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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP) | Behavioral | Clinic-based hypertension educational intervention delivered by a Community Health Worker. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Controlled blood pressure (BP) is defined as systolic BP<140 mmHg and diastolic BP <90 mmHg. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julian Hertz, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KCMC | Moshi | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39689146 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CHAMP 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Units | Scheduled sessions | 6 months | Scheduled sessions | Scheduled sessions |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP): Clinic-based hypertension educational intervention delivered by a Community Health Worker. Control of Blood Pressure and Risk Attenuation (COBRA): Multi-component counseling program addressing patient education, provider training, coordination of care, and subsidizing care costs. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julian Hertz, MD, MSc | Duke University | 919-681-0196 | julian.hertz@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2024 | Jan 12, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 5, 2024 | May 9, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003150 | Community Health Workers |
| ID | Term |
|---|---|
| D000488 | Allied Health Personnel |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| 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. |
|
| 6 months |
| Hypertension Knowledge-Level Scale (HK-LS) Scores at 6-month Follow-up | 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. | 6 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Number of Participants Reporting Adherence to an Anti-hypertensive Medication at 6-month Follow-up | Participants who completed the study. | Posted | Count of Participants | Participants | 6 months |
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|
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| Secondary | Number of Participants With Controlled Blood Pressure at 6-month Follow-up | Controlled blood pressure (BP) is defined as systolic BP<140 mmHg and diastolic BP <90 mmHg. | Participants who completed the study. | Posted | Count of Participants | Participants | 6 months |
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|
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| Secondary | Hypertension Knowledge-Level Scale (HK-LS) Scores at 6-month Follow-up | 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. | Participants who completed the study. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
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