Impact of Physical Activity and Diet on Symptom Experience in People Living With HIV (PROSPER-HIV)

• ClinicalTrials.gov Identifier: NCT03790501
• Recruitment Status: Unknown
• First Posted: December 31, 2018
• Last Update Posted: June 8, 2021
• Sponsor: University of Washington
• Collaborators: University of Alabama at Birmingham; National Institute of Nursing Research (NINR)
• Information provided by (Responsible Party): Allison Webel, University of Washington

Tracking Information

• First Submitted Date: December 28, 2018
• First Posted Date: December 31, 2018
• Last Update Posted Date: June 8, 2021
• Actual Study Start Date: January 22, 2019
• Estimated Primary Completion Date: April 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 28, 2018)

Symptom Distress [ Time Frame: Four years ]

Symptom distress will be measured with the-20 item HIV Symptom Index. As recommended, our primary endpoints include 1) total symptom count (sum all symptoms that are reported as having the symptom and it bothers the participant at least a little); and 2) a total count of symptoms that bother the participant a lot (high symptom distress).

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Impact of Physical Activity and Diet on Symptom Experience in People Living With HIV
• Official Title: Impact of Physical Activity Routines and Dietary Intake on the Longitudinal Symptom Experience of People Living With HIV
• Brief Summary: We will conduct a four-year, observational study of 850 participants to measure physical activity and diet, once a year for three years. All participants will also complete the standard Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) patient-reported outcomes (PRO) and clinical assessment procedures. An enhanced PRO assessment (consisting measures of physical activity, diet intake and anthropomorphic factors) will be included after the routine patient clinic visit at four CNICS sites: Case Western Reserve University, University of Alabama at Birmingham, University of Washington, and Fenway Health.

Detailed Description

PROSPER-HIV is a four-year, prospective, observational study of 850 CNICS participants who will complete an enhanced patient-reported outcome (PRO) assessment to measure physical activity and diet intake, once a year for three years. All participants will also complete the standard CNICS PRO and clinical assessment procedures. We propose to integrate the following measures, physical activity (triaxial accelerometery), dietary intake (24-hour diet recalls), and anthropomorphic factors (waist-hip-ratio), into an enhanced annual assessment of patient reported outcomes at four CNICS sites: Case Western Reserve University, University of Alabama at Birmingham, University of Washington, and Fenway Health. Our four primary objectives are to:

1. Identify and characterize longitudinal, objectively measured, physical activity and dietary patterns among PLHIV
2. Examine the relationship between objectively-measured physical activity and self-reported physical activity on the Lipid Research Clinics Physical Activity Questionnaire.
3. Determine which aspects of physical activity patterns and diet quality are associated with decreased symptom burden and intensity in PLHIV, and if this relationship is moderated by age and sex.
4. Explore the potential mediating effect of anthropomorphic and physical fitness variables on the relationships between physical activity, dietary patterns, and symptom burden and intensity in PLHIV.

We hypothesize that people living with HIV who 1) have more intense, frequent and longer physical activity bouts will have age- and sex-dependent reduced symptom burden; 2) eat better quality diets (e.g., more fiber and protein, fewer carbohydrates) will have reduced symptom burden and intensity and that this relationship will also vary by age and sex.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: We will recruit and enroll 850 people living with HIV (PLHIV) who participate in the Centers for AIDS Research Network of Integrated Clinical Systems cohort to participate in this longitudinal observational study.
• Condition: HIV/AIDS

Intervention

Other: No intervention

As an observational study, no intervention will be associated with the study group.

Study Groups/Cohorts

People living with HIV (PLHIV).

We will recruit and enroll 850 people living with HIV (PLHIV) to participate in this longitudinal observational study.

Intervention: Other: No intervention

• Publications *: Webel AR, Long D, Rodriguez B, Davey CH, Buford TW, Crane HM, Mayer K, Saag MS, Willig AL. The PROSPER-HIV Study: A Research Protocol to Examine Relationships Among Physical Activity, Diet Intake, and Symptoms in Adults Living With HIV. J Assoc Nurses AIDS Care. 2020 May-Jun;31(3):346-352. doi: 10.1097/JNC.0000000000000145. No abstract available.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 28, 2018): 850
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 30, 2023
• Estimated Primary Completion Date: April 30, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Be an active CNICS participant
2. aged ≥18 years
3. prescribed HIV antiretroviral therapy, and
4. have an undetectable HIV viral load: defined as the most recent HIV viral load <200 copies/mL, checked within the past year.

Exclusion Criteria:

1) Did not complete the HIV Symptom Index in the PRO assessment (2) No reliable access to a telephone or internet-enable telephone services needed to complete the 24-diet recalls (3) Was pregnant, breast-feeding, or planning a pregnancy at the time of PRO assessment (4) Planning to move out of the area in the next 36 months, or (5) Non-English speaking.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03790501
• Other Study ID Numbers: STUDY00013048; R01NR018391 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Data will be shared consistent with the CNICS Data Sharing Policy found here: https://www.uab.edu/cnics/images/CNICSdatasharing_policy_v081515.pdf
• Supporting Materials: Study Protocol
• Supporting Materials: Informed Consent Form (ICF)
• URL: https://www.uab.edu/cnics/images/CNICSdatasharing_policy_v081515.pdf

• Current Responsible Party: Allison Webel, University of Washington
• Original Responsible Party: Allison Webel, Case Western Reserve University, Assistant Profsssor
• Current Study Sponsor: University of Washington
• Original Study Sponsor: Case Western Reserve University

Collaborators

• University of Alabama at Birmingham
• National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Allison Webel, BSN, PhD; University of Washington

• PRS Account: University of Washington
• Verification Date: June 2021