The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China

HIV Clinical Trial

Official title:

IGHID 12001 - The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426656
• Other study ID #: 19-3481
• Secondary ID: R01AI114310
• Status: Completed
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: April 2, 2021

Study information

• Verified date: January 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to use a mini-application on the popular Chinese social media mobile platform, WeChat, to improve HIV pre-exposure prophylaxis (PrEP) uptake among at-risk men who have sex with men (MSM). UNC investigators will work in close partnership with a well-established HIV special hospital and the local MSM community to understand key barriers to PrEP use, and develop a mobile-based intervention to increase PrEP uptake among young MSM in Guangzhou, China.

Description:

This study includes two parts. Before the start of Part 1, a mini-app prototype for promoting HIV pre-exposure prophylaxis (PrEP) uptake will have been developed from a prior MSM community-driven hackathon contest. PrEP is an antiretroviral medicines-based prevention strategy against HIV infection, which has been proved save and effective.

Part 1 includes in-depth interviews with 40 HIV-negative young MSM (18 and above) with a brief survey to collect demographic data. The interview topics include PrEP-related perceptions and feedback on the design of a mini-app prototype. Findings from Part 1 will inform refining the mini-app before the start of Part 2.

In Part 2, a small two-arm randomized control trial with 70 young MSM (18 and above) will be conducted to evaluate the preliminary efficacy of the mini-app in improving PrEP-related perceptions and actual PrEP uptake, compared to a control group of standard of care.

Participants in Part 2 will be followed up for 12 weeks (8 week intervention and after-intervention follow-up at 12th week). A subgroup of participants (n=15) from both the intervention arm and the control arm will receive two rounds of in-depth interviews, separately at the 4th and 8th week, to share their experience of using the app and changed perceptions and/or behaviors related to PrEP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2, 2021
• Est. primary completion date: April 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Part 1: HIV-negative men who have sex with men (MSM): must self-report: being assigned male sex at birth, HIV-negative, age 18 and above, ever having had anal sex with another man, identify as a Chinese citizen, own a smartphone, able to being willing to sign written informed consent and participate in the study as procedures required.

Part 2: HIV-negative men who have sex with men (MSM): same characteristics as in Part 1.

AND, they must report :

• Having a smartphone with WeChat installed.

• Being assigned male sex at birth, HIV-negative, age 18 and above, ever having had anal sex with another man, currently reside in Guangzhou, China, identifying as a Chinese citizen, able to sign written informed consent and participate in the study as procedures require. AND

• At least one criterion associated with high risk of HIV infection in the past 6 months prior to enrollment as follows:

• Unprotected (condomless) anal intercourse with male partner(s)

• More than two male partners (regardless of condom use and HIV serostatus)

• Reported STI, such as syphilis, Herpes Simplex Virus-2 (HSV-2), gonorrhea, chlamydia, chancroid, or lymphogranuloma venereum.

• Reported use of post-exposure prophylaxis (PEP)

• Have a sexual partner living with HIV

Exclusion Criteria:

• Part 1: Individuals who report any following status will be excluded from participating Part 1:

• HIV-positive

• Mental health issues which may compromise participant adherence or safety, including memory loss, cognitive impairment, intellectual disability, or communication disorders.

• Part 2:

• HIV-positive (self-report or lab-confirmed)

• Currently taking oral PrEP based on self-report

• Symptoms of acute HIV infection within the prior 30 days

• Contradictions to taking oral PrEP

• Personal diagnosis or family history of hemophilia

• Chronic Hepatitis B (self-report)

• Participating in another research study related to HIV and antiretroviral therapy or other intervention study

• Having serious chronic disease, including metabolic diseases (such as diabetes), neurological, and psychiatric disorders

• Mental health issues which may compromise participant adherence or safety, including memory loss, cognitive impairment, intellectual disability, or communication disorders

Related Conditions & MeSH terms

• HIV
• Pre-exposure Prophylaxis

Intervention

Behavioral:
• Phone application
The mini-app (used in Part 2) has four main functions: a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese; an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time); an asynchronous message function that allows users to chat with a study staff (C.Li); and a user profile page where users can manage all HIV test orders.

Locations

Country	Name	City	State
China	Guangzhou No. 8 People's Hospital	Guangzhou

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Intention to Use PrEP Score	Individual perceived likelihood to start using PrEP, measured by a one-item question with a bipolar response scale (-3 to 3). Higher score indicates higher intention to use.	Baseline and up to 12 weeks
Primary	Number of Participants Who Initiate PrEP by Week 8	Individual's self-reported whether starting use of PrEP medication (binary: Yes/No)	Up to 8 weeks
Primary	Number of Participants at Different Change Stages to PrEP Initiation at Baseline	Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.	Baseline
Primary	Number of Participants at Different Change Stages to PrEP Initiation at Week 4	Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.	Week 4
Primary	Number of Participants at Different Change Stages to PrEP Initiation at Week 8	Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.	Week 8
Primary	Number of Participants at Different Change Stages to PrEP Initiation at Week 12	Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.	Week 12
Secondary	Change in PrEP Knowledge Score at Week 4, 8 and 12	Individual's understanding of PrEP, measured by a 5-item True/False quiz. Values range from 0-5. Higher score indicates better PrEP knowledge.	Baseline and up to 12 weeks
Secondary	Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP	Willingness to pay for PrEP ranging from 0-100% of monthly income. Amount spent will be assessed at Baseline, Weeks 4, 8, and 12.	Up to 12 weeks
Secondary	Change in PrEP Self-Efficacy Score	Self-Efficacy will be assessed at Baseline, Weeks 4, 8, and 12 using an 8-item PrEP self-efficacy scale. Values range from 0-5. Higher scores indicate higher self-efficacy to use PrEP.	Baseline and up to 12 weeks
Secondary	Change in PrEP Attitude Score	Individual's attitude towards PrEP, measured by a 5-item scale. Values range from 0-5. Higher scores indicate more positive attitude toward PrEP. The PrEP Attitude will be assessed at Baseline, Weeks 4, 8, and 12.	Baseline and up to 12 weeks
Secondary	Change in PrEP Stigma Score	Individual's perceived stigma related to PrEP, measured by 5-item PrEP stigma scale. Values range from 0-5. Higher score indicates higher perceived stigma related to PrEP. The PrEP Stigma will be assessed at Baseline, Weeks 4, 8, and 12.	Baseline and up to 12 weeks
Secondary	Number of Participants Who Ordered At-home HIV/Syphilis Tests	Number of participants who ordered at-home HIV/syphilis tests through the mini-app based on the study record. Values range from 0 to greater than 0. Higher indicates higher frequency of participants who ordered HIV/syphilis tests completed through the study.	12 weeks