Implementation a Data-to-Care Strategy to Improve HIV Continuum Outcomes for Out of Care People L… (NCT05821413) | Clinical Trial Compass
CompletedNot Applicable
Implementation a Data-to-Care Strategy to Improve HIV Continuum Outcomes for Out of Care People Living With HIV (PLWH) in Ukraine
Ukraine160 participantsStarted 2023-06-16
Plain-language summary
The goal of this clinical trial is to study the preliminary effectiveness of a data to care intervention versus standard of care for people living with HIV in Ukraine. The main questions it aims to answer are:
* Does a data to care strategy improve primary outcomes of HIV care engagement, antiretroviral therapy initiation or re-initiation, and viral suppression among not-in-care people living with HIV?
* Does a data to care strategy improve secondary outcomes of engagement or re-engagement in ancillary services (e.g., drug treatment) and quality of life?
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:
* Registered in the Ukrainian Medical Information System as having received an HIV diagnosis at any time in the past
* missed a clinical visit (medication pick-up or other) more than 7 days ago
* registered with injection drug use (IDU) as probable mode of HIV transmission, or history of IDU documented at any clinical visit
* not been contacted by other clinical staff after the current missed visit
* 18 years or older
Exclusion Criteria:
* Patient is already re-engaged in care and visited the clinic recently
* Patient has sufficient supply of medications (available to him for any reason)
* Patient moved to another clinic, city, country, or penitentiary institution
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 Participants Engaged in HIV Care as Assessed by Number of Clinical Visits
Timeframe: 12 months
2
Number of Participants Initiating ART (re-)Initiation
Timeframe: 3 months
3
Number of Participants ART Adherent as Assessed by the Percentage of Days in Possession of Medication
Timeframe: One month
4
Number of Participants With HIV Viral Suppression as Assessed by Viral Load (VL) Test
Timeframe: 12 months
Trial details
NCT IDNCT05821413
SponsorJohns Hopkins Bloomberg School of Public Health