HypertensionNCT05459077
Addressing Barriers to Anti-hypertensive Medication Adherence Among PLWH Who Have Achieved Viral Suppression
A study of Hypertension and HIV-1-infection, run by Duke University at 1 site in United States.
Trial summary
Among those with hypertension, persons living with HIV (PWH) have a 50% higher risk of incident myocardial infarction compared to the general population, and they often fail to meet evidence-based treatment goals for hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, HIV-1-infection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aims 1A and 1B
- Age ≥18 years
- Confirmed HIV+ diagnosis
- Undetectable HIV viral load: defined as the most recent HIV viral load <200 copies/mL checked within the past year (assessed via chart abstraction)
- Hypertension diagnosis in medical records
- Taking an antihypertensive medication
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- Receiving care at the Duke HIV clinic
- Aim 2
- HIV providers including infectious disease physicians, internists or advance practice practitioners who have a patient pool of PLWH under their care in the last 6 months.
- Aim 3A
- Stakeholders composed of willing participants recruited from the Duke ID clinic and may include, HIV providers, clinic directors, nurses, pharmacists, social workers, people living with HIV who have hypertension and take antihypertensive medications, and representatives of the community advisory boards, and any other key stakeholders.
- Aim 3 B
- Age ≥18 years
- Confirmed HIV+ diagnosis
- Receiving care at the Duke ID clinic
- Achievement of HIV suppression defined as having HIV-1 RNA <200 copies/ml
- Take antihypertensive medications
- Uncontrolled BP over a 12 months period defined by participants with systolic BP>130mmHg on ≥ 2 occasions in the past 12 months as indicated in the individual patient's electronic medical records
Who cannot join
- Aims 1A, 1B and 3B
- Severely hearing or speech impaired, or other disability that would limit participation in the intervention components
- In a nursing home and/or receiving in-patient psychiatric care
- Terminal illness with life expectancy < 4 months
- No reliable access to a telephone
- Pregnant, breast-feeding, or planning a pregnancy during the study period
- Planning to move out of the area in the next 6 months
- Non-English speaking.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke University
Durham, North Carolina, 27710
Mersedes Brown, MPH, 919 668-7364, mersedes.brown@duke.edu
About this study
Official title: Addressing Barriers to Anti-hypertensive Medication Adherence Among Persons Living With HIV Who Have Achieved Viral Suppression
Among those with hypertension, persons living with HIV (PWH) have a 50% higher risk of incident myocardial infarction compared to the general population, and they often fail to meet evidence-based treatment goals for hypertension. An important contributing factor for insufficient blood pressure control is non-adherence to antihypertensive medications. Research on medication adherence for PWH has largely focused on antiretroviral therapy adherence with limited focus on adherence to other non-AIDS condition medications.
With a large proportion of PWH in the U.S. achieving viral suppression, providers may now have an opportunity to focus on the management of non-AIDS conditions like hypertension. However, because PWH who have achieved suppression have reduced clinic encounters (once or twice a year) there is potential loss of opportunity to effectively monitor and intensify hypertension treatment as needed an important opportunity to focus on preventing cardiovascular disease. CVD and other non-AIDS comorbidities.
The study's overarching goal is to improve the hypertension outcomes for PWH on suppressive ART to reduce cardiovascular disease risk. In this study, we will identify and evaluate healthcare and patient-level factors that must be addressed in an intervention to increase hypertension medication adherence for PWH who have achieved viral suppression. We will use these factors to tailor an intervention and assess the feasibility and acceptability at the Duke ID clinic.
