HIVNCT06931106
Behavioral Intervention for PrEP Service Utilization Among Chinese MSM: A HAPA and CEI Integrated Model
A study testing HAPA and CEI behavioral intervention and HAPA-based intervention in people with HIV and PrEP, run by Peking University.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of a novel, intelligent intervention platform in bridging the "intention-behavior gap" for pre-exposure prophylaxis (PrEP) uptake among men who have sex with men (MSM) in China, a population at high risk for HIV infection. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- What is being tested?
- HAPA and CEI behavioral intervention and HAPA-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years at enrollment;
- Assigned male at birth with a history of ≥1 male-male sexual encounter (anal or oral intercourse);
- HIV-negative confirmed by antibody testing at baseline;
- No prior use of PrEP;
- Expressed interest in PrEP intervention and commitment to complete scheduled follow-ups and data collection procedures;
- Mentally competent to provide informed consent and participate in decision-making;
- High HIV risk (meeting ≥1 of the following in the past 6 months): (1) Condomless anal/penile-vaginal intercourse; (2)Shared needle use during illicit drug injection; (3) Sexual contact with HIV-positive partner(s); (4) Newly diagnosed STI; (5) Repeated use of PEP for HIV prevention; or (6) Self-identified as PrEP candidate through voluntary request.
Who cannot join
- Confirmed HIV-positive status or unknown serostatus with refusal of HIV testing;
- Clinically significant health conditions contraindicating PrEP use (e.g., creatinine clearance <60 mL/min, documented hypersensitivity to PrEP components);
- Severe mental illness or neurological disorders impairing informed consent process.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Behavioral Intervention to Enhance HIV Pre-Exposure Prophylaxis Service Utilization Among Men Who Have Sex With Men in China Based on Health Action Process Approach and Conditional Economic Incentives
The goal of this clinical trial is to evaluate the effectiveness of a novel, intelligent intervention platform in bridging the "intention-behavior gap" for pre-exposure prophylaxis (PrEP) uptake among men who have sex with men (MSM) in China, a population at high risk for HIV infection. The study aims to address the following main questions:
- Can the intervention platform, guided by the Health Action Process Approach (HAPA) and Conditional Economic Incentive (CEI) dual-track theoretical framework, significantly increase PrEP initiation rates among MSM?
- What are the key mechanisms and pathways underlying the transition from PrEP intention to actual usage behavior?
Read more
Researchers will compare participants receiving the intelligent intervention platform (intervention group) with those receiving basic PrEP information (control group) to determine the platform's impact on PrEP initiation rates. Participants will:
- Use a mobile health platform equipped with personalized HIV risk assessments, PrEP knowledge resources, action planning tools, peer support features, and economic incentives.
- Complete baseline and follow-up surveys at 3 months and 6 months to assess PrEP initiation, adherence, and related behaviors.
- Engage in peer group activities and receive tailored feedback based on their progress.
This study seeks to provide evidence for scalable and sustainable strategies to improve PrEP uptake and contribute to HIV prevention efforts in high-risk populations.
- Conditions
- HIV, PrEP, MSM, Behavior Changes
- Being tested
- HAPA and CEI behavioral intervention, HAPA-based intervention
- Keywords
- HIV, pre-exposure prophylaxis, men who have sex with men, health action process approach, economic incentive
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAPA and CEI behavioral interventionBehavioural
The intervention group will receive a 3-month technology-facilitated PrEP intervention and tailored messages will be developed using BCTs based on theoretical guidance. PrEP teleconsultations will be delivered by certified healthcare professionals, including infectious disease specialists, CDC-affiliated prevention officers, and MSM community leaders. Participants will be stratified into peer cohorts through algorithm-driven grouping based on demographic characteristics. Six participants will form a peer group, and the economic incentive amount will be based on the group-level PrEP initiation rates (verified by physician prescriptions). The economic incentive will decrease progressively based on the average completion rate within the group and will be divided into three tiers: 22 USD (completion rate of 80-100%), 11 USD (completion rate of 50-79%), and 0 USD (completion rate <50%).
HAPA-based interventionBehavioural
This group receives information pushes via a mini-program (3 messages per week) and two brief PrEP consultations; the first brief consultation is delivered jointly by community volunteers and a physician immediately after the baseline survey completion, based on a standardized consultation outline, and the second brief consultation is delivered jointly by community volunteers and a physician after the completion of the first monthly assessment (conducted within the mini-program), based on the standardized consultation outline and the results of that monthly assessment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group-B | Experimental | Participants will receive the AI-based HAPA and CEI behavioral intervention. Receives: Behavioral: HAPA and CEI behavioral intervention |
| Control group | No intervention | Participants will receive non-personalized HIV prevention information, including free HIV testing and condom use, following the guidelines provided by the CDC and the operational standards of the community organizations, with weekly information push notifications. |
| Intervention group-A | Experimental | Participants will receive HAPA-based behavioral intervention on the We-chat mini progarm. Receives: Behavioral: HAPA-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Initiation
The primary outcome indicators of this study is the rate of PrEP initiation, based on PrEP prescriptions issued by doctors.
Measured: 3 months
Secondary outcomes (5)
PrEP adherence
Secondary outcome indicators include the rate of PrEP adherence after initiating (based on self-reported adherence and the medication calendar in the program). Self-reported adherence: Assessed via validated questionnaires (e.g., visual analog scales or Likert scales) integrated into the mini-program, capturing missed doses, timing, and barriers. Medication calendar: Digitally tracked in the mini-program, recording daily PrEP intake with automated reminders and timestamped logs.
Adherence rate calculated as the proportion of prescribed doses taken (e.g., ≥80% adherence threshold).
Measured: 3 months
Intention to pay for PrEP
Structured questionnaires evaluating willingness to use three PrEP types (daily oral, on-demand, long-acting injectable) and maximum acceptable out-of-pocket payment (Likert scales (1-5) for willingness).
Measured: 3 months
PrEP-related stigma
10-item HIV Pre-Exposure Prophylaxis Stigma Scale (HPSS) will be used to measure the PrEP-related stigma. The response format is 5-point Likert scale (1 = strongly disagree; 5 = strongly agree).
Measured: 3 months
Changes in condomless sex
Retrospective self-reporting: Number of condomless acts in the past 3 months.
Measured: 3 months
Changes in sexual partner numbers
Retrospective self-reporting: Number of sexual partners in the past 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wangnan Cao, Peking University
- Investigators
- Wangnan Cao, Ph.D, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931106
- Sponsor's protocol ID
- IRB00001052-24167
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared publicly due to heightened privacy risks for MSM participants in China. Anonymization challenges and re-identification risks further limit safe sharing. Ethical approvals and informed consent agreements also restrict data use beyond the original study scope. Aggregated results will be published to ensure scientific transparency while safeguarding participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Intervention to Enhance HIV Pre-Exposure Prophylaxis Service Utilization Among Men Who Have Sex With Men in China Based on Health Action Process Approach and Conditional Economic Incentives
- ClinicalTrials.gov ID
- NCT06931106
- Acronym / sponsor ID
- IRB00001052-24167
- Conditions
- HIV, PrEP, MSM, Behavior Changes
- Keywords
- HIV, pre-exposure prophylaxis, men who have sex with men, health action process approach, economic incentive
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 17 Apr 2025 (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.
The goal of this clinical trial is to evaluate the effectiveness of a novel, intelligent intervention platform in bridging the "intention-behavior gap" for pre-exposure prophylaxis (PrEP) uptake among men who have sex with men (MSM) in China, a population at high risk for HIV infection. The study aims to address the following main questions:
- Can the intervention platform, guided by the Health Action Process Approach (HAPA) and Conditional Economic Incentive (CEI) dual-track theoretical framework, significantly increase PrEP initiation rates among MSM?
- What are the key mechanisms and pathways underlying the transition from PrEP intention to actual usage behavior?
