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

  • STATUS
    Recruiting
  • End date
    Nov 6, 2023
  • participants needed
    3200
  • sponsor
    University of Chicago
Updated on 10 October 2021
Accepts healthy volunteers

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 men who have sex with men (MSM) and youth in Wuhan and Guangzhou, China.

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.

Three thousand two hundred at-risk youth and young 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.

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. 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, adverse effect, and utilization of the mini-application.

In addition, 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.

Details
Condition HIV Preexposure Prophylaxis
Treatment WeChat mobile mini-application
Clinical Study IdentifierNCT04754139
SponsorUniversity of Chicago
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 - 30
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
Outside the age range of 18-30
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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