Clinical Trials

MainTitle

Biomedical HIV/AIDS Prevention Program Yunnan (B-HAPPY)

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified July 2020 by Aaron Diamond AIDS Research Center

Sponsor
Aaron Diamond AIDS Research Center

Collaborator
Yunnan Center for Disease Control and Prevention
Oregon Social Learning Center
Hunter College of The City University of New York

Information provided by (Responsible Party)
Aaron Diamond AIDS Research Center
ClinicalTrials.gov Identifier
NCT03992274

First received: June 18, 2019
Last updated: July 8, 2020
Last Verified: July 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV/AIDS

Other : Enhanced implementation of PrEP
Drug : PrEP
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Yunnan-ADARC HIV Prevention Program: Developing and Testing a Model to Implement and Sustain PrEP Delivery in China

Further study details as provided by Aaron Diamond AIDS Research Center:

Primary Outcome Measures

  • PrEP awareness [ Time Frame: Up to 48 months ]
    Number of clients who are aware of PrEP
  • PrEP eligible [ Time Frame: Up to 48 months ]
    Number of clients who are eligible for PrEP
  • PrEP offer [ Time Frame: Up to 48 months ]
    Number of clients who are offered PrEP
  • PrEP initiation [ Time Frame: Up to 48 months ]
    Number of clients initiating PrEP
  • PrEP continuation [ Time Frame: Up to 48 months ]
    Number of PrEP initiators who remain PrEP-eligible and sustain use at six 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.
  • 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.
  • 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.

Estimated Enrollment: 1064
Anticipated Study Start Date: January 2021
Estimated Study Completion Date: October 2024
Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Standard implementation
During Standard Implementation, sites will use standard Yunnan CDC strategies to introduce HIV prevention innovations.
Drug: PrEP

Pre-exposure prophylaxis (PrEP) is a biomedical HIV prevention strategy. A fixed-dose of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) was approved by the U.S. FDA in 2012.

Experimental: Enhanced implementation
During Enhanced Implementation, sites will transition to receive enhanced Implementation Support to plan and implement PrEP.
Other: Enhanced 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.

Drug: PrEP

Pre-exposure prophylaxis (PrEP) is a biomedical HIV prevention strategy. A fixed-dose of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) was approved by the U.S. FDA in 2012.

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 CDC 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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  

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 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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03992274

Contacts

Contact:   Kathrine Meyers, DrPH,MPP,MSc 1-212-448-5087 kmeyers@adarc.org

Sponsors and Collaborators

Aaron Diamond AIDS Research Center
Yunnan Center for Disease Control and Prevention
Oregon Social Learning Center
Hunter College of The City University of New York

Investigators

Principal Investigator: Kathrine Meyers, DrPH,MPP,MSc Aaron Diamond AIDS Research Center
More Information

More Information


Responsible Party: Aaron Diamond AIDS Research Center  
ClinicalTrials.gov Identifier: NCT03992274   History of Changes  
Other Study ID Numbers: ACP-101  
Study First Received: June 18, 2019  
Last Updated: July 8, 2020  
Individual Participant Data    
Plan to Share IPD: Yes  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Aaron Diamond AIDS Research Center:

HIV prevention
Implementation science
Pre-Exposure Prophylaxis
Men who have sex with men
China

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections

ClinicalTrials.gov processed this data on August 07, 2020
This information is provided by ClinicalTrials.gov.