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Effectiveness of HIV/Sexually Transmitted Infection Training for Physicians in China

Primary Purpose

HIV Infections, Gonorrhea, Chlamydia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Physician Ai Shi Zi training
Standard care
Patient risk-reduction counseling
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Risk Reduction Counseling, Anhui, China, HIV, STI

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for Patient Participants:

  • Tests positive for the presence of gonorrhea or chlamydia
  • Plans on living in current community for at least 9 months after study entry
  • Willing to provide contact information for 9-month follow-up

Inclusion Criteria for County Level Physician Participants:

  • Specializes in STI, obstetrics/gynecology, urology, infectious disease, or HIV care
  • Minimum of 3 years of clinical experience as verified by practice supervisor
  • Sees HIV/STI and related patients in his/her practice
  • Willing to participate for the entire duration of the training, including secondary training stage

Inclusion Criteria for Township Level Physicians Participants:

  • Minimum of 3 years of clinical experience as verified by practice supervisor
  • Works in a high service volume area (among the top one-third within his/her host township health center)
  • Sees HIV/STI and related patients in his/her practice
  • Willing to participate for the entire duration of the training, including secondary training stage

Exclusion Criteria for All Participants:

  • Presence of an obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation in the assessment

Sites / Locations

  • Anhui Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

No Intervention

No Intervention

Sham Comparator

Arm Label

1

2

3

4

5

6

Arm Description

Physicians of county level will receive Ai Shi Zi training provided by experts in the fields of HIV/STIs, behavioral counseling, and stigma reduction.

Physicians of township level will receive Ai Shi Zhi training provided by the county level physicians.

HIV/STI patients will receive standard of care and specialized care from physician participants trained in Ai Shi Zi.

Physicians of county level who will not participate in Ai Shi Zi training

Physicians of township level who will not participate in Ai Shi Zi training

HIV/STI patients who will receive standard care only

Outcomes

Primary Outcome Measures

Scores from curriculum exams performed by physicians

Secondary Outcome Measures

Incidence of STIs in intervention patients

Full Information

First Posted
March 24, 2008
Last Updated
December 11, 2013
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00644150
Brief Title
Effectiveness of HIV/Sexually Transmitted Infection Training for Physicians in China
Official Title
Project Ai Shi Zi: Integrating HIV/STI Prevention and Treatment in China
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the effectiveness of a physician training program, the Ai Shi Zi program, in improving HIV/sexually transmitted infection diagnosis, treatment, and management by Chinese physicians and in reducing the number of subsequent infections in their patients.
Detailed Description
HIV and sexually transmitted infections (STIs) are among the foremost public health concerns worldwide, with the number of infections continuing to rise significantly. Specifically, in China, the number of cases of HIV is estimated to rise from 650,000 in 2006 to more than 10 million by the year 2010. The reasons for the drastic increase may be associated with a lack of education about proper condom use and consequences of sexual risk behaviors and the existing stigma toward HIV/STI patients. Therefore, increased knowledge of HIV/STI prevention and treatment is necessary for both physicians and patients in China. A program that provides training in HIV/STI prevention, treatment, and management to physicians may be an effective means of enhancing their abilities to deliver high quality, integrated HIV/STI prevention and treatment. The Ai Shi Zi program, which provides training on stigma, risk-reduction counseling methods, and treatment skills to county and township level physicians in China, may be an effective means of implementing HIV/STI training. This study will evaluate the effectiveness of the Ai Shi Zi program in improving HIV/STI diagnosis, treatment, and management by Chinese physicians and in reducing the number of subsequent HIV/STI infections in their patients. Participants in this study will include county level physicians and their patients and township level physicians. All physicians will first undergo baseline assessments that will include questions about knowledge of HIV/STI, capability of administering HIV/STI screening and risk-reduction counseling, and attitudes toward working with HIV/STI-infected individuals. Physicians will then be assigned randomly to receive the Ai Shi Zi program or no training. Physician training in the Ai Shi Zi program will consist of multiple components: an orientation workshop on fundamental knowledge and skills of HIV/STI treatment and prevention, a 3-month practice period, a 3-month post-practice seminar on preventive counseling, another 3-month practice period, and a 6-month post-practice seminar on clinical HIV and STI management. Physicians will keep weekly journals during both 3-month practice periods, citing the most interesting or difficult STI or HIV case they experienced during the week. The practice periods will promote learning-by-doing to further enhance physicians' abilities to deliver high quality, integrated HIV/STI prevention and treatment. Both post-practice seminars will allow physicians to share experiences gained during the previous 3-month practice period. County level physicians will receive the seminar training from experts in the fields of HIV/STIs, behavioral counseling, and stigma reduction. After completing the first post-practice seminar, the county level physicians then, in turn, will present the training to the township level physicians. All physicians will undergo repeat baseline assessments at post-training; post-practice seminars; and Months 1, 2, and 15 after orientation. Upon completion of the 6-month post-practice seminar, physicians will begin to implement the Ai Shi Zi program in their clinics. Each patient participant who seeks treatment from physician participants, who have received either Ai Shi Zi training or no training, will first undergo a test for chlamydia and gonorrhea. On this initial visit, the physicians who have received the Ai Shi Zi program will provide HIV/STI risk-behavior counseling to their patients. The counseling will include discussion of topics such as partner notification, HIV/STI prevention, expected difficulties in changing behaviors, and development of a risk-reduction plan. Patient participants will then return within 2 weeks to receive their test results and additional behavioral counseling. If the STI is confirmed by the lab test, patients will be treated with standard care and will be asked to complete an assessment. The assessment will include a 30-minute interview about HIV/STI-related knowledge, attitudes, beliefs, practices, service utilization, and risk behaviors. Nine months after baseline, patient participants will undergo a repeat interview.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Gonorrhea, Chlamydia
Keywords
Risk Reduction Counseling, Anhui, China, HIV, STI

