Reproduce this form for additional signatures. For additional information, contact Joyce Evans, 713/798-4443.

2. Body of application

A. Specific aims

This project in Tomsk, Russia will be a collaboration between Baylor College of Medicine (BCM) and the Tomsk Regional Center for Prevention and Treatment of AIDS and Infectious Diseases (TRCAID). Project goals are to reduce HIV-infection among at-risk women and prevent mother-to-child transmission (MTCT) of HIV by (1) identifying HIV status and relevant risk behaviors in women, (2) assessing barriers to HIV screening and prenatal care, and (3) facilitating proactive use of antiretroviral (ARV) therapy for MTCT prevention programs. Specific aims are to:

1. Develop and conduct a survey identifying HIV risk factors among women in six targeted groups, i.e., commercial sex workers (CSW), intravenous drug users (IVDU), pregnant women, incarcerated women, patients diagnosed with sexually transmitted diseases (STDs), and youth (university students).
2. Develop a risk profile for each of the targeted groups by using the survey results to assess baseline risk behaviors, sexual partner networks, social support systems, and other cultural factors that increase HIV risk.

B. Background and significance of research.

HIV/AIDS in Russia. The AIDS epidemic is spreading faster in the former Soviet bloc than anywhere else in the world, surpassing rates in the US. More than 75,000 new infections were noted in Russia by early November, 2002, representing a 15-fold increase over the previous three years, although there is considerable regional variability in rates of infection.1,2 Reported figures are probably largely underestimated and the real numbers may be up to four times higher. Furthermore, Russia has the highest number of incarcerated individuals in the world. Once released from prison, they provide additional risks to their communities.3 In general, the epidemiological impact of HIV, TB, and STDs in Siberia is much worse than for the European part of Russia. The main contributing factors include severe regional poverty, inaccessible medical services in distant residential regions; invisible subpopulations of HIV-infected and HIV-at risk (young adults, homosexual men, newly infected heterosexual patients, IVDU, victims of domestic violence, pregnant women, discordant heterosexual partners of HIV infected and those engaged in criminal activity); denial of risk status and subsequent delays in diagnosis; and a lack of infrastructure for sustainable manufacturing and purchase of medications.

HIV/AIDS in Tomsk. Tomsk is experiencing a disastrous confluence of risk behaviors. The capital city of Tomsk (population 540,000) has a large concentration of young people in seven major national universities, with students representing one third of the population. Since the southern borders through the NIS have opened, the flow of drugs and sexual trafficking of commercial sex workers has increased. Furthermore, the newly expanded oil field commerce is also impacting HIV rates in the Tomsk oblast. Its current population is approximately 43,000. In 1999, the HIV epidemic exploded and by 2001 the number of cases had increased 10-fold in the IVDU population. The number of HIV infected individuals is estimated to be 863/100,000, or 4.7% of the local population, compared with 2% of the Russian population as a whole.4 Because the oil workers shared needles, syringes, washing vessels and solutions, HIV rapidly spread within this closed community.5,6 In contrast, AIDS cases per 100, 000 in the United States are substantially lower (Blacks 74.2 per 100,000; Hispanics 30.4 per 100,000; 7.9 per 100,000 for Whites).7 For all practical purposes, no highly active antiretroviral therapy (HAART) is available for standard treatment of HIV/AIDS.

Based on TRCAID medical records, the total number of HIV-infected persons registered in Tomsk region is in 2001 was 2.2 times higher than in 2000 and 9.4 times higher than in 1999. In line with national trends in Russia, notable risk factors for HIV infection include intravenous drug use (IVDU) as well as heterosexual transmission. Compared with 2001, 2002 data indicate that 91.1% of HIV infected persons contracted the virus via IVDU, a decline from 93.7%; 8.2% via heterosexual intercourse, increased from 5.3%. The current rate of 0.9% for vertical transmission is projected to increase rapidly, in parallel with the current doubling of HIV infected pregnant women. In 2002, 22 HIV+ children were born to infected mothers. Tomsk does not currently have polymerase chain reaction technology, hence their final HIV status is currently unknown. Among HIV-infected individuals 61.7% are 20-29 years of age, and 13.2% are 30 years of age and older. The male to female ratio shifted from 3.9:1 to 2.6:1 between 2001-2002.4

Of approximately 27,000 IV drug users in the Tomsk oblast, about 7% are estimated to be already HIV infected. The estimated number of prostitutes in Tomsk is 2,500, of whom about 10% are IV drug users, 64.5% intermittently use condoms, and 1% are HIV+. The median number of sexual contacts per day is three, and for 100 to 150 rubles, they will forego condom usage.5 Thirty three percent of the commercial sex workers (CSW) seen at the Harm Reduction Clinic were treated for STDs in the last month. It is estimated that 50% of the CSWs were treated for syphilis at the Venereology Clinic. The typical number of women treated per month at the STD clinic is 200. CSWs may also receive non-STD gynecological care at the Harm Reduction Clinic. In May 2003, more than 100 women were treated.