Researchers will compare participants receiving the intelligent intervention platform (intervention group) with those receiving basic PrEP information (control group) to determine the platform's impact on PrEP initiation rates. Participants will:
- Use a mobile health platform equipped with personalized HIV risk assessments, PrEP knowledge resources, action planning tools, peer support features, and economic incentives.
- Complete baseline and follow-up surveys at 3 months and 6 months to assess PrEP initiation, adherence, and related behaviors.
- Engage in peer group activities and receive tailored feedback based on their progress.
This study seeks to provide evidence for scalable and sustainable strategies to improve PrEP uptake and contribute to HIV prevention efforts in high-risk populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group-B | Experimental | Behavioral: HAPA and CEI behavioral interventionParticipants will receive the AI-based HAPA and CEI behavioral intervention. |
| Control group | No intervention | –Participants will receive non-personalized HIV prevention information, including free HIV testing and condom use, following the guidelines provided by the CDC and the operational standards of the community organizations, with weekly information push notifications. |
| Intervention group-A | Experimental | Behavioral: HAPA-based interventionParticipants will receive HAPA-based behavioral intervention on the We-chat mini progarm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years at enrollment;
- Assigned male at birth with a history of ≥1 male-male sexual encounter (anal or oral intercourse);
- HIV-negative confirmed by antibody testing at baseline;
- No prior use of PrEP;
- Expressed interest in PrEP intervention and commitment to complete scheduled follow-ups and data collection procedures;
Key exclusion criteria (3 listed)
- Confirmed HIV-positive status or unknown serostatus with refusal of HIV testing;
- Clinically significant health conditions contraindicating PrEP use (e.g., creatinine clearance <60 mL/min, documented hypersensitivity to PrEP components);
- Severe mental illness or neurological disorders impairing informed consent process.
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 |
|---|---|---|
| HAPA and CEI behavioral interventionThe intervention group will receive a 3-month technology-facilitated PrEP intervention and tailored messages will be developed using BCTs based on theoretical guidance. PrEP teleconsultations will be delivered by certified healthcare professionals, including infectious disease specialists, CDC-affiliated prevention officers, and MSM community leaders. Participants will be stratified into peer cohorts through algorithm-driven grouping based on demographic characteristics. Six participants will form a peer group, and the economic incentive amount will be based on the group-level PrEP initiation rates (verified by physician prescriptions). The economic incentive will decrease progressively based on the average completion rate within the group and will be divided into three tiers: 22 USD (completion rate of 80-100%), 11 USD (completion rate of 50-79%), and 0 USD (completion rate <50%). | Behavioural | Intervention group-B |
| HAPA-based interventionThis group receives information pushes via a mini-program (3 messages per week) and two brief PrEP consultations; the first brief consultation is delivered jointly by community volunteers and a physician immediately after the baseline survey completion, based on a standardized consultation outline, and the second brief consultation is delivered jointly by community volunteers and a physician after the completion of the first monthly assessment (conducted within the mini-program), based on the standardized consultation outline and the results of that monthly assessment. | Behavioural | Intervention group-A |
Primary outcome
PrEP Initiation
Time frame: 3 months
The primary outcome indicators of this study is the rate of PrEP initiation, based on PrEP prescriptions issued by doctors.
5 secondary outcomes
PrEP adherence
Time frame: 3 months
Intention to pay for PrEP
Time frame: 3 months
PrEP-related stigma
Time frame: 3 months
Changes in condomless sex
Time frame: 3 months
Changes in sexual partner numbers
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No. IPD will not be shared publicly due to heightened privacy risks for MSM participants in China. Anonymization challenges and re-identification risks further limit safe sharing. Ethical approvals and informed consent agreements also restrict data use beyond the original study scope. Aggregated results will be published to ensure scientific transparency while safeguarding participant confidentiality.
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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.
Wangnan Cao, Ph.D principal investigator
Peking University
Questions about this trial
What is this clinical trial studying?
A study testing HAPA and CEI behavioral intervention and HAPA-based intervention in people with HIV and PrEP, run by Peking University.
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 7 inclusion and 3 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: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Lin (+86 18610528952, linhao@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP Initiation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2025.