Trial Outcomes & Findings for Package of Resources for Assisted Contact Tracing: Implementation, Costs, and Effectiveness (NCT NCT05343390)
NCT ID: NCT05343390
Last Updated: 2025-02-06
Results Overview
Health care workers will be observed counseling actual index clients. The scores on the 15-item index client fidelity assessment will be compared between arms (range 0-100% with higher scores being better)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
841 participants
Primary outcome timeframe
1 year after training
Results posted on
2025-02-06
Participant Flow
33 clusters were randomized in a 1:2 ratio (Enhanced:Standard). Within these clusters Healthcare workers, Index clients, Contact clients and data from registers were observed. To clearly represent the groups within each arm, four "periods" are shown below. Periods do not reflect a time element, but rather the four populations measured within these clusters (units).
Unit of analysis: Clusters
Participant milestones
| Measure |
Enhanced Implementation Strategy
Digitally guided training and continuous quality improvement
Enhanced implementation package: Individual training with teaching and modeling (tablet-guided, \~8 hours) Small group training with practice and feedback (tablet-guided, \~16 hours) Ongoing continuous quality improvement sessions (tablet-guided, \~2 hours/month)
Standard implementation package: Individual training with teaching (facilitator-guided, \~2 hours) Small group practice (facilitator-guided, \~1 hour) Ongoing clinic support (facilitator-guided, \~30 minutes/month)
|
Standard Implementation Strategy
Standard training and clinical support
Standard implementation package: Individual training with teaching (facilitator-guided, \~2 hours) Small group practice (facilitator-guided, \~1 hour) Ongoing clinic support (facilitator-guided, \~30 minutes/month)
|
|---|---|---|
|
Clusters and Healthcare Workers
STARTED
|
125 11
|
181 22
|
|
Clusters and Healthcare Workers
COMPLETED
|
115 11
|
174 22
|
|
Clusters and Healthcare Workers
NOT COMPLETED
|
10 0
|
7 0
|
|
Clusters and Index Clients
STARTED
|
124 11
|
217 22
|
|
Clusters and Index Clients
COMPLETED
|
124 11
|
217 22
|
|
Clusters and Index Clients
NOT COMPLETED
|
0 0
|
0 0
|
|
Clusters and Contact Clients
STARTED
|
67 11
|
127 22
|
|
Clusters and Contact Clients
COMPLETED
|
67 11
|
127 22
|
|
Clusters and Contact Clients
NOT COMPLETED
|
0 0
|
0 0
|
|
Clusters and Register-Extracted Data
STARTED
|
21248 11
|
33272 22
|
|
Clusters and Register-Extracted Data
COMPLETED
|
21248 11
|
33272 22
|
|
Clusters and Register-Extracted Data
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data are reported separately for Heathcare Workers, Index clients, and Contact clients. Data were not provided by 1 healthcare worker.
Baseline characteristics by cohort
| Measure |
Enhanced Implementation Strategy
n=316 Participants
Standard training and clinical support
\+ Enhanced digitally guided training and continuous quality improvement
|
Standard Implementation Strategy
n=525 Participants
Standard training and clinical support
|
Total
n=841 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Healthcare Workers
|
34 years
n=125 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients. Data were not provided by 1 healthcare worker.
|
33 years
n=180 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients. Data were not provided by 1 healthcare worker.
|
34 years
n=305 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients. Data were not provided by 1 healthcare worker.
|
|
Age, Continuous
Index Clients
|
35 years
n=124 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients. Data were not provided by 1 healthcare worker.
|
34 years
n=217 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients. Data were not provided by 1 healthcare worker.
|
34 years
n=341 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients. Data were not provided by 1 healthcare worker.
|
|
Age, Continuous
Contact Clients
|
39 years
n=67 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients. Data were not provided by 1 healthcare worker.
|
35 years
n=127 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients. Data were not provided by 1 healthcare worker.
|
37 years
n=194 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients. Data were not provided by 1 healthcare worker.
