HypertensionCOACHNCT06503991
Community Health Worker Optimization of Antihypertensive Care in HIV
A study testing Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP) in people with Hypertension and HIV, run by Duke University at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertension, HIV
- What is being tested?
- Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTanzania
- Study dates
- 13 Dec 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No documented elevated blood pressure
- No HIV infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community and Physician Perceptions of Barriers to Care for Acute Coronary Syndrome Among HIV-infected and -Uninfected Patients in Moshi, Tanzania_1
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.
Read the 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
- Being tested
- Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP), Control of Blood Pressure and Risk Attenuation (COBRA)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP)Behavioural
Clinic-based hypertension educational intervention delivered by a Community Health Worker.
Control of Blood Pressure and Risk Attenuation (COBRA)Behavioural
Multi-component counseling program addressing patient education, provider training, coordination of care, and subsidizing care costs.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP); Behavioral: Control of Blood Pressure and Risk Attenuation (COBRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Number of Participants Reporting Adherence to an Anti-hypertensive Medication at 6-month Follow-up
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start13 Dec 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Julian Hertz, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503991
- Sponsor's protocol ID
- Pro00090902_1
- Acronym
- COACH
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2024
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hertz JT, Rahim F, Wang C, Vaidyanathan A, Wanda L, Sakita FM, Mmbaga BT, Kweka GL, Mlangi JJ, Zebedayo R, Gwasma F, Prakash T, Jafar TH, Bosworth HB, Thielman NM, Manavalan P. Optimizing Antihypertensive Care for Tanzanians Living With HIV: Effectiveness Outcomes From the COACH Pilot Trial. J Acquir Immune Defic Syndr. 2026 Aug 1;101(8):896-906. doi: 10.1097/QAI.0000000000003874.
PubMed 42439100Min 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.
PubMed 39689146
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community and Physician Perceptions of Barriers to Care for Acute Coronary Syndrome Among HIV-infected and -Uninfected Patients in Moshi, Tanzania_1
- ClinicalTrials.gov ID
- NCT06503991
- Acronym / sponsor ID
- COACH / Pro00090902_1
- Conditions
- Hypertension, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Posted 2 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COBRA and CHAMP (COACH) adapted intervention | Experimental | Behavioral: Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP), Behavioral: Control of Blood Pressure and Risk Attenuation (COBRA)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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- No documented elevated blood pressure
- No HIV infection
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 |
|---|---|---|
| Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP)Clinic-based hypertension educational intervention delivered by a Community Health Worker. | Behavioural | COBRA and CHAMP (COACH) adapted intervention |
| Control of Blood Pressure and Risk Attenuation (COBRA)Multi-component counseling program addressing patient education, provider training, coordination of care, and subsidizing care costs. | Behavioural | COBRA and CHAMP (COACH) adapted intervention |
Primary outcome
Feasibility as Measured by the Number of Total Scheduled Intervention Sessions (CHW Counseling Sessions, Doctor's Visits, Phone Calls) Attended
Time frame: 6 months
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.
3 secondary outcomes
Number of Participants Reporting Adherence to an Anti-hypertensive Medication at 6-month Follow-up
Time frame: 6 months
Number of Participants With Controlled Blood Pressure at 6-month Follow-up
Time frame: 6 months
Hypertension Knowledge-Level Scale (HK-LS) Scores at 6-month Follow-up
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 42439100Hertz JT, Rahim F, Wang C, Vaidyanathan A, Wanda L, Sakita FM, Mmbaga BT, Kweka GL, Mlangi JJ, Zebedayo R, Gwasma F, Prakash T, Jafar TH, Bosworth HB, Thielman NM, Manavalan P. Optimizing Antihypertensive Care for Tanzanians Living With HIV: Effectiveness Outcomes From the COACH Pilot Trial. J Acquir Immune Defic Syndr. 2026 Aug 1;101(8):896-906. doi: 10.1097/QAI.0000000000003874.
- Derived from this study: PubMed 39689146Min 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Julian Hertz, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP) in people with Hypertension and HIV, run by Duke University at 1 site in Tanzania.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. 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?
Yes. Results are posted in the registry (first posted 2 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as Measured by the Number of Total Scheduled Intervention Sessions (CHW Counseling Sessions, Doctor's Visits, Phone Calls) Attended (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06503991, which also lists 2 linked publications.
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 Oct 2026.