WiseApp for Spanish Speakers Living With HIV (NCT05398185) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
WiseApp for Spanish Speakers Living With HIV
United States, Dominican Republic241 participantsStarted 2023-03-01
Plain-language summary
This study aims to conduct a 12-month randomized controlled trial to adapt the mobile app, WiseApp, and a smart pill dispenser for Spanish-speaking people living with HIV (PLWH) in the New York City (NYC) area and La Romana, Dominican Republic (DR). The study will assess the efficacy and sustainability of WiseApp as well as identify barriers with its widespread use among Spanish speakers. With disproportionately high rates of HIV in the New York City area and the Dominican Republic, this project seeks to identify distinct contextual factors related to Spanish speaking people living with HIV and increase the likelihood of engagement with technology and improvements in clinical outcomes.
Who can participate
Age range
18 Years
Sex
ALL
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:
* Able to speak, read, and write in Spanish;
* Aged ≥18 years;
* Willing to participate in any assigned arm of the intervention;
* Have an HIV-1 RNA level \>50 copies/mL;
* Own a smartphone (DR participants who are eligible but without access to a smartphone will get one as part of the study at the time of enrollment); and
* Ability and willingness to provide informed consent for study participation and consent for access to medical records.
Exclusion Criteria:
* Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment;
* Terminal illness with life expectancy \<6 months;
* Planning to move out of the area in the next 12 months;
* A cognitive state minimum score measured by the Mini-Mental State Examination (MMSE) to ensure participants are oriented to time and place.
* Spouses/partners may not enroll in this study. The study will be limited to only 1 person from the same family/domestic household.
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
Change in self-reported ART adherence
Timeframe: Baseline, 3 month follow up, 6 month follow up, and 12 month follow up