In 2002, the TRCAID conducted a Behavioral Monitoring Survey in conjunction with UNICEF. Of 200 STD clinic patients surveyed, 90% received their STDs from “spontaneous sex” rather than “commercial sex”.5 This represents an important new vector for HIV infection and transmission. A survey of male college students reveals 2-3 new sexual partners a month, in contrast to adult males with 2-3 partners a year. Of the students surveyed, 10% revealed that they were experimenting with different drugs but did not consider themselves addicts.4,5,8 Most of these individuals are unaware of their HIV status.

The TRCAID is an independent government medical facility functioning under the Health Ministry of the Russian Federation. The Center works with various international organizations and has received commendations from the Health Ministry because of its successes in the Tomsk oblast. TRCAID collaborates with various city and oblast administrative departments, including the Interdepartmental Prophylactics Committee, Department for HIV Preventive Services within the Tomsk Health Department, and various departments of education and culture. The Center provides medical/consultative services for incarcerated individuals and is the major HIV/AIDS information source for rural medical facilities. To prevent MTCT, HIV-infected pregnant women receive medical services according to recommendations of the Health Ministry of Russian Federation.9 This includes the use of zidovudine and nevirapine. Newborns are monitored from the time of birth. In Tomsk, approximately 1,000 deliveries occur per month. There are eight maternity hospitals in Tomsk. The Harm Reduction Center organizes and conducts educational seminars for adolescents and young people using the motto “Living in the Era of AIDS”. Many of these events involve volunteers, media, and sociological surveys. A preliminary demonstration grant Behavioral Monitoring Survey conducted in cooperation with UNICEF (2002) revealed previously invisible high-risk behaviors in college students, women of childbearing age, married couples, commercial sex workers and men having sex with men in Tomsk. Results of that survey are a direct stimulus for this proposed study, focusing especially on women.

C. Study Design, Methodology, Data Analysis And Any Problem Areas Anticipated.

Design. The research question to be addressed by this study is as follows: As identified by a survey of HIV risk factors, are there statistically significant differences in risk factors/behaviors (risk profiles) among six groups of at-risk women in Tomsk?

Sample. The study sample will be composed of 900 women, 150 from each of six groups, including women who are (1) CSWs, (2) IVDUs, (3) incarcerated, (4) STD patients, (5) pregnant, and (6) college students. CSWs and IVDUs will be recruited from among patients at the Harm Reduction Clinic. STD patients will be recruited from the Venereology Clinic. Prisoners will be identified and recruited at the single women’s jail in Tomsk. Pregnant women will be recruited from among patients at the eight maternity centers. Students will be recruited through the Polytechnical University, which has an enrollment of 17,000. We do not anticipate any problems gaining access to research subjects. Dr. Yelena Borzunova, Director of the Department of Prevention at TRCAID, directs the Harm Reduction Clinic. Dr. Chernov, Director of TRCAID, sees patients in the prison system and has excellent relations with both the university. Dr. Ludmilla Neronova is Chief Regional Obstetrician for the Tomsk Health Department and oversees all eight maternity hospitals.

Sample size. The sample size for the survey has been set at 150 for each of the study groups, based on an estimate of available resources and time. Power calculations based on 150 per group indicate that there will be sufficient power to test the primary research questions. For example, we intend to test for differences in risk behaviors among the six groups. When the sample size in each of the 6 groups is 150, a 0.05 level Chi-square test will have 99% power to detect a difference in proportions characterized by a Variance of proportions of 0.006 and an average proportion of 0.15. With that sample size, the study will have the strength to detect true differences in voluntary and referral as small as a 10% increase or decrease in the primary outcome. Sample size and power estimations were conducted using the software, nQuery Advisor Release 5.0.10

Table 1 shows the approximate numbers of subjects seen at the various venues. Expected HIV+ numbers are based on unpublished data from the TRCAID and the 2002 Behavioral Monitoring Survey.

