group Type: EXPERIMENTAL

Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP)

Intervention Type: BEHAVIORAL

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

Control of Blood Pressure and Risk Attenuation (COBRA)

Intervention Type: BEHAVIORAL

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

Interventions

Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP)

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

Intervention Type: BEHAVIORAL

Control of Blood Pressure and Risk Attenuation (COBRA)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• No documented elevated blood pressure
• No HIV infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julian Hertz, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

KCMC

Moshi, , Tanzania

Countries

Tanzania

References

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.

Reference Type: DERIVED

PMID: 39689146 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00090902_1

Identifier Type: -

Identifier Source: org_study_id