HIV Infections Clinical Trial
Official title:
Project Ai Shi Zi: Integrating HIV/STI Prevention and Treatment in China
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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