Trial Outcomes & Findings for Implementation a Data-to-Care Strategy to Improve HIV Continuum Outcomes for Out of Care People Living With HIV (PLWH) in Ukraine (NCT NCT05821413)
NCT ID: NCT05821413
Last Updated: 2026-02-12
Results Overview
At least 3 clinical visits with at least 3 months apart within 12 months after study enrollment
COMPLETED
NA
160 participants
12 months
2026-02-12
Participant Flow
Recruitment took place between June and October 2023 at four specialized HIV care clinics in Ukraine (Dnipro, Odesa, Kyiv, Poltava). Eligible patient lists were generated and randomly sorted at each site. Outreach specialists contacted patients sequentially in the order they appeared and conducted brief scripted counseling to encourage them to visit the clinic, mentioning the opportunity to enroll in the study.
Sites were randomized prior to participant recruitment.
Unit of analysis: Clinics
Participant milestones
| Measure |
Data to Care
Two clinics randomized to the intervention arm will implement the data to care strategy, which includes a 5-step process: (1) identify not-in-care PLWH using the a medical information system, (2) verify eligibility criteria, (3) contact patients and invite to visit the clinic, (4) determine care status and reengage into care, and (5) provide case management services and confirm engagement in care.
|
Standard of Care
Participants in the two standard of care sites will receive existing case management and supportive services from the HIV clinic.
|
|---|---|---|
|
Overall Study
STARTED
|
80 2
|
80 2
|
|
Overall Study
COMPLETED
|
80 2
|
80 2
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Data to Care
n=80 Participants
Clinics randomized to the intervention arm will implement the data to care strategy, which includes a 5-step process: (1) identify not-in-care PLWH using the a medical information system, (2) verify eligibility criteria, (3) contact patients and invite to visit the clinic, (4) determine care status and reengage into care, and (5) provide case management services and confirm engagement in care.
|
Standard of Care
n=80 Participants
Participants in the standard of care sites will receive existing case management and supportive services from the HIV clinic.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to 40 years of age
|
29 Participants
n=80 Participants
|
20 Participants
n=80 Participants
|
49 Participants
n=160 Participants
|
|
Age, Customized
41 to 50 years of age
|
33 Participants
n=80 Participants
|
44 Participants
n=80 Participants
|
77 Participants
n=160 Participants
|
|
Age, Customized
51 or older years of age
|
18 Participants
n=80 Participants
|
16 Participants
n=80 Participants
|
34 Participants
n=160 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=80 Participants
|
30 Participants
n=80 Participants
|
53 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=80 Participants
|
50 Participants
n=80 Participants
|
107 Participants
n=160 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 12 monthsAt least 3 clinical visits with at least 3 months apart within 12 months after study enrollment
Outcome measures
| Measure |
Data to Care
n=80 Participants
Clinics randomized to the intervention arm will implement the data to care strategy, which includes a 5-step process: (1) identify not-in-care PLWH using the a medical information system, (2) verify eligibility criteria, (3) contact patients and invite to visit the clinic, (4) determine care status and reengage into care, and (5) provide case management services and confirm engagement in care.
|
Standard of Care
n=80 Participants
Participants in the standard of care sites will receive existing case management and supportive services from the HIV clinic.
|
|---|---|---|
|
Number of Participants Engaged in HIV Care as Assessed by Number of Clinical Visits
|
34 Participants
|
58 Participants
|
PRIMARY outcome
Timeframe: 3 monthsInitiating or re-initiating ART within 3 months after study enrollment
Outcome measures
| Measure |
Data to Care
n=80 Participants
Clinics randomized to the intervention arm will implement the data to care strategy, which includes a 5-step process: (1) identify not-in-care PLWH using the a medical information system, (2) verify eligibility criteria, (3) contact patients and invite to visit the clinic, (4) determine care status and reengage into care, and (5) provide case management services and confirm engagement in care.
|
Standard of Care
n=80 Participants
Participants in the standard of care sites will receive existing case management and supportive services from the HIV clinic.
