Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338845
Status:
COMPLETED
Last Update Posted:
2013-04-11
First Post:
2006-06-16
Brief Title:
Share Safer Sex Counseling Program for Changing Sexual Risk Behaviors in Mexican Female Sex Workers
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Safer Sex Intervention for At-risk Women in Mexico
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effectiveness of the Share Safer Sex Program in reducing sexual risk behaviors among female sex workers in four Mexican cities close to the US border
Detailed Description:
Mexican female sex workers FSWs represent a large portion of the reported cases of AIDS and other sexually transmitted diseases STDs in Mexico Despite the imbalance in the distribution of reported cases there have been few efforts to change high-risk sexual behaviors in this population There has been a dramatic increase in HIV and other STDs over the past decade especially in Mexican cities along the United States border Border cities often have a thriving sex trade industry and some are considered sexual tourist destinations FSWs in these border cities however often do not know how to practice safe sex A previous study showed that a culturally sensitive risk reduction counseling program was effective in reducing sexual risk behavior in FSWs in Tijuana Mexico It may therefore be possible to implement the same program with similar efficacy in other Mexican cities near the US border This study will evaluate the effectiveness of the Share Safer Sex Program versus a standard counseling program in reducing sexual risk behaviors among FSWs in the Mexican cities of Tijuana Ciudad Juarez Nuevo Laredo and Matamoros
Participants in this open label study will be randomly assigned to either the Share Safer Sex Program or a standard counseling program Both programs will last for 6 months and will consist of a single counseling session lasting between 35 and 40 minutes All participants will undergo blood collection and a gynecological exam upon study entry and 6 months later The standard counseling program will be based on a sexual risk reduction counseling program developed by the Centers for Disease Control and Prevention and will focus on personal risk assessment and strategies for risk reduction Additionally it will incorporate risk reduction materials provided by CENSIDA Mexicos National Center for AIDS Studies The Share Safer Sex Program will be tailored to the needs values beliefs and behaviors of the participants and will take into account gender and cultural differences Counselors will work with participants to increase personal awareness of their current unsafe behaviors and the associated risks help them understand their motivation to change and increase their knowledge about how to practice safe sex Demonstrations and practice exercises will be used to improve participants attitudes about as well as intentions to practice condom use The counseling session will include the following activities assessing readiness for change building motivation for change and performing exercises in decisional balance identification of problem and problem-solving and knowledge and skill-building Outcomes for both treatment groups will be assessed after 6 months Participants in the standard counseling program will be offered an opportunity to participate in the Share Safer Sex Program upon completion of the study
Participants in this open label study will be randomly assigned to either the Share Safer Sex Program or a standard counseling program Both programs will last for 6 months and will consist of a single counseling session lasting between 35 and 40 minutes All participants will undergo blood collection and a gynecological exam upon study entry and 6 months later The standard counseling program will be based on a sexual risk reduction counseling program developed by the Centers for Disease Control and Prevention and will focus on personal risk assessment and strategies for risk reduction Additionally it will incorporate risk reduction materials provided by CENSIDA Mexicos National Center for AIDS Studies The Share Safer Sex Program will be tailored to the needs values beliefs and behaviors of the participants and will take into account gender and cultural differences Counselors will work with participants to increase personal awareness of their current unsafe behaviors and the associated risks help them understand their motivation to change and increase their knowledge about how to practice safe sex Demonstrations and practice exercises will be used to improve participants attitudes about as well as intentions to practice condom use The counseling session will include the following activities assessing readiness for change building motivation for change and performing exercises in decisional balance identification of problem and problem-solving and knowledge and skill-building Outcomes for both treatment groups will be assessed after 6 months Participants in the standard counseling program will be offered an opportunity to participate in the Share Safer Sex Program upon completion of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DAHBR 9A-ASI | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH065849 |
| R01MH065849 | NIH | None | None |