Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05129345 |
| Other study ID # |
Pro00108897 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 7, 2022 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
July 2023 |
| Source |
Duke University |
| Contact |
Stuart T Carr, BA |
| Phone |
919 668-4849 |
| Email |
stuart.carr[@]duke.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
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.
