HIV InfectionsNCT00644150
Effectiveness of HIV/Sexually Transmitted Infection Training for Physicians in China
A study testing Physician Ai Shi Zi training and Patient risk-reduction counseling in people with HIV Infections and Gonorrhea, run by University of California, Los Angeles at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- HIV Infections, Gonorrhea, Chlamydia
- What is being tested?
- Physician Ai Shi Zi training and Patient risk-reduction counseling
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,373 participants
- Where
- 1 siteChina
- Study dates
- Apr 2007to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Presence of an obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation in the assessment
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV Infections, Gonorrhea, Chlamydia
- Being tested
- Physician Ai Shi Zi training, Standard care, Patient risk-reduction counseling
- Keywords
- Risk Reduction Counseling, Anhui, China, HIV, STI
- Medical subject headings
- HIV Infections, Gonorrhea, Chlamydia Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician Ai Shi Zi trainingBehavioural
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.
Standard careDrug
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).
Patient risk-reduction counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physician Ai Shi Zi training |
| 2 | Experimental | Physicians of township level will receive Ai Shi Zhi training provided by the county level physicians. Receives: 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. Receives: 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 Receives: Drug: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores from curriculum exams performed by physicians
Measured: Measured at Month 15
Secondary outcomes (1)
Incidence of STIs in intervention patients
Measured: Measured at Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startApr 2007
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,373 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Thomas J. Coates, University of California, Los Angeles
- Investigators
- Thomas J. Coates, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644150
- Sponsor's protocol ID
- R01MH075639
- Other IDs
- R01MH075639, DAHBR 9A-ASG-P
- Status last verified
- Dec 2013
- First submitted
- 24 Mar 2008
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26718807
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Ai Shi Zi: Integrating HIV/STI Prevention and Treatment in China
- ClinicalTrials.gov ID
- NCT00644150
- Acronym / sponsor ID
- R01MH075639
- Conditions
- HIV Infections, Gonorrhea, Chlamydia
- Keywords
- Risk Reduction Counseling, Anhui, China, HIV, STI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,373 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Physician Ai Shi Zi trainingPhysicians of county level will receive Ai Shi Zi training provided by experts in the fields of HIV/STIs, behavioral counseling, and stigma reduction. |
| 2 | Experimental | Behavioral: Physician Ai Shi Zi trainingPhysicians of township level will receive Ai Shi Zhi training provided by the county level physicians. |
| 3 | Experimental | Drug: Standard care, Behavioral: Patient risk-reduction counselingHIV/STI patients will receive standard of care and specialized care from physician participants trained in Ai Shi Zi. |
| 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 | Drug: Standard careHIV/STI patients who will receive standard care only |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (1 listed)
- Presence of an obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation in the assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician Ai Shi Zi trainingThis 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. | Behavioural | 1, 2 |
| Standard careIf 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). | Drug | 3, 6 |
| Patient risk-reduction counselingOn 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. | Behavioural | 3 |
Primary outcome
Scores from curriculum exams performed by physicians
Time frame: Measured at Month 15
1 secondary outcome
Incidence of STIs in intervention patients
Time frame: Measured at Month 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
- Derived from this study: PubMed 26718807Operario 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J. Coates, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician Ai Shi Zi training and Patient risk-reduction counseling in people with HIV Infections and Gonorrhea, run by University of California, Los Angeles at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores from curriculum exams performed by physicians (time frame: Measured at Month 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00644150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2013.