HIV/AIDS
Conditions
Keywords
HIV prevention, Implementation science, Pre-Exposure Prophylaxis, Men who have sex with men, China
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.
Interventions
OTHEREnhanced implementation of PrEP
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.
Sponsors
Yunnan Center for Disease Control and Prevention
Oregon Social Learning Center
Hunter College of The City University of New York
National Institute of Mental Health (NIMH)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Participant flow
Recruitment details
Participants include clients and staff. The study was conducted at 8 study sites Yunnan, China.
Pre-assignment details
No participants or sites progressed beyond the Pre-Baseline.
Participants by arm
| Arm | Count |
|---|---|
| Clients MSM clients (men who have sex with men) who are involved in PrEP implementation | 58 |
| Staff Program staff who are involved in PrEP implementation | 56 |
| Total | 114 |
Baseline characteristics
| Characteristic | Clients | Staff | Total |
|---|---|---|---|
| Age, Customized >=18 years old | 58 Participants | 56 Participants | 114 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 56 Participants | 114 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 58 Participants | 56 Participants | 114 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 58 participants | 56 participants | 114 participants |
| Sex: Female, Male Female | 0 Participants | — | 0 Participants |
| Sex: Female, Male Male | 58 Participants | — | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: Up to 48 months
Population: Due to the closure of the study and loss of funding, intervention was not implemented, and data was not collected or analyzed.
Primary
PrEP Awareness
Number of clients who are aware of PrEP
Time frame: Up to 48 months
Population: Due to the closure of the study and loss of funding, intervention was not implemented, and data was not collected or analyzed.
Primary
PrEP Continuation
Number of PrEP initiators who remain PrEP-eligible and sustain use at six months
Time frame: Up to 48 months
Population: Due to the closure of the study and loss of funding, intervention was not implemented, and data was not collected or analyzed.
Primary
PrEP Eligible
Number of clients who are eligible for PrEP
Time frame: Up to 48 months
Population: Due to the closure of the study and loss of funding, intervention was not implemented, and data was not collected or analyzed.
Primary
PrEP Initiation
Number of clients initiating PrEP
Time frame: Up to 48 months
Population: Due to the closure of the study and loss of funding, intervention was not implemented, and data was not collected or analyzed.
Primary
PrEP Offer
Number of clients who are offered PrEP
Time frame: Up to 48 months
Population: Due to the closure of the study and loss of funding, intervention was not implemented, and data was not collected or analyzed.
Primary
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.
Time frame: Up to 48 months
Population: Due to the closure of the study and loss of funding, intervention was not implemented, and data was not collected or analyzed.
Primary
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.
Time frame: Up to 48 months
Population: Due to the closure of the study and loss of funding, intervention was not implemented, and data was not collected or analyzed.