Table 1 SPIRIT Checklist

Primary registry and trial identifying number

Clinicaltrials.gov Identifier: NCT 03839212

Date of registration in primary registry

8 February, 2019

Secondary identifying numbers

U54MD002266

Source(s) of monetary or material support

National Institute on Minority Health and Health Disparities (NIMHD)

Primary sponsor

University of Miami

Contact for public queries

Daniel Jimenez, Ph.D. (dej18@miami.edu)

Contact for scientific queries

Daniel Jimenez, Ph.D. (dej18@miami.edu)

Public title

The Happy Older Latinos Are Active (HOLA) Health Promotion Study in HIV-Infected Latino Men (HOLAHIV)

Scientific title

Preventing Cardiometabolic Disease in HIV-Infected Latino Men Through a Culturally Tailored Health Promotion Intervention

Countries of recruitment

USA

Health condition(s) or problem(s) studied

Human immunodeficiency virus (HIV),

cardiometabolic risk

Intervention(s)

Happy Older Latinos are Active (HOLA):

A 16-week multi-component, health promotion intervention

Key inclusion and exclusion criteria

Ages eligible for study: ≥ 50 years

Sexes eligible for study: men

Accepts healthy volunteers: no

Inclusion criteria: older Latino (≥ 50 years); HIV infected but are virologically suppressed have documented risk of cardiometabolic disease.

Exclusion criteria: diagnosis of diabetes, any neurodegenerative disorder, or dementia, or significant cognitive impairment; contraindications to physical activity; terminal physical illness; acute or severe medical illness that precludes safe participation.

Study type

Interventional

Interventional study model: single group assignment

Number of arms: 1

Masking: none (open label)

Allocation: N/A

Target sample size

18

Recruitment status

Not recruiting

Recruitment Rate

6 participants per month

Primary outcome(s)

Number of eligible participants refusing to participate: 20% or less of eligible participants refusing to participate

Retention rate: 85% or more of participants completing the post-intervention assessment

Acceptability of intervention: 80% or more of sessions attended by participants

Key secondary outcomes

Change in cardiometabolic risk

Change in psychosocial functioning

Change in health-related quality of life

Statistical methods

Descriptive statistics with 95% confidence intervals;

For continuous variables that are normally distributed: means and standard deviations.

For continuous variables that are skewed: median and range;

Categorical variables: summarized using counts and percentages.