Trial Outcomes & Findings for The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China (NCT NCT04426656)
NCT ID: NCT04426656
Last Updated: 2022-03-02
Results Overview
Individual perceived likelihood to start using PrEP, measured by a one-item question with a bipolar response scale (-3 to 3). Higher score indicates higher intention to use.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
Baseline and up to 12 weeks
Results posted on
2022-03-02
Participant Flow
Participant milestones
| Measure |
Part 2 Standard of Care
Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
|
Part 2 Mini-app
In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.
Phone application: The mini-app (used in Part 2) has four main functions:
1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
3. an asynchronous message function that allows users to chat with a study staff (C.Li); and
4. a user profile page where users can manage all HIV test orders.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
46
|
|
Overall Study
COMPLETED
|
21
|
43
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China
Baseline characteristics by cohort
| Measure |
Part 2 Standard of Care
n=24 Participants
Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
|
Part 2 Mini-app
n=46 Participants
In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.
Phone application: The mini-app (used in Part 2) has four main functions:
1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
3. an asynchronous message function that allows users to chat with a study staff (C.Li); and
4. a user profile page where users can manage all HIV test orders.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.5 years
STANDARD_DEVIATION 4.6 • n=99 Participants
|
28.2 years
STANDARD_DEVIATION 6.8 • n=107 Participants
|
28.0 years
STANDARD_DEVIATION 6.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
China
|
24 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 12 weeksIndividual perceived likelihood to start using PrEP, measured by a one-item question with a bipolar response scale (-3 to 3). Higher score indicates higher intention to use.
Outcome measures
| Measure |
Part 2 Standard of Care
n=21 Participants
Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
|
Part 2 Mini-app
n=43 Participants
In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.
Phone application: The mini-app (used in Part 2) has four main functions:
1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
3. an asynchronous message function that allows users to chat with a study staff (C.Li); and
4. a user profile page where users can manage all HIV test orders.
|
|---|---|---|
|
Change in Intention to Use PrEP Score
Baseline to Week 4
|
0.19 score on a scale
Standard Deviation 1.72
|
0.00 score on a scale
Standard Deviation 2.32
|
|
Change in Intention to Use PrEP Score
Baseline to Week 8
|
0.57 score on a scale
Standard Deviation 2.62
|
-0.09 score on a scale
Standard Deviation 2.29
|
|
Change in Intention to Use PrEP Score
Baseline to Week 12
|
1.00 score on a scale
Standard Deviation 2.59
|
-0.40 score on a scale
Standard Deviation 2.59
|
PRIMARY outcome
Timeframe: Up to 8 weeksIndividual's self-reported whether starting use of PrEP medication (binary: Yes/No)
Outcome measures
| Measure |
Part 2 Standard of Care
n=24 Participants
Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
|
Part 2 Mini-app
n=46 Participants
In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.
Phone application: The mini-app (used in Part 2) has four main functions:
1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
3. an asynchronous message function that allows users to chat with a study staff (C.Li); and
4. a user profile page where users can manage all HIV test orders.
|
|---|---|---|
|
Number of Participants Who Initiate PrEP by Week 8
|
5 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Only participants with no missing data were included in this analysis.
Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.
Outcome measures
| Measure |
Part 2 Standard of Care
n=21 Participants
Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
|
Part 2 Mini-app
n=43 Participants
In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.
Phone application: The mini-app (used in Part 2) has four main functions:
1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
3. an asynchronous message function that allows users to chat with a study staff (C.Li); and
4. a user profile page where users can manage all HIV test orders.
|
|---|---|---|
|
Number of Participants at Different Change Stages to PrEP Initiation at Baseline
Pre-contemplation
|
9 Participants
|
15 Participants
|
|
Number of Participants at Different Change Stages to PrEP Initiation at Baseline
Contemplation
|
8 Participants
|
24 Participants
|
|
Number of Participants at Different Change Stages to PrEP Initiation at Baseline
Preparation
|
4 Participants
|
4 Participants
|
|
Number of Participants at Different Change Stages to PrEP Initiation at Baseline
Action
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: Only participants with no missing data were included in this analysis.
Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.
Outcome measures
| Measure |
Part 2 Standard of Care
n=21 Participants
Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
|
Part 2 Mini-app
n=43 Participants
In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.
Phone application: The mini-app (used in Part 2) has four main functions:
1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
3. an asynchronous message function that allows users to chat with a study staff (C.Li); and
4. a user profile page where users can manage all HIV test orders.
|
|---|---|---|
|
Number of Participants at Different Change Stages to PrEP Initiation at Week 4
Pre-contemplation
|
10 Participants
|
15 Participants
|
|
Number of Participants at Different Change Stages to PrEP Initiation at Week 4
Contemplation
|
5 Participants
|
12 Participants
|
|
Number of Participants at Different Change Stages to PrEP Initiation at Week 4
Preparation
|
6 Participants
|
12 Participants
|
|
Number of Participants at Different Change Stages to PrEP Initiation at Week 4
Action
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Only participants with no missing data were included in this analysis.
Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.
Outcome measures
| Measure |
Part 2 Standard of Care
n=21 Participants
Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
|
Part 2 Mini-app
n=43 Participants
In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.
Phone application: The mini-app (used in Part 2) has four main functions:
1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
3. an asynchronous message function that allows users to chat with a study staff (C.Li); and
4. a user profile page where users can manage all HIV test orders.
|
|---|---|---|
|
Number of Participants at Different Change Stages to PrEP Initiation at Week 8
Pre-contemplation
|
8 Participants
|
20 Participants
|
|
Number of Participants at Different Change Stages to PrEP Initiation at Week 8
Contemplation
|
4 Participants
|
7 Participants
|
|
Number of Participants at Different Change Stages to PrEP Initiation at Week 8
Preparation
|
4 Participants
|
8 Participants
|
|
Number of Participants at Different Change Stages to PrEP Initiation at Week 8
Action
|
5 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Week 12Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.
Outcome measures
| Measure |
Part 2 Standard of Care
n=21 Participants
Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
|
Part 2 Mini-app
n=43 Participants
In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.
Phone application: The mini-app (used in Part 2) has four main functions:
1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
3. an asynchronous message function that allows users to chat with a study staff (C.Li); and
4. a user profile page where users can manage all HIV test orders.
|
|---|---|---|
|
Number of Participants at Different Change Stages to PrEP Initiation at Week 12
Pre-contemplation
|
8 Participants
|
17 Participants
|
|
Number of Participants at Different Change Stages to PrEP Initiation at Week 12
Contemplation
|
3 Participants
|
11 Participants
|
|
Number of Participants at Different Change Stages to PrEP Initiation at Week 12
Preparation
|
5 Participants
|
7 Participants
|
|
Number of Participants at Different Change Stages to PrEP Initiation at Week 12
Action
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to 12 weeksPopulation: Participants analyzed here only include those with complete data at a certain follow-up week.
Individual's understanding of PrEP, measured by a 5-item True/False quiz. Values range from 0-5. Higher score indicates better PrEP knowledge.
Outcome measures
| Measure |
Part 2 Standard of Care
n=21 Participants
Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
|
Part 2 Mini-app
n=43 Participants
In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.
Phone application: The mini-app (used in Part 2) has four main functions:
1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
3. an asynchronous message function that allows users to chat with a study staff (C.Li); and
4. a user profile page where users can manage all HIV test orders.
|
|---|---|---|
|
Change in PrEP Knowledge Score at Week 4, 8 and 12
Baseline to Week 4
|
0.33 score on a scale
Standard Deviation 0.72
|
0.13 score on a scale
Standard Deviation 0.79
|
|
Change in PrEP Knowledge Score at Week 4, 8 and 12
Baseline to Week 8
|
0.33 score on a scale
Standard Deviation 0.66
|
0.16 score on a scale
Standard Deviation 0.78
|
|
Change in PrEP Knowledge Score at Week 4, 8 and 12
Baseline to Week 12
|
0.38 score on a scale
Standard Deviation 0.50
|
0.19 score on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Up to 12 weeksWillingness to pay for PrEP ranging from 0-100% of monthly income. Amount spent will be assessed at Baseline, Weeks 4, 8, and 12.
Outcome measures
| Measure |
Part 2 Standard of Care
n=21 Participants
Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
|
Part 2 Mini-app
n=43 Participants
In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.
Phone application: The mini-app (used in Part 2) has four main functions:
1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
3. an asynchronous message function that allows users to chat with a study staff (C.Li); and
4. a user profile page where users can manage all HIV test orders.
|
|---|---|---|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Baseline · Any amount
|
0 Participants
|
6 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Baseline · 30-50%
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Baseline · 15-25%
|
0 Participants
|
4 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Baseline · 10-15%
|
1 Participants
|
6 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Baseline · < 10%
|
4 Participants
|
14 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Baseline · Not any
|
9 Participants
|
5 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Baseline · Not sure
|
3 Participants
|
4 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Baseline · Other
|
4 Participants
|
4 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 4 · Any amount
|
0 Participants
|
4 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 4 · 30-50%
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 4 · 15-25%
|
0 Participants
|
7 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 4 · 10-15%
|
5 Participants
|
5 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 4 · < 10%
|
11 Participants
|
14 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 4 · Not any
|
1 Participants
|
7 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 4 · Not sure
|
1 Participants
|
3 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 4 · Other
|
3 Participants
|
3 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 8 · Any amount
|
0 Participants
|
5 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 8 · 30-50%
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 8 · 15-25%
|
1 Participants
|
4 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 8 · 10-15%
|
4 Participants
|
5 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 8 · < 10%
|
9 Participants
|
17 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 8 · Not any
|
2 Participants
|
6 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 8 · Not sure
|
3 Participants
|
3 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 8 · Other
|
2 Participants
|
2 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 12 · Any amount
|
0 Participants
|
3 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 12 · 30-50%
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 12 · 15-25%
|
2 Participants
|
5 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 12 · 10-15%
|
8 Participants
|
8 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 12 · < 10%
|
5 Participants
|
20 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 12 · Not any
|
2 Participants
|
4 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 12 · Not sure
|
1 Participants
|
2 Participants
|
|
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Week 12 · Other
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to 12 weeksSelf-Efficacy will be assessed at Baseline, Weeks 4, 8, and 12 using an 8-item PrEP self-efficacy scale. Values range from 0-5. Higher scores indicate higher self-efficacy to use PrEP.
