Clinical trial NCT03992274: Biomedical HIV/AIDS Prevention Program Yunnan
Official title: Yunnan-ADARC HIV Prevention Program: Developing and Testing a Model to Implement and Sustain PrEP Delivery in China
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV prevention
Implementation science
Pre-Exposure Prophylaxis
Men who have sex with men
China
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Yunnan Center for Disease Control and Prevention
name: Oregon Social Learning Center
name: Hunter College of The City University of New York
name: National Institute of Mental Health (NIMH)
First posted: 2019-06-20
Enrollment: 114
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: PrEP Awareness
timeFrame: Up to 48 months
measure: PrEP Eligible
timeFrame: Up to 48 months
measure: PrEP Offer
timeFrame: Up to 48 months
measure: PrEP Initiation
timeFrame: Up to 48 months
measure: PrEP Continuation
timeFrame: Up to 48 months
measure: Proportion of PrEP Implementation Activities Completed
timeFrame: Up to 48 months
measure: Time to Completion for Each Implementation Phase
timeFrame: Up to 48 months
measure: Cost and Resource Allocation for Completion of Each Implementation Phase
timeFrame: Up to 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: Yunnan Center for Disease Prevention and Control
state: Yunnan
Study officials:
affiliation: Aaron Diamond AIDS Research Center, Columbia University
name: Kathrine Meyers, DrPH,MPP,MSc
role: PRINCIPAL_INVESTIGATOR
References: