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

Columbia University

Status

Terminated

Conditions

HIV/AIDS

Treatments

Other: Enhanced implementation of PrEP

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03992274

1R01MH119884-01A1 (U.S. NIH Grant/Contract)

AAAS8800

Details and patient eligibility

About

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.

Full 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.

Enrollment

114 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

114 participants in 2 patient groups

Standard implementation

No Intervention group

Description:

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

Enhanced implementation

Experimental group

Description:

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

Treatment:

Other: Enhanced implementation of PrEP

Trial documents