HIVNCT01280838
Safer Sex Intervention for Male Clients of Female Sex Workers in Tijuana, Mexico
A study testing Hombre Seguro in people with HIV and Sexually Transmitted Diseases, run by University of California, San Diego at 1 site in Mexico.
Trial summary
Behavioral interventions designed 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Sexually Transmitted Diseases
- What is being tested?
- Hombre Seguro
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2011to Feb 2015
- Phase
- Interventional
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 previous 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)
Who cannot join
- Consistent use of condoms for vaginal and anal sex with all FSWs during the previous 4 months
- Transgender male (i.e, biologically female)
- Tests HIV-positive at baseline
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Comisión de Salud Fronteriza México-Estados Unidos
Tijuana, Estado de Baja California, 22320
About this study
Behavioral interventions designed 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.e., sex without a condom) with FSWs as well as their rates of infection with HIV and STIs. 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 numbers of people crossing the border in both directions, many of them specifically to purchase sex from FSWs in Tijuana.
Read the detailed description
Interventions designed to reduce STI/HIV risk have mostly failed to consider clients of FSWs, who may act as a 'bridge' to the general population. Our recent survey of U.S and Mexican clients seeking FSWs in Tijuana revealed a startling HIV prevalence rate of 4.1%. Based on qualitative and quantitative interviews with clients from Tijuana Mexico and the U.S. the investigators developed a theory-based intervention (Hombre Seguro) that uses Motivational Interviewing, active participation, and problem solving to increase clients' use of condoms with FSWs. The investigators now propose an RCT to test the efficacy of this one-hour intervention in Tijuana which will enroll 400 HIV-negative men (200 residents of San Diego County; 200 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.S. versus Mexican clients; 3) determine the extent to which theoretically-based components of our intervention (e.g., self-efficacy) represent underlying mechanisms of change in primary outcomes (e.g., lower HIV/STI incidence); and 4) explore subgroup differences in efficacy of the intervention based on background characteristics (e.g., age), contextual factors (e.g., substance use before/during sex), psychosexual factors (e.g., social-sexual effectiveness), and psychosocial factors (e.g., social network influence). Our primary analytic approach will utilize a generalized linear mixed models (GLMM) approach to repeated measures analysis. This bi-national study will contribute significantly 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.
- Conditions
- HIV, Sexually Transmitted Diseases
- Being tested
- Hombre Seguro, Didactic attention-control condition
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hombre SeguroBehavioural
A theory-based intervention that uses principles of behavior change derived from Social Cognitive Theory (SCT), Cognitive Behavioral Therapy (CBT), Theory of Reasoned Action (TRA), and MI to increase clients' use of condoms with FSWs.
Didactic attention-control conditionBehavioural
The didactic control condition is a modified version of the CDC's revised guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). The one-session, 60-minute counseling intervention focuses on HIV and STI prevention, risk appraisal, and the development of a risk reduction plan.
| Study group | Role | What they receive |
|---|---|---|
| Theory-based behavioral intervention | Experimental | Participants in this arm will receive a single-session, theory-based intervention (Hombre Seguro) at baseline that uses principles of behavior change derived from Social Cognitive Theory (SCT), Cognitive Behavioral Therapy (CBT), Theory of Reasoned Action (TRA), and Motivational Interviewing (MI) to increase clients' use of condoms with FSWs. The intervention lasts approximately 45 minutes. Receives: Behavioral: Hombre Seguro |
| Didactic attention-control condition | Active comparator | The didactic control condition is a modified version of the CDC's revised guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). The one-session, 60-minute counseling intervention focuses on HIV and STI prevention, risk appraisal, and the development of a risk reduction plan. Receives: Behavioral: Didactic attention-control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of unprotected vaginal or anal sex acts with a female sex worker
Participants will be asked to specify the number 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.
Measured: 12 months
Secondary outcomes (2)
HIV status
Participants will be tested for the presence of HIV antibodies at baseline and at 12 months post-baseline.
Measured: 12 months
STI status
Participants will be tested for syphilis, gonorrhea, and chlamydia at baseline and at 12 months post-baseline.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas L. Patterson, University of California, San Diego
- Investigators
- Thomas L Patterson, Ph.D., Principal investigator, University of California, San DiegoCarlos Magis Rodriguez, MD, MPH, Study director, Comisión de Salud Fronteriza Mexico-Estados Unidos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280838
- Sponsor's protocol ID
- DA029008
- Status last verified
- May 2015
- First submitted
- 19 Jan 2011
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pitpitan EV, Chavarin CV, Semple SJ, Magis-Rodriguez C, Strathdee SA, Patterson TL. Hombre Seguro (Safe Men): a sexual risk reduction intervention for male clients of female sex workers. BMC Public Health. 2014 May 20;14:475. doi: 10.1186/1471-2458-14-475.
