Trial Outcomes & Findings for HIV Testing at Family Planning Clinics in Mombasa County, Kenya (NCT NCT02994355)
NCT ID: NCT02994355
Last Updated: 2023-11-30
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Months 9-12 of the study
Results posted on
2023-11-30
Participant Flow
Unit of analysis: Family Planning Clinics
Participant milestones
| Measure |
Intervention Clinics
Clinics randomized to the intervention will be introduced to the Systems Analysis and Improvement Approach (SAIA) to understand barriers to HIV testing in family planning clinics. Sequential process flow mapping will be used to highlight areas for improvement and then specific interventions will be implemented for the clinics with the goal of increasing HIV testing rates.
Systems Analysis and Improvement Approach: 1. Understanding the cascade from FP clinic enrollment to HIV testing 2. Use process mapping to identify modifiable bottlenecks 3. Define and implement workflow adaptations to eliminate modifiable bottlenecks 4. Monitor change in performance 5. Repeat the analysis and improvement cycle (steps 1-4)
|
Control Clinics
Clinics randomized to the control arm of the study will continue HIV testing as per usual procedures.
|
|---|---|---|
|
Overall Study
STARTED
|
0 12
|
0 12
|
|
Overall Study
COMPLETED
|
0 11
|
0 11
|
|
Overall Study
NOT COMPLETED
|
0 1
|
0 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HIV Testing at Family Planning Clinics in Mombasa County, Kenya
Baseline characteristics by cohort
| Measure |
Intervention Clinics
n=12 Family Planning Clinics
Clinics randomized to the intervention will be introduced to the Systems Analysis and Improvement Approach (SAIA) to understand barriers to HIV testing in family planning clinics. Sequential process flow mapping will be used to highlight areas for improvement and then specific interventions will be implemented for the clinics with the goal of increasing HIV testing rates.
Systems Analysis and Improvement Approach: 1. Understanding the cascade from FP clinic enrollment to HIV testing 2. Use process mapping to identify modifiable bottlenecks 3. Define and implement workflow adaptations to eliminate modifiable bottlenecks 4. Monitor change in performance 5. Repeat the analysis and improvement cycle (steps 1-4)
|
Control Clinics
n=11 Family Planning Clinics
Clinics randomized to the control arm of the study will continue HIV testing as per usual procedures.
|
Total
n=23 Family Planning Clinics
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
NA Family Planning Clinics
n=12 Family Planning Clinics
|
NA Family Planning Clinics
n=11 Family Planning Clinics
|
NA Family Planning Clinics
n=23 Family Planning Clinics
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
NA Family Planning Clinics
n=12 Family Planning Clinics
|
NA Family Planning Clinics
n=11 Family Planning Clinics
|
NA Family Planning Clinics
n=23 Family Planning Clinics
|
|
Race (NIH/OMB)
Asian
|
NA Family Planning Clinics
n=12 Family Planning Clinics
|
NA Family Planning Clinics
n=11 Family Planning Clinics
|
NA Family Planning Clinics
n=23 Family Planning Clinics
|
|
Age, Categorical
<=18 years
|
NA Family Planning Clinics
n=12 Family Planning Clinics
|
NA Family Planning Clinics
n=11 Family Planning Clinics
|
NA Family Planning Clinics
n=23 Family Planning Clinics
|
|
Age, Categorical
Between 18 and 65 years
|
NA Family Planning Clinics
n=12 Family Planning Clinics
|
NA Family Planning Clinics
n=11 Family Planning Clinics
|
NA Family Planning Clinics
n=23 Family Planning Clinics
|
|
Age, Categorical
>=65 years
|
NA Family Planning Clinics
n=12 Family Planning Clinics
|
NA Family Planning Clinics
n=11 Family Planning Clinics
|
NA Family Planning Clinics
n=23 Family Planning Clinics
|
|
Sex: Female, Male
Female
|
NA Family Planning Clinics
n=12 Family Planning Clinics
|
NA Family Planning Clinics
n=11 Family Planning Clinics
|
NA Family Planning Clinics
n=23 Family Planning Clinics
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
NA Family Planning Clinics
n=12 Family Planning Clinics
|
NA Family Planning Clinics
n=11 Family Planning Clinics
|
NA Family Planning Clinics
n=23 Family Planning Clinics
|
|
Race (NIH/OMB)
Black or African American
|
NA Family Planning Clinics
n=12 Family Planning Clinics
|
NA Family Planning Clinics
n=11 Family Planning Clinics
|
NA Family Planning Clinics
n=23 Family Planning Clinics
|
|
Race (NIH/OMB)
White
|
NA Family Planning Clinics
n=12 Family Planning Clinics
|
NA Family Planning Clinics
n=11 Family Planning Clinics
|
NA Family Planning Clinics
n=23 Family Planning Clinics
|
|
Race (NIH/OMB)
More than one race
|
NA Family Planning Clinics
n=12 Family Planning Clinics
|
NA Family Planning Clinics
n=11 Family Planning Clinics
|
NA Family Planning Clinics
n=23 Family Planning Clinics
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
NA Family Planning Clinics
n=12 Family Planning Clinics
|
NA Family Planning Clinics
n=11 Family Planning Clinics
|
NA Family Planning Clinics
n=23 Family Planning Clinics
|
|
Public Clinic
|
6 Family Planning Clinics
n=12 Family Planning Clinics
|
6 Family Planning Clinics
n=11 Family Planning Clinics
|
12 Family Planning Clinics
n=23 Family Planning Clinics
