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Potential participants will be approached at each sample cluster defined and told about the study and referred to the study site. Two study sites will be rented in the main target areas of MSM activity. There will be no remuneration for participation although refreshments (tea, water, cookies) and shower facilities will be available at the study sites. After field worker referral, potential participants will voluntarily present at the study clinic. There they will be enrolled after the study is explained and all questions answered. Verbal consent will be administered by the interviewer in a private setting and witnessed by the physician/clinical officer. No identifying characteristics will be collected. All participants will be 18 years old or older. In a private room the interviewer will administer a standard questionnaire. The questionnaire will include the following topics: socio-demographic profile, presence of related STD symptoms, sexual behavior and practices, number of sexual partners, history of previous STD, the presence of STD related symptoms and condom use. Upon completion of the questionnaire, the trained clinician will then perform the routine genital examinations for the presence of genital discharge, ulcers, and warts. Any visible urethral discharge will be cultured for N. gonorrhoeae. Additionally, an anal inspection will be done and the presence of discharge, ulcers and warts will be noted, then an anal swab will be collected for PCR examination for N. gonorrhoeae and C. trachomatis and N. gonorrhoeae culture. After genital examination, each participant will be asked to provide freshly voided urine for PCR examination for N. gonorrhoeae and C. trachomatis. Blood samples will be taken from subjects for syphilis and HIV serologic testing. All questionnaires and specimens will be marked with a study number. No names will appear on the forms or collected specimens. Participants will be given a card with their study number and a time to return to the study site for test results and STD treatment (if necessary) of a sub-set their tests: syphilis serology and gonorrhea cultures. At this time they will receive additional counseling on STDs. Condoms will be given and demonstrated. Participants will also have the choice to obtain the result of the HIV test. This result will be given during post-test counseling at the National Center of Dermatology and Venerology (Street Neru Sangkat Khan 7 January Psar Depot, Phnom Penh). This center has been recommended by NCHADS. Respondents' ID numbers with their corresponding HIV test results will be sent to NCHADS and given to the counseling center. Respondents have to show the card with their ID number to obtain the result of their HIV test. To ensure confidentiality no test results will be provided if a respondent can not show this ID card – even if they remember the correct ID number. No exception to this rule will be allowed under any circumstances C) Study procedures Clinical Examination:
Laboratory procedures N. gonorrhoeae culture: Once the sample of urethral and anal discharge is inoculated on modified Thayer-Martin medium will be kept in a candle extinction jar and stored in a portable incubator set at 36oC until transport to the central laboratory in Phnom Penh where the jars will be place in an incubator at 36oC. Culture plates will be read at 48 and 72 hours. Identification of N. gonorrhoeae will be based on colony characteristics, Gram stain morphology and oxidase reaction. Isolates will be frozen and tested for antimicrobial susceptibility using E-test strips in the central lab in Phnom Penh and with agar dilution in a reference laboratory outside of Cambodia. Polymerase chain reaction (PCR) for N. gonorrhoeae and C. trachomatis: Anal swabs inoculated into transport media and urine specimens from men will be stored in a cool box until transport to the laboratory on Phnom Penh. There the urine specimens will be aloquoted and the urine and anal specimens will be frozen at –20, batched, and transported to an international laboratory for processing. PCR for herpes simplex virus, T. pallidum and H. ducreyi: Swabs of any ulcerations found in the course of this study will be placed in PCR transport media and placed in a cool box until transport to the central laboratory in Phnom Penh where they will be stored at –20 C until transport to the U.S. for testing with Roche Multiplex. Syphilis testing will be done on sera transported in a cool box to the central laboratory in Phnom Penh using quantitative rapid plasma reagin (RPR) screening test with Treponema pallidum hemagglutination assay (TPHA) confirmatory test. HIV infection: Sera will be tested using the standard HIV testing protocol used at the HIV voluntary counseling and testing center of the Institute Pasteur. Two HIV antibody tests of different formats will be used. The first test is a particle agglutination test. All positives on this particle agglutination test will be tested using enzyme linked immunosorbant assay. IV. DATA ANALYSIS Questionnaire and clinical data forms will be transported daily from the field with the specimens and stored at the FHI/IMPACT office in a locked filing cabinet. Laboratory data forms will be collected on a periodic basis from the Institute Pasteur laboratories and sent on a periodic basis from the internal laboratory. Data entry will be done at the FHI/IMPACT office using standard database software. Data will be entered twice to maximize accuracy. Data analysis will be perform using SPSS. Chi square analysis and the two-tailed Fisher exact test will be used to assess the correlation between symptoms and STDs. Odds Ratios will be calculated. Simple proportions will be calculated to determine prevalence. Continuous variables will be assessed using student's t-test. Multivariate analysis, stepwise logistic-regression analysis will be used to for algorithm validation. The sensitivity, specificity, and positive predictive values with 95% confidence intervals will be calculated for each proposed algorithm. Treatment cost per confirmed case will be calculated for each algorithm V. POTENTIAL RISKS AND BENEFITS Potential Risks There are minimal physical risks of bleeding and bruising related to venipuncture. However, the study will use only trained medical personnel to draw a blood and will ensure and adequate supply of new, sterile disposable needles. There may be discomfort from the anal swab. However, trained medical providers will perform the examinations. For individuals who are positive for syphilis and agree to treatment, there is a small risk of allergy go penicillin, the drug of choice for treatment. A trained medical practitioner will administer the treatment with the appropriate treatment for an adverse reaction in the setting. Alternative therapies will be offered to all those with a history suggestive of allergy. There is a psychological risk due to the sensitive nature of the questions in the structured questionnaire. The questionnaire will be administered by same-sex study personnel in a private setting, will not contain identifiers and the participants will be told that they can refuse to answer any questions. There are also some psychological risks from learning that one has an STD or HIV infection. Participants will be referred to professional counselors to obtain the result of the HIV test. Appropriate referrals for HIV care services will be made. Medical staff will be trained on counseling for STD. There may be social risks of being diagnosed with an STD or HIV or being identified as an MSM. Participants will be assigned a study number at the time of enrollment. No names or other personal identifiers will be recorded anywhere. This study number will not be linked to any personal identifiers. Study participants will have a card with a number that they must show to get their study results. |
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