Adolescent Behavior, Hiv
Conditions
Keywords
stepped care
Brief 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. 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.
Interventions
BEHAVIORALData-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
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* HIV-positive * Enrolled in HIV care * Provision of informed consent * Willing and able to give informed consent
Exclusion criteria
\- Not able or willing to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Kenya
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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 | 895 |
| 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. | 1,016 |
| Total | 1,911 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 2 |
Baseline characteristics
| Characteristic | Data-informed Stepped Care (DiSC) Arm | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 16 years | 17 years | 17 years |
| Always come to this clinic by yourself | 541 Participants | 694 Participants | 1235 Participants |
| Race/Ethnicity, Customized Black | 895 Participants | 1016 Participants | 1911 Participants |
| Sex: Female, Male Female | 532 Participants | 570 Participants | 1102 Participants |
| Sex: Female, Male Male | 353 Participants | 443 Participants | 796 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 895 | 2 / 1,016 |
| other Total, other adverse events | 0 / 895 | 0 / 1,016 |
| serious Total, serious adverse events | 1 / 895 | 0 / 1,016 |
Outcome results
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.
Time frame: 12 months
Population: Five participants did not have clinic visit data matched in the medical records.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Data-informed Stepped Care (DiSC) Arm | Proportion of Missed Visits | 406 Scheduled visits |
| Standard of Care | Proportion of Missed Visits | 433 Scheduled visits |
p-value: 0.63195% CI: [0.89, 1.2]Mixed Models Analysis
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.
Time frame: 12 months
Population: Five participants did not have clinic visit data matched in the medical records.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Data-informed Stepped Care (DiSC) Arm | Incidence Rate of Loss to Follow-up | 61 Person-year |
| Standard of Care | Incidence Rate of Loss to Follow-up | 73 Person-year |
p-value: 0.99195% CI: [0.71, 1.41]Regression, Cox
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.
Time frame: 12 months
Population: One hundred and forty-four participants did not have viral loads data matched in the medical records.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Data-informed Stepped Care (DiSC) Arm | Proportion of Viral Load Results Showing Viral Non-suppression | 125 Viral load assays |
| Standard of Care | Proportion of Viral Load Results Showing Viral Non-suppression | 184 Viral load assays |
p-value: 0.23795% CI: [0.54, 1.16]Mixed Models Analysis
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.
Time frame: 12 months
Population: Seven participants did not have clinic visit data matched in the medical records.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Data-informed Stepped Care (DiSC) Arm | Proportion of Visit Intervals With Good Adherence | 4065 Intervals |
| Standard of Care | Proportion of Visit Intervals With Good Adherence | 4486 Intervals |
p-value: 0.38695% CI: [0.94, 1.02]Mixed Models Analysis
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.
Time frame: 12 months
Population: Five participants did not have clinic visit data matched in the medical records.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Data-informed Stepped Care (DiSC) Arm | Proportion of Visits Enrolled in Differentiated Care Services (Fast-track Visits) | 517 Visits |
| Standard of Care | Proportion of Visits Enrolled in Differentiated Care Services (Fast-track Visits) | 520 Visits |
p-value: 0.03795% CI: [1.01, 1.46]Mixed Models Analysis
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.
Time frame: 12 months
Population: Five participants did not have clinic visit data matched in the medical records.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Data-informed Stepped Care (DiSC) Arm | Proportion of Visits Enrolled in Differentiated Care Services (Multi-month Refills) | 1939 Scheduled visits |
| Standard of Care | Proportion of Visits Enrolled in Differentiated Care Services (Multi-month Refills) | 2180 Scheduled visits |
p-value: 0.27695% CI: [0.97, 1.12]Mixed Models Analysis