Measures. The HIV Risk Factor Survey will be a revised version of the Behavioral Monitoring Survey developed in consultation with UNICEF and Moscow and administered in Tomsk in 2002. The types of questions will cover (1) subjects’ knowledge of HIV/AIDS and HIV/AIDS risk factors, (2) actual risk factors present, (3) subjects’ knowledge of their own HIV/AIDS clinical status, (4) baseline socio-demographic information, and (5) selected questions from previous surveys to measure behavioral change in IVDU and CSW populations. Results of the survey will produce a patient risk profile, with scores based on specified risk factors, i.e., (1) barrier use with oral sex; (2) barrier use with vaginal sex; (3) barrier use with anal sex; (4) STD history; (5) multiple partners; (6) sex partner at risk; (7) sex partner with multiple partners; (8) buying sex with money or drugs; (9) selling sex for money or drugs; (10) drug use with sex; (11) sharing needles; (12) history of sexual or other personal violence; (13) knowledge about HIV/AIDS risk factors; and (14) knowledge of one’s own HIV status.

The Risk Profile will be created by assigning scores to the percent of subjects indicating a risk factor, e.g.:

Adding up the risk scores for all the risk factors for each study group will thus create a risk score for each subpopulation.11 Reliability data are not available for the Behavioral Monitoring Survey conducted in Tomsk in 2002. However, reliabilities for BRFSS questions range from .58-.85, and we anticipate similar reliabilities for the HIV Risk Factor Survey to be developed for this study. The Risk Profile will allow us to estimate risk prevalence for the study groups in each of the targeted venues. In addition, such risk estimates can be incorporated into future behavioral interventions targeting the various groups.12,13,14

Analysis Plan of statistical analysis: The study design for the survey is cross-sectional. The cross-sectional survey data will be used to attempt to define and describe the six study subpopulations for the ‘risk’ characteristics of interest. The statistical software, Stata Release 8.0,29 will be used to analyze the results of the survey. This software has the ability to account for the unique characteristics of survey data, such as sampling (probability) weights, cluster sampling and stratification. Initially the survey data will be described in simple terms using means, totals, ratios, and proportions among the six subpopulations. Tests will be applied to detect potential differences among the groups, using multiple comparison procedures to detect specific differences between groups. Regression models for complex survey data will be used to investigate risk profiles of the subpopulations in relation with STD or HIV status.15 The models are estimated using pseudo-maximum-likelihood methods. Methods for linear regression, logistic regression, probit models, multinominal logistic regression, Poisson regression and negative binomial regression models are available with the Stata software. For example, using the ‘svyologit’ command in Stata, we could determine predictors of self-reported health status as collected using a Likert scale with the values 1-5. Predictors might be age, subgroup and location. Via the model’s regression coefficients we could learn, for example, that after controlling for the other factors, ‘younger’ women give self-reports of poorer health status than ‘older’ women.

Methods. The projedct will proceed in three phases

Phase 1. Months 1-6 will be devoted to several types of activity.

1. Months 1-3. Development, pilot testing, revision of the HIV risk factor survey. This will include:
   1. review of the HIV Behavioral Monitoring Survey administered in Tomsk in 2002
   2. review of CDC BRFSS, Youth BRFSS, and/or other HIV risk factor profiles and incorporation of appropriate HIV and STD questions from them into a new survey specific to this study
   3. development of an HIV/AIDS Risk Factor Survey for this study
   4. translation of the new survey into Russian
2. Months 1-3. Development of a Bilingual HIV/AIDS Risk Factor Data Base program. This program will allow data entry and report generation in Russian or English. Consequently, while data entry will take place in Tomsk, the data base can be e-mailed to the BCM researchers, who can perform quality assurance review and generate reports in English.
3. Months 1-3. The NIAID CIPRA planning grant will pay for Dr. Chernov and three TRCAID Department Heads to travel to Houston for consultation with the BCM investigators; observation of how HIV and STDs are treated at BCM and its affiliated hospitals; and general discussion about the project, research design, educational materials and the bilingual data entry software program.
4. Months 4-5. Six focus groups representive of the subsample groups, in coordination with the TRCAID and Harm Reduction clinics will be convened to review the Russian version of the HIV Risk Factor Survey. The purpose of the focus groups will be to pilot test the survey and provide feedback about whether the questions and language are appropriate and “resonate” with the reality of the subjects’ experience. Based on this feedback, the survey will be revised for testing. The focus groups will be composed of 10 representatives from each of the targeted study groups and will be led by one of the Project investigators and an interviewer. The focus group participants will be paid a stipend for participating but will not be included in the actual study sample. The group leaders will be women, and we will attempt to use interviewers who participated in the Behavioral Monitoring Survey and are peers of the focus group participants. Besides question review, the focus groups will also provide an opportunity for generating additional qualitative questions by women in the high risk groups. The revised questionnaires will be pilot tested again during interviewers’ training.
5. Month 6. Ten interviewers will be trained in administration of the HIV Risk Factor Survey. The interviewers will be women peers from the targeted study groups. To the degree possible, we will rehire interviewers who conducted the Behavioral Monitoring Survey. If additional interviewers are required, they will be trained by Dr. Valentina Shipovskya, from the Sociology Department of Tomsk State University. She works with Dr. Borozunova at the Harm Reduction Center, has extensive experience with IVDU and CSW populations, and participated in the previous surveys of high risk populations in Tomsk. She will organize and analyze results of the focus groups that review the new survey prior to implementation. Due to her previous research contacts, she has the trust of high risk populations within the Tomsk oblast and will supervise the project outreach worker/interviewers. The training will last two days and each interviewer will practice administering the survey. The training will be conducted by TRCAID Project Personnel, including Dr. Shipovskya.
6. Month 6. During Month 6, Dr. Miller and Ms. Sara Rozin (Project Manager) will travel to Tomsk. Dr. Miller and Ms. Rozin will consult with the TRCAID Personnel on general administrative matters and participate in the interviewer training seminar. As mentioned earlier, travel costs will be covered by the NIAHD CIPRA grant that has been awarded to Dr. Chernov.

Phase 2. Months 7-10 will be used for survey data collection.

1. Project staff will randomly select individuals in each of the six targeted groups.
2. The trained interviewers will contact the individuals and recruit them to the study. In all settings, the interview-subject interactions will be in private. Upon contact, the interviewer will:
   1. Explain the study and invite the subject to participate
   2. Review informed consent procedures with the subject, including the expectation that the subject will be paid a stipend to participate.
   3. If and when the subject agrees to participate, she will sign the informed consent form.
   4. Administer the survey face-to-face in order to minimize errors that may be associated with language barriers, subject illiteracy, or other dynamics.
   5. Each questionnaire will be color coded per site. Survey and serological testing will be performed in tandem on site. The study participants will be paid $2.50 for a completed survey. These rates are the community standard. Depending on prison regulations, the incarcerated women may receive non-cash incentives, such as food or other items.
   6. The interviewers will keep a running anonymous record of reasons why individuals refuse to participate.
   7. Project staff will monitor the completeness and consistency of the questionnaires. Each interviewer will sign and date completed surveys. For quality assurance, project staff will meet with interviewers weekly to proactively review and address problems, discrepancies between interviewers, and unanticipated barriers.
3. Data entry. Coding methods will be similar to those used with the Behavioral Monitoring Survey and other surveys previously conducted by the Harm Reduction and Colorline projects. Interviewers will sign completed surveys for quality control and monitoring. Project staff will assign a unique, alpha-numeric identifier to completed surveys prior to data entry in order to maintain subject confidentiality. Data will be entered twice to assure accuracy.
4. Quality assurance.
   1. Project investigators will monitor interviews and completed questionnaires, and BCM investigators will be in at least weekly e-mail or telephone contact with TRCAID investigators, for purposes of quality assurance. Especially early on, interviewers whose data collection is not satisfactory will be given feedback and additional training, if necessary. Preliminary data analysis will be conducted during the months of data collection for purposes of formative evaluation and additional quality assurance.
   2. Database Management will include double data entry to assure accuracy, weekly backup of the files, and other standard data quality assurance procedures.

Phase 3. Months 11-12 will be used for data analysis.

During this period, the BCM and TRCAID investigators will review the study results in order to (1) determine behavior patterns related to new infections in the various targeted study groups and (2) develop proposals for new HIV prevention interventions, tailored to the risk profiles that emerge from the study. Data analysis will be completed in Houston and the final report written during Month 12.

As shown in Figure 1, the project will proceed in three phases.

Figure 1. Project Timeline

D. Literature cited

1. UNAIDS: “AIDS epidemic spreading faster in Eastern Europe than in the rest of the world: new figures”, (28 November 2001) (www.UNAIDS.org)
2. WHO: “The Work of WHO on HIV/AIDS: Progress Report”, September 2002.
3. V.L. Sazhin, V. Yuriev, “Health and Diseases of Convicted”. 1999 St. Petersburg.
4. Rubin, LK. The Health Ministry of the Russian Federation, Omsk Scientific Research Institute for Infectious Diseases. Siberian Regional Center for Prevention and Eradication of AIDS. Epidemic situation for HIV infection for the period until November 1st, 2002. Document #99-04/6. November 11, 2002. Table, translated by the present investigators
5. Survey (unpublished) UNAIDS funded project “Men can change AIDS epidemic” (Tomsk, 2002).
6. Reid G, Costigan G: “Revisiting The Hidden Epidemic: A Situation Assessment of Drug Use in Asia in the Context of HIV/AIDS”, The Centre for Harm Reduction, The Burnet Institute, Australia (January 2002); 1-240.
7. Paxton L, “The Epidemiology Of HIV Transmission: The US Perspective. Conference Report June 6-7, 2002, Atlanta, GA.
8. Survey (unpublished) SOROS Open Society Fund “Diminishing Harm – Tomsk” (Tomsk 2002)
9. Federal Law on the Prevention of the Spread in the Russian Federation of the Disease Caused by the Human Immunodeficiency Virus (HIV-Infection), 30 March 1995
10. Janet D. Elashoff (2002). nQuery Advisor. Version 5.0 User’s Guide. Los Angeles, CA.
11. Texas Department of Health. Bureau of HIV and STD Prevention. The 2000 Texas HIV Epidemic Profile. http://www.tdh.state.tx.us/hivstd/profiles/2000/
12. Andresen EM, Catlin TK, Wyrwich KW, Jackson-Thompson J.Retest reliability of surveillance questions on health related quality of life. J Epidemiol Community Health. 2003 May;57(5):339-43.
13. Nelson DE, Holtzman D, Bolen J, Stanwyck CA, Mack KA. Reliability and validity of measures from the Behavioral Risk Factor Surveillance System (BRFSS). Soz Praventivmed. 2001;46 Suppl 1:S3-42.
14. Brownson RC, Jackson-Thompson J, Wilkerson JC, Kiani F. Reliability of information on chronic disease risk factors collected in the Missouri Behavioral Risk Factor Surveillance System. Epidemiology. 1994 Sep;5(5):545-9.
15. Analysis of Complex Surveys, ed. C.J. Skinner, D. Holt, and T.M.F. Smith, 23-58. New York: John Wiley & Sons.

3. Briefly describe the long-term goals of the research project that you hope to develop,
if the pilot project is successful.
Provide a short rationale for the proposed pilot project and planned research program,
based on past experience of the applicant (maximum, 1 page).

This proposal addresses several targeted CFAR research areas that will: (1) enhance international capabilities and develop sustainable research capacity in the developing country; (2) develop behavioral interventions in clinical treatment settings; (3) help understand implications of substance-abuse and co-infections in AIDS pathogenesis, therapeutic, and behavioral studies; and (4) elucidate the role of sex and gender in therapy and prevention for women and girls. This project provides an excellent opportunity to apply lessons learned from US and worldwide experience to help mitigate the growing HIV/AIDS problem in Tomsk. The unfortunate unavailability of HAART therapy in Tomsk means that there are a large number of ARV naïve patients who would be eligible for future clinical trials. Thus, from the perspectives of both public health and clinical research, this project has great potential to enhance CFAR international capabilities and develop sustainable research.

Dr. Susan Miller, from the Department of Medicine Section of General Medicine, and Dr. Larry Laufman, from the Chronic Disease Prevention and Control Research Center in the Department of Medicine, have previously consulted with Dr. Alexander Chernov Director and Chief Physician at the TRCAID. Especially pertinent to the present proposal, Dr. Chernov has been awarded a planning grant from the Comprehensive International Program of Research on AIDS (CIPRA) of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH). Proposed travel for this project will be covered by budget from that planning grant.

As described in the body of this proposal, the HIV epidemic in Russia and Tomsk is a high public health priority. Knowledge gained from this study will enable us to better address reduction of MTCT by tailoring preventive medicine and screening interventions to targeted high risk populations. Because the TRCAID is part of a network of about 80 national AIDS Centers in Russia, the potential dissemination and impact of study results is considerable. This study will contribute directly to developing future research proposals that will involve actual interventions to reduce HIV/AIDS risk in Tomsk and its surrounding region. In 2002, the U.S. Agency for International Development (USAID) initiated a new $25 million, five-year health communication activity called Healthy Russia 2020. The initiative is designed to promote healthy behavior by encouraging adoption of “best-practices” and advocating community collaboration to reverse declining health indicators. Tomsk is one of the seven targeted regions by this initiative partially because of regional increases in HIV and MTB.20

Taken together, the epidemiology, sociology, and political economy of HIV/AIDS in Tomsk provide a compelling case for a concerted program to identify HIV status in pregnant women and women of child-bearing age. This will facilitate effective provision of ARV as part of MTCT prevention programs. The project will strengthen HIV clinical and behavioral surveillance activities, which will in turn help in design of improved, targeted behavioral interventions in the future. In combination with a strengthened MTCT prevention program, voluntary counseling and testing (including STD) will help women make informed choices based on personal knowledge.

4. Appendix material (optional; maximum of 2 pages)

Insert cvs for Larry and Sasha

Budget Justification - Baylor College of Medicine

Personnel

Susan Miller, MD, MPH, will devote 2% FTE to the project as PI for this study, with overall responsibility for direction of the project. She will work closely with the project personnel at both Baylor College of Medicine (BCM) and the Tomsk Regional Center for Prevention and Treatment of AIDS and Infectious Diseases (TRCAID). She has consulted with Dr. Chernov and the staff of the TRCAID since 1998 and for this project, she will travel to Tomsk twice, to participate in the training activities and at the end of the project to review the results with the TRCAID colleagues.

Sara Rozin, M.S., will devote 12% FTE to the project as Project Manager, with day-to-day responsibility for all project activities. She is Project Manager for the Chronic Disease Research Center international healthcare partnerships and is fluent in Russian language. She has professional background in data processing and directed development of the bilingual cancer registry software program for the Center’s healthcare partnership in Kazakhstan. For this project, she will have similar responsibility for development of the bilingual data entry program.

Note: Fringe for salaries is calculated at 30%.

Supplies

Long distance telephone communication with Tomsk is estimated @ $30/month, for a total of $360.

Other Expenses

Development of bilingual data entry software is estimated at $4,000 (approximately 10 programmer days @ $400/day). This is based on previous experience of the Chronic Disease Research Center in developing bilingual cancer registry software for the Houston-Semipalatinsk, Kazakhstan Healthcare Partnership.

Consortium/Contractual Costs

For this project we will subcontract with the TRCAID to conduct project activities “on the ground” in Tomsk. Budget justification for the TRCAID project activities are found on the following pages. The total direct costs for the TRCAID subcontract is $10,000.

Budget Justification – TRCAID

Note: Fringe is not calculated as part of salaries for Tomsk personnel because healthcare and other fringe benefits are provided separately by the Tomsk Regional Center for Prevention and Treatment of AIDS and Infectious Diseases (TRCAID) and will not be covered by this grant.

Personnel

Alexander Chernov, M.D., will devote 10% FTE in kind to the project as Principal Investigator for the subcontract to the Tomsk Regional Center for AIDS and other Infectious Diseases (TRCAID). Dr. Chernov is Chief Physician and Director of the TRCAID.

He has been involved in the study design and will oversee all aspects of implementation in Tomsk. He has extensive administrative and grant experience with nongovernmental organizations (NGOs) including UNAIDS, UNICEF, and the Soros Foundation. Since 1998, he has worked with Dr. Susan Miller, the Baylor College of Medicine (BCM) Principal Investigator for the study, and she consulted with him for a planning grant proposal to the Comprehensive International Program of Research on AIDS (CIPRA), recently funded by the National Institute of Allergy and Infectious Diseases (NIAID). The CIPRA grant will cover costs for Dr. Chernov to travel with three Tomsk co-investigators to Houston for consultation with the Houston investigators during the first quarter of the project year. He will interact on a daily basis with his co-investigators at TRCAID and on a regular basis with Dr. Miller.

Yelena Borzunova, M.D., will devote 20% FTE in kind to the project as a Co-Investigator. Dr. Borzunova is Chief of the Department of Prevention at TRCAID. She is in charge of the Harm Reduction clinic and also is Director of the Tomsk-Anti-AIDS Charity Fund. She has been involved with establishment of a new TRCAID Institutional Review Board (IRB) for Protection of Human Subjects. She will coordinate recruitment of subjects through the Harm Reduction Clinic and will also consult with Dr. Miller on issues related to protection of vulnerable patient populations.

Yelena I. Makarova, M.D., will devote 10% FTE in kind to the project as a Co-Investigator. She directs the Outpatient Treatment Department at TRCAID. She also serves as Clinical Assistant to the Chief Physician, Dr. Chernov, in the TRCAID Administrative Department. Her activities include a focus on prevention, treatment, and patient and public education.She will oversee and help coordinate patient education aspects of the project.

Vasilievna Lubov, M.D., will devote 10% FTE in kind to the project. She works at the TRCAID under the direct supervision of Dr.Makarova and will become directly involved in day-to-day care of new HIV infected patients as they are identified through the study.