|
|---|---|---|
|
Number of Participants Initiating ART (re-)Initiation
|
80 Participants
|
78 Participants
|
PRIMARY outcome
Timeframe: One monthNumber of participants ART adherent assessed by the percentage of days in possession of medication (pharmacy refill gap method)
Outcome measures
| Measure |
Data to Care
n=80 Participants
Clinics randomized to the intervention arm will implement the data to care strategy, which includes a 5-step process: (1) identify not-in-care PLWH using the a medical information system, (2) verify eligibility criteria, (3) contact patients and invite to visit the clinic, (4) determine care status and reengage into care, and (5) provide case management services and confirm engagement in care.
|
Standard of Care
n=80 Participants
Participants in the standard of care sites will receive existing case management and supportive services from the HIV clinic.
|
|---|---|---|
|
Number of Participants ART Adherent as Assessed by the Percentage of Days in Possession of Medication
|
64 Participants
|
40 Participants
|
PRIMARY outcome
Timeframe: 12 monthsHaving at least one VL test with \<200cp/ml and none with \>=200cp/ml within 12 months after study enrollment
Outcome measures
| Measure |
Data to Care
n=80 Participants
Clinics randomized to the intervention arm will implement the data to care strategy, which includes a 5-step process: (1) identify not-in-care PLWH using the a medical information system, (2) verify eligibility criteria, (3) contact patients and invite to visit the clinic, (4) determine care status and reengage into care, and (5) provide case management services and confirm engagement in care.
|
Standard of Care
n=80 Participants
Participants in the standard of care sites will receive existing case management and supportive services from the HIV clinic.
|
|---|---|---|
|
Number of Participants With HIV Viral Suppression as Assessed by Viral Load (VL) Test
|
57 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants with data collected
The Drug Abuse Screening Test (DAST-10) is a 10-item brief screening tool. Each question requires a yes or no response. This tool assesses drug use, not including alcohol or tobacco use. Scores of 0 indicates no problems; 1-2 indicates low level, 3-5 indicates moderate level, 6-8 indicates substantial level, and 9-10 is severe.
Outcome measures
| Measure |
Data to Care
n=71 Participants
Clinics randomized to the intervention arm will implement the data to care strategy, which includes a 5-step process: (1) identify not-in-care PLWH using the a medical information system, (2) verify eligibility criteria, (3) contact patients and invite to visit the clinic, (4) determine care status and reengage into care, and (5) provide case management services and confirm engagement in care.
|
Standard of Care
n=74 Participants
Participants in the standard of care sites will receive existing case management and supportive services from the HIV clinic.
|
|---|---|---|
|
Number of Participants With Substantial or Severe Substance Use as Assessed by the Drug Abuse Screening Test (DAST-10)
|
13 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants with data collected
The Patient Health Questionnaire (PHQ-9) assesses degree of depression severity. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. The PHQ-9 scores range from 0-27. Scores of 10 or higher are indicative of moderate or severe depressive symptoms.
Outcome measures
| Measure |
Data to Care
n=79 Participants
Clinics randomized to the intervention arm will implement the data to care strategy, which includes a 5-step process: (1) identify not-in-care PLWH using the a medical information system, (2) verify eligibility criteria, (3) contact patients and invite to visit the clinic, (4) determine care status and reengage into care, and (5) provide case management services and confirm engagement in care.
|
Standard of Care
n=78 Participants
Participants in the standard of care sites will receive existing case management and supportive services from the HIV clinic.
|
|---|---|---|
|
Number of Participants With Moderate or Severe Depressive Symptoms as Assessed by the Patient Health Questionnaire (PHQ-9)
|
15 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants with data collected
General Health Function as measured by the Physical Component of the Medical Outcomes Study SF-12. The t-scores are based on a standardized reference population with m = 50 and SD = 10. Higher scores indicate higher functioning.
Outcome measures
| Measure |
Data to Care
n=71 Participants
Clinics randomized to the intervention arm will implement the data to care strategy, which includes a 5-step process: (1) identify not-in-care PLWH using the a medical information system, (2) verify eligibility criteria, (3) contact patients and invite to visit the clinic, (4) determine care status and reengage into care, and (5) provide case management services and confirm engagement in care.
|
Standard of Care
n=74 Participants
Participants in the standard of care sites will receive existing case management and supportive services from the HIV clinic.
|
|---|---|---|
|
Health-Related Quality of Life as Assessed by SF12
|
48.5 t-score
Standard Deviation 8.4
|
43.8 t-score
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants with data collected
HIV transmission risk score based on self-reported episodes of sexual intercourse. The score is the expected number of onward HIV transmissions over one year (X10000) estimated from Bernoulli transmission models. Higher scores indicate higher risk of onward HIV transmission. The index does not have an upper limit. The Lower limit is 0, and the observed range is 0 - 158.8.
