Biomedical HIV/AIDS Prevention Program Yunnan

NCT03992274 | Terminated Results

• 2 other identifiers: AAAS88001R01MH119884-01A1
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

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

Outcome Measures

Primary Outcomes (8)

• PrEP Awareness

  Number of clients who are aware of PrEP

  Up to 48 months

• PrEP Eligible

  Number of clients who are eligible for PrEP

  Up to 48 months

• PrEP Offer

  Number of clients who are offered PrEP

  Up to 48 months

• PrEP Initiation

  Number of clients initiating PrEP

  Up to 48 months

• PrEP Continuation

  Number of PrEP initiators who remain PrEP-eligible and sustain use at six months

  Up to 48 months

• 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.

  Up to 48 months

• 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.

  Up to 48 months

• 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.

  Up to 48 months

Study Arms (2)

Standard implementation

NO INTERVENTION

During Standard Implementation, sites will use standard Yunnan Center for Disease Control and Prevention strategies to introduce HIV prevention innovations.

Enhanced implementation

EXPERIMENTAL

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

Other: Enhanced implementation of PrEP

Interventions

Enhanced implementation of PrEP OTHER

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.

Enhanced implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Aged 18 years or older
• Employed at site for at least 3 months
• Willing and able to provide consent
• 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

Sponsors & Collaborators

• Columbia University: lead
• Yunnan Center for Disease Control and Prevention: collaborator
• Oregon Social Learning Center: collaborator
• Hunter College of The City University of New York: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Yunnan Center for Disease Prevention and Control

Kunming, Yunnan, 650000, China

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Homosexuality

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sexuality; Sexual Behavior; Behavior

Limitations and Caveats

Due to the lack of support and approval by the Yunnan Provincial Health Authority, the planned study was not able to proceed into the PrEP implementation phase but is considered as completed at the preparatory (pre-baseline) phase.

Results Point of Contact

• Title: Kathrine Meyers, DrPH, MPP, MSc
• Organization: Columbia University

kam2157@cumc.columbia.edu

2123046110

Study Officials

• Kathrine Meyers, DrPH,MPP,MSc

  Aaron Diamond AIDS Research Center, Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 20, 2019
• Study Start: August 1, 2020
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: January 30, 2025
• Results First Posted: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)