HIV InfectionsPhase 2NCT00338845
Share Safer Sex Counseling Program for Changing Sexual Risk Behaviors in Mexican Female Sex Workers
A Phase 2 study testing Share Safer Sex program and Standard didactic safer-sex counseling program in people with HIV Infections and Sexually Transmitted Diseases, run by University of California, San Diego at 1 site in Mexico.
Trial 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 U.S. border. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- Share Safer Sex program and Standard didactic safer-sex counseling program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteMexico
- Study dates
- Dec 2003to Nov 2008
- Phase
- Phase 2
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Reports having had unprotected vaginal, oral, or anal sex at least once within 2 weeks prior to study entry
Who cannot join
- Consistent use of condoms or dental dams for vaginal, oral, and anal sex with all clients within 2 weeks prior to study entry
- Duration of employment as an FSW is less than 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safer Sex Intervention for At-risk Women in Mexico
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 U.S. border.
Read the 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 U.S. 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, Mexico's 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.
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Being tested
- Share Safer Sex program, Standard didactic safer-sex counseling program
- Keywords
- STDs
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Share Safer Sex programBehavioural
The Share Safer Sex intervention will consist of a single, 30 to 40 minute, one-on-one counseling session designed to increase personal awareness of the participant's current unsafe behaviors and the associated risks, help her understand her motivation to change, and increase her 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.
Standard didactic safer-sex counseling programBehavioural
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, Mexico's National Center for AIDS Studies.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive the Share Safer Sex counseling program Receives: Behavioral: Share Safer Sex program |
| 2 | Active comparator | Participants will receive a standard didactic safer-sex counseling session Receives: Behavioral: Standard didactic safer-sex counseling program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of unprotected vaginal, oral, and anal sex with clients and spouse or steady partner
Measured: Measured at Month 6 post-treatment
Secondary outcomes (2)
STD incidence
Measured: Measured at Month 6 post-treatment
Knowledge, self-efficacy, and positive outcome expectancies re: condom use
Measured: Measured at Month 6 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startDec 2003
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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, San DiegoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Thomas L. Patterson, University of California, San Diego
- Investigators
- Thomas L. Patterson, PhD, Principal investigator, Dept. of Psychiatry, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338845
- Sponsor's protocol ID
- R01MH065849
- Other IDs
- R01MH065849, DAHBR 9A-ASI
- Status last verified
- Apr 2013
- First submitted
- 16 Jun 2006
- Last updated
- 11 Apr 2013
- Results posted
- No
Publications
Patterson TL, Mausbach B, Lozada R, Staines-Orozco H, Semple SJ, Fraga-Vallejo M, Orozovich P, Abramovitz D, de la Torre A, Amaro H, Martinez G, Magis-Rodriguez C, Strathdee SA. Efficacy of a brief behavioral intervention to promote condom use among female sex workers in Tijuana and Ciudad Juarez, Mexico. Am J Public Health. 2008 Nov;98(11):2051-7. doi: 10.2105/AJPH.2007.130096. Epub 2008 Sep 17.
PubMed 18799768Strathdee SA, Lozada R, Semple SJ, Orozovich P, Pu M, Staines-Orozco H, Fraga-Vallejo M, Amaro H, Delatorre A, Magis-Rodriguez C, Patterson TL. Characteristics of female sex workers with US clients in two Mexico-US border cities. Sex Transm Dis. 2008 Mar;35(3):263-8. doi: 10.1097/OLQ.0b013e31815b0.
PubMed 18032996Patterson TL, Semple SJ, Staines H, Lozada R, Orozovich P, Bucardo J, Philbin MM, Pu M, Fraga M, Amaro H, Torre Ade L, Martinez G, Magis-Rodriguez C, Strathdee SA. Prevalence and correlates of HIV infection among female sex workers in 2 Mexico-US border cities. J Infect Dis. 2008 Mar 1;197(5):728-32. doi: 10.1086/527379.
PubMed 18260766Burgos JL, Gaebler JA, Strathdee SA, Lozada R, Staines H, Patterson TL. Cost-effectiveness of an intervention to reduce HIV/STI incidence and promote condom use among female sex workers in the Mexico-US border region. PLoS One. 2010 Jun 30;5(6):e11413. doi: 10.1371/journal.pone.0011413.
PubMed 20617193Loza O, Patterson TL, Rusch M, Martinez GA, Lozada R, Staines-Orozco H, Magis-Rodriguez C, Strathdee SA; Proyecto Mujer Segura. Drug-related behaviors independently associated with syphilis infection among female sex workers in two Mexico-US border cities. Addiction. 2010 Aug;105(8):1448-56. doi: 10.1111/j.1360-0443.2010.02985.x. Epub 2010 Apr 27.