|
|
Urban Clinic
|
4 Family Planning Clinics
n=12 Family Planning Clinics
|
4 Family Planning Clinics
n=11 Family Planning Clinics
|
8 Family Planning Clinics
n=23 Family Planning Clinics
|
|
Complete auditory privacy
|
7 Family Planning Clinics
n=12 Family Planning Clinics
|
7 Family Planning Clinics
n=11 Family Planning Clinics
|
14 Family Planning Clinics
n=23 Family Planning Clinics
|
|
Complete visual privacy
|
8 Family Planning Clinics
n=12 Family Planning Clinics
|
6 Family Planning Clinics
n=11 Family Planning Clinics
|
14 Family Planning Clinics
n=23 Family Planning Clinics
|
|
FP clinic manager aware of most recent National HIV Guidelines
|
6 Family Planning Clinics
n=12 Family Planning Clinics
|
9 Family Planning Clinics
n=11 Family Planning Clinics
|
15 Family Planning Clinics
n=23 Family Planning Clinics
|
|
Number of FP providers trained in HTC
|
1 Family Planning Clinics
n=12 Family Planning Clinics
|
1 Family Planning Clinics
n=11 Family Planning Clinics
|
1 Family Planning Clinics
n=23 Family Planning Clinics
|
|
Clients required to pay for HIV testing
|
2 Family Planning Clinics
n=12 Family Planning Clinics
|
3 Family Planning Clinics
n=11 Family Planning Clinics
|
5 Family Planning Clinics
n=23 Family Planning Clinics
|
PRIMARY outcome
Timeframe: Months 9-12 of the studyPopulation: Data was collected at the clinic level.
Outcome measures
| Measure |
Intervention Clinics
n=12 FP Clinics
Clinics randomized to the intervention will be introduced to the Systems Analysis and Improvement Approach (SAIA) to understand barriers to HIV testing in family planning clinics. Sequential process flow mapping will be used to highlight areas for improvement and then specific interventions will be implemented for the clinics with the goal of increasing HIV testing rates.
Systems Analysis and Improvement Approach: 1. Understanding the cascade from FP clinic enrollment to HIV testing 2. Use process mapping to identify modifiable bottlenecks 3. Define and implement workflow adaptations to eliminate modifiable bottlenecks 4. Monitor change in performance 5. Repeat the analysis and improvement cycle (steps 1-4)
|
Control Clinics
n=11 FP Clinics
Clinics randomized to the control arm of the study will continue HIV testing as per usual procedures.
|
|---|---|---|
|
Percentage of Eligible (Not Known HIV+) New FP Clients Who Are Tested for HIV in the Months 9-12 of the Study in Intervention and Control Facilities
|
42 Percentage tested for HIV
Standard Deviation 26
|
32 Percentage tested for HIV
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Months 9-12 of the studyPopulation: Data was collected at the clinic level.
Outcome measures
| Measure |
Intervention Clinics
n=12 FP Clinics
Clinics randomized to the intervention will be introduced to the Systems Analysis and Improvement Approach (SAIA) to understand barriers to HIV testing in family planning clinics. Sequential process flow mapping will be used to highlight areas for improvement and then specific interventions will be implemented for the clinics with the goal of increasing HIV testing rates.
Systems Analysis and Improvement Approach: 1. Understanding the cascade from FP clinic enrollment to HIV testing 2. Use process mapping to identify modifiable bottlenecks 3. Define and implement workflow adaptations to eliminate modifiable bottlenecks 4. Monitor change in performance 5. Repeat the analysis and improvement cycle (steps 1-4)
|
Control Clinics
n=11 FP Clinics
Clinics randomized to the control arm of the study will continue HIV testing as per usual procedures.
|
|---|---|---|
|
Percentage of New FP Clients Who Are Counseled About HIV Testing in the Months 9-12 of the Study in Intervention and Control Facilities, Adjusted for Baseline
|
85 Percentage counseled for HIV
Standard Deviation 27
|
67 Percentage counseled for HIV
Standard Deviation 34
|
SECONDARY outcome
Timeframe: Months 13-24 of the studyPopulation: Data was collected at the clinic level.
Outcome measures
| Measure |
Intervention Clinics
n=12 FP Clinics
Clinics randomized to the intervention will be introduced to the Systems Analysis and Improvement Approach (SAIA) to understand barriers to HIV testing in family planning clinics. Sequential process flow mapping will be used to highlight areas for improvement and then specific interventions will be implemented for the clinics with the goal of increasing HIV testing rates.
Systems Analysis and Improvement Approach: 1. Understanding the cascade from FP clinic enrollment to HIV testing 2. Use process mapping to identify modifiable bottlenecks 3. Define and implement workflow adaptations to eliminate modifiable bottlenecks 4. Monitor change in performance 5. Repeat the analysis and improvement cycle (steps 1-4)
|
Control Clinics
n=11 FP Clinics
Clinics randomized to the control arm of the study will continue HIV testing as per usual procedures.
|
|---|---|---|
|
Percentage of New FP Clients Who Are Tested for HIV After Year of Minimal Support
|
61 % tested for HIV
Standard Error 7
|
19 % tested for HIV
Standard Error 6
|
Adverse Events
Intervention Clinics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Clinics
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place