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Addressing Barriers to Anti-hypertensive Medication Adherence Among PLWH Who Have Achieved Viral Suppression

Addressing Barriers to Anti-hypertensive Medication Adherence Among Persons Living With HIV Who Have Achieved Viral Suppression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at what makes it hard for people with HIV to take their blood pressure medicine. It will use what it learns to shape and try a support program at the Duke clinic. It is for people whose HIV is well controlled, and some parts include care providers and others connected to the clinic.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Rules differ by study part.
  • Parts 1A and 1B: Be 18 or older, have confirmed HIV, and receive care at the Duke HIV clinic.
  • Parts 1A and 1B: Your latest HIV blood test, done within the past year, must show fewer than 200 copies of the virus per mL.
  • Parts 1A and 1B: Have high blood pressure listed in your medical record and take blood pressure medicine.
  • Part 2: Be an HIV care provider, such as a doctor or advanced practice provider, who has cared for people with HIV in the last 6 months.
  • Part 3A: Be a willing participant recruited from the Duke infectious disease clinic. This may include providers, clinic leaders, nurses, pharmacists, social workers, people with HIV taking blood pressure medicine, community advisory board members, or other key people.
  • Part 3B: Be 18 or older, have confirmed HIV, receive care at the Duke infectious disease clinic, take blood pressure medicine, and have an HIV blood test showing fewer than 200 copies per mL.
  • Part 3B: Your medical record must show a top blood pressure number above 130 at least twice in the past 12 months.

Who can't join

  • These rules apply to Parts 1A, 1B, and 3B.
  • Severe trouble hearing or speaking, or another disability that would limit taking part in the program.
  • Living in a nursing home or staying in a facility for mental health treatment.
  • An illness expected to leave you with less than 4 months to live.
  • No dependable access to a phone.
  • Pregnant, breastfeeding, or planning to become pregnant during the study.
  • Planning to move out of the area in the next 6 months.
  • Not able to speak English.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 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 * 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 Exclusion Criteria: 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.

Study sites (1)

NC