Duke University
Durham, North Carolina, 27710, United States
NCT Number: NCT05459077
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Aims 1A and 1B
Aim 2
Aim 3A
Aim 3 B
Exclusion criteria
Aims 1A, 1B and 3B
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..
Time frame: 1 year
Number of participants enrolled divided by total number of eligible patients in Duke Clinic 1K
Time frame: Week 24
Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)
Time frame: Week 24
Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)
Time frame: Week 24
Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)
Time frame: Week 24
Intervention Measure (Likert scale 1 completely disagree to 5 completely agree)
Time frame: Week 24
# of times participant was engaged via phone calls including successful and unsuccessful contacts
Time frame: Week 24
time frame it took for participant to self-report a reduced bp reading within a normal range
Time frame: Week 24
# of specialty referrals that the participant experienced during the duration of study enrollment
Time frame: Week 24
# of times medication changes (including switch to a different antihypertensive medication or the addition of another anti-hypertensive medication)
Time frame: Baseline and Week 24
Adherence to Hypertension and Medication Scales (Likert scale strongly disagree to strongly agree and not at all to very much)
Time frame: Baseline and Week 24
Comparison of baseline versus Week 24 visit measurements
Contact information is provided by the study sponsor or research team.
Mersedes Brown, MPH
CONTACT
Stuart T Carr, BA
CONTACT
Duke University
Other
Addressing Barriers to Anti-hypertensive Medication Adherence Among Persons Living With HIV Who Have Achieved Viral Suppression
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05129345
Cardiovascular Diseases, Diabetes Mellitus
Charlotte, North Carolina, United States
View Trial DetailsNCT04661813
Cardiovascular Diseases, HIV-1-infection
Durham, North Carolina, United States
View Trial DetailsNCT07730879
Apnea, Cardiovascular Diseases
Braga, Portugal
View Trial DetailsNCT07719660
Blood Pressure Monitoring, Cardiovascular Diseases
Dresden, Saxony, Germany
View Trial Details