Biomedical HIV/AIDS Prevention Program Yunnan
- Conditions
- HIV/AIDS
- Interventions
- Other: Enhanced implementation of PrEP
- Registration Number
- NCT03992274
- Lead Sponsor
- Columbia University
- Brief 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.
- 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:
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 352
Not provided
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enhanced implementation Enhanced implementation of PrEP During Enhanced Implementation, sites will transition to receive enhanced Implementation Support to plan and implement PrEP.
- Primary Outcome Measures
Name Time Method 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 awareness Up to 48 months Number of clients who are aware of PrEP
PrEP continuation Up to 48 months Number of PrEP initiators who remain PrEP-eligible and sustain use at six months
PrEP eligible Up to 48 months Number of clients who are eligible for PrEP
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.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Yunnan Center for Disease Prevention and Control
🇨🇳Kunming, Yunnan, China