HIV/AIDSB-HAPPYNCT03992274
Biomedical HIV/AIDS Prevention Program Yunnan
A study testing Enhanced implementation of PrEP in people with HIV/AIDS, run by Columbia University at 1 site in China.
Trial summary
B-HAPPY is an implementation project to study the process by which pre-exposure prophylaxis (PrEP) is introduced and integrated into a specific international health system facing high rates of HIV incidence among men who have sex with men. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Enhanced implementation of PrEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 27 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Clients at study sites (VCT or STI [sexually transmitted infections] clinics) are eligible for inclusion in the study if they meet all of the following criteria:
- Aged 18 years or older
- Male sex at birth
- Willing and able to provide written consent form
- Able and willing to provide finger-scan and contact information
- Not infected with HIV-1
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- Any male sex partner in past 12 months
- Staff at study sites (VCT or STI clinics) are eligible for inclusion in the study if they meet all of the following criteria:
- Aged 18 years or older
- Employed at site for at least 3 months
- Willing and able to provide consent
Who cannot join
- Clients at study sites (VCT or STI clinics) will be excluded from the study if they meet any of the following criteria:
- Diagnosed with HIV or AIDS
- Signs or symptoms of acute HIV infection
- Unable to provide inform consent
- At enrollment, has any medical, psychological, or social condition that, in the opinion of the investigator, would jeopardize the health or wellbeing of the participant during the study or the integrity of the data
- Study staff:
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- Staff at study sites (VCT or STI clinics) will be excluded from the study if they meet any of the following criteria:
- Unable to provide consent
- At enrollment, has any medical, psychological, or social condition that, in the opinion of the investigator, would jeopardize the health or wellbeing of the participant during the study or the integrity of the data
Trial locations and contacts
1 site in 1 country.
China1 site
Yunnan Center for Disease Prevention and Control
Kunming, Yunnan, 650000
About this study
Official title: Yunnan-ADARC HIV Prevention Program: Developing and Testing a Model to Implement and Sustain PrEP Delivery in China
B-HAPPY is an implementation project to study the process by which pre-exposure prophylaxis (PrEP) is introduced and integrated into a specific international health system facing high rates of HIV incidence among men who have sex with men. The study will use a stepped wedge design to compare implementation outcomes across eight municipalities in Yunnan, China.
Read the detailed description
B-HAPPY is an implementation science project that will introduce and evaluate the implementation of PrEP among over 1000 men who have sex with men (MSM), in eight municipalities in Yunnan, China. The project aims to compare the effectiveness of two implementation strategy bundles: 1) Standard Implementation: comprising the strategies that the Yunnan Center for Disease Control and Prevention would usually use to introduce HIV prevention innovations in the absence of the proposed study; and 2) Enhanced Implementation: standard implementation enhanced by a SIC-guided approach to plan and implement PrEP.
This study will use a stepped-wedge design, where sites will go through four study periods: a Pre-Baseline Period (Routine Service with no PrEP Implementation), a Baseline Period (Standard Implementation of PrEP), an Experiment Period (Enhanced Implementation of PrEP), and a Post-Experiment-Observation Period. Sites are randomized to the timing of the intervention initiation, with 2 sites moving from Standard Implementation to Enhanced Implementation every 6 months. The intervention condition changes over time and the intervention effect is the difference in outcomes between the Baseline and Experiment Periods, and the Post-Experiment and Baseline Periods.
The specific aims of the proposed study are:
- To evaluate whether the addition of SIC-guided PrEP delivery (Enhanced Implementation) to standard health system PrEP delivery improves services outcomes. Through a stepped-wedge randomized trial across eight Yunnan municipalities, within site change over time will be examined; timing of introduction of Enhanced Implementation will be randomized across four cohorts of two sites each. Client-services outcomes include progress to achieving the "Five-80s" (patient PrEP awareness, screening, offering, initiation, continuation).
- To examine the implementation process and efficiency of the Enhanced versus Standard implementation approaches. Using the Stages of Implementation Completion (SIC) and Cost of Implementing New Strategies (COINS) tools, sites will be monitored for implementation process and resource use. Outcomes will include proportion of implementation activities completed; duration of each implementation phase; and cost and resource allocation for completion of each implementation phase.
