'Ai Pono Cooking Demonstrations
NCT06526650
Body Weight, Cardiovascular Diseases
Honolulu, Hawaii, United States
View Trial DetailsNCT Number: NCT05129345
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Duke University - Charlotte Study Sites, Charlotte, North Carolina, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Aims 1 and 2
Aim 3
Exclusion criteria
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
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.
Time frame: Up to 3 months
Tailoring of self-management support and education intervention using stakeholder engagement strategies
Contact information is provided by the study sponsor or research team.
Charles Muiruri, PhD
CONTACT
Stuart T Carr, BA
CONTACT
Duke University
Other
Addressing Barriers to Achieving Cardiometabolic Disorders Prevention and Treatment Goals for Persons Living With HIV in the Southeastern United States
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.
NCT06526650
Body Weight, Cardiovascular Diseases
Honolulu, Hawaii, United States
View Trial DetailsNCT06526273
Body Weight, Cardiovascular Diseases
Honolulu, Hawaii, United States
View Trial DetailsNCT05000996
Bariatric Surgery Candidate, Body Weight
Nashville, Tennessee, United States
View Trial DetailsNCT06380322
Cardiovascular Diseases, Diabetes Mellitus
Fort Carson, Colorado, United States
View Trial Details