HIV, Pre-exposure Prophylaxis
Conditions
Keywords
HIV, PrEP
Brief summary
This study aims to use a mini-application on the popular Chinese social media mobile platform, WeChat, to improve HIV pre-exposure prophylaxis (PrEP) uptake among at-risk men who have sex with men (MSM). UNC investigators will work in close partnership with a well-established HIV special hospital and the local MSM community to understand key barriers to PrEP use, and develop a mobile-based intervention to increase PrEP uptake among young MSM in Guangzhou, China.
Detailed description
This study includes two parts. Before the start of Part 1, a mini-app prototype for promoting HIV pre-exposure prophylaxis (PrEP) uptake will have been developed from a prior MSM community-driven hackathon contest. PrEP is an antiretroviral medicines-based prevention strategy against HIV infection, which has been proved save and effective. Part 1 includes in-depth interviews with 40 HIV-negative young MSM (18 and above) with a brief survey to collect demographic data. The interview topics include PrEP-related perceptions and feedback on the design of a mini-app prototype. Findings from Part 1 will inform refining the mini-app before the start of Part 2. In Part 2, a small two-arm randomized control trial with 70 young MSM (18 and above) will be conducted to evaluate the preliminary efficacy of the mini-app in improving PrEP-related perceptions and actual PrEP uptake, compared to a control group of standard of care. Participants in Part 2 will be followed up for 12 weeks (8 week intervention and after-intervention follow-up at 12th week). A subgroup of participants (n=15) from both the intervention arm and the control arm will receive two rounds of in-depth interviews, separately at the 4th and 8th week, to share their experience of using the app and changed perceptions and/or behaviors related to PrEP.
Interventions
BEHAVIORALPhone 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.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Mixed methods study, including a 2-arm randomized controlled trial.
Eligibility
Sex/Gender
MALE
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Part 1: HIV-negative men who have sex with men (MSM): must self-report: being assigned male sex at birth, HIV-negative, age 18 and above, ever having had anal sex with another man, identify as a Chinese citizen, own a smartphone, able to being willing to sign written informed consent and participate in the study as procedures required. Part 2: HIV-negative men who have sex with men (MSM): same characteristics as in Part 1. AND, they must report : * Having a smartphone with WeChat installed. * Being assigned male sex at birth, HIV-negative, age 18 and above, ever having had anal sex with another man, currently reside in Guangzhou, China, identifying as a Chinese citizen, able to sign written informed consent and participate in the study as procedures require. AND * At least one criterion associated with high risk of HIV infection in the past 6 months prior to enrollment as follows: * Unprotected (condomless) anal intercourse with male partner(s) * More than two male partners (regardless of condom use and HIV serostatus) * Reported STI, such as syphilis, Herpes Simplex Virus-2 (HSV-2), gonorrhea, chlamydia, chancroid, or lymphogranuloma venereum. * Reported use of post-exposure prophylaxis (PEP) * Have a sexual partner living with HIV
Exclusion criteria
* Part 1: Individuals who report any following status will be excluded from participating Part 1: * HIV-positive * Mental health issues which may compromise participant adherence or safety, including memory loss, cognitive impairment, intellectual disability, or communication disorders. * Part 2: * HIV-positive (self-report or lab-confirmed) * Currently taking oral PrEP based on self-report * Symptoms of acute HIV infection within the prior 30 days * Contradictions to taking oral PrEP * Personal diagnosis or family history of hemophilia * Chronic Hepatitis B (self-report) * Participating in another research study related to HIV and antiretroviral therapy or other intervention study * Having serious chronic disease, including metabolic diseases (such as diabetes), neurological, and psychiatric disorders * Mental health issues which may compromise participant adherence or safety, including memory loss, cognitive impairment, intellectual disability, or communication disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants at Different Change Stages to PrEP Initiation at Week 12 | Week 12 | 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. |
| Change in Intention to Use PrEP Score | Baseline and up to 12 weeks | 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. |
| Number of Participants Who Initiate PrEP by Week 8 | Up to 8 weeks | Individual's self-reported whether starting use of PrEP medication (binary: Yes/No) |