PubMed 24885949
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safer Sex Intervention for Male Clients of Female Sex Workers in Tijuana, Mexico
- ClinicalTrials.gov ID
- NCT01280838
- Acronym / sponsor ID
- DA029008
- Conditions
- HIV, Sexually Transmitted Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Jan 2011 (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.
Behavioral interventions designed 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.e., sex without a condom) with FSWs as well as their rates of infection with HIV and STIs. 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 numbers of people crossing the border in both directions, many of them specifically to purchase sex from FSWs in Tijuana.
Detailed description
Interventions designed to reduce STI/HIV risk have mostly failed to consider clients of FSWs, who may act as a 'bridge' to the general population. Our recent survey of U.S and Mexican clients seeking FSWs in Tijuana revealed a startling HIV prevalence rate of 4.1%. Based on qualitative and quantitative interviews with clients from Tijuana Mexico and the U.S. the investigators developed a theory-based intervention (Hombre Seguro) that uses Motivational Interviewing, active participation, and problem solving to increase clients' use of condoms with FSWs. The investigators now propose an RCT to test the efficacy of this one-hour intervention in Tijuana which will enroll 400 HIV-negative men (200 residents of San Diego County; 200 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.S. versus Mexican clients; 3) determine the extent to which theoretically-based components of our intervention (e.g., self-efficacy) represent underlying mechanisms of change in primary outcomes (e.g., lower HIV/STI incidence); and 4) explore subgroup differences in efficacy of the intervention based on background characteristics (e.g., age), contextual factors (e.g., substance use before/during sex), psychosexual factors (e.g., social-sexual effectiveness), and psychosocial factors (e.g., social network influence). Our primary analytic approach will utilize a generalized linear mixed models (GLMM) approach to repeated measures analysis. This bi-national study will contribute significantly 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theory-based behavioral intervention | Experimental | Behavioral: Hombre SeguroParticipants in this arm will receive a single-session, theory-based intervention (Hombre Seguro) at baseline that uses principles of behavior change derived from Social Cognitive Theory (SCT), Cognitive Behavioral Therapy (CBT), Theory of Reasoned Action (TRA), and Motivational Interviewing (MI) to increase clients' use of condoms with FSWs. The intervention lasts approximately 45 minutes. |
| Didactic attention-control condition | Active comparator | Behavioral: Didactic attention-control conditionThe didactic control condition is a modified version of the CDC's revised guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). The one-session, 60-minute counseling intervention focuses on HIV and STI prevention, risk appraisal, and the development of a risk reduction plan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 previous 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)
Key exclusion criteria (3 listed)
- Consistent use of condoms for vaginal and anal sex with all FSWs during the previous 4 months
- Transgender male (i.e, biologically female)
- Tests HIV-positive at baseline
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 |
|---|---|---|
| Hombre SeguroA theory-based intervention that uses principles of behavior change derived from Social Cognitive Theory (SCT), Cognitive Behavioral Therapy (CBT), Theory of Reasoned Action (TRA), and MI to increase clients' use of condoms with FSWs. | Behavioural | Theory-based behavioral intervention |
| Didactic attention-control conditionThe didactic control condition is a modified version of the CDC's revised guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). The one-session, 60-minute counseling intervention focuses on HIV and STI prevention, risk appraisal, and the development of a risk reduction plan. | Behavioural | Didactic attention-control condition |
Primary outcome
Number of unprotected vaginal or anal sex acts with a female sex worker
Time frame: 12 months
Participants will be asked to specify the number 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.
2 secondary outcomes
HIV status
Time frame: 12 months
STI status
Time frame: 12 months
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 27 May 2015.
- Derived from this study: PubMed 24885949Pitpitan EV, Chavarin CV, Semple SJ, Magis-Rodriguez C, Strathdee SA, Patterson TL. Hombre Seguro (Safe Men): a sexual risk reduction intervention for male clients of female sex workers. BMC Public Health. 2014 May 20;14:475. doi: 10.1186/1471-2458-14-475.
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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, Ph.D. principal investigator
University of California, San Diego
Carlos Magis Rodriguez, MD, MPH study director
Comisión de Salud Fronteriza Mexico-Estados Unidos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hombre Seguro in people with HIV 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 5 inclusion and 3 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 27 May 2015. 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.
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?
Number of unprotected vaginal or anal sex acts with a female sex worker (time frame: 12 months). 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 NCT01280838, which also lists 1 linked publication.
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 27 May 2015.