Read the detailed description
The study is divided into 5 separate groups, Aim 1A, Aim 1B, Aim 2, Aim 3A and Aim 3B. Aims 1A and 1B will identify and evaluate patient-level factors that must be addressed in an intervention to increase hypertension medication adherence for (persons living with HIV) PWH who have achieved viral suppression. Aim 2 will identify HIV providers' practice norms after their patients achieve viral suppression and explore barriers faced in monitoring and managing patient adherence to antihypertensive medications to inform an intervention aimed at increasing antihypertensive medication adherence. Aim 3A will adapt the health care delivery intervention components to the Duke ID clinic context with key stakeholder input and data from Aims 1 and 2. Aim 3B will evaluate the feasibility and acceptability of the adapted health care delivery intervention to improve anti-hypertensive medication adherence and BP control in PWH at 24 weeks.
- Conditions
- Hypertension, HIV-1-infection
- Being tested
- Hypertension control through education and monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertension control through education and monitoringBehavioural
Enrollment of 60 PLWH ≥18 years old receiving care at the Duke ID clinic who have achieved HIV viral suppression who take antihypertensive medication and have uncontrolled blood pressure. Subjects will have be given educational materials, blood pressure monitors to use and report findings, follow up with study coordinator and communication with subject's HIV provider in order to maximize blood pressure control..
| Study group | Role | What they receive |
|---|---|---|
| Aim 3B | Other | This aim will evaluate the feasibility and acceptability of the adapted health care delivery intervention to improve anti-hypertensive medication adherence and blood pressure control in persons living with HIV at 24 weeks. Receives: Behavioral: Hypertension control through education and monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by enrollment
Number of participants enrolled divided by total number of eligible patients in Duke Clinic 1K
Measured: 1 year
Acceptability of nurse managed adherence strategy
Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)
Measured: Week 24
Usefulness of contact with nurse
Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)
Measured: Week 24
Subject's evaluation regarding ease of use of blood pressure machine
Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)
Measured: Week 24
Subject's evaluation of ease of the completion of blood pressure logs
Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)
Measured: Week 24
Secondary outcomes (6)
Total number of telephone contacts
# of times participant was engaged via phone calls including successful and unsuccessful contacts
Measured: Week 24
Duration of time to reduce elevated BP to an under-control reading
time frame it took for participant to self-report a reduced bp reading within a normal range
Measured: Week 24
Total number of specialty referrals
# of specialty referrals that the participant experienced during the duration of study enrollment
Measured: Week 24
Number of anti-hypertensive medication changes
# of times medication changes (including switch to a different antihypertensive medication or the addition of another anti-hypertensive medication)
Measured: Week 24
Change in subject's self report of anti-hypertensive medication adherence
Adherence to Hypertension and Medication Scales (Likert scale strongly disagree to strongly agree and not at all to very much)
Measured: Baseline and Week 24
Change in systolic blood pressure measurements
Comparison of baseline versus Week 24 visit measurements
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start3 Dec 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Aim 3B group will participate in an adapted intervention related to blood pressure management.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Muiruri, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459077
- Sponsor's protocol ID
- Pro00108808
- Status last verified
- Mar 2026
- First submitted
- 11 Jul 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Barriers to Anti-hypertensive Medication Adherence Among Persons Living With HIV Who Have Achieved Viral Suppression
- ClinicalTrials.gov ID
- NCT05459077
- Acronym / sponsor ID
- Pro00108808
- Conditions
- Hypertension, HIV-1-infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 3 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Among those with hypertension, persons living with HIV (PWH) have a 50% higher risk of incident myocardial infarction compared to the general population, and they often fail to meet evidence-based treatment goals for hypertension. An important contributing factor for insufficient blood pressure control is non-adherence to antihypertensive medications. Research on medication adherence for PWH has largely focused on antiretroviral therapy adherence with limited focus on adherence to other non-AIDS condition medications.
With a large proportion of PWH in the U.S. achieving viral suppression, providers may now have an opportunity to focus on the management of non-AIDS conditions like hypertension. However, because PWH who have achieved suppression have reduced clinic encounters (once or twice a year) there is potential loss of opportunity to effectively monitor and intensify hypertension treatment as needed an important opportunity to focus on preventing cardiovascular disease. CVD and other non-AIDS comorbidities.
