- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03992274
Biomedical HIV/AIDS Prevention Program Yunnan (B-HAPPY)
Yunnan-ADARC HIV Prevention Program: Developing and Testing a Model to Implement and Sustain PrEP Delivery in China
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kathrine Meyers, DrPH,MPP,MSc
- Phone Number: 2123046110
- Email: kam2157@cumc.columbia.edu
Study Locations
-
-
Yunnan
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Kunming, Yunnan, China, 650000
- Recruiting
- Yunnan Center for Disease Prevention and Control
-
Contact:
- Yanling Ma
-
Principal Investigator:
- Yanling Ma
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Standard implementation
During Standard Implementation, sites will use standard Yunnan Center for Disease Control and Prevention strategies to introduce HIV prevention innovations.
|
|
EXPERIMENTAL: Enhanced implementation
During Enhanced Implementation, sites will transition to receive enhanced Implementation Support to plan and implement 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PrEP awareness
Time Frame: Up to 48 months
|
Number of clients who are aware of PrEP
|
Up to 48 months
|
PrEP eligible
Time Frame: Up to 48 months
|
Number of clients who are eligible for PrEP
|
Up to 48 months
|
PrEP offer
Time Frame: Up to 48 months
|
Number of clients who are offered PrEP
|
Up to 48 months
|
PrEP initiation
Time Frame: Up to 48 months
|
Number of clients initiating PrEP
|
Up to 48 months
|
PrEP continuation
Time Frame: Up to 48 months
|
Number of PrEP initiators who remain PrEP-eligible and sustain use at six months
|
Up to 48 months
|
Proportion of PrEP implementation activities completed
Time Frame: 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.
|
Up to 48 months
|
Time to completion for each implementation phase
Time Frame: 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.
|
Up to 48 months
|
Cost and resource allocation for completion of each implementation phase
Time Frame: 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.
|
Up to 48 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathrine Meyers, DrPH,MPP,MSc, Aaron Diamond AIDS Research Center, Columbia University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- AAAS8800
- 1R01MH119884-01A1 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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