Addressing Barriers to Achieving Cardiometabolic Disorders Prevention and Treatment Goals for PLWH in the SE US

July 11, 2023 updated by: Duke University

Addressing Barriers to Achieving Cardiometabolic Disorders Prevention and Treatment Goals for Persons Living With HIV in the Southeastern United States

This study has 3 aims. Aim 1: Identify social determinants of cardiometabolic health and determine facilitators and modifiable barriers in achieving treatment goals.

Aim 2: Assess PLWH knowledge, skills, and confidence for self-management of cardiometabolic disorders.

Aim 3: Tailor a self-management support and education intervention with stakeholder input to address barriers to achieving treatment goals for cardiometabolic disorders in PLWH at the study sites.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Aim 1: 20 PLWH ages 35 years and older with at least one cardiometabolic disorder (hypertension, dyslipidemia, or type 2 diabetes) will participate in in-depth interviews (IDIs) using photo elicitation to capture the social environment and contextual determinants of cardiometabolic disorders for PLWH. Prior to IDIs, PLWH will take photographs of facilitators and barriers to reaching their cardiometabolic health goals. During IDIs we will discuss the content of the photographs and explore the most salient facilitators and barriers that an intervention (Aim 3) must address to achieve treatment goals for cardiometabolic disorders at the study sites.

Aim 2: 120 PLWH with the same eligibility criteria as Aim 1 across the study sites will complete a Patient Activation Measure survey to assess knowledge, skills, and confidence for self-management of their cardiometabolic disorders. Logistic regression models will assess the predictors of knowledge, skills and confidence for self management of these disorders in order to inform the tailoring of the intervention in Aim 3.

Aim 3: Guided by the Behavior Change Wheel model and using the human-centered design approach, we will engage key stakeholders (healthcare providers, community advisory board members, and PLWH with cardiometabolic disorders) in the tailoring of a self-management support and education intervention that has been found to be effective in the general population. We will engage stakeholders in an iterative process spanning three months by first developing understanding of the self-management and education intervention, reviewing the results from Aim 1 and 2 and brainstorming possible tailoring options within the context in which PLWH live and receive care in order to arrive at an intervention that is desirable, feasible, and viable. A final recommendation of the tailored intervention will be presented to the participating HIV providers, Ending the HIV Epidemic Committee in Mecklenburg County, and the Duke Center for AIDS Research Community Advisory Board. The completion of these aims will provide the data for publication, an adapted evidence-based intervention, and community and healthcare collaborations necessary to launch an R21 application to assess the acceptability, fidelity, and appropriateness of the intervention.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28205
        • Recruiting
        • Duke University - Charlotte Study Sites
        • Contact:
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University - Duke Study Site
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Aims 1 and 2

  • People living with HIV who are at least 35 years of age and who have one or more of the following conditions: hypertension, dyslipidemia, or type 2 diabetes.

Aim 3

  • Participants recruited from the participating clinics and community based organizations and may include, HIV providers, nurses, pharmacists, people living with HIV who have cardiometabolic disorders, and representatives of the community advisory boards, and any other key stakeholders. Age 18 or older.

Description

Inclusion Criteria:

Aims 1 and 2

  • People living with HIV who are at least 35 years of age and who have one or more of the following conditions: hypertension, dyslipidemia, or type 2 diabetes.

Aim 3

  • Participants recruited from the participating clinics and community based organizations and may include, HIV providers, nurses, pharmacists, people living with HIV who have cardiometabolic disorders, and representatives of the community advisory boards, and any other key stakeholders. Age 18 or older.

Exclusion Criteria:

  • Those who don't understand English and those who are blind.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Aim 1
People living with HIV who are at least 35 years of age and who have one or more of the following conditions: hypertension, dyslipidemia, or type 2 diabetes. All genders, races and ethnicities will be included in this study. Subjects will have a telephone visit including being consented electronically and complete a demographic survey, a photography training visit and an interview visit.
Aim 2
People living with HIV who are at least 35 years of age and who have one or more of the following conditions: hypertension, dyslipidemia, or type 2 diabetes. All genders, races and ethnicities will be included in this study. Subjects will have a telephone visit and be electronically consented to study and complete an electronic survey.
Aim 3
Group composed of 10 willing participants recruited from the participating clinics and community based organizations and may include, HIV providers, nurses, pharmacists, people living with HIV who have cardiometabolic disorders, and representatives of the community advisory boards, and any other key stakeholders. There will be 3 one hour meetings over 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aim 1: Number of social determinants of cardiometabolic health identified from interviews
Time Frame: 2 weeks after enrollment
Interviews with PLWH who have cardiometabolic disorders to determine salient barriers and facilitators of achieving treatment goals for cardiometabolic disorders
2 weeks after enrollment
Aim 2: Patient engagement in healthcare as measured by the Patient Activation Measure (PAM)
Time Frame: Baseline
Assess PLWH knowledge, skills, and confidence for self-management using the PAM which is a 13 item survey, Likert scale from strongly disagree to agree strongly.
Baseline
Aim 3: Number of strategies modified in the self-management support and education
Time Frame: Up to 3 months
Tailoring of self-management support and education intervention using stakeholder engagement strategies
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Charles Muiruri, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2022

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

November 10, 2021

First Posted (Actual)

November 22, 2021

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00108897

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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