| Number of Participants at Different Change Stages to PrEP Initiation at Baseline | Baseline | 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. |
| Number of Participants at Different Change Stages to PrEP Initiation at Week 4 | Week 4 | 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. |
| Number of Participants at Different Change Stages to PrEP Initiation at Week 8 | Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PrEP Knowledge Score at Week 4, 8 and 12 | Baseline and up to 12 weeks | Individual's understanding of PrEP, measured by a 5-item True/False quiz. Values range from 0-5. Higher score indicates better PrEP knowledge. |
| Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Up to 12 weeks | Willingness to pay for PrEP ranging from 0-100% of monthly income. Amount spent will be assessed at Baseline, Weeks 4, 8, and 12. |
| Change in PrEP Self-Efficacy Score | Baseline and up to 12 weeks | Self-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. |
| Change in PrEP Attitude Score | Baseline and up to 12 weeks | Individual'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. |
| Change in PrEP Stigma Score | Baseline and up to 12 weeks | Individual'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. |
| Number of Participants Who Ordered At-home HIV/Syphilis Tests | 12 weeks | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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. | 46 |
| Total | 70 |
Baseline characteristics
| Characteristic | Part 2 Standard of Care | Total | Part 2 Mini-app |
|---|---|---|---|
| Age, Continuous | 27.5 years STANDARD_DEVIATION 4.6 | 28.0 years STANDARD_DEVIATION 6.1 | 28.2 years STANDARD_DEVIATION 6.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 70 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 24 Participants | 70 Participants | 46 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 24 Participants | 70 Participants | 46 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 24 Participants | 70 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 46 |
| other Total, other adverse events | 0 / 24 | 0 / 46 |
| serious Total, serious adverse events | 0 / 24 | 0 / 46 |
Outcome results
Primary
Change in Intention to Use PrEP Score
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.
Time frame: Baseline and up to 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 Standard of Care | Change in Intention to Use PrEP Score | Baseline to Week 4 | 0.19 score on a scale | Standard Deviation 1.72 |
| Part 2 Standard of Care | Change in Intention to Use PrEP Score | Baseline to Week 8 | 0.57 score on a scale | Standard Deviation 2.62 |
| Part 2 Standard of Care | Change in Intention to Use PrEP Score | Baseline to Week 12 | 1.00 score on a scale | Standard Deviation 2.59 |
| Part 2 Mini-app | Change in Intention to Use PrEP Score | Baseline to Week 4 | 0.00 score on a scale | Standard Deviation 2.32 |
| Part 2 Mini-app | Change in Intention to Use PrEP Score | Baseline to Week 8 | -0.09 score on a scale | Standard Deviation 2.29 |
| Part 2 Mini-app | Change in Intention to Use PrEP Score | Baseline to Week 12 | -0.40 score on a scale | Standard Deviation 2.59 |
Comparison: The comparison was made using the outcome variable measured at Week 12.p-value: 0.85Wilcoxon (Mann-Whitney)
Primary
Number of Participants at Different Change Stages to PrEP Initiation at Baseline
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.
Time frame: Baseline
Population: Only participants with no missing data were included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2 Standard of Care | Number of Participants at Different Change Stages to PrEP Initiation at Baseline | Pre-contemplation | 9 Participants |
| Part 2 Standard of Care | Number of Participants at Different Change Stages to PrEP Initiation at Baseline | Contemplation | 8 Participants |
| Part 2 Standard of Care | Number of Participants at Different Change Stages to PrEP Initiation at Baseline | Preparation | 4 Participants |
| Part 2 Standard of Care | Number of Participants at Different Change Stages to PrEP Initiation at Baseline | Action | 0 Participants |
| Part 2 Mini-app | Number of Participants at Different Change Stages to PrEP Initiation at Baseline | Action | 0 Participants |
| Part 2 Mini-app | Number of Participants at Different Change Stages to PrEP Initiation at Baseline | Pre-contemplation | 15 Participants |
| Part 2 Mini-app | Number of Participants at Different Change Stages to PrEP Initiation at Baseline | Preparation | 4 Participants |
| Part 2 Mini-app | Number of Participants at Different Change Stages to PrEP Initiation at Baseline | Contemplation | 24 Participants |
p-value: 0.318Fisher Exact
Primary
Number of Participants at Different Change Stages to PrEP Initiation at Week 12
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.
