Trial · NCT05007717
Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes (UH3)
NCT05007717, Not applicable, Completed, University of Washington; results first posted 2024-11-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes (UH3). Trials, record NCT05007717. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05007717
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes (UH3)
- NCT number
- NCT05007717
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,911 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Adolescent Behavior, Hiv
- Interventions
- Data-informed Stepped Care (DiSC)
- First posted
- 2021-08-16
- Last updated
- 2024-11-27
- Results first posted
- 2024-11-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Missed Visits | 12 months | We will evaluate retention using a definition of missed visit and calculate the proportion of scheduled visits that are missed. Missed visits will be defined as a participant not seen within 30 days after each scheduled visit. Each scheduled visit will be classified as missed versus not missed. |
| Secondary | Proportion of Viral Load Results Showing Viral Non-suppression | 12 months | We will evaluate viral load test results and calculate the proportion of results that show non-suppression. Viral non-suppression will be defined as having HIV RNA viral loads (VL) \>1,000 copies per milliliter. Each VL test result will be classified as VL suppressed vs. unsuppressed. |
| Secondary | Proportion of Visit Intervals With Good Adherence | 12 months | We will evaluate adherence by calculating the number of pills dispensed divided by the number of days during an inter-visit interval. A proportion of adherence greater than 0.8 will be classified as good adherence. The level of adherence during the past inter-visit interval will be assessed at each visit. |
| Secondary | Incidence Rate of Loss to Follow-up | 12 months | We will also analyze retention using loss to follow-up (LTFU). LTFU will be defined as a participant not seen within 30 days of a scheduled visit and not return to care within the 12-month study period. The incidence rate of LTFU is the ratio of the number of new cases of LTFU to the total time the study participants was at risk of LTFU. The denominator is the sum of the time each participant (person-year) was observed, totaled for all participants. |
| Secondary | Proportion of Visits Enrolled in Differentiated Care Services (Fast-track Visits) | 12 months | We will calculate the proportion of visits enrolled in differentiated care using two definitions. The first is fast-track visit, which evaluates if participants are assigned to fast-track status during visits. Each visit will be assessed as enrolled in differentiated care (assigned to fast-track) or not. |
| Secondary | Proportion of Visits Enrolled in Differentiated Care Services (Multi-month Refills) | 12 months | We will calculate the proportion of visits enrolled in differentiated care using two definitions. The second is multi-month prescription refills, which evaluates if participants are given multi-month refill intervals more than 3 months. Each visit will be assessed as enrolled in differentiated care (given multi-month refills) or not. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Missed Visits | 12 months | Five participants did not have clinic visit data matched in the medical records. | Scheduled visits | COUNT_OF_UNITS |
| SECONDARY | Proportion of Viral Load Results Showing Viral Non-suppression | 12 months | One hundred and forty-four participants did not have viral loads data matched in the medical records. | Viral load assays | COUNT_OF_UNITS |
| SECONDARY | Proportion of Visit Intervals With Good Adherence | 12 months | Seven participants did not have clinic visit data matched in the medical records. | Intervals | COUNT_OF_UNITS |
| SECONDARY | Incidence Rate of Loss to Follow-up | 12 months | Five participants did not have clinic visit data matched in the medical records. | Person-year | COUNT_OF_UNITS |
| SECONDARY | Proportion of Visits Enrolled in Differentiated Care Services (Fast-track Visits) | 12 months | Five participants did not have clinic visit data matched in the medical records. | Visits | COUNT_OF_UNITS |
| SECONDARY | Proportion of Visits Enrolled in Differentiated Care Services (Multi-month Refills) | 12 months | Five participants did not have clinic visit data matched in the medical records. | Scheduled visits | COUNT_OF_UNITS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Missed Visits | Data-informed Stepped Care (DiSC) Arm | 406 | Scheduled visits | ||
| Proportion of Missed Visits | Standard of Care | 433 | Scheduled visits | ||
| Proportion of Viral Load Results Showing Viral Non-suppression | Data-informed Stepped Care (DiSC) Arm | 125 | Viral load assays | ||
| Proportion of Viral Load Results Showing Viral Non-suppression | Standard of Care | 184 | Viral load assays | ||
| Proportion of Visit Intervals With Good Adherence | Data-informed Stepped Care (DiSC) Arm | 4065 | Intervals | ||
| Proportion of Visit Intervals With Good Adherence | Standard of Care | 4486 | Intervals | ||
| Incidence Rate of Loss to Follow-up | Data-informed Stepped Care (DiSC) Arm | 61 | Person-year | ||
| Incidence Rate of Loss to Follow-up | Standard of Care | 73 | Person-year | ||
| Proportion of Visits Enrolled in Differentiated Care Services (Fast-track Visits) | Data-informed Stepped Care (DiSC) Arm | 517 | Visits | ||
| Proportion of Visits Enrolled in Differentiated Care Services (Fast-track Visits) | Standard of Care | 520 | Visits |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Data-informed Stepped Care (DiSC) Arm | 895 | 12 |
| Overall Study | STARTED | Standard of Care | 1,016 | 12 |
| Overall Study | COMPLETED | Data-informed Stepped Care (DiSC) Arm | 892 | 12 |
| Overall Study | COMPLETED | Standard of Care | 1,014 | 12 |
| Overall Study | NOT COMPLETED | Data-informed Stepped Care (DiSC) Arm | 3 | 0 |
| Overall Study | NOT COMPLETED | Standard of Care | 2 | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Hearing loss | Ear and labyrinth disorders | Data-informed Stepped Care (DiSC) Arm | 1 | 895 | 1 |
| serious | Hearing loss | Ear and labyrinth disorders | Standard of Care | 1,016 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Data-informed Stepped Care (DiSC) Arm | 3 | 895 |
| Total, all-cause mortality | Standard of Care | 2 | 1,016 |
| Total, other adverse events | Data-informed Stepped Care (DiSC) Arm | 0 | 895 |
| Total, other adverse events | Standard of Care | 0 | 1,016 |
| Total, serious adverse events | Data-informed Stepped Care (DiSC) Arm | 1 | 895 |
| Total, serious adverse events | Standard of Care | 0 | 1,016 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UH3HD096906 | Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes | KOHLER, PAMELA; JOHN-STEWART, GRACE C. | UNIVERSITY OF WASHINGTON | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2020 to 2022 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Data-informed Stepped Care (DiSC) Arm vs Standard of Care: deaths from any cause | Trial comparisons |
| Data-informed Stepped Care (DiSC) Arm vs Standard of Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05007717
GET https://conductscience.org/api/trials/v1/NCT05007717/registered