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Study record managers: refer to the Data Element Definitions if submitting registration or information. The intervention lasts approximately 45 minutes. The one-session, minute counseling intervention focuses on HIV and STI prevention, risk appraisal, and the development of a risk reduction plan. Outcome Measures Go to Top of Study Description Study De Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Primary Outcome Measures : of unprotected vaginal or anal sex acts with a female sex worker [ Time Frame: 12 months ] Participants will be asked to specify the of unprotected sex acts they had with female sex workers, spouses, steady partners, and casual partners over the past four months.
This question will be asked at baseline and at 4 months, 8 months, and 12 months post-baseline. STI status [ Time Frame: 12 months ] Participants will be tested for syphilis, gonorrhea, and chlamydia at baseline and at 12 months post-baseline. Talk with your doctor and family members or friends about deciding to a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information.
Search for terms. Save this study. Warning You have reached the maximum of saved studies Safer Sex Intervention for Male Clients of Female Sex Workers in Tijuana, Mexico The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : May 27, Thomas L. Patterson, University of California, San Diego.
Study Description. Behavioral interventions deed to reduce risk of HIV and sexually transmitted infections STIs have mostly failed to consider clients of female sex workers FSWs , who may act as a "bridge" to the general population. This study proposes to test a brief, one-hour counseling intervention with male clients in Tijuana, Mexico, to reduce their rates of unprotected sex i.
Finding an effective intervention for this population is important given the rising rates of HIV infection in Tijuana as documented in earlier studies and the large s of people crossing the border in both directions, many of them specifically to purchase sex from FSWs in Tijuana. Detailed Description:. Our recent survey of U. Based on qualitative and quantitative interviews with clients from Tijuana Mexico and the U.
The investigators now propose an RCT to test the efficacy of this one-hour intervention in Tijuana which will enroll HIV-negative men residents of San Diego County; Tijuana residents who report having unprotected sex with FSWs in the past 4 months. Our theory-based participatory intervention will be evaluated in comparison with a time and information equivalent didactic control condition. Participants will be recruited in Tijuana where they will undergo a baseline CAPI-administered interview, STI testing HIV, syphilis, gonorrhea, Chlamydia , and intervention counseling with follow-up interviews at 4, 8, and 12 months post-baseline conducted in either Tijuana or San Diego.
Our study aims are to: 1 evaluate the efficacy of Hombres Seguro to increase condom use of clients with FSWs; 2 determine if the intervention is as efficacious among U. Our primary analytic approach will utilize a generalized linear mixed models GLMM approach to repeated measures analysis.
This bi-national study will contribute ificantly to HIV prevention research by addressing the role of male clients in the escalating HIV epidemics in Tijuana and San Diego, and could have application to other settings where HIV prevalence is high among FSWs and their clients. FDA Resources. Arms and Interventions. Outcome Measures.
Primary Outcome Measures : of unprotected vaginal or anal sex acts with a female sex worker [ Time Frame: 12 months ] Participants will be asked to specify the of unprotected sex acts they had with female sex workers, spouses, steady partners, and casual partners over the past four months. Participants will be tested for syphilis, gonorrhea, and chlamydia at baseline and at 12 months post-baseline. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Living in either Tijuana or San Diego County Reports having purchased sex for money, drugs, shelter or goods in the last 4 months Reports having had unprotected vaginal or anal sex with a FSW in Tijuana at least once during the 4 months Tests HIV-negative at baseline Agrees to receive antibiotic treatment for Chlamydia, gonorrhea, and syphilis if he tests positive to allow us to differentiate incident from prevalent cases at follow-up Exclusion Criteria: Consistent use of condoms for vaginal and anal sex with all FSWs during the 4 months Transgender male i.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. Publications automatically indexed to this study by ClinicalTrials. Hombre Seguro Safe Men : a sexual risk reduction intervention for male clients of female sex workers. BMC Public Health. National Library of Medicine U. National Institutes of Health U.
Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Behavioral: Hombre Seguro Behavioral: Didactic attention-control condition. Not Applicable. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. January 21, Key Record Dates.Tijuana women sex
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Safer Sex Intervention for Male Clients of Female Sex Workers in Tijuana, Mexico