Biomedical HIV/AIDS Prevention Program Yunnan

Study Overview
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Brief Summary
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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
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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.

Official Title
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Yunnan-ADARC HIV Prevention Program: Developing and Testing a Model to Implement and Sustain PrEP Delivery in China

Conditions
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HIV/AIDS

Intervention / Treatment
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* Other: Enhanced implementation of PrEP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard implementation<br>During Standard Implementation, sites will use standard Yunnan Center for Disease Control and Prevention strategies to introduce HIV prevention innovations. | |
| Experimental: Enhanced implementation<br>During Enhanced Implementation, sites will transition to receive enhanced Implementation Support to plan and implement PrEP. | Other: Enhanced implementation of PrEP<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP awareness | Number of clients who are aware of PrEP | Up to 48 months | 
| PrEP eligible | Number of clients who are eligible for PrEP | Up to 48 months | 
| PrEP offer | Number of clients who are offered PrEP | Up to 48 months | 
| PrEP initiation | Number of clients initiating PrEP | Up to 48 months | 
| PrEP continuation | Number of PrEP initiators who remain PrEP-eligible and sustain use at six months | 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. | 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. | 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. | Up to 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV prevention, Implementation science, Pre-Exposure Prophylaxis, Men who have sex with men, China