- Conditions
- HIV/AIDS
- Being tested
- Enhanced implementation of PrEP
- Keywords
- HIV prevention, Implementation science, Pre-Exposure Prophylaxis, Men who have sex with men, China
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced implementation of PrEPOther
During Enhanced Implementation study sites will receive Implementation Support to plan and introduce PrEP by following the eight stages of the PrEP-adapted SIC. Implementation Support specifically will involve a centralized technical assistance system developed using US-based PrEP experience focused on addressing implementation issues identified through real-time analysis of client, clinic, and implementation data.
| Study group | Role | What they receive |
|---|---|---|
| Standard implementation | No intervention | During Standard Implementation, sites will use standard Yunnan Center for Disease Control and Prevention strategies to introduce HIV prevention innovations. |
| Enhanced implementation | Experimental | During Enhanced Implementation, sites will transition to receive enhanced Implementation Support to plan and implement PrEP. Receives: Other: Enhanced implementation of PrEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Awareness
Number of clients who are aware of PrEP
Measured: Up to 48 months
PrEP Eligible
Number of clients who are eligible for PrEP
Measured: Up to 48 months
PrEP Offer
Number of clients who are offered PrEP
Measured: Up to 48 months
PrEP Initiation
Number of clients initiating PrEP
Measured: Up to 48 months
PrEP Continuation
Number of PrEP initiators who remain PrEP-eligible and sustain use at six months
Measured: Up to 48 months
Proportion of PrEP Implementation Activities Completed
The SIC is an 8-stage observational assessment tool recording organizational site completion of implementation activities that map onto the three phases of implementation (Pre-Implementation, Implementation, Sustainability). Proportion of PrEP implementation activities completed will be measured.
Measured: Up to 48 months
Time to Completion for Each Implementation Phase
The SIC is an 8-stage observational assessment tool recording organizational site completion of implementation activities that map onto the three phases of implementation (Pre-Implementation, Implementation, Sustainability). Time to completion of each implementation phase will be measured.
Measured: Up to 48 months
Cost and Resource Allocation for Completion of Each Implementation Phase
Costs and resource allocation for completion of each implementation phase will be measured with the Cost of Implementing New Strategies (COINS) tool.
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Aug 2020
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Why it stopped: Lack of support and approval by the Yunnan Provincial Health Authority
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Yunnan Center for Disease Control and Prevention, Oregon Social Learning Center, Hunter College of The City University of New York, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kathrine Meyers, Columbia University
- Investigators
- Kathrine Meyers, DrPH,MPP,MSc, Principal investigator, Aaron Diamond AIDS Research Center, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992274
- Sponsor's protocol ID
- AAAS8800
- Other IDs
- 1R01MH119884-01A1
- Acronym
- B-HAPPY
- Status last verified
- Jan 2025
- First submitted
- 18 Jun 2019
- Last updated
- 30 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data from the B-HAPPY project will be available at end of the project by contacting the study PI.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yunnan-ADARC HIV Prevention Program: Developing and Testing a Model to Implement and Sustain PrEP Delivery in China
- ClinicalTrials.gov ID
- NCT03992274
- Acronym / sponsor ID
- B-HAPPY / AAAS8800
- Conditions
- HIV/AIDS
- Keywords
- HIV prevention, Implementation science, Pre-Exposure Prophylaxis, Men who have sex with men, China
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of support and approval by the Yunnan Provincial Health Authority
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Yunnan Center for Disease Control and Prevention, Oregon Social Learning Center, Hunter College of The City University of New York, National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Posted 30 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
B-HAPPY is an implementation project to study the process by which pre-exposure prophylaxis (PrEP) is introduced and integrated into a specific international health system facing high rates of HIV incidence among men who have sex with men. The study will use a stepped wedge design to compare implementation outcomes across eight municipalities in Yunnan, China.
Detailed description
B-HAPPY is an implementation science project that will introduce and evaluate the implementation of PrEP among over 1000 men who have sex with men (MSM), in eight municipalities in Yunnan, China. The project aims to compare the effectiveness of two implementation strategy bundles: 1) Standard Implementation: comprising the strategies that the Yunnan Center for Disease Control and Prevention would usually use to introduce HIV prevention innovations in the absence of the proposed study; and 2) Enhanced Implementation: standard implementation enhanced by a SIC-guided approach to plan and implement PrEP.
