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

HIV Infections Clinical Trial

Official title:

Project Ai Shi Zi: Integrating HIV/STI Prevention and Treatment in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644150
• Other study ID #: R01MH075639
• Secondary ID: R01MH075639DAHBR
• Status: Completed
• Phase: N/A
• First received: March 24, 2008
• Last updated: December 11, 2013
• Start date: April 2007
• Est. completion date: July 2011

Study information

• Verified date: December 2013
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1373
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chlamydia
• Gonorrhea
• HIV Infections
• Sexually Transmitted Diseases

Intervention

Behavioral:
• Physician Ai Shi Zi training
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.

Drug:
• Standard care
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).

Behavioral:
• Patient risk-reduction counseling
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.

Locations

Country	Name	City	State
China	Anhui Medical University	Hefei	Anhui

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores from curriculum exams performed by physicians		Measured at Month 15	No
Secondary	Incidence of STIs in intervention patients		Measured at Month 9	No