Trial Outcomes & Findings for Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes (UH3) (NCT NCT05007717)
NCT ID: NCT05007717
Last Updated: 2024-11-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1911 participants
Primary outcome timeframe
12 months
Results posted on
2024-11-27
Participant Flow
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.
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.
Unit of analysis: facility
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
895 12
|
1016 12
|
|
Overall Study
COMPLETED
|
892 12
|
1014 12
|
|
Overall Study
NOT COMPLETED
|
3 0
|
2 0
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
Death
|
3
|
2
|
Baseline Characteristics
Seven participants missed the behavioral survey at baseline.
Baseline characteristics by cohort
| Measure |
Data-informed Stepped Care (DiSC) Arm
n=895 Participants
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
|
Standard of Care
n=1016 Participants
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.
|
Total
n=1911 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16 years
n=888 Participants • Seven participants missed the behavioral survey at baseline.
|
17 years
n=1016 Participants • Seven participants missed the behavioral survey at baseline.
|
17 years
n=1904 Participants • Seven participants missed the behavioral survey at baseline.
|
|
Sex: Female, Male
Female
|
532 Participants
n=885 Participants • Seven participants missed the behavioral survey at baseline. Six participants reported unknown or no answer
|
570 Participants
n=1013 Participants • Seven participants missed the behavioral survey at baseline. Six participants reported unknown or no answer
|
1102 Participants
n=1898 Participants • Seven participants missed the behavioral survey at baseline. Six participants reported unknown or no answer
|
|
Sex: Female, Male
Male
|
353 Participants
n=885 Participants • Seven participants missed the behavioral survey at baseline. Six participants reported unknown or no answer
|
443 Participants
n=1013 Participants • Seven participants missed the behavioral survey at baseline. Six participants reported unknown or no answer
|
796 Participants
n=1898 Participants • Seven participants missed the behavioral survey at baseline. Six participants reported unknown or no answer
|
|
Race/Ethnicity, Customized
Black
|
895 Participants
n=895 Participants
|
1016 Participants
n=1016 Participants
|
1911 Participants
n=1911 Participants
|
|
Always come to this clinic by yourself
|
541 Participants
n=886 Participants • Seven participants missed the behavioral survey at baseline. Seven participants reported unknown or no answer.
|
694 Participants
n=1011 Participants • Seven participants missed the behavioral survey at baseline. Seven participants reported unknown or no answer.
|
1235 Participants
n=1897 Participants • Seven participants missed the behavioral survey at baseline. Seven participants reported unknown or no answer.
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Five participants did not have clinic visit data matched in the medical records.
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.
Outcome measures
| Measure |
Data-informed Stepped Care (DiSC) Arm
n=4784 Scheduled visits
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
|
Standard of Care
n=5248 Scheduled visits
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.
|
|---|---|---|
|
Proportion of Missed Visits
|
406 Scheduled visits
|
433 Scheduled visits
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: One hundred and forty-four participants did not have viral loads data matched in the medical records.
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.
Outcome measures
| Measure |
Data-informed Stepped Care (DiSC) Arm
n=833 Participants
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
|
Standard of Care
n=1899 Viral load assays
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.
|
|---|---|---|
|
Proportion of Viral Load Results Showing Viral Non-suppression
|
125 Viral load assays
|
184 Viral load assays
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Seven participants did not have clinic visit data matched in the medical records.
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.
Outcome measures
| Measure |
Data-informed Stepped Care (DiSC) Arm
n=4382 Intervals
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
|
Standard of Care
n=4741 Intervals
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.
|
|---|---|---|
|
Proportion of Visit Intervals With Good Adherence
|
4065 Intervals
|
4486 Intervals
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Five participants did not have clinic visit data matched in the medical records.
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.
Outcome measures
| Measure |
Data-informed Stepped Care (DiSC) Arm
n=796 Person-year
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
|
Standard of Care
n=913 Person-year
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.
|
|---|---|---|
|
Incidence Rate of Loss to Follow-up
|
61 Person-year
|
73 Person-year
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Five participants did not have clinic visit data matched in the medical records.
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.
Outcome measures
| Measure |
Data-informed Stepped Care (DiSC) Arm
n=4586 Visits
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
|
Standard of Care
n=4963 Visits
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.
|
|---|---|---|
|
Proportion of Visits Enrolled in Differentiated Care Services (Fast-track Visits)
|
517 Visits
|
520 Visits
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Five participants did not have clinic visit data matched in the medical records.
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.
Outcome measures
| Measure |
Data-informed Stepped Care (DiSC) Arm
n=5273 Scheduled visits
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
|
Standard of Care
n=5760 Scheduled visits
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.
|
|---|---|---|
|
Proportion of Visits Enrolled in Differentiated Care Services (Multi-month Refills)
|
1939 Scheduled visits
|
2180 Scheduled visits
|
Adverse Events
Data-informed Stepped Care (DiSC) Arm
Serious events: 1 serious events
Other events: 0 other events
Deaths: 3 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Data-informed Stepped Care (DiSC) Arm
n=895 participants at risk
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
|
Standard of Care
n=1016 participants at risk
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.
|
|---|---|---|
|
Ear and labyrinth disorders
Hearing loss
|
0.11%
1/895 • Number of events 1 • 12 months
|
0.00%
0/1016 • 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place