Adolescent BehaviorNCT05007717
Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes (UH3)
A study testing Data-informed Stepped Care (DiSC) in people with Adolescent Behavior and Hiv, run by University of Washington at 24 sites in Kenya.
Trial summary
The investigators will conduct a Phase III cluster randomized controlled trial (cRCT) to evaluate the effectiveness of the implementation of a data-informed stepped care (DiSC) intervention for HIV treatment management among adolescents living with HIV (ALHIV) in high-volume HIV clinics in Kenya. Read more about this study
- Who is it for?
- Ages 10 to 24 years
- Conditions the study is for
- Adolescent Behavior, Hiv
- What is being tested?
- Data-informed Stepped Care (DiSC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,911 participants
- Where
- 24 sitesKenya
- Study dates
- 19 Apr 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV-positive
- Enrolled in HIV care
- Provision of informed consent
- Willing and able to give informed consent
Who cannot join
- Not able or willing to give informed consent
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Kenya24 sites
Asumbi Health Centre
Homa Bay
Homa Hills Health Centre
Homa Bay
Kendu Adventist Hospital
Homa Bay
Marindi Sub County Referral Hospital
Homa Bay
Mbita District Hospital
Homa Bay
Rachuonyo District Hospital
Homa Bay
Rangwe Sub-District Hospital
Homa Bay
Shirikisho Health Centre
Homa Bay
Suba District Hospital
Homa Bay
Nyabondo Mission Hospital
Kisumu
Nyahera Sub County Hospital
Kisumu
Nyang'oma Health Centre
Kisumu
Rabour Health Centre
Kisumu
St. Elizabeth Chiga
Kisumu
Awendo Sub County Hospital
Migori
Dede Health Centre
Migori
Godkwer
Migori
Macalder Mission Hospital
Migori
Migori County Mission Hospital
Migori
Nyamaraga Health Centre
Migori
Rongo Sub County Hospital
Migori
Sony Medical Centre
Migori
St. Joseph's Mission Hospital
Migori
Uriri Sub County Hospital
Migori
About this study
The investigators will conduct a Phase III cluster randomized controlled trial (cRCT) to evaluate the effectiveness of the implementation of a data-informed stepped care (DiSC) intervention for HIV treatment management among adolescents living with HIV (ALHIV) in high-volume HIV clinics in Kenya. The DiSC intervention is comprised of a system to assign ALHIV to care based on their health needs and the different levels of care for each assignment group. The primary outcome will be ALHIV retention, and the secondary outcomes will include adherence, viral non-suppression, and receipt of differentiated care among ALHIV.
Read the detailed description
UNAIDS '95-95-95' targets cannot be achieved without additional support for adolescents living with HIV (ALHIV) to increase retention in care and to support viral suppression. Risk prediction tools as well as a stepped care approach to care can support differentiation of ALHIV to different risk groups, and tailor care based on risk.
The investigators have conducted informative work with ALHIV, caregivers, healthcare workers (HCW) and policy makers, and has developed a clinical prediction tool to identify ALHIV at highest risk of not being retained in care and poor viral suppression that could be adapted to identify adolescents who may need more support in their care. Understanding how best to use the risk prediction tool as well as how to tailor services based on risk may ultimately result in more efficient HIV care services, as well as adequate support for ALHIV at highest risk of poor outcomes.
Building on that informative work, in this protocol, the investigators will conduct a Phase III cluster randomized controlled trial (cRCT) by implementing a data-informed stepped care (DiSC) intervention of ALHIV HIV treatment management in high-volume HIV clinics in Kenya.
The cRCT will be conducted at up to 24 HIV care and treatment facilities located in Kisumu, Homabay, Migori county in Western Kenya, in which approximately 2000 HIV positive adolescents and young adults ages 10-24 years enrolled in HIV care will be recruited in this study.
Clinics randomized to the DiSC intervention arm will use a data-driven system to assign ALHIV to different levels of care depending on their current and anticipated health care needs. The intervention will be delivered at the individual level by HCW providing routine care during routine HIV clinic visits. Clinics randomized to the control arm will continue with standard of care approaches for adolescent clinic visits (usually 1-3 monthly visits), regardless of health care needs and additional support as needed.
As secondary objectives, this study also aims to evaluate the effectiveness of the DiSC intervention on ALHIV cascade outcomes (adherence, viral non-suppression) and receiving differentiated HIV care based on health status evaluation.
- Conditions
- Adolescent Behavior, Hiv
- Being tested
- Data-informed Stepped Care (DiSC)
- Keywords
- stepped care
- Medical subject headings
- Adolescent Behavior, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data-informed Stepped Care (DiSC)Behavioural
The DiSC intervention is comprised of a data-driven system to assign adolescents to care based on their health needs and the different levels of care for each assignment group.