Time frame: Week 12
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2 Standard of Care | Number of Participants at Different Change Stages to PrEP Initiation at Week 12 | Pre-contemplation | 8 Participants |
| Part 2 Standard of Care | Number of Participants at Different Change Stages to PrEP Initiation at Week 12 | Contemplation | 3 Participants |
| Part 2 Standard of Care | Number of Participants at Different Change Stages to PrEP Initiation at Week 12 | Preparation | 5 Participants |
| Part 2 Standard of Care | Number of Participants at Different Change Stages to PrEP Initiation at Week 12 | Action | 5 Participants |
| Part 2 Mini-app | Number of Participants at Different Change Stages to PrEP Initiation at Week 12 | Action | 8 Participants |
| Part 2 Mini-app | Number of Participants at Different Change Stages to PrEP Initiation at Week 12 | Pre-contemplation | 17 Participants |
| Part 2 Mini-app | Number of Participants at Different Change Stages to PrEP Initiation at Week 12 | Preparation | 7 Participants |
| Part 2 Mini-app | Number of Participants at Different Change Stages to PrEP Initiation at Week 12 | Contemplation | 11 Participants |
p-value: 0.678Fisher Exact
Primary
Number of Participants at Different Change Stages to PrEP Initiation at Week 4
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.
Time frame: Week 4
Population: Only participants with no missing data were included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2 Standard of Care | Number of Participants at Different Change Stages to PrEP Initiation at Week 4 | Pre-contemplation | 10 Participants |
| Part 2 Standard of Care | Number of Participants at Different Change Stages to PrEP Initiation at Week 4 | Contemplation | 5 Participants |
| Part 2 Standard of Care | Number of Participants at Different Change Stages to PrEP Initiation at Week 4 | Preparation | 6 Participants |
| Part 2 Standard of Care | Number of Participants at Different Change Stages to PrEP Initiation at Week 4 | Action | 0 Participants |
| Part 2 Mini-app | Number of Participants at Different Change Stages to PrEP Initiation at Week 4 | Action | 4 Participants |
| Part 2 Mini-app | Number of Participants at Different Change Stages to PrEP Initiation at Week 4 | Pre-contemplation | 15 Participants |
| Part 2 Mini-app | Number of Participants at Different Change Stages to PrEP Initiation at Week 4 | Preparation | 12 Participants |
| Part 2 Mini-app | Number of Participants at Different Change Stages to PrEP Initiation at Week 4 | Contemplation | 12 Participants |
p-value: 0.527Fisher Exact
Primary
Number of Participants at Different Change Stages to PrEP Initiation at Week 8
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.
Time frame: Week 8
Population: Only participants with no missing data were included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2 Standard of Care | Number of Participants at Different Change Stages to PrEP Initiation at Week 8 | Pre-contemplation | 8 Participants |
| Part 2 Standard of Care | Number of Participants at Different Change Stages to PrEP Initiation at Week 8 | Contemplation | 4 Participants |
| Part 2 Standard of Care | Number of Participants at Different Change Stages to PrEP Initiation at Week 8 | Preparation | 4 Participants |
| Part 2 Standard of Care | Number of Participants at Different Change Stages to PrEP Initiation at Week 8 | Action | 5 Participants |
| Part 2 Mini-app | Number of Participants at Different Change Stages to PrEP Initiation at Week 8 | Action | 8 Participants |
| Part 2 Mini-app | Number of Participants at Different Change Stages to PrEP Initiation at Week 8 | Pre-contemplation | 20 Participants |
| Part 2 Mini-app | Number of Participants at Different Change Stages to PrEP Initiation at Week 8 | Preparation | 8 Participants |
| Part 2 Mini-app | Number of Participants at Different Change Stages to PrEP Initiation at Week 8 | Contemplation | 7 Participants |
p-value: 0.928Fisher Exact
Primary
Number of Participants Who Initiate PrEP by Week 8
Individual's self-reported whether starting use of PrEP medication (binary: Yes/No)
Time frame: Up to 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 2 Standard of Care | Number of Participants Who Initiate PrEP by Week 8 | 5 Participants |
| Part 2 Mini-app | Number of Participants Who Initiate PrEP by Week 8 | 8 Participants |
p-value: 0.72Chi-squared
Secondary
Change in PrEP Attitude Score
Individual'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.