Outcome measures
| Measure |
Data to Care
n=71 Participants
Clinics randomized to the intervention arm will implement the data to care strategy, which includes a 5-step process: (1) identify not-in-care PLWH using the a medical information system, (2) verify eligibility criteria, (3) contact patients and invite to visit the clinic, (4) determine care status and reengage into care, and (5) provide case management services and confirm engagement in care.
|
Standard of Care
n=74 Participants
Participants in the standard of care sites will receive existing case management and supportive services from the HIV clinic.
|
|---|---|---|
|
HIV-related Risk Behaviors
|
0 risk score
Interval 0.0 to 4.0
|
0 risk score
Interval 0.0 to 3.2
|
SECONDARY outcome
Timeframe: One YearPopulation: Participants with data collected
Assesses beliefs, opinions, and attitudes about doctors and health issues. The Trust in Physician Scale is an 11-item self-report instrument developed to assess an individual's trust in his/her physician. The items use a five point scale (1=Strongly Disagree to 5= Strongly Agree), and the scale has a possible range of 11-55 with higher scores indicating higher trust in physicians.
Outcome measures
| Measure |
Data to Care
n=71 Participants
Clinics randomized to the intervention arm will implement the data to care strategy, which includes a 5-step process: (1) identify not-in-care PLWH using the a medical information system, (2) verify eligibility criteria, (3) contact patients and invite to visit the clinic, (4) determine care status and reengage into care, and (5) provide case management services and confirm engagement in care.
|
Standard of Care
n=74 Participants
Participants in the standard of care sites will receive existing case management and supportive services from the HIV clinic.
|
|---|---|---|
|
Trust in Physicians as Assessed by the Trust in Physician Scale (TPS)
|
39.2 score on a scale
Standard Deviation 7.6
|
38.5 score on a scale
Standard Deviation 5.3
|
Adverse Events
Data to Care
Standard of Care
Serious adverse events
| Measure |
Data to Care
n=80 participants at risk
Clinics randomized to the intervention arm will implement the data to care strategy, which includes a 5-step process: (1) identify not-in-care PLWH using the a medical information system, (2) verify eligibility criteria, (3) contact patients and invite to visit the clinic, (4) determine care status and reengage into care, and (5) provide case management services and confirm engagement in care.
|
Standard of Care
n=80 participants at risk
Participants in the standard of care sites will receive existing case management and supportive services from the HIV clinic.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Mortality due to drug overdose
|
1.2%
1/80 • From enrollment to 12 months post-enrollment
|
1.2%
1/80 • From enrollment to 12 months post-enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Mortality due to bacterial pneumonia
|
0.00%
0/80 • From enrollment to 12 months post-enrollment
|
1.2%
1/80 • From enrollment to 12 months post-enrollment
|
|
Blood and lymphatic system disorders
Death due to primary thrombophilia
|
0.00%
0/80 • From enrollment to 12 months post-enrollment
|
1.2%
1/80 • From enrollment to 12 months post-enrollment
|
|
Nervous system disorders
Mortality due to stroke
|
1.2%
1/80 • From enrollment to 12 months post-enrollment
|
0.00%
0/80 • From enrollment to 12 months post-enrollment
|
|
General disorders
Mortality due to undetermined cause
|
0.00%
0/80 • From enrollment to 12 months post-enrollment
|
2.5%
2/80 • From enrollment to 12 months post-enrollment
|
Other adverse events
| Measure |
Data to Care
n=80 participants at risk
Clinics randomized to the intervention arm will implement the data to care strategy, which includes a 5-step process: (1) identify not-in-care PLWH using the a medical information system, (2) verify eligibility criteria, (3) contact patients and invite to visit the clinic, (4) determine care status and reengage into care, and (5) provide case management services and confirm engagement in care.
|
Standard of Care
n=80 participants at risk
Participants in the standard of care sites will receive existing case management and supportive services from the HIV clinic.
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
1.2%
1/80 • From enrollment to 12 months post-enrollment
|
6.2%
5/80 • From enrollment to 12 months post-enrollment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place