|
|
Sex: Female, Male
Healthcare Workers · Female
|
59 Participants
n=125 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
87 Participants
n=180 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
146 Participants
n=305 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Sex: Female, Male
Healthcare Workers · Male
|
66 Participants
n=125 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
93 Participants
n=180 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
159 Participants
n=305 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Sex: Female, Male
Index Clients · Female
|
81 Participants
n=124 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
159 Participants
n=217 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
240 Participants
n=341 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Sex: Female, Male
Index Clients · Male
|
43 Participants
n=124 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
58 Participants
n=217 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
101 Participants
n=341 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Sex: Female, Male
Contact Clients · Female
|
25 Participants
n=67 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
61 Participants
n=127 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
86 Participants
n=194 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Sex: Female, Male
Contact Clients · Male
|
42 Participants
n=67 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
66 Participants
n=127 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
108 Participants
n=194 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Ethnicity (NIH/OMB)
Healthcare Workers · Hispanic or Latino
|
0 Participants
n=125 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=181 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=306 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Ethnicity (NIH/OMB)
Healthcare Workers · Not Hispanic or Latino
|
123 Participants
n=125 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
181 Participants
n=181 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
304 Participants
n=306 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Ethnicity (NIH/OMB)
Healthcare Workers · Unknown or Not Reported
|
2 Participants
n=125 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=181 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
2 Participants
n=306 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Ethnicity (NIH/OMB)
Index Clients · Hispanic or Latino
|
0 Participants
n=124 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=217 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=341 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Ethnicity (NIH/OMB)
Index Clients · Not Hispanic or Latino
|
124 Participants
n=124 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
217 Participants
n=217 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
341 Participants
n=341 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Ethnicity (NIH/OMB)
Index Clients · Unknown or Not Reported
|
0 Participants
n=124 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=217 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=341 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Ethnicity (NIH/OMB)
Contact Clients · Hispanic or Latino
|
0 Participants
n=67 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=127 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=194 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Ethnicity (NIH/OMB)
Contact Clients · Not Hispanic or Latino
|
67 Participants
n=67 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
127 Participants
n=127 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
194 Participants
n=194 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Ethnicity (NIH/OMB)
Contact Clients · Unknown or Not Reported
|
0 Participants
n=67 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=127 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=194 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Healthcare Workers · American Indian or Alaska Native
|
0 Participants
n=125 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=180 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=305 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Healthcare Workers · Asian
|
0 Participants
n=125 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=180 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=305 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Healthcare Workers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=125 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=180 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=305 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Healthcare Workers · Black or African American
|
125 Participants
n=125 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
180 Participants
n=180 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
305 Participants
n=305 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Healthcare Workers · White
|
0 Participants
n=125 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=180 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=305 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Healthcare Workers · More than one race
|
0 Participants
n=125 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=180 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=305 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Healthcare Workers · Unknown or Not Reported
|
0 Participants
n=125 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=180 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=305 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Index Clients · American Indian or Alaska Native
|
0 Participants
n=124 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=217 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=341 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Index Clients · Asian
|
0 Participants
n=124 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=217 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=341 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Index Clients · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=124 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=217 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=341 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Index Clients · Black or African American
|
124 Participants
n=124 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
217 Participants
n=217 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
341 Participants
n=341 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Index Clients · White
|
0 Participants
n=124 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=217 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=341 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Index Clients · More than one race
|
0 Participants
n=124 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=217 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=341 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Index Clients · Unknown or Not Reported
|
0 Participants
n=124 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=217 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=341 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Contact Clients · American Indian or Alaska Native
|
0 Participants
n=67 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=127 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=194 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Contact Clients · Asian
|
0 Participants
n=67 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=127 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=194 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Contact Clients · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=67 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=127 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=194 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Contact Clients · Black or African American
|
67 Participants
n=67 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
127 Participants
n=127 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
194 Participants
n=194 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Contact Clients · White
|
0 Participants
n=67 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=127 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=194 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Contact Clients · More than one race
|
0 Participants
n=67 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=127 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=194 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Race (NIH/OMB)
Contact Clients · Unknown or Not Reported
|
0 Participants
n=67 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=127 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
0 Participants
n=194 Participants • Data are reported separately for Heathcare Workers, Index clients, and Contact clients.
|
|
Region of Enrollment
Malawi
|
316 participants
n=316 Participants
|
525 participants
n=525 Participants
|
841 participants
n=841 Participants
|
PRIMARY outcome
Timeframe: 1 year after trainingPopulation: Data were missing for 2 participants.
Health care workers will be observed counseling actual index clients. The scores on the 15-item index client fidelity assessment will be compared between arms (range 0-100% with higher scores being better)
Outcome measures
| Measure |
Enhanced Implementation Strategy
n=122 Participants
Standard training and clinical support
\+ Enhanced digitally guided training and continuous quality improvement
|
Standard Implementation Strategy
n=217 Participants
Standard training and clinical support
|
|---|---|---|
|
Index Client Fidelity Assessment
|
66.30 score on a scale
Interval 62.8 to 69.7
|
45.70 score on a scale
Interval 42.8 to 48.6
|
PRIMARY outcome
Timeframe: 1 year after trainingPopulation: Data were missing for 3 participants.