This study will use a stepped-wedge design, where sites will go through four study periods: a Pre-Baseline Period (Routine Service with no PrEP Implementation), a Baseline Period (Standard Implementation of PrEP), an Experiment Period (Enhanced Implementation of PrEP), and a Post-Experiment-Observation Period. Sites are randomized to the timing of the intervention initiation, with 2 sites moving from Standard Implementation to Enhanced Implementation every 6 months. The intervention condition changes over time and the intervention effect is the difference in outcomes between the Baseline and Experiment Periods, and the Post-Experiment and Baseline Periods.
The specific aims of the proposed study are:
- To evaluate whether the addition of SIC-guided PrEP delivery (Enhanced Implementation) to standard health system PrEP delivery improves services outcomes. Through a stepped-wedge randomized trial across eight Yunnan municipalities, within site change over time will be examined; timing of introduction of Enhanced Implementation will be randomized across four cohorts of two sites each. Client-services outcomes include progress to achieving the "Five-80s" (patient PrEP awareness, screening, offering, initiation, continuation).
- To examine the implementation process and efficiency of the Enhanced versus Standard implementation approaches. Using the Stages of Implementation Completion (SIC) and Cost of Implementing New Strategies (COINS) tools, sites will be monitored for implementation process and resource use. Outcomes will include proportion of implementation activities completed; duration of each implementation phase; and cost and resource allocation for completion of each implementation phase.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard implementation | No intervention | –During Standard Implementation, sites will use standard Yunnan Center for Disease Control and Prevention strategies to introduce HIV prevention innovations. |
| Enhanced implementation | Experimental | Other: Enhanced implementation of PrEPDuring Enhanced Implementation, sites will transition to receive enhanced Implementation Support to plan and implement PrEP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Clients at study sites (VCT or STI [sexually transmitted infections] clinics) are eligible for inclusion in the study if they meet all of the following criteria:
- Aged 18 years or older
- Male sex at birth
- Willing and able to provide written consent form
- Able and willing to provide finger-scan and contact information
Key exclusion criteria (9 listed)
- Clients at study sites (VCT or STI clinics) will be excluded from the study if they meet any of the following criteria:
- Diagnosed with HIV or AIDS
- Signs or symptoms of acute HIV infection
- Unable to provide inform consent
- At enrollment, has any medical, psychological, or social condition that, in the opinion of the investigator, would jeopardize the health or wellbeing of the participant during the study or the integrity of the data
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 |
|---|---|---|
| Enhanced implementation of PrEPDuring Enhanced Implementation study sites will receive Implementation Support to plan and introduce PrEP by following the eight stages of the PrEP-adapted SIC. Implementation Support specifically will involve a centralized technical assistance system developed using US-based PrEP experience focused on addressing implementation issues identified through real-time analysis of client, clinic, and implementation data. | Other | Enhanced implementation |
Primary outcome
PrEP Awareness
Time frame: Up to 48 months
Number of clients who are aware of PrEP
PrEP Eligible
Time frame: Up to 48 months
Number of clients who are eligible for PrEP
PrEP Offer
Time frame: Up to 48 months
Number of clients who are offered PrEP
PrEP Initiation
Time frame: Up to 48 months
Number of clients initiating PrEP
PrEP Continuation
Time frame: Up to 48 months
Number of PrEP initiators who remain PrEP-eligible and sustain use at six months
Proportion of PrEP Implementation Activities Completed
Time frame: Up to 48 months
The SIC is an 8-stage observational assessment tool recording organizational site completion of implementation activities that map onto the three phases of implementation (Pre-Implementation, Implementation, Sustainability). Proportion of PrEP implementation activities completed will be measured.
Time to Completion for Each Implementation Phase
Time frame: Up to 48 months
The SIC is an 8-stage observational assessment tool recording organizational site completion of implementation activities that map onto the three phases of implementation (Pre-Implementation, Implementation, Sustainability). Time to completion of each implementation phase will be measured.
Cost and Resource Allocation for Completion of Each Implementation Phase
Time frame: Up to 48 months
Costs and resource allocation for completion of each implementation phase will be measured with the Cost of Implementing New Strategies (COINS) tool.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data from the B-HAPPY project will be available at end of the project by contacting the study PI.
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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.
Kathrine Meyers, DrPH,MPP,MSc principal investigator
Aaron Diamond AIDS Research Center, Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced implementation of PrEP in people with HIV/AIDS, run by Columbia University at 1 site 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 11 inclusion and 9 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: stopped early, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 30 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Awareness (time frame: Up to 48 months). The study lists 8 primary outcomes in all. 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 30 Jan 2025.