Time frame: Baseline and up to 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 Standard of Care | Change in PrEP Attitude Score | Baseline to Week 4 | 0.06 score on a scale | Standard Deviation 0.32 |
| Part 2 Standard of Care | Change in PrEP Attitude Score | Baseline to Week 8 | 0.23 score on a scale | Standard Deviation 0.79 |
| Part 2 Standard of Care | Change in PrEP Attitude Score | Baseline to Week 12 | 0.02 score on a scale | Standard Deviation 0.44 |
| Part 2 Mini-app | Change in PrEP Attitude Score | Baseline to Week 4 | 0.07 score on a scale | Standard Deviation 0.66 |
| Part 2 Mini-app | Change in PrEP Attitude Score | Baseline to Week 8 | 0.01 score on a scale | Standard Deviation 0.72 |
| Part 2 Mini-app | Change in PrEP Attitude Score | Baseline to Week 12 | 0.02 score on a scale | Standard Deviation 0.72 |
Comparison: This comparison was made using data at Week 12.p-value: 0.58Wilcoxon (Mann-Whitney)
Secondary
Change in PrEP Knowledge Score at Week 4, 8 and 12
Individual's understanding of PrEP, measured by a 5-item True/False quiz. Values range from 0-5. Higher score indicates better PrEP knowledge.
Time frame: Baseline and up to 12 weeks
Population: Participants analyzed here only include those with complete data at a certain follow-up week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 Standard of Care | 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 |
| Part 2 Standard of Care | 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 |
| Part 2 Standard of Care | Change in PrEP Knowledge Score at Week 4, 8 and 12 | Baseline to Week 12 | 0.38 score on a scale | Standard Deviation 0.5 |
| Part 2 Mini-app | Change in PrEP Knowledge Score at Week 4, 8 and 12 | Baseline to Week 4 | 0.13 score on a scale | Standard Deviation 0.79 |
| Part 2 Mini-app | Change in PrEP Knowledge Score at Week 4, 8 and 12 | Baseline to Week 8 | 0.16 score on a scale | Standard Deviation 0.78 |
| Part 2 Mini-app | Change in PrEP Knowledge Score at Week 4, 8 and 12 | Baseline to Week 12 | 0.19 score on a scale | Standard Deviation 0.82 |
Comparison: The comparison test was made using the outcome variable measured at Week 12.p-value: 0.26Wilcoxon (Mann-Whitney)
Secondary
Change in PrEP Self-Efficacy Score
Self-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.
Time frame: Baseline and up to 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 Standard of Care | Change in PrEP Self-Efficacy Score | Baseline to Week 4 | 0.05 score on a scale | Standard Deviation 0.4 |
| Part 2 Standard of Care | Change in PrEP Self-Efficacy Score | Baseline to Week 8 | 0.08 score on a scale | Standard Deviation 0.5 |
| Part 2 Standard of Care | Change in PrEP Self-Efficacy Score | Baseline to Week 12 | 0.10 score on a scale | Standard Deviation 0.47 |
| Part 2 Mini-app | Change in PrEP Self-Efficacy Score | Baseline to Week 12 | 0.13 score on a scale | Standard Deviation 0.44 |
| Part 2 Mini-app | Change in PrEP Self-Efficacy Score | Baseline to Week 4 | 0.07 score on a scale | Standard Deviation 0.39 |
| Part 2 Mini-app | Change in PrEP Self-Efficacy Score | Baseline to Week 8 | 0.03 score on a scale | Standard Deviation 0.41 |
Comparison: The comparison was made using data measured at Week 12.p-value: 0.03Wilcoxon (Mann-Whitney)
Secondary
Change in PrEP Stigma Score
Individual'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.