Health care workers will be observed counseling actual contact clients. The scores on the 15-item contact client fidelity assessment will be compared between arms (range 0-100% with higher scores being better)
Outcome measures
| Measure |
Enhanced Implementation Strategy
n=64 Participants
Standard training and clinical support
\+ Enhanced digitally guided training and continuous quality improvement
|
Standard Implementation Strategy
n=127 Participants
Standard training and clinical support
|
|---|---|---|
|
Contact Client Fidelity Assessment
|
63.70 score on a scale
Interval 58.8 to 68.6
|
52.50 score on a scale
Interval 50.8 to 54.2
|
PRIMARY outcome
Timeframe: 1 year after trainingPopulation: Data unavailable for one cluster in Quarter 4 of the standard arm.
The total number of index clients who participate in assisted contact tracing relative to the number of total potential index clients measured per facility per calendar quarter (3-month period). Each cluster contributes 4 quarters of data.
Outcome measures
| Measure |
Enhanced Implementation Strategy
n=44 Cluster-quarters
Standard training and clinical support
\+ Enhanced digitally guided training and continuous quality improvement
|
Standard Implementation Strategy
n=87 Cluster-quarters
Standard training and clinical support
|
|---|---|---|
|
Index Clients Who Participate in Assisted Contact Tracing
|
0.56 proportion of participants
Interval 0.33 to 0.87
|
0.46 proportion of participants
Interval 0.3 to 0.68
|
PRIMARY outcome
Timeframe: 1 year after trainingPopulation: Data unavailable for one cluster in Quarter 4 of the standard arm.
The number of contact clients listed by participating index clients relative to the number of total potential index clients measured per facility per calendar quarter (3-month period). Each cluster contributes 4 quarters of data.
Outcome measures
| Measure |
Enhanced Implementation Strategy
n=44 Cluster-quarters
Standard training and clinical support
\+ Enhanced digitally guided training and continuous quality improvement
|
Standard Implementation Strategy
n=87 Cluster-quarters
Standard training and clinical support
|
|---|---|---|
|
Contact Clients Elicited
|
0.19 proportion of participants
Interval 0.13 to 0.27
|
0.13 proportion of participants
Interval 0.09 to 0.19
|
PRIMARY outcome
Timeframe: 1 year after trainingPopulation: Data unavailable for one cluster in Quarter 4 of the standard arm.
The number of HIV self-test kits distributed relative to the number of total potential index clients measured per facility per calendar quarter (3-month period). Each cluster contributes 4 quarters of data.
Outcome measures
| Measure |
Enhanced Implementation Strategy
n=44 Cluster-quarters
Standard training and clinical support
\+ Enhanced digitally guided training and continuous quality improvement
|
Standard Implementation Strategy
n=87 Cluster-quarters
Standard training and clinical support
|
|---|---|---|
|
HIV Self-test Kits Distributed
|
0.016 proportion of participants
Interval 0.008 to 0.028
|
0.006 proportion of participants
Interval 0.0 to 0.016
|
PRIMARY outcome
Timeframe: 1 year after trainingPopulation: Data unavailable for one cluster in Quarter 4 of the standard arm.
The number of contact clients tested relative to the number of total potential index clients measured per facility per calendar quarter (3-month period). Each cluster contributes 4 quarters of data.
Outcome measures
| Measure |
Enhanced Implementation Strategy
n=44 Cluster-quarters
Standard training and clinical support
\+ Enhanced digitally guided training and continuous quality improvement
|
Standard Implementation Strategy
n=87 Cluster-quarters
Standard training and clinical support
|
|---|---|---|
|
Contact Clients Tested
|
0.11 proportion of participants
Interval 0.06 to 0.2
|
0.08 proportion of participants
Interval 0.05 to 0.11
|
PRIMARY outcome
Timeframe: 1 year after trainingPopulation: Data unavailable for one cluster in Quarter 4 of the standard arm.
The number of contact clients living with HIV identified relative to the number of total potential index clients measured per facility per calendar quarter (3-month period). Each cluster contributes 4 quarters of data.
Outcome measures
| Measure |
Enhanced Implementation Strategy
n=44 Cluster-quarters
Standard training and clinical support
\+ Enhanced digitally guided training and continuous quality improvement
|
Standard Implementation Strategy
n=87 Cluster-quarters
Standard training and clinical support
|
|---|---|---|
|
Contact Clients Living With HIV Identified
|
0.005 proportion of participants
Interval 0.002 to 0.008
|
0.004 proportion of participants
Interval 0.003 to 0.008
|
PRIMARY outcome
Timeframe: 1 year after trainingPopulation: Calculations were driven from the 'Clusters and Register-Extracted Data' population. The full range of incremental cost was derived based on variability in cost associated with implementation strategy development. Number of participants analyzed in the Standard Arm is Zero due to this outcome being an incremental measure; no additional clients were tested in the Standard Arm.