The trajectory of services moves from a relative position of ALHIV autonomy to more intensive service provision. Intervention steps start with 1) multi-month refills or community treatment delivery (differentiated care); 2) a standard of care level for those with medical needs such as pregnancy or opportunistic infections or patient choice; 3) patient reminders/tracking and counseling and referral services for mental health needs; 4) case management of unsuppressed individuals, including enhanced counseling and case conference problem-solving
| Study group | Role | What they receive |
|---|---|---|
| Data-informed Stepped Care (DiSC) arm | Experimental | At intervention sites, HCW will assign ALHIV to different levels or intensity of HIV services depending on their current and anticipated health care needs. The stepped care framework is designed to be flexible, to accommodate variable individual and social support services available at each facility. Receives: Behavioral: Data-informed Stepped Care (DiSC) |
| Standard of care | No intervention | Sites randomized to the control arm will continue with standard of care approaches for adolescent clinic visits (usually 1-3 monthly visits) regardless of health care needs and additional support as needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Missed Visits
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.
Measured: 12 months
Secondary outcomes (5)
Proportion of Viral Load Results Showing Viral Non-suppression
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.
Measured: 12 months
Proportion of Visit Intervals With Good Adherence
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.
Measured: 12 months
Incidence Rate of Loss to Follow-up
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.
Measured: 12 months
Proportion of Visits Enrolled in Differentiated Care Services (Fast-track Visits)
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.
Measured: 12 months
Proportion of Visits Enrolled in Differentiated Care Services (Multi-month Refills)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start19 Apr 2022
- Primary completion19 Sep 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,911 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Pamela Kohler, University of Washington
- Investigators
- Pamela K Kohler, RN, MPH, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007717
- Sponsor's protocol ID
- STUDY00011096
- Other IDs
- UH3HD096906
- Status last verified
- Nov 2024
- First submitted
- 13 Jul 2021
- Last updated
- 27 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share all IPD that underlie results in the primary publication after deidentification procedures.
Publications
Chhun N, Mangale DI, Agot K, Masyuko S, Kibugi J, Jiang W, Hicks S, Badia J, Owade WA, Ounda NA, Okumu OA, Ouma LA, Odote PO, Songa VA, Kohler PK, John-Stewart G, Beima-Sofie K. Application of the RE-AIM framework to evaluate a stepped care intervention for adolescents and youth living with HIV in Kenya: a mixed methods approach. Implement Sci Commun. 2026 Feb 23;7(1):59. doi: 10.1186/s43058-026-00888-0.
PubMed 41724939Chhun N, Mangale DI, Agot K, Owade WA, Kadima J, Badia J, Kibugi JK, Kohler PK, John-Stewart G, Beima-Sofie K. Determinants of implementation of a stepped care intervention for adolescents and youth living with HIV in Kenya: a qualitative evaluation. BMC Health Serv Res. 2025 May 15;25(1):702. doi: 10.1186/s12913-025-12875-7.
PubMed 40369586Kohler P, Agot K, Njuguna IN, Dyer J, Badia J, Jiang W, Beima-Sofie K, Chhun N, Inwani I, Shah SK, Richardson BA, Chaktoura N, John-Stewart G. Data-informed stepped care to improve youth engagement in HIV care in Kenya: a protocol for a cluster randomised trial of a health service intervention. BMJ Open. 2022 Oct 31;12(10):e062134. doi: 10.1136/bmjopen-2022-062134.
PubMed 36316073
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes (UH3)
- ClinicalTrials.gov ID
- NCT05007717
- Acronym / sponsor ID
- STUDY00011096
- Conditions
- Adolescent Behavior, Hiv
- Keywords
- stepped care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,911 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Posted 27 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct a Phase III cluster randomized controlled trial (cRCT) to evaluate the effectiveness of the implementation of a data-informed stepped care (DiSC) intervention for HIV treatment management among adolescents living with HIV (ALHIV) in high-volume HIV clinics in Kenya. The DiSC intervention is comprised of a system to assign ALHIV to care based on their health needs and the different levels of care for each assignment group. The primary outcome will be ALHIV retention, and the secondary outcomes will include adherence, viral non-suppression, and receipt of differentiated care among ALHIV.
Detailed description
UNAIDS '95-95-95' targets cannot be achieved without additional support for adolescents living with HIV (ALHIV) to increase retention in care and to support viral suppression. Risk prediction tools as well as a stepped care approach to care can support differentiation of ALHIV to different risk groups, and tailor care based on risk.
The investigators have conducted informative work with ALHIV, caregivers, healthcare workers (HCW) and policy makers, and has developed a clinical prediction tool to identify ALHIV at highest risk of not being retained in care and poor viral suppression that could be adapted to identify adolescents who may need more support in their care. Understanding how best to use the risk prediction tool as well as how to tailor services based on risk may ultimately result in more efficient HIV care services, as well as adequate support for ALHIV at highest risk of poor outcomes.
