The Happy Older Latinos Are Active (HOLA) Health Promotion Study in HIV-Infected Latino Men (NCT03839212) | Clinical Trial Compass
CompletedNot Applicable
The Happy Older Latinos Are Active (HOLA) Health Promotion Study in HIV-Infected Latino Men
United States18 participantsStarted 2019-10-01
Plain-language summary
The purpose of this study is to examine the feasibility of an intervention to prevent chronic diseases like diabetes, high blood pressure, and obesity in midlife and older Latino adults living with HIV. The investigators expect that the participant will be in this study for seven months. Participants will be interviewed and asked to take part in walking groups.
Who can participate
Age range
50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* are Latino (self-identified);
* are age 50+ years;
* are male;
* are HIV infected but are virologically suppressed (viral load \<200 copies/mL);
* volunteer informed consent;
* have medical clearance by a physician;
* expect to stay in Miami for the next 6 months; and
* have documented risk of cardiometabolic disease.
Exclusion Criteria:
* diabetes diagnosis;
* at baseline meet criteria for current major depressive disorder or generalized anxiety disorder;
* meet criteria for current alcohol or other substance abuse disorders;
* have a lifetime history of bipolar disorder or other psychotic disorder;
* have a diagnosis of any neurodegenerative disorder or dementia (Parkinson's disease, Alzheimer's, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a Mini Mental Status Exam score \<24;
* have contraindications to physical activity outlined in the American College of Sports Medicine standards;
* have high suicide risk i.e., intent or plan to attempt suicide in the near future (a response of "yes" to questions 3, 4, and/or 5 on the Paykel Questionnaire);
* are unable to complete 10 m walk test;
* currently residing in a nursing or group home;
* have a terminal physical illness expected to result in the death within one year;
* have an acute or severe medical illness that precludes them from safely participating in a health promotion intervention.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Eligible Participants Refusing to Participate.