The study's overarching goal is to improve the hypertension outcomes for PWH on suppressive ART to reduce cardiovascular disease risk. In this study, we will identify and evaluate healthcare and patient-level factors that must be addressed in an intervention to increase hypertension medication adherence for PWH who have achieved viral suppression. We will use these factors to tailor an intervention and assess the feasibility and acceptability at the Duke ID clinic.
Detailed description
The study is divided into 5 separate groups, Aim 1A, Aim 1B, Aim 2, Aim 3A and Aim 3B. Aims 1A and 1B will identify and evaluate patient-level factors that must be addressed in an intervention to increase hypertension medication adherence for (persons living with HIV) PWH who have achieved viral suppression. Aim 2 will identify HIV providers' practice norms after their patients achieve viral suppression and explore barriers faced in monitoring and managing patient adherence to antihypertensive medications to inform an intervention aimed at increasing antihypertensive medication adherence. Aim 3A will adapt the health care delivery intervention components to the Duke ID clinic context with key stakeholder input and data from Aims 1 and 2. Aim 3B will evaluate the feasibility and acceptability of the adapted health care delivery intervention to improve anti-hypertensive medication adherence and BP control in PWH at 24 weeks.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Aim 3B group will participate in an adapted intervention related to blood pressure management.
| Arm | Type | Receives |
|---|---|---|
| Aim 3B | Other | Behavioral: Hypertension control through education and monitoringThis aim will evaluate the feasibility and acceptability of the adapted health care delivery intervention to improve anti-hypertensive medication adherence and blood pressure control in persons living with HIV at 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Aims 1A and 1B
- Age ≥18 years
- Confirmed HIV+ diagnosis
- Undetectable HIV viral load: defined as the most recent HIV viral load <200 copies/mL checked within the past year (assessed via chart abstraction)
- Hypertension diagnosis in medical records
Key exclusion criteria (8 listed)
- Aims 1A, 1B and 3B
- Severely hearing or speech impaired, or other disability that would limit participation in the intervention components
- In a nursing home and/or receiving in-patient psychiatric care
- Terminal illness with life expectancy < 4 months
- No reliable access to a telephone
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 |
|---|---|---|
| Hypertension control through education and monitoringEnrollment of 60 PLWH ≥18 years old receiving care at the Duke ID clinic who have achieved HIV viral suppression who take antihypertensive medication and have uncontrolled blood pressure. Subjects will have be given educational materials, blood pressure monitors to use and report findings, follow up with study coordinator and communication with subject's HIV provider in order to maximize blood pressure control.. | Behavioural | Aim 3B |
Primary outcome
Feasibility as measured by enrollment
Time frame: 1 year
Number of participants enrolled divided by total number of eligible patients in Duke Clinic 1K
Acceptability of nurse managed adherence strategy
Time frame: Week 24
Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)
Usefulness of contact with nurse
Time frame: Week 24
Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)
Subject's evaluation regarding ease of use of blood pressure machine
Time frame: Week 24
Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)
Subject's evaluation of ease of the completion of blood pressure logs
Time frame: Week 24
Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)
6 secondary outcomes
Total number of telephone contacts
Time frame: Week 24
Duration of time to reduce elevated BP to an under-control reading
Time frame: Week 24
Total number of specialty referrals
Time frame: Week 24
Number of anti-hypertensive medication changes
Time frame: Week 24
Change in subject's self report of anti-hypertensive medication adherence
Time frame: Baseline and Week 24
Change in systolic blood pressure measurements
Time frame: Baseline and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- 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.
Charles Muiruri, PhD 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 of Hypertension and HIV-1-infection, run by Duke University at 1 site in United States.
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 18 inclusion and 8 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: opening soon, as of the sponsor's last update on 1 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stuart T Carr, BA (919 668-4849, stuart.carr@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by enrollment (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2026.