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

April 25, 2022 updated by: Kathrine Meyers, Columbia University

Yunnan-ADARC HIV Prevention Program: Developing and Testing a Model to Implement and Sustain PrEP Delivery in China

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Interventional

Enrollment (Anticipated)

352

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Yunnan
      • Kunming, Yunnan, China, 650000
        • Recruiting
        • Yunnan Center for Disease Prevention and Control
        • Contact:
          • Yanling Ma
        • Principal Investigator:
          • Yanling Ma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kathrine Meyers, DrPH,MPP,MSc, Aaron Diamond AIDS Research Center, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ANTICIPATED)

April 1, 2024

Study Completion (ANTICIPATED)

October 1, 2024

Study Registration Dates

First Submitted

June 18, 2019

First Submitted That Met QC Criteria

June 19, 2019

First Posted (ACTUAL)

June 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data from the B-HAPPY project will be available at end of the project by contacting the study PI.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on HIV/AIDS

Clinical Trials on Enhanced implementation of PrEP

3
Subscribe