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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)
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.

Tanzania1 site
  • KCMC

    Moshi

Other trials in Tanzania

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 groups in NCT06503991
Study groupRoleWhat they receive
COBRA and CHAMP (COACH) adapted interventionExperimentalPersons 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.

  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.

    Measured: 6 months

Secondary outcomes (3)
  1. Number of Participants Reporting Adherence to an Anti-hypertensive Medication at 6-month Follow-up

    Measured: 6 months

  2. 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

  3. 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.

  1. First posted16 Jul 2024
  2. Study start13 Dec 2024
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

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)
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
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 42439100
  • 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.

    PubMed 39689146

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.

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