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Trial Outcomes & Findings for Patient Actor Training to Improve HIV Services for Adolescents in Kenya (NCT NCT02928900)

NCT ID: NCT02928900

Last Updated: 2024-12-09

Results Overview

The primary outcome is change in retention in HIV care between the intervention and control periods, where retention is defined as return for first follow-up visit within 3 months among newly enrolled adolescent clients OR follow-up visit after 're-engagement visit' (after lost-to-follow-up for \>90 days since last visit, with no record of death or transfer).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Up to four years after baseline

Results posted on

2024-12-09

Participant Flow

Stepped wedge design: 24 facilities randomized to when they received the training intervention. Once trained, all sites were considered intervention exposed for the duration of the study. De-identified adolescent medical records were analyzed for the primary outcome

Unit of analysis: HIV Clinics

Participant milestones

Participant milestones
Measure
Standardized Patient Training
Once assigned to the intervention, clinics received standardized patient actor training to improve quality of adolescent HIV care
Control
Time period before exposure to training
Baseline
STARTED
0 0
0 24
Baseline
COMPLETED
0 0
0 24
Baseline
NOT COMPLETED
0 0
0 0
Wave 1
STARTED
0 6
0 18
Wave 1
COMPLETED
0 6
0 18
Wave 1
NOT COMPLETED
0 0
0 0
Wave 2
STARTED
0 12
0 12
Wave 2
COMPLETED
0 12
0 12
Wave 2
NOT COMPLETED
0 0
0 0
Wave 3
STARTED
0 18
0 6
Wave 3
COMPLETED
0 18
0 6
Wave 3
NOT COMPLETED
0 0
0 0
Wave 4
STARTED
0 24
0 0
Wave 4
COMPLETED
0 24
0 0
Wave 4
NOT COMPLETED
0 0
0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patient Actor Training to Improve HIV Services for Adolescents in Kenya

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
SP Training Intervention
n=2123 Medical records
HIV clinics were randomized to when they received the training intervention. The intervention consisted of a 2-day training for health providers at participating clinics. Once trained, all sites were considered intervention exposed for the duration of the study.
No Training Intervention
n=2472 Medical records
Clinics prior to receiving training
Total
n=4595 Medical records
Total of all reporting groups
Age, Customized
10-14
220 Medical records
n=2123 Medical records
278 Medical records
n=2472 Medical records
498 Medical records
n=4595 Medical records
Age, Customized
15-19
474 Medical records
n=2123 Medical records
639 Medical records
n=2472 Medical records
1113 Medical records
n=4595 Medical records
Age, Customized
20-24
1429 Medical records
n=2123 Medical records
1555 Medical records
n=2472 Medical records
2984 Medical records
n=4595 Medical records
Sex/Gender, Customized
Female
1761 Medical records
n=2123 Medical records
2021 Medical records
n=2472 Medical records
3782 Medical records
n=4595 Medical records
Sex/Gender, Customized
Male
362 Medical records
n=2123 Medical records
450 Medical records
n=2472 Medical records
812 Medical records
n=4595 Medical records
Sex/Gender, Customized
Missing
0 Medical records
n=2123 Medical records
1 Medical records
n=2472 Medical records
1 Medical records
n=4595 Medical records
Race (NIH/OMB)
American Indian or Alaska Native
0 Medical records
n=2123 Medical records
0 Medical records
n=2472 Medical records
0 Medical records
n=4595 Medical records
Race (NIH/OMB)
Asian
0 Medical records
n=2123 Medical records
0 Medical records
n=2472 Medical records
0 Medical records
n=4595 Medical records
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Medical records
n=2123 Medical records
0 Medical records
n=2472 Medical records
0 Medical records
n=4595 Medical records
Race (NIH/OMB)
Black or African American
2123 Medical records
n=2123 Medical records
2472 Medical records
n=2472 Medical records
4595 Medical records
n=4595 Medical records
Race (NIH/OMB)
White
0 Medical records
n=2123 Medical records
0 Medical records
n=2472 Medical records
0 Medical records
n=4595 Medical records
Race (NIH/OMB)
More than one race
0 Medical records
n=2123 Medical records
0 Medical records
n=2472 Medical records
0 Medical records
n=4595 Medical records
Race (NIH/OMB)
Unknown or Not Reported
0 Medical records
n=2123 Medical records
0 Medical records
n=2472 Medical records
0 Medical records
n=4595 Medical records
Region of Enrollment
Kenya
2123 Medical records
n=2123 Medical records
2472 Medical records
n=2472 Medical records
4595 Medical records
n=4595 Medical records

PRIMARY outcome

Timeframe: Up to four years after baseline

Population: Medical record review. Final analysis accounts for clustering by facility, time (stepped wedge design), and newly enrolled in care status.

The primary outcome is change in retention in HIV care between the intervention and control periods, where retention is defined as return for first follow-up visit within 3 months among newly enrolled adolescent clients OR follow-up visit after 're-engagement visit' (after lost-to-follow-up for \>90 days since last visit, with no record of death or transfer).

Outcome measures

Outcome measures
Measure
Adolescent Records - Intervention Exposed
n=2123 Participants
Records from adolescents whose first eligible visit occurred at a facility that had already received the training intervention
Adolescent Records - Unexposed
n=2472 Participants
Records from adolescents whose first eligible visit occurred at a facility before the facility received the training intervention
Retention in HIV Care
1570 Participants
1855 Participants

SECONDARY outcome

Timeframe: Up to one month after last day of training

The proportion of HCW participants who achieved competency upon completion of the training.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to one week after last day of training

All SP actors will complete a check-list to provide non-technical feedback to each HCW participant. Scores will be used to compute the overall pass/fail score at completion of the training.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and every nine months for up to four years

This outcome is measured as change in mean competency score between intervention and control periods using a structured survey.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and every nine months for up to four years

This outcome is measured as change in mean satisfaction scores between intervention (post-training) and control periods (pre-training), using a structured survey. These surveys will be conducted at baseline, and every nine months at the end of the training in each wave. Exit interviews among trained participants will be conducted about one year after each training wave for up to four waves to complement the quantitative results.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and every nine months for up to four years

This outcome is defined as mean change in satisfaction score between intervention and control periods, using a structured survey.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and every nine months for up to four years

A secondary measure of retention in HIV care is return for any follow-up visit within 3 months (90 days) among currently enrolled HIV-positive adolescent patients

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and every nine months for up to four years

This measure is defined as change in the proportion of visits with ART refills within 1 week of scheduled visit between intervention and control periods using available electronic medical record (EMR) data.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and every nine months for up to four years

This measure is defined as change in viral load between intervention and control periods using available EMR data.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and every nine months for up to four years

This measure is defined as change in the proportion of visits with referrals to affiliated services (e.g. family planning) between intervention and control periods using available EMR data.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and every nine months for up to four years

This measure is defined as change in the proportion of visits with any AIDS defining illness between intervention and control periods using available EMR data.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and every nine months for up to four years

This measure is defined as change in the proportion of deaths between intervention and control periods using available EMR data.

Outcome measures

Outcome data not reported

Adverse Events

SP Training Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No Training Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pamela Kohler

University of Washington

Phone: 206.221.5746

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place