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1373 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Physicians of county level will receive Ai Shi Zi training provided by experts in the fields of HIV/STIs, behavioral counseling, and stigma reduction.
Arm Title
2
Arm Type
Experimental
Arm Description
Physicians of township level will receive Ai Shi Zhi training provided by the county level physicians.
Arm Title
3
Arm Type
Experimental
Arm Description
HIV/STI patients will receive standard of care and specialized care from physician participants trained in Ai Shi Zi.
Arm Title
4
Arm Type
No Intervention
Arm Description
Physicians of county level who will not participate in Ai Shi Zi training
Arm Title
5
Arm Type
No Intervention
Arm Description
Physicians of township level who will not participate in Ai Shi Zi training
Arm Title
6
Arm Type
Sham Comparator
Arm Description
HIV/STI patients who will receive standard care only
Intervention Type
Behavioral
Intervention Name(s)
Physician Ai Shi Zi training
Intervention Description
This training uses a curriculum developed specifically for Project Ai Shi Zi and includes training in stigma; risk-reduction counseling; and quality HIV/STI diagnosis, treatment, and management. Physician training will consist of multiple components: an orientation workshop on fundamental knowledge and skills of HIV/STI treatment and prevention, a 3-month practice period, a 3-month post-practice seminar on preventive counseling, another 3-month practice period, and a 6-month post-practice seminar on clinical HIV and STI management. The practice periods will promote learning-by-doing to further enhance physicians' abilities to deliver high quality, integrated HIV/STI prevention and treatment. Post-practice seminars will allow participants to share experiences gained during the previous 3-month practice period.
Intervention Type
Drug
Intervention Name(s)
Standard care
Intervention Description
If an STI is confirmed by a lab test, participants will receive standard of care treatment. Gonorrhea will be treated with a single dose of 250 mg of ceftriaxone sodium administered by intramuscular injection. If patients are allergic to ceftriaxone, they will be treated with azithromycin (2 g single oral dose). Chlamydia will be treated with azithromycin (1 g single oral dose).
Intervention Type
Behavioral
Intervention Name(s)
Patient risk-reduction counseling
Intervention Description
On the initial visit, participants will receive HIV/STI risk-behavior counseling from the physician trained in Ai Shi Zi. The process is based on motivational interviewing techniques and will include discussing topics such as partner notification, HIV/STI prevention, and expected difficulties in changing behaviors. This risk-reduction model encourages the HIV/STI-infected or -uninfected person to develop a risk-reduction plan. The objective is to decrease the chance of infection for that individual and for others, too. Patients will develop a list of risk-reduction strategies to follow.
Primary Outcome Measure Information:
Title
Scores from curriculum exams performed by physicians
Time Frame
Measured at Month 15
Secondary Outcome Measure Information:
Title
Incidence of STIs in intervention patients
Time Frame
Measured at Month 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Patient Participants: Tests positive for the presence of gonorrhea or chlamydia Plans on living in current community for at least 9 months after study entry Willing to provide contact information for 9-month follow-up Inclusion Criteria for County Level Physician Participants: Specializes in STI, obstetrics/gynecology, urology, infectious disease, or HIV care Minimum of 3 years of clinical experience as verified by practice supervisor Sees HIV/STI and related patients in his/her practice Willing to participate for the entire duration of the training, including secondary training stage Inclusion Criteria for Township Level Physicians Participants: Minimum of 3 years of clinical experience as verified by practice supervisor Works in a high service volume area (among the top one-third within his/her host township health center) Sees HIV/STI and related patients in his/her practice Willing to participate for the entire duration of the training, including secondary training stage Exclusion Criteria for All Participants: Presence of an obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation in the assessment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J. Coates, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26718807
Citation
Operario D, Wang D, Zaller ND, Yang MF, Blaney K, Cheng J, Hong Q, Zhang H, Chai J, Szekeres G, Galea J, Coates TJ. Effect of a knowledge-based and skills-based programme for physicians on risk of sexually transmitted reinfections among high-risk patients in China: a cluster randomised trial. Lancet Glob Health. 2016 Jan;4(1):e29-36. doi: 10.1016/S2214-109X(15)00249-1.
Results Reference
derived

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Effectiveness of HIV/Sexually Transmitted Infection Training for Physicians in China

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