Pre-Exposure Prophylaxis
Conditions
Keywords
HIV Prevention, HIV Testing, Condom use, MSM, Dating Mobile Application
Brief summary
The proposed research includes a longitudinal pilot study to assess the feasibility and acceptability of Blued+. This combination HIV prevention intervention will integrate a combination package of HIV prevention services into Blued, a gay dating App, for men who have sex with men (MSM) in China. Despite high HIV incidence among MSM, HIV prevention interventions such as pre-exposure prophylaxis (PrEP) use remains low in China. If the HIV prevention intervention services provided through the Blued+ App prove feasible and acceptable, the pilot test will facilitate the design of a larger study of intervention efficacy. The study population will be self-reported HIV-negative Blued users who are 18 years of age or greater, were assigned a male sex at birth, report having anal sex with a man in the last 6 months, eligible for PrEP according to China's consensus statement, and reside in metropolitan Beijing or Chengdu, China.
Detailed description
The pilot study will be an interrupted time series cohort of 400 MSM. In two cities, a three-month baseline standard of care (SOC) period with measurement at 0 and 3 months will be followed by a 12-month intervention period with the measurement at 6, 9, 12, and 15 months. During the intervention, enrolled study participants will take surveys every 3 months, as well as have free access to the enhanced version of the Blued App, Blued+, which additionally provides HIV prevention intervention services such as HIV health messages, PrEP drugs, at-home HIV self-testing kits, condoms, and lubricants for no costs. Participants interested in PrEP will be required to have additional PrEP initiation physical exam clinical visits, follow-up clinical visits, and dry blood spot collection lab visits for blood PrEP level measurements. The total study period is 15 months (3 months control run-in period and 12 months intervention). Online surveys are provided over the study period, 2 for the enrollment and basement, and 4 follow-ups for every 3 months of the intervention; physical exam visits are required for participants who chose to initiate and refill PrEP; 1 dry blood spot collection visit is provided for participants who chose to measure blood PrEP level. The participants will be recruited online through the Blued App.
Interventions
BEHAVIORALBlued+ Service Platform
During the intervention period, participants received the enhanced version of the Blued app. The free HIV prevention services were integrated into the Blued app: health messaging, in-home HIV testing, linkage to care for those testing HIV positive, condoms, lubricants, in-app screening, and provision to PrEP.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
BlueD China
Emory University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Registered Blued app user * ≥18 years of age * Male sex at birth * Self-report anal sex with a man in the last 6 months * HIV-negative or unknown HIV status * Behaviorally eligible for PrEP per published China guidance * Able to complete study instruments in Mandarin Chinese * Resident of the metropolitan area of Beijing or Chengdu, China * Eligible for PrEP based on China's consensus statement * Additional Inclusion criteria apply for PrEP
Exclusion criteria
* Not a registered Blued app user * \<18 years of age * Not male sex at birth * Does not report anal sex with a man in the last 6 months * Has previously tested positive for HIV * Not eligible for PrEP per published China guidance * Unable to complete study instruments in Mandarin Chinese * Not a resident of the metropolitan area of Beijing or Chengdu, China * Currently enrolled in another HIV prevention study * Evidence of fraudulent participation, such as a duplicate IP address, multiple screening attempts, duplicate emails, etc. * Additional Inclusion criteria apply for PrEP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Blued+ in China | 12 months after intervention initiation, 15 months after first study interaction | The intervention will be determined to be feasible if a minimum proportion of participants receive services for home HIV testing (benchmark ≥30%) and PrEP initiation (benchmark ≥20%) through Blued+ |
| System Usability Scale (SUS) | 12 months after intervention initiation, 15 months after first study interaction | Acceptability of Blued+ in China will be measured using the System Usability Scale (SUS). The SUS is a widely used scale that evaluates the usability of products and systems through a 10-item question set. The total range of a score on this scale is 0 to 100. This scale does not have any sub-scales. Higher scores on this scale represent higher levels of intervention usability, with 100 being the highest usability and 0 being the lowest usability. Information on this scale and how to calculate values is found in: Bangor, Aaron, Philip T. Kortum, and James T. Miller. An empirical evaluation of the system usability scale. Intl. Journal of Human-Computer Interaction 24.6 (2008): 574-594. The intervention will be considered acceptable if it reaches a total SUS rating score of ≥ 71/100, which has been interpreted as being 'good' usability. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Blued App A three-month run-in period with the standard of care followed by the Blued+ intervention with participants for 12 months.
Blued+ Service Platform: During the intervention period, participants received the enhanced version of the Blued app. The free HIV prevention services were integrated into the Blued app: health messaging, in-home HIV testing, linkage to care for those testing HIV positive, condoms, lubricants, in-app screening, and provision to PrEP. | 423 |
| Total | 423 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 24 |
Baseline characteristics
| Characteristic | Blued App |
|---|---|
| Age, Continuous | 30 years STANDARD_DEVIATION 7.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 423 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment China | 423 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 423 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 423 |
| other Total, other adverse events | 0 / 423 |
| serious Total, serious adverse events | 0 / 423 |
Outcome results
Primary
Feasibility of Blued+ in China
The intervention will be determined to be feasible if a minimum proportion of participants receive services for home HIV testing (benchmark ≥30%) and PrEP initiation (benchmark ≥20%) through Blued+
Time frame: 12 months after intervention initiation, 15 months after first study interaction
Population: Participants retained at endline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Blued App | Feasibility of Blued+ in China | Participants receiving PrEP through Blued+ | 193 Participants |
| Blued App | Feasibility of Blued+ in China | Participants receiving HIV testing through Blued+ | 316 Participants |
Primary
System Usability Scale (SUS)
Acceptability of Blued+ in China will be measured using the System Usability Scale (SUS). The SUS is a widely used scale that evaluates the usability of products and systems through a 10-item question set. The total range of a score on this scale is 0 to 100. This scale does not have any sub-scales. Higher scores on this scale represent higher levels of intervention usability, with 100 being the highest usability and 0 being the lowest usability. Information on this scale and how to calculate values is found in: Bangor, Aaron, Philip T. Kortum, and James T. Miller. An empirical evaluation of the system usability scale. Intl. Journal of Human-Computer Interaction 24.6 (2008): 574-594. The intervention will be considered acceptable if it reaches a total SUS rating score of ≥ 71/100, which has been interpreted as being 'good' usability.
Time frame: 12 months after intervention initiation, 15 months after first study interaction
Population: Participants completing all items in the SUS scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blued App | System Usability Scale (SUS) | 73.4 score on a scale | Standard Deviation 14.4 |