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

NCT00644150 | Completed DMC

• 2 other identifiers: R01MH075639DAHBR 9A-ASG-P
• Study Type: interventional
• Target: 1,373
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Gonorrhea; Chlamydia

Keywords

Risk Reduction Counseling; Anhui, China; HIV; STI

Outcome Measures

Primary Outcomes (1)

• Scores from curriculum exams performed by physicians

  Measured at Month 15

Secondary Outcomes (1)

• Incidence of STIs in intervention patients

  Measured at Month 9

Study Arms (6)

1

EXPERIMENTAL

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

Behavioral: Physician Ai Shi Zi training

2

EXPERIMENTAL

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

Behavioral: Physician Ai Shi Zi training

3

EXPERIMENTAL

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

Drug: Standard care; Behavioral: Patient risk-reduction counseling

4

NO INTERVENTION

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

5

NO INTERVENTION

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

6

SHAM COMPARATOR

HIV/STI patients who will receive standard care only

Drug: Standard care

Interventions

Physician Ai Shi Zi training BEHAVIORAL

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.

1; 2

Standard care DRUG

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).

3; 6

Patient risk-reduction counseling BEHAVIORAL

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.

3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Anhui Medical University

Hefei, Anhui, China

Location

Related Publications (1)

• 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.

  PMID: 26718807 DERIVED

MeSH Terms

Conditions

HIV Infections; Gonorrhea; Chlamydia Infections; Sexually Transmitted Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Chlamydiaceae Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Thomas J. Coates, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 26, 2008
• Study Start: April 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 13, 2013

Record last verified: 2013-12

Locations

CN (1)