Trial Outcomes & Findings for Biomedical HIV/AIDS Prevention Program Yunnan (NCT NCT03992274)
NCT ID: NCT03992274
Last Updated: 2025-01-30
Results Overview
Number of clients who are aware of PrEP
TERMINATED
NA
114 participants
Up to 48 months
2025-01-30
Participant Flow
Participants include clients and staff. The study was conducted at 8 study sites Yunnan, China.
No participants or sites progressed beyond the Pre-Baseline.
Unit of analysis: sites
Participant milestones
| Measure |
Sequence 1: 6 Months Pre-Baseline, Then 6 Months Baseline
Sequence 1: 6 months Pre-Baseline, 6 months Standard Implementation, 12 months Enhanced Implementation, and 6 months Post-Experiment Observation.
Pre-Baseline: Routine Service with no PrEP Implementation.
Baseline Period: Standard Implementation of PrEP.
Experiment Period: Enhanced Implementation of PrEP.
|
Sequence 2: 6 Months Pre-Baseline, Then 12 Months Baseline
Sequence 2: 6 months Pre-Baseline, 6 months Standard Implementation, 12 months Enhanced Implementation, and 6 months Post-Experiment Observation
Pre-Baseline: Routine Service with no PrEP Implementation.
Baseline Period: Standard Implementation of PrEP.
Experiment Period: Enhanced Implementation of PrEP.
|
Sequence 3: 6 Months Pre-Baseline, Then 18 Months Baseline
Sequence 3: 6 months Pre-Baseline, 18 months Standard Implementation, 12 months Enhanced Implementation, and 6 months Post-Experiment Observation
Pre-Baseline: Routine Service with no PrEP Implementation.
Baseline Period: Standard Implementation of PrEP.
Experiment Period: Enhanced Implementation of PrEP.
|
Sequence 4: 6 Months Pre-Baseline, Then 24 Months Baseline
Sequence 4: 6 months Pre-Baseline, 24 months Standard Implementation, 12 months Enhanced Implementation, and 6 months Post-Experiment Observation
Pre-Baseline: Routine Service with no PrEP Implementation.
Baseline Period: Standard Implementation of PrEP.
Experiment Period: Enhanced Implementation of PrEP.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
114 8
|
0 0
|
0 0
|
0 0
|
|
Overall Study
Clients
|
58 8
|
0 0
|
0 0
|
0 0
|
|
Overall Study
Staff
|
56 8
|
0 0
|
0 0
|
0 0
|
|
Overall Study
COMPLETED
|
114 8
|
0 0
|
0 0
|
0 0
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sex/Gender data were not collected from staff.
Baseline characteristics by cohort
| Measure |
Clients
n=58 Participants
MSM clients (men who have sex with men) who are involved in PrEP implementation
|
Staff
n=56 Participants
Program staff who are involved in PrEP implementation
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>=18 years old
|
58 Participants
n=58 Participants
|
56 Participants
n=56 Participants
|
114 Participants
n=114 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=58 Participants • Sex/Gender data were not collected from staff.
|
—
|
0 Participants
n=58 Participants • Sex/Gender data were not collected from staff.
|
|
Sex: Female, Male
Male
|
58 Participants
n=58 Participants • Sex/Gender data were not collected from staff.
|
—
|
58 Participants
n=58 Participants • Sex/Gender data were not collected from staff.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=58 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=58 Participants
|
56 Participants
n=56 Participants
|
114 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=58 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
58 Participants
n=58 Participants
|
56 Participants
n=56 Participants
|
114 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=58 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=58 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=58 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=58 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=114 Participants
|
|
Region of Enrollment
China
|
58 participants
n=58 Participants
|
56 participants
n=56 Participants
|
114 participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Up to 48 monthsPopulation: Due to the closure of the study and loss of funding, intervention was not implemented, and data was not collected or analyzed.
Number of clients who are aware of PrEP
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 48 monthsPopulation: Due to the closure of the study and loss of funding, intervention was not implemented, and data was not collected or analyzed.
Number of clients who are eligible for PrEP
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 48 monthsPopulation: Due to the closure of the study and loss of funding, intervention was not implemented, and data was not collected or analyzed.
Number of clients who are offered PrEP
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 48 monthsPopulation: Due to the closure of the study and loss of funding, intervention was not implemented, and data was not collected or analyzed.
Number of clients initiating PrEP
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 48 monthsPopulation: Due to the closure of the study and loss of funding, intervention was not implemented, and data was not collected or analyzed.
Number of PrEP initiators who remain PrEP-eligible and sustain use at six months
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 48 monthsPopulation: Due to the closure of the study and loss of funding, intervention was not implemented, and data was not collected or analyzed.
The SIC is an 8-stage observational assessment tool recording organizational site completion of implementation activities that map onto the three phases of implementation (Pre-Implementation, Implementation, Sustainability). Proportion of PrEP implementation activities completed will be measured.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 48 monthsPopulation: Due to the closure of the study and loss of funding, intervention was not implemented, and data was not collected or analyzed.
The SIC is an 8-stage observational assessment tool recording organizational site completion of implementation activities that map onto the three phases of implementation (Pre-Implementation, Implementation, Sustainability). Time to completion of each implementation phase will be measured.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 48 monthsPopulation: Due to the closure of the study and loss of funding, intervention was not implemented, and data was not collected or analyzed.
Costs and resource allocation for completion of each implementation phase will be measured with the Cost of Implementing New Strategies (COINS) tool.
Outcome measures
Outcome data not reported
Adverse Events
Standard and Enhanced Implementation
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