Svetlana Giorgevna Rogozkina, M.D., will devote 20% FTE in kind to the project. She is an Ob/Gyn physician who provides direct patient care at the Harm Reduction Clinic and oversees the clinic’s outreach programs for IVDUs and commercial sex workers. She will be involved in the diagnosis of STDs, HIV, and direct education regarding harm reduction behaviors.

Ludmilla Neronova, MD, will devote 5% FTE in kind to the project. She is the Chief Regional Obstetrician for the Tomsk Health Department. She was instrumental in developing the HIV Women’s Unit at Maternity Hospital #2 and will coordinate prenatal care for women patients in the study at the other seven maternity hospitals in the Tomsk oblast. Dr. Neronova will also coordinate education efforts with Dr. Chernov for the regional CME conference on HIV infection for the obstetricians and gynecologists.

V. I. Reshetnikov will devote 10% FTE in kind to the project. He is Director of Laboratory Services for TCRAID. As the volume of HIV and STDs laboratory samples increases as part of this project, he will be involved in the quality assurance of the data collected. He will also work with Drs Makarova, Lubov, Rogzkina, Chukova, and Shulyepove to make sure newly identified patients receive appropriate diagnostic testing and follow-up.

Ludmilla Alexandrovna Lebedeva will devote 20% FTE in kind to the project. Working under the direct supervision of Dr. Chernov, she is the TRCAID epidemiologist involved in analyzing data and epidemiological trends at the clinic. She will be responsible for accuracy and overall quality assurance for the study data collection. She will also work closely with S. Tatarchenko, the TRCAID data manager, and with Sara Rozin, the Project Manager, on implementation of the project data collection software program.

Dr. Valentina Shipovskaya will devote 10% FTE in kind to the project. She is a sociologist who works directly with Dr. Borozunova at the Harm Reduction Center. She has extensive experience in the Tomsk oblast with IVDU and CSW populations. Having participated in the previous surveys of high risk populations in Tomsk, she will organization and analysis results of the focus groups that review the new survey prior to implementation. She will also be a moderator for the interviewing and physician training seminars. Due to her previous research contacts, she has the trust of high risk populations within the Tomsk oblast and will supervise the project outreach worker/interviewers.

Sergei Yurivich Tatarchenko will devote 15% FTE in kind to the project as Data Manager. He will be involved in development, maintenance, and data entry of the survey data. He will work directly with Ludmilla Alexandrovna Lebedeva, the TRCAID epidemiologist, and Sara Rozin, the Project Manager. He also has extensive computer experience will assist in pilot testing and implementing the bilingual data entry program.

Yana Alexandrovna Sutermina and Maria Alexadrovna Vershinina will each devote 50% FTE in kind to the project as outreach workers/interviewers. They both have extensive logistical experience as outreach workers with CSW and IVDU populations. Having participated in previous NGO surveys, they have established trust and credibility within these high risk populations. They will be involved in recruiting research participations, organizing focus groups, and training of additional interviewers for the study. They will also participate in the physician CME seminar. Their knowledge and experience will help to identify appropriate approaches to obtain the cooperation of patients in the targeted high risk groups.

Professor Tatiana Bourykhina will devote 15% FTE in kind to the project as its Medical Translator. Under Dr. Chernov’s supervision, she will work closely with Sara Rozin, MS, the BCM Project Manager. In addition to translation of documents, she will also serve as primary translator for the BCM personnel during their visits to Tomsk. She is a Professor of English and Methods of Training, in the Department of International Management Studies, at the Russian-American Center of Tomsk Polytechnic University. She has served as a Medical Translator for multiple HIV-related protocols at TRCAID since 1998 and is very familiar with medical terminology, especially as related to HIV/AIDS.

Marina Chukova, MD, will donate 20% FTE in kind to the project. She will participate in the interviewer training seminar as well as the physician CME program related to assessment and management of high risk populations within the oblast. She will have primary responsibility for survey administration and will oversee the Strezevoi interviewers. She will also oversee quality assurance for the laboratory tests collected as part of the study, working with with Dr. Chernov to make sure the data are complete and transferred directly to Tomsk.

Tatiana Shulyepova, MD will devote 10% FTE in kind to the project. She will work directly with Dr. Chukova in assessment, treatment and prevention activities for high risk women. She will oversee the administration of the behavioral surveys and participate in the quality assurance for the data collection process.

