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| ID | Type | Description | Link |
|---|---|---|---|
| UH3HD096906 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data-informed Stepped Care (DiSC) | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
- Not able or willing to give informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Pamela K Kohler, RN, MPH, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asumbi Health Centre | Homa Bay | Kenya | ||||
| Homa Hills Health Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41724939 | Derived | 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. | |
| 40369586 | Derived | Chhun 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. |
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We plan to share all IPD that underlie results in the primary publication after deidentification procedures.
Beginning 3 months and ending 5 years following article publication.
The final public-facing repository for clinical data and/or biospecimen information will be the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH)
The intervention was implemented at clinic-level, then people at clinics were recruited for participation. Participants at the intervention sites received the intervention; participants at the control sites received standard of care.
Participants were recruited from 24 HIV care and treatment facilities located in Western Kenya between April 2022 and July 2022. The first participant was enrolled on April 19, 2022 and the last participant was enrolled on July 19, 2022.
| ID | Title | Description |
|---|---|---|
| FG000 | Data-informed Stepped Care (DiSC) Arm | Participants at intervention facilities received different levels or intensity of HIV services depending on their current and anticipated health care needs. 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 20, 2023 | Jul 31, 2024 |
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| 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. | 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. | 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. | 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. | 12 months |
| Homa Bay |
| Kenya |
| Kendu Adventist Hospital | Homa Bay | Kenya |
| Marindi Sub County Referral Hospital | Homa Bay | Kenya |
| Mbita District Hospital | Homa Bay | Kenya |
| Rachuonyo District Hospital | Homa Bay | Kenya |
| Rangwe Sub-District Hospital | Homa Bay | Kenya |
| Shirikisho Health Centre | Homa Bay | Kenya |
| Suba District Hospital | Homa Bay | Kenya |
| Nyabondo Mission Hospital | Kisumu | Kenya |
| Nyahera Sub County Hospital | Kisumu | Kenya |
| Nyang'oma Health Centre | Kisumu | Kenya |
| Rabour Health Centre | Kisumu | Kenya |
| St. Elizabeth Chiga | Kisumu | Kenya |
| Awendo Sub County Hospital | Migori | Kenya |
| Dede Health Centre | Migori | Kenya |
| Godkwer | Migori | Kenya |
| Macalder Mission Hospital | Migori | Kenya |
| Migori County Mission Hospital | Migori | Kenya |
| Nyamaraga Health Centre | Migori | Kenya |
| Rongo Sub County Hospital | Migori | Kenya |
| Sony Medical Centre | Migori | Kenya |
| St. Joseph's Mission Hospital | Migori | Kenya |
| Uriri Sub County Hospital | Migori | Kenya |
| 36316073 | Derived | Kohler 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. |
| FG001 | Standard of Care | Participants at the control facilities continued with standard of care approaches for adolescent clinic visits (usually 1-3 monthly visits) regardless of health care needs and additional support as needed. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Data-informed Stepped Care (DiSC) Arm | Participants at intervention sites received different levels or intensity of HIV services depending on their current and anticipated health care needs. 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 |
| BG001 | Standard of Care | Participants at the control sites continued with standard of care approaches for adolescent clinic visits (usually 1-3 monthly visits) regardless of health care needs and additional support as needed. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Seven participants missed the behavioral survey at baseline. | Median | Inter-Quartile Range | years |
| ||||||||||||||
| Sex: Female, Male | Seven participants missed the behavioral survey at baseline. Six participants reported unknown or no answer | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Always come to this clinic by yourself | Seven participants missed the behavioral survey at baseline. Seven participants reported unknown or no answer. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Five participants did not have clinic visit data matched in the medical records. | Posted | Count of Units | Scheduled visits | 12 months | Scheduled visits | Scheduled visits |
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| Secondary | 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. | One hundred and forty-four participants did not have viral loads data matched in the medical records. | Posted | Count of Units | Viral load assays | 12 months | Viral load assays | Viral load assays |
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| Secondary | 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. | Seven participants did not have clinic visit data matched in the medical records. | Posted | Count of Units | Intervals | 12 months | Intervals | Intervals |
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| Secondary | 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. | Five participants did not have clinic visit data matched in the medical records. | Posted | Count of Units | Person-year | 12 months | Person-year | Person-year |
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| Secondary | 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. | Five participants did not have clinic visit data matched in the medical records. | Posted | Count of Units | Visits | 12 months | Visits | Visits |
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| Secondary | 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. | Five participants did not have clinic visit data matched in the medical records. | Posted | Count of Units | Scheduled visits | 12 months | Scheduled visits | Scheduled visits |
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12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Data-informed Stepped Care (DiSC) Arm | Participants at intervention sites received different levels or intensity of HIV services depending on their current and anticipated health care needs. 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 | 3 | 895 | 1 | 895 | 0 | 895 |
| EG001 | Standard of Care | Participants at the control sites continued with standard of care approaches for adolescent clinic visits (usually 1-3 monthly visits) regardless of health care needs and additional support as needed. | 2 | 1,016 | 0 | 1,016 | 0 | 1,016 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hearing loss | Ear and labyrinth disorders | Non-systematic Assessment | Complained of ringing in the ears, worsened and eventually lost hearing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Data Analyst | University of Washington | 7347809402 | wenwenj@uw.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2023 | Aug 19, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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Participants at the control sites continued with standard of care approaches for adolescent clinic visits (usually 1-3 monthly visits) regardless of health care needs and additional support as needed. |
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Participants at the control sites continued with standard of care approaches for adolescent clinic visits (usually 1-3 monthly visits) regardless of health care needs and additional support as needed.
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| OG001 |
| Standard of Care |
Participants at the control sites continued with standard of care approaches for adolescent clinic visits (usually 1-3 monthly visits) regardless of health care needs and additional support as needed. |
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Participants at the control sites continued with standard of care approaches for adolescent clinic visits (usually 1-3 monthly visits) regardless of health care needs and additional support as needed. |
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| Standard of Care |
Participants at the control sites continued with standard of care approaches for adolescent clinic visits (usually 1-3 monthly visits) regardless of health care needs and additional support as needed. |
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