Incremental cost per contact tested for HIV = Total additional cost in enhanced arm ($127,319) / total number of additional individual tested for HIV in the enhanced arm (1119). The outcome is an incremental cost effectiveness ratio. Because no additional cost was incurred in the Standard arm, the value was reported as 0.
Outcome measures
| Measure |
Enhanced Implementation Strategy
n=1119 Participants
Standard training and clinical support
\+ Enhanced digitally guided training and continuous quality improvement
|
Standard Implementation Strategy
Standard training and clinical support
|
|---|---|---|
|
Incremental Cost Per Contact Tested
|
114 US Dollars
Interval 70.0 to 142.0
|
—
|
PRIMARY outcome
Timeframe: 1 year after trainingPopulation: Calculations were driven from the 'Clusters and Register-Extracted Data' population. The full range of incremental cost was derived based on variability in cost associated with implementation strategy development. Number of participants analyzed in the Standard Arm is Zero due to this outcome being an incremental measure; no additional clients were diagnosed with HIV in the Standard Arm.
Incremental cost per contact tested for HIV = Total additional cost in enhanced arm ($127,319) / total number of additional individual diagnosed with HIV in the enhanced arm (64). The outcome is an incremental cost effectiveness ratio. Because no additional cost was incurred in the Standard arm, the value is reported as 0.
Outcome measures
| Measure |
Enhanced Implementation Strategy
n=64 Participants
Standard training and clinical support
\+ Enhanced digitally guided training and continuous quality improvement
|
Standard Implementation Strategy
Standard training and clinical support
|
|---|---|---|
|
Incremental Cost Per Person Living With HIV Diagnosed
|
1977 US Dollars
Interval 1209.0 to 2471.0
|
—
|
Adverse Events
Enhanced Implementation Strategy Healthcare Workers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Implementation Strategy Index Clients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Implementation Strategy Contact Clients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Implementation Strategy Healthcare Workers
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Standard Implementation Strategy Index Clients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Implementation Strategy Contact Clients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enhanced Implementation Strategy Healthcare Workers
n=125 participants at risk
Standard training and clinical support
\+ Enhanced digitally guided training and continuous quality improvement
|
Enhanced Implementation Strategy Index Clients
n=124 participants at risk
Standard training and clinical support
\+ Enhanced digitally guided training and continuous quality improvement
|
Enhanced Implementation Strategy Contact Clients
n=67 participants at risk
Standard training and clinical support
\+ Enhanced digitally guided training and continuous quality improvement
|
Standard Implementation Strategy Healthcare Workers
n=181 participants at risk
Standard training and clinical support
|
Standard Implementation Strategy Index Clients
n=217 participants at risk
Standard training and clinical support
|
Standard Implementation Strategy Contact Clients
n=127 participants at risk
Standard training and clinical support
|
|---|---|---|---|---|---|---|
|
General disorders
Surgery complication
|
0.00%
0/125 • From the time of enrollment through study completion (approximately 12 months).
The "Cluster and Register-Extracted data" population are not considered enrolled participants in the study. These are extracted data from register and no data were collected from these individuals.
|
0.00%
0/124 • From the time of enrollment through study completion (approximately 12 months).
The "Cluster and Register-Extracted data" population are not considered enrolled participants in the study. These are extracted data from register and no data were collected from these individuals.
|
0.00%
0/67 • From the time of enrollment through study completion (approximately 12 months).
The "Cluster and Register-Extracted data" population are not considered enrolled participants in the study. These are extracted data from register and no data were collected from these individuals.
|
0.55%
1/181 • Number of events 1 • From the time of enrollment through study completion (approximately 12 months).
The "Cluster and Register-Extracted data" population are not considered enrolled participants in the study. These are extracted data from register and no data were collected from these individuals.
|
0.00%
0/217 • From the time of enrollment through study completion (approximately 12 months).
The "Cluster and Register-Extracted data" population are not considered enrolled participants in the study. These are extracted data from register and no data were collected from these individuals.
|
0.00%
0/127 • From the time of enrollment through study completion (approximately 12 months).
The "Cluster and Register-Extracted data" population are not considered enrolled participants in the study. These are extracted data from register and no data were collected from these individuals.
|
Other adverse events
Adverse event data not reported
Additional Information
Nora E. Rosenberg, PhD
University of North Carolina at Chapel Hill
Phone: (919) 966-3761
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place