Trial Outcomes & Findings for The Blued+ Combination HIV Prevention Pilot Study in China (NCT NCT06647173)

Last Updated: 2025-07-16

Results Overview

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+

Recruitment status

COMPLETED

Target enrollment

423 participants

Primary outcome timeframe

12 months after intervention initiation, 15 months after first study interaction

Results posted on

2025-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	423
Overall Study COMPLETED	399
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	24

Baseline Characteristics

The Blued+ Combination HIV Prevention Pilot Study in China

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blued App n=423 Participants 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.
Age, Continuous	30 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	423 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	423 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment China	423 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months after intervention initiation, 15 months after first study interaction

Population: Participants retained at endline

Outcome measures

Outcome measures
Measure	Blued App n=399 Participants 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.
Feasibility of Blued+ in China Participants receiving PrEP through Blued+	193 Participants
Feasibility of Blued+ in China Participants receiving HIV testing through Blued+	316 Participants

PRIMARY outcome

Timeframe: 12 months after intervention initiation, 15 months after first study interaction

Population: Participants completing all items in the SUS scale

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.

Outcome measures

Outcome measures
Measure	Blued App n=343 Participants 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.
System Usability Scale (SUS)	73.4 score on a scale Standard Deviation 14.4

Adverse Events

Blued 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

Dr. Aaron Siegler

Emory University

Phone: 404-712-9733

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place