Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT05129345

Conditions

Hypertension

Dyslipidemias

Type 2 Diabetes

HIV-1-infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Hypertension

Dyslipidemias

Type 2 Diabetes

HIV-1-infection

Study ID

NCT05129345

Start date

Jun 7, 2022

Status verified date

Jul, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: 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.

Exclusion Criteria:

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Aim 1: Number of social determinants of cardiometabolic health identified from interviews [ Time Frame: 2 weeks after enrollment ]
  • Aim 2: Patient engagement in healthcare as measured by the Patient Activation Measure (PAM) [ Time Frame: Baseline ]
  • Aim 3: Number of strategies modified in the self-management support and education [ Time Frame: Up to 3 months ]

Central Contacts and Locations

Central contacts

Stuart T Carr, BA

919 668-4849stuart.carr@duke.edu

Charles Muiruri, PhD

919 660-3212charles.muiruri@duke.edu

Locations

Duke University - Charlotte Study Sites

Recruiting

Charlotte, North Carolina, United States, 28205

Contacts

Lalia Victoria, BA, MSW

704-641-0772lalia.victoria@duke.edu

Duke University - Duke Study Site

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Laura Farrow, BA

919-668-0176laura.farrow@duke.edu

More Information

Sponsor

Duke University

Last update posted

Jul 24, 2025

Last verified

Jul, 2025

Keywords

  • Hypertension
  • Dyslipidemias
  • Type 2 Diabetes
  • HIV-1-infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2025-07-24.