Time frame: Baseline and up to 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 Standard of Care | Change in PrEP Stigma Score | Baseline to Week 4 | 0.06 score on a scale | Standard Deviation 0.32 |
| Part 2 Standard of Care | Change in PrEP Stigma Score | Baseline to Week 8 | 0.23 score on a scale | Standard Deviation 0.79 |
| Part 2 Standard of Care | Change in PrEP Stigma Score | Baseline to Week 12 | 0.02 score on a scale | Standard Deviation 0.44 |
| Part 2 Mini-app | Change in PrEP Stigma Score | Baseline to Week 4 | -0.02 score on a scale | Standard Deviation 0.69 |
| Part 2 Mini-app | Change in PrEP Stigma Score | Baseline to Week 8 | 0.09 score on a scale | Standard Deviation 0.72 |
| Part 2 Mini-app | Change in PrEP Stigma Score | Baseline to Week 12 | 0.03 score on a scale | Standard Deviation 0.72 |
Comparison: The comparison was made using data measured at Week 12.p-value: 0.85Wilcoxon (Mann-Whitney)
Secondary
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Willingness to pay for PrEP ranging from 0-100% of monthly income. Amount spent will be assessed at Baseline, Weeks 4, 8, and 12.
Time frame: Up to 12 weeks
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 8 | Other | 2 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Baseline | Not sure | 3 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 12 | Not sure | 1 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Baseline | Other | 4 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 12 | 15-25% | 2 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 4 | Any amount | 0 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 12 | Other | 3 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 4 | 30-50% | 0 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 12 | Any amount | 0 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 4 | 15-25% | 0 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Baseline | Any amount | 0 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 4 | 10-15% | 5 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 12 | 10-15% | 8 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 4 | < 10% | 11 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Baseline | 30-50% | 0 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 4 | Not any | 1 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 8 | Not sure | 3 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 4 | Not sure | 1 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Baseline | 15-25% | 0 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 4 | Other | 3 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 12 | < 10% | 5 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 8 | Any amount | 0 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Baseline | 10-15% | 1 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 8 | 30-50% | 0 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 12 | 30-50% | 0 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 8 | 15-25% | 1 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Baseline | < 10% | 4 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 8 | 10-15% | 4 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 12 | Not any | 2 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 8 | < 10% | 9 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Baseline | Not any | 9 Participants |
| Part 2 Standard of Care | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 8 | Not any | 2 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 4 | 30-50% | 0 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 8 | Not any | 6 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 8 | Not sure | 3 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 12 | Any amount | 3 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 12 | 30-50% | 1 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 12 | 15-25% | 5 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 12 | 10-15% | 8 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 12 | < 10% | 20 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 12 | Not any | 4 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 12 | Not sure | 2 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 12 | Other | 0 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Baseline | Any amount | 6 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Baseline | 30-50% | 0 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Baseline | 15-25% | 4 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Baseline | 10-15% | 6 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Baseline | < 10% | 14 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Baseline | Not any | 5 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Baseline | Not sure | 4 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Baseline | Other | 4 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 4 | Any amount | 4 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 8 | Other | 2 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 4 | 15-25% | 7 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 4 | 10-15% | 5 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 4 | < 10% | 14 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 4 | Not any | 7 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 4 | Not sure | 3 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 4 | Other | 3 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 8 | Any amount | 5 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 8 | 30-50% | 1 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 8 | 15-25% | 4 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 8 | 10-15% | 5 Participants |
| Part 2 Mini-app | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Week 8 | < 10% | 17 Participants |
Comparison: The comparison was made using data measured at Week 12.p-value: 0.08Fisher Exact
Secondary
Number of Participants Who Ordered At-home HIV/Syphilis Tests
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 2 Mini-app | Number of Participants Who Ordered At-home HIV/Syphilis Tests | 13 Participants |