Supplies

Other Expenses

• There will be 6 focus groups of 10 individuals from each subject group, to review the survey questionnaire and provide insight for contacting the target populations. Each focus group participant and the moderator will be paid $5 to participate (6 x 11 persons x $5) = $330.
• The interviewers will receive $1.00 for each usable survey that they complete and turn in, or $900. 900 subjects @ $2.50 incentive per survey = $2,250.
• Banking fees for conversion funds from dollars to rubles are estimated @ 2% of the budget, or $200.

6. Sources and amounts of funds currently available to support research on this or related subjects by the applicant and/or by a senior investigator with whom the applicant is associated.
If such funds exist, the applicant should state clearly why CFAR developmental funds are needed. List any pending applications at granting agencies with potential budgetary overlap

There are no additional funds available to conduct the proposed research. The NIAID CIPRA Planning Grant will be in effect during the period of this CFAR project. However, that grant will only fund complementary activities, e.g., travel to Houston for the Tomsk researchers to receive training. It will not cover expenses directly related to the research proposed in this application.

Biographical sketch

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CURRENT ACADEMIC APPOINTMENTS:

10/01 – present Honorary Faculty, TCRAID (Tomsk Siberia)
9/97 – present Associate Chief, Department of Medicine, Baylor College of Medicine
1/97 – present Medical Director and Co-Principal Investigator, Women’s Health Initiative (NIH)
6/97 – present Medical Director, Center for Women’s Health
5/97 – present Associate Professor, Baylor College of Medicine, Department of Medicine, Center for Ethics and Health Policy.
7/97-2000 Medical Director, Baylor Internal Medicine Consultants
7/91-8/97 Medical Director, Thomas Street Clinic
2000-present Faculty Consultant, AIHA
1989-1992 Member, Institutional Review Board (Human Subjects) Committee

PUBLICATIONS: (selected)

Hirsch R, Miller S, and Reveille J.D. HIV-associated mycobacterial skeletal infections: a report of five cases and review of the literature. Arthritis and Rheumatology 25:1-11, 1996.
Miller SM: Infectious Disease: Ambulatory Management of AIDS, In: Rakel RE, (ed.) Textbook of Family Practice, 4th edition. Philadelphia, W.B. Saunders Co., 1990:487-495.
Miller SM and Williamson DS: Primary care of the homosexual patient. In: Rakel RE (ed.) Textbook of Family Practice, 4th edition. Philadelphia, W.B. Saunders Co., 1990: 1547-1551.
Miller SM: Treatment of opportunistic infections associated with acquired immune deficiency syndrome (AIDS). In Carter B (ed) Primary Care: Pharmacotherapy. Philadelphia, W.B. Saunders Co., 1990: 543-564.
Miller SM and Cate TR: Management of HIV infection. In: Rakel RE (ed.) Conn’s Current Therapy. Phill W.B. Saunders Co., 1991.
Miller SM: Case Study: Ambulatory Management of AIDS. In: Rakel RE (ed.) Essentials of Family Practice. Philadelphia, W.B. Saunders Co., 1991.
Miller SM: Care of the Adult HIV-1-Infected Patient. In Rakel RE (ed.) Textbook of Family Practice, 5th edition, Philadelphia, W.B. Saunders, Co., 1995:393-410.
White, AC, Miller SM: HIV infection after needle sticks (letter to the editor). Ann Intern Med 1991: 114:253/

FUNDING:

1994-2005 The Clinical Center for the Clinical Trial and Observations Study of the Women’s Health Initiative - West, NIH-WHI-93-30-W Co-investigator, Medical Director ($522,806).
1994-1998 “Cost and Services Utilization Study”, Principal Investigator ($20,000) , Rand Corporation.
1996-1997 “SEQUUS 30-38 – Double-blind, randomized evaluation of clinical benefits in patients treated with DOXIL or DaunoXome whose AIDS related Kaposi’s Sarcoma progressed on prior systemic combination chemotherapy”, Principal Investigator ($60,000), Sequus Pharmaceuticals.
1995-1997 “NV15182 – A randomized, placebo-controlled, double-blind, parallel group multicenter study with open-label extension of the safety and activity of Saquinavir soft-gelatin capsule formulation in combination with other antiretroviral drugs”, Principal Investigator ($35,000), Hoffman-LaRoche.
1996-1998 “A phase II, randomized double-blind, placebo-controlled study of the safety and efficacy of Viracept in combination with antiretroviral therapy in HIV positive women with < 1 month of prior treatment with stavudine and/or lamivudine”, Principal Investigator ($84,888), Agouron Pharmaceuticals.