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

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.

Study Overview

• Status: Completed
• Conditions: HIV Preexposure Prophylaxis
• Intervention / Treatment: Other: WeChat mobile mini-application

Detailed Description

The China National Medical Products Administration (NMPA) recently approved TDF/FTC (Truvada) for PrEP making it the first HIV prevention medicine available in China. While this is a significant step in addressing the country's rising rates of new HIV diagnoses, implementation and scale-up of this resource will be the next challenge.

3200 at-risk adults will be engaged by word of mouth and social media. Individuals will be asked to complete a survey of risk and PrEP interest, to download the study mobile mini-application onto their cell phone, and will be offered an HIV and syphilis screen. One thousand two hundred of these subjects who are eligible and willing to start PrEP will be enrolled in the study. The first 700 participants enrolled in each site will complete an additional four-phased, WeChat-based adherence intervention through a stepped-wedge design, with each cluster starting at three-month intervals.

Enrolled participants will undergo baseline laboratory testing before brought to a collaborating hospital where an established physician will provide TDF/FTC and arrange follow-up. Rural and out-of-town enrollees may undergo testing at an outside lab. All subjects will be encouraged to keep using the mini-application for receiving constant health education and counseling support on HIV/STI prevention, PrEP initiation and/or adherence management. Subjects on PrEP will be contacted every three months over the course of two years to answer questions on adherence including number of missed pills and/or sex events not covered by on-demand PrEP, adverse effect, and utilization of the mini-application. 120 enrollees in Guangdong will additionally participate in a pill count adherence sub study that counts the number of unused pills at each clinical follow-up

A PrEP messaging open contest will be organized to assess the best images and videos to enhance PrEP adherence among those who start PrEP. New content will be developed using crowdsourcing and introduced into the mini-application at staggered times. The effect of this content will be evaluated through a stepped wedge approach nested within this single arm study.

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Guangzhou Eighth People's Hospital
  • Wuhan, China
    • Zhongnan Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WeChat mobile mini-application; 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; Sexual health education and the role of PrEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP prescriptions	Number of PrEP prescriptions fulfilled in Wuhan and Guangzhou, China	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV Screenings	Number of HIV screenings performed	2 years
Syphilis screenings	Number of syphilis screenings performed	2 years
Retention	Number of subjects retained in PrEP care at 6 and 12 months	12 months
Adherence	Number of subjects that self-report PrEP adherence	2 years
New HIV infection	Number of new HIV infections reported in PrEP users	2 years
New syphilis infection	Number of new syphilis infections reported in PrEP users	2 years

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: Gilead Sciences; Zhongnan Hospital; Guangzhou 8th People's Hospital; Social Entrepreneurship to Spur Health (SESH)
• Investigators: Principal Investigator: Aniruddha Hazra, MD, University of Chicago

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2021
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Preexposure prophylaxis (PrEP), Prevention, mHealth
• Other Study ID Numbers: IRB20-1388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No