Biomedical HIV/AIDS Prevention Program Yunnan (NCT03992274) | Clinical Trial Compass
TerminatedNot Applicable
Biomedical HIV/AIDS Prevention Program Yunnan
Stopped: Lack of support and approval by the Yunnan Provincial Health Authority
China114 participantsStarted 2020-08-01
Plain-language 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. The study will use a stepped wedge design to compare implementation outcomes across eight municipalities in Yunnan, China.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
This study will recruit two types of study participants: A. MSM clients at study sites; B. study staff who will be involved in the implementation of this project.
A. MSM clients:
Inclusion criteria:
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
* Any male sex partner in past 12 months
Exclusion Criteria:
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
B. Study staff:
Inclusion criteria:
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
Exclusion criteria:
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 consen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PrEP Awareness
Timeframe: Up to 48 months
2
PrEP Eligible
Timeframe: Up to 48 months
3
PrEP Offer
Timeframe: Up to 48 months
4
PrEP Initiation
Timeframe: Up to 48 months
5
PrEP Continuation
Timeframe: Up to 48 months
6
Proportion of PrEP Implementation Activities Completed
Timeframe: Up to 48 months
7
Time to Completion for Each Implementation Phase
Timeframe: Up to 48 months
8
Cost and Resource Allocation for Completion of Each Implementation Phase