Biomedical HIV/AIDS Prevention Program Yunnan

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:

1. 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).
2. 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.

• Enhanced implementation of PrEP (Other): 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.

Primary outcomes

• PrEP Awareness [Up to 48 months]: Number of clients who are aware of PrEP
• PrEP Eligible [Up to 48 months]: Number of clients who are eligible for PrEP
• PrEP Offer [Up to 48 months]: Number of clients who are offered PrEP
• PrEP Initiation [Up to 48 months]: Number of clients initiating PrEP
• PrEP Continuation [Up to 48 months]: Number of PrEP initiators who remain PrEP-eligible and sustain use at six months
• Proportion of PrEP Implementation Activities Completed [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 [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 [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.

Sex: Male, ages: 18 Years to any, accepts healthy volunteers

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

Participant flow

Outcome results

• PrEP Awareness (Primary)
• PrEP Eligible (Primary)
• PrEP Offer (Primary)
• PrEP Initiation (Primary)
• PrEP Continuation (Primary)
• Proportion of PrEP Implementation Activities Completed (Primary)
• Time to Completion for Each Implementation Phase (Primary)
• Cost and Resource Allocation for Completion of Each Implementation Phase (Primary)

Adverse events

Time frame: Adverse event data was not collected

Limitations and caveats: Due to the lack of support and approval by the Yunnan Provincial Health Authority, the planned study was not able to proceed into the PrEP implementation phase but is considered as completed at the preparatory (pre-baseline) phase.

• Study Protocol and Statistical Analysis Plan (PDF, 2023-08-31)

• Kathrine Meyers, DrPH,MPP,MSc, Principal investigator, Aaron Diamond AIDS Research Center, Columbia University

NIH grants: R01MH119884