Outcome measures
| Measure |
Part 2 Standard of Care
n=21 Participants
Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
|
Part 2 Mini-app
n=43 Participants
In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.
Phone application: The mini-app (used in Part 2) has four main functions:
1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
3. an asynchronous message function that allows users to chat with a study staff (C.Li); and
4. a user profile page where users can manage all HIV test orders.
|
|---|---|---|
|
Change in PrEP Self-Efficacy Score
Baseline to Week 4
|
0.05 score on a scale
Standard Deviation 0.40
|
0.07 score on a scale
Standard Deviation 0.39
|
|
Change in PrEP Self-Efficacy Score
Baseline to Week 8
|
0.08 score on a scale
Standard Deviation 0.50
|
0.03 score on a scale
Standard Deviation 0.41
|
|
Change in PrEP Self-Efficacy Score
Baseline to Week 12
|
0.10 score on a scale
Standard Deviation 0.47
|
0.13 score on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: Baseline and up to 12 weeksIndividual's attitude towards PrEP, measured by a 5-item scale. Values range from 0-5. Higher scores indicate more positive attitude toward PrEP. The PrEP Attitude will be assessed at Baseline, Weeks 4, 8, and 12.
Outcome measures
| Measure |
Part 2 Standard of Care
n=21 Participants
Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
|
Part 2 Mini-app
n=43 Participants
In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.
Phone application: The mini-app (used in Part 2) has four main functions:
1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
3. an asynchronous message function that allows users to chat with a study staff (C.Li); and
4. a user profile page where users can manage all HIV test orders.
|
|---|---|---|
|
Change in PrEP Attitude Score
Baseline to Week 4
|
0.06 score on a scale
Standard Deviation 0.32
|
0.07 score on a scale
Standard Deviation 0.66
|
|
Change in PrEP Attitude Score
Baseline to Week 8
|
0.23 score on a scale
Standard Deviation 0.79
|
0.01 score on a scale
Standard Deviation 0.72
|
|
Change in PrEP Attitude Score
Baseline to Week 12
|
0.02 score on a scale
Standard Deviation 0.44
|
0.02 score on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Baseline and up to 12 weeksIndividual's perceived stigma related to PrEP, measured by 5-item PrEP stigma scale. Values range from 0-5. Higher score indicates higher perceived stigma related to PrEP. The PrEP Stigma will be assessed at Baseline, Weeks 4, 8, and 12.
Outcome measures
| Measure |
Part 2 Standard of Care
n=21 Participants
Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
|
Part 2 Mini-app
n=43 Participants
In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.
Phone application: The mini-app (used in Part 2) has four main functions:
1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
3. an asynchronous message function that allows users to chat with a study staff (C.Li); and
4. a user profile page where users can manage all HIV test orders.
|
|---|---|---|
|
Change in PrEP Stigma Score
Baseline to Week 4
|
0.06 score on a scale
Standard Deviation 0.32
|
-0.02 score on a scale
Standard Deviation 0.69
|
|
Change in PrEP Stigma Score
Baseline to Week 8
|
0.23 score on a scale
Standard Deviation 0.79
|
0.09 score on a scale
Standard Deviation 0.72
|
|
Change in PrEP Stigma Score
Baseline to Week 12
|
0.02 score on a scale
Standard Deviation 0.44
|
0.03 score on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: This outcome is only applicable to the participants in the Part 2 mini-app arm who had access to the At-home HIV/syphilis tests per protocol.
Number of participants who ordered at-home HIV/syphilis tests through the mini-app based on the study record. Values range from 0 to greater than 0. Higher indicates higher frequency of participants who ordered HIV/syphilis tests completed through the study.
Outcome measures
| Measure |
Part 2 Standard of Care
Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
|
Part 2 Mini-app
n=46 Participants
In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.
Phone application: The mini-app (used in Part 2) has four main functions:
1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
3. an asynchronous message function that allows users to chat with a study staff (C.Li); and
4. a user profile page where users can manage all HIV test orders.
|
|---|---|---|
|
Number of Participants Who Ordered At-home HIV/Syphilis Tests
|
—
|
13 Participants
|
Adverse Events
Part 2 Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2 Mini-app
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
Chunyan Li, MSc
University of North Carolina at Chapel Hill
Phone: 919-966-6695
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place