A Promotion and Implementation Project of HIV Pre-Exposure Prophylaxis Among High Risk Population

NCT04754139 | Completed

• 1 other identifier: IRB20-1388
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to use a social media mini-application-enabled intervention to successfully promote the initiation and persistence of pre-exposure prophylaxis (PrEP) among at-risk people 18 years and above (including men who have sex with men (MSM), transgender women, sex workers, and other key populations) in Wuhan and Guangzhou, China.

Conditions

HIV Preexposure Prophylaxis

Keywords

Preexposure prophylaxis (PrEP), Prevention, mHealth

Outcome Measures

Primary Outcomes (1)

• PrEP prescriptions

  Number of PrEP prescriptions fulfilled in Wuhan and Guangzhou, China

  2 years

Secondary Outcomes (6)

• HIV Screenings

  2 years

• Syphilis screenings

  2 years

• Retention

  12 months

• Adherence

  2 years

• New HIV infection

  2 years

Study Arms (1)

WeChat mobile mini-application

EXPERIMENTAL

WeChat mini-application will increase knowledge base about sexual health through interactive health education and counseling support on HIV/STI prevention as well as PrEP initiation and/or adherence management.

Other: WeChat mobile mini-application

Interventions

WeChat mobile mini-application OTHER

Sexual health education and the role of PrEP

WeChat mobile mini-application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+
• Engaged in at-risk sex. At risk sex is defined as sex with \>1 partner in the past 90 days, inconsistent condom use with vaginal or anal sex, ongoing sexual relationship with an HIV-positive partner, participation in commercial sex work, or any bacterial STI diagnosed or reported in the past 6 months.

You may not qualify if:

• History renal dysfunction
• Chronic hepatitis B (HBV) infection
• HIV infection
• Indication for HIV post-exposure prophylaxis
• Signs and symptoms consistent with acute HIV infection
• Under the age range of 18

Sponsors & Collaborators

• University of Chicago: lead
• Gilead Sciences: collaborator
• Guangzhou 8th People's Hospital: collaborator
• Social Entrepreneurship to Spur Health: collaborator
• Zhongnan Hospital: collaborator

Study Sites (2)

Guangzhou Eighth People's Hospital

Guangzhou, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, China

Location

Related Publications (1)

• Sha Y, Li C, Xiong Y, Hazra A, Lio J, Jiang I, Huang H, Kerman J, Molina J, Li L, Liang K, Gong D, Li Q, Wu S, Sherer R, Tucker JD, Tang W. Co-creation using crowdsourcing to promote PrEP adherence in China: study protocol for a stepped-wedge randomized controlled trial. BMC Public Health. 2022 Sep 7;22(1):1697. doi: 10.1186/s12889-022-14117-5.

  PMID: 36071401 DERIVED

Study Officials

• Aniruddha Hazra, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 15, 2021
• Study Start: September 24, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)