Building on that informative work, in this protocol, the investigators will conduct a Phase III cluster randomized controlled trial (cRCT) by implementing a data-informed stepped care (DiSC) intervention of ALHIV HIV treatment management in high-volume HIV clinics in Kenya.
The cRCT will be conducted at up to 24 HIV care and treatment facilities located in Kisumu, Homabay, Migori county in Western Kenya, in which approximately 2000 HIV positive adolescents and young adults ages 10-24 years enrolled in HIV care will be recruited in this study.
Clinics randomized to the DiSC intervention arm will use a data-driven system to assign ALHIV to different levels of care depending on their current and anticipated health care needs. The intervention will be delivered at the individual level by HCW providing routine care during routine HIV clinic visits. Clinics randomized to the control arm will continue with standard of care approaches for adolescent clinic visits (usually 1-3 monthly visits), regardless of health care needs and additional support as needed.
As secondary objectives, this study also aims to evaluate the effectiveness of the DiSC intervention on ALHIV cascade outcomes (adherence, viral non-suppression) and receiving differentiated HIV care based on health status evaluation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Data-informed Stepped Care (DiSC) arm | Experimental | Behavioral: Data-informed Stepped Care (DiSC)At intervention sites, HCW will assign ALHIV to different levels or intensity of HIV services depending on their current and anticipated health care needs. The stepped care framework is designed to be flexible, to accommodate variable individual and social support services available at each facility. |
| Standard of care | No intervention | –Sites randomized to the control arm will continue with standard of care approaches for adolescent clinic visits (usually 1-3 monthly visits) regardless of health care needs and additional support as needed. |
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- HIV-positive
- Enrolled in HIV care
- Provision of informed consent
- Willing and able to give informed consent
Key exclusion criteria (1 listed)
- Not able or willing to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data-informed Stepped Care (DiSC)The DiSC intervention is comprised of a data-driven system to assign adolescents to care based on their health needs and the different levels of care for each assignment group. The trajectory of services moves from a relative position of ALHIV autonomy to more intensive service provision. Intervention steps start with 1) multi-month refills or community treatment delivery (differentiated care); 2) a standard of care level for those with medical needs such as pregnancy or opportunistic infections or patient choice; 3) patient reminders/tracking and counseling and referral services for mental health needs; 4) case management of unsuppressed individuals, including enhanced counseling and case conference problem-solving | Behavioural | Data-informed Stepped Care (DiSC) arm |
Primary outcome
Proportion of Missed Visits
Time frame: 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.
5 secondary outcomes
Proportion of Viral Load Results Showing Viral Non-suppression
Time frame: 12 months
Proportion of Visit Intervals With Good Adherence
Time frame: 12 months
Incidence Rate of Loss to Follow-up
Time frame: 12 months
Proportion of Visits Enrolled in Differentiated Care Services (Fast-track Visits)
Time frame: 12 months
Proportion of Visits Enrolled in Differentiated Care Services (Multi-month Refills)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41724939Chhun N, Mangale DI, Agot K, Masyuko S, Kibugi J, Jiang W, Hicks S, Badia J, Owade WA, Ounda NA, Okumu OA, Ouma LA, Odote PO, Songa VA, Kohler PK, John-Stewart G, Beima-Sofie K. Application of the RE-AIM framework to evaluate a stepped care intervention for adolescents and youth living with HIV in Kenya: a mixed methods approach. Implement Sci Commun. 2026 Feb 23;7(1):59. doi: 10.1186/s43058-026-00888-0.
- Derived from this study: PubMed 40369586Chhun N, Mangale DI, Agot K, Owade WA, Kadima J, Badia J, Kibugi JK, Kohler PK, John-Stewart G, Beima-Sofie K. Determinants of implementation of a stepped care intervention for adolescents and youth living with HIV in Kenya: a qualitative evaluation. BMC Health Serv Res. 2025 May 15;25(1):702. doi: 10.1186/s12913-025-12875-7.
- Derived from this study: PubMed 36316073Kohler P, Agot K, Njuguna IN, Dyer J, Badia J, Jiang W, Beima-Sofie K, Chhun N, Inwani I, Shah SK, Richardson BA, Chaktoura N, John-Stewart G. Data-informed stepped care to improve youth engagement in HIV care in Kenya: a protocol for a cluster randomised trial of a health service intervention. BMJ Open. 2022 Oct 31;12(10):e062134. doi: 10.1136/bmjopen-2022-062134.
- Individual participant dataSharing planned: Yes. We plan to share all IPD that underlie results in the primary publication after deidentification procedures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela K Kohler, RN, MPH, PhD principal investigator
University of Washington
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data-informed Stepped Care (DiSC) in people with Adolescent Behavior and Hiv, run by University of Washington at 24 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Missed Visits (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05007717, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024; AzTrials last refreshed its copy on 1 Nov 2026.