PubMed 20456292
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safer Sex Intervention for At-risk Women in Mexico
- ClinicalTrials.gov ID
- NCT00338845
- Acronym / sponsor ID
- R01MH065849
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Keywords
- STDs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2003
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 20 Jun 2006 (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 the Share Safer Sex Program in reducing sexual risk behaviors among female sex workers in four Mexican cities close to the U.S. 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 U.S. 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, Mexico's 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Share Safer Sex programParticipants will receive the Share Safer Sex counseling program |
| 2 | Active comparator | Behavioral: Standard didactic safer-sex counseling programParticipants will receive a standard didactic safer-sex counseling session |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Reports having had unprotected vaginal, oral, or anal sex at least once within 2 weeks prior to study entry
Key exclusion criteria (2 listed)
- Consistent use of condoms or dental dams for vaginal, oral, and anal sex with all clients within 2 weeks prior to study entry
- Duration of employment as an FSW is less than 2 weeks
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 |
|---|---|---|
| Share Safer Sex programThe Share Safer Sex intervention will consist of a single, 30 to 40 minute, one-on-one counseling session designed to increase personal awareness of the participant's current unsafe behaviors and the associated risks, help her understand her motivation to change, and increase her 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. | Behavioural | 1 |
| Standard didactic safer-sex counseling programThe 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, Mexico's National Center for AIDS Studies. | Behavioural | 2 |
Primary outcome
Frequency of unprotected vaginal, oral, and anal sex with clients and spouse or steady partner
Time frame: Measured at Month 6 post-treatment
2 secondary outcomes
STD incidence
Time frame: Measured at Month 6 post-treatment
Knowledge, self-efficacy, and positive outcome expectancies re: condom use
Time frame: Measured at Month 6 post-treatment
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 11 Apr 2013.
- Results publication: PubMed 18799768Patterson TL, Mausbach B, Lozada R, Staines-Orozco H, Semple SJ, Fraga-Vallejo M, Orozovich P, Abramovitz D, de la Torre A, Amaro H, Martinez G, Magis-Rodriguez C, Strathdee SA. Efficacy of a brief behavioral intervention to promote condom use among female sex workers in Tijuana and Ciudad Juarez, Mexico. Am J Public Health. 2008 Nov;98(11):2051-7. doi: 10.2105/AJPH.2007.130096. Epub 2008 Sep 17.
- Results publication: PubMed 18032996Strathdee SA, Lozada R, Semple SJ, Orozovich P, Pu M, Staines-Orozco H, Fraga-Vallejo M, Amaro H, Delatorre A, Magis-Rodriguez C, Patterson TL. Characteristics of female sex workers with US clients in two Mexico-US border cities. Sex Transm Dis. 2008 Mar;35(3):263-8. doi: 10.1097/OLQ.0b013e31815b0.
- Results publication: PubMed 18260766Patterson TL, Semple SJ, Staines H, Lozada R, Orozovich P, Bucardo J, Philbin MM, Pu M, Fraga M, Amaro H, Torre Ade L, Martinez G, Magis-Rodriguez C, Strathdee SA. Prevalence and correlates of HIV infection among female sex workers in 2 Mexico-US border cities. J Infect Dis. 2008 Mar 1;197(5):728-32. doi: 10.1086/527379.
- Derived from this study: PubMed 20617193Burgos JL, Gaebler JA, Strathdee SA, Lozada R, Staines H, Patterson TL. Cost-effectiveness of an intervention to reduce HIV/STI incidence and promote condom use among female sex workers in the Mexico-US border region. PLoS One. 2010 Jun 30;5(6):e11413. doi: 10.1371/journal.pone.0011413.
- Derived from this study: PubMed 20456292Loza O, Patterson TL, Rusch M, Martinez GA, Lozada R, Staines-Orozco H, Magis-Rodriguez C, Strathdee SA; Proyecto Mujer Segura. Drug-related behaviors independently associated with syphilis infection among female sex workers in two Mexico-US border cities. Addiction. 2010 Aug;105(8):1448-56. doi: 10.1111/j.1360-0443.2010.02985.x. Epub 2010 Apr 27.
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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 L. Patterson, PhD principal investigator
Dept. of Psychiatry, University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Share Safer Sex program and Standard didactic safer-sex counseling program in people with HIV Infections and Sexually Transmitted Diseases, run by University of California, San Diego at 1 site in Mexico.
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 1 inclusion and 2 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 11 Apr 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 Mexico. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Frequency of unprotected vaginal, oral, and anal sex with clients and spouse or steady partner (time frame: Measured at Month 6 post-treatment). 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 NCT00338845, which also lists 5 linked publications.
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 11 Apr 2013.