Biomedical HIV/AIDS Prevention Program Yunnan

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Aaron Diamond AIDS Research Center; Columbia University
• Collaborators: Hunter College of The City University of New York; Oregon Social Learning Center; Yunnan Center for Disease Control and Prevention

Criteria

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 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