HIV Preexposure ProphylaxisNCT04754139
A Promotion and Implementation Project of HIV Pre-Exposure Prophylaxis Among High Risk Population
A study testing WeChat mobile mini-application in people with HIV Preexposure Prophylaxis, run by University of Chicago at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Preexposure Prophylaxis
- What is being tested?
- WeChat mobile mini-application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 2 sitesChina
- Study dates
- 24 Sep 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Guangzhou Eighth People's Hospital
Guangzhou
Zhongnan Hospital of Wuhan University
Wuhan
About this study
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.
Read the 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.
- Conditions
- HIV Preexposure Prophylaxis
- Being tested
- WeChat mobile mini-application
- Keywords
- Preexposure prophylaxis (PrEP), Prevention, mHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeChat mobile mini-applicationOther
Sexual health education and the role of PrEP
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: WeChat mobile mini-application |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP prescriptions
Number of PrEP prescriptions fulfilled in Wuhan and Guangzhou, China
Measured: 2 years
Secondary outcomes (6)
HIV Screenings
Number of HIV screenings performed
Measured: 2 years
Syphilis screenings
Number of syphilis screenings performed
Measured: 2 years
Retention
Number of subjects retained in PrEP care at 6 and 12 months
Measured: 12 months
Adherence
Number of subjects that self-report PrEP adherence
Measured: 2 years
New HIV infection
Number of new HIV infections reported in PrEP users
Measured: 2 years
New syphilis infection
Number of new syphilis infections reported in PrEP users
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start24 Sep 2021
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV Preexposure ProphylaxisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, Guangzhou 8th People's Hospital, Social Entrepreneurship to Spur Health, Zhongnan Hospital
- Responsible party
- Sponsor
- Investigators
- Aniruddha Hazra, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754139
- Sponsor's protocol ID
- IRB20-1388
- Status last verified
- Oct 2024
- First submitted
- 11 Feb 2021
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu J, Wu S, Li Q, Yin Z, Li C, Fan C, Dai Y, Wang K, Jiang I, Huang H, Lio J, Hazra A, Tucker JD, Sherer R, Li L, Tang W, Liang K. The safety and tolerability of oral TDF/FTC as pre-exposure prophylaxis among men who have sex with men in China: a prospective cohort study. BMC Infect Dis. 2026 May 21;26(1):1336. doi: 10.1186/s12879-026-13384-6.
PubMed 42168904Sha 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.
PubMed 36071401
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Promotion and Implementation Project of HIV Pre-Exposure Prophylaxis Among High Risk Population
- ClinicalTrials.gov ID
- NCT04754139
- Acronym / sponsor ID
- IRB20-1388
- Conditions
- HIV Preexposure Prophylaxis
- Keywords
- Preexposure prophylaxis (PrEP), Prevention, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Gilead Sciences, Guangzhou 8th People's Hospital, Social Entrepreneurship to Spur Health, Zhongnan Hospital
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WeChat mobile mini-application | Experimental | Other: WeChat mobile mini-applicationWeChat 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- History renal dysfunction
- Chronic hepatitis B (HBV) infection
- HIV infection
- Indication for HIV post-exposure prophylaxis
- Signs and symptoms consistent with acute HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WeChat mobile mini-applicationSexual health education and the role of PrEP | Other | WeChat mobile mini-application |
Primary outcome
PrEP prescriptions
Time frame: 2 years
Number of PrEP prescriptions fulfilled in Wuhan and Guangzhou, China
6 secondary outcomes
HIV Screenings
Time frame: 2 years
Syphilis screenings
Time frame: 2 years
Retention
Time frame: 12 months
Adherence
Time frame: 2 years
New HIV infection
Time frame: 2 years
New syphilis infection
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Derived from this study: PubMed 42168904Liu J, Wu S, Li Q, Yin Z, Li C, Fan C, Dai Y, Wang K, Jiang I, Huang H, Lio J, Hazra A, Tucker JD, Sherer R, Li L, Tang W, Liang K. The safety and tolerability of oral TDF/FTC as pre-exposure prophylaxis among men who have sex with men in China: a prospective cohort study. BMC Infect Dis. 2026 May 21;26(1):1336. doi: 10.1186/s12879-026-13384-6.
- Derived from this study: PubMed 36071401Sha 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aniruddha Hazra, MD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WeChat mobile mini-application in people with HIV Preexposure Prophylaxis, run by University of Chicago at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP prescriptions (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04754139, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.