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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-07

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reducing Cardiovascular Disease Risk in Perimenopausal Latinas

NCT04313751

Cardiovascular Risk Factor Health Behavior Physical Activity +2 more

COMPLETED NA

Family Diabetes Prevention Program Pilot Study

NCT05358444

PreDiabetes Overweight and Obesity Type 2 Diabetes +3 more

COMPLETED NA

Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

NCT02535169

Obesity Prediabetic State Type 2 Diabetes

COMPLETED NA

Community-Based Nutrition-Lifestyle Therapy for Pregnant Latina Women With Diabetes

NCT06218147

Diabetes Mellitus, Type 2 Diabetes Mel Gestational - in Pregnancy

COMPLETED NA

Healthy Living Partnership to Prevent Diabetes

NCT00631345

Prediabetes Obesity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Dyslipidemias Type 2 Diabetes HIV-1-infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.