HIVNCT01465607
Implementation of an Efficacious Intervention for High Risk Women in Mexico
A study testing Mujer Segura and CENSIDA counseling program in people with HIV and Syphilis, run by University of California, San Diego at 4 sites in Mexico.
Trial summary
This project seeks to determine the personal and organizational conditions that are most conducive to the widespread adoption by community-based organizations (CBOs) of effective programs for reducing the spread of HIV and other sexually transmitted infections (STIs). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Mujer Segura and CENSIDA counseling program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,228 participants
- Where
- 4 sitesMexico
- Study dates
- Nov 2011to Apr 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Self-identify as female sex worker
- Exchanged sex for money, drugs, shelter, or other benefit in last 2 months
- Had unprotected anal or vaginal sex with male client at least once in last 2 months
- Agree to be tested for HIV \& STIs at baseline and 6-month follow-u0
Who cannot join
- Previous positive HIV test result
Trial locations and contacts
4 sites in 1 country.
Mexico4 sites
CSM Guadalajara
Guadalajara, Jalisco, 44270
Centro de Servicios Medicos (CSM) Revolucion
Mexico City, D.f., 06080
CSM Naranjos
Naranjos, Veracruz, 92300
CSM Veracruz
Veracruz, Veracruz, 91910
About this study
This project seeks to determine the personal and organizational conditions that are most conducive to the widespread adoption by community-based organizations (CBOs) of effective programs for reducing the spread of HIV and other sexually transmitted infections (STIs). Taking a brief, single-session counseling program (called "Mujer Segura") that has been proven effective in reducing HIV and STIs in female sex workers who work in Mexican cities along the U.S. border, this project will study the implementation of the program in CBOs in 12 additional cities throughout Mexico to determine how best to ensure that the program remains true to the original model and retains its effectiveness. Mexico has been chosen because HIV is a global problem that respects no international borders, and because HIV prevention programs that can be implemented in settings with limited resources are urgently needed in many parts of the world.
- Being tested
- Mujer Segura, CENSIDA counseling program
- Keywords
- Condom use
- Medical subject headings
- Syphilis, Gonorrhea, Chlamydia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mujer SeguraBehavioural
Brief (35-minute) counseling intervention using techniques from Motivational Interviewing and principles of social cognitive theory (SCT) and theory of reasoned action (TRA).
CENSIDA counseling programBehavioural
Didactic HIV and STI counseling involving some personal risk assessment and presenting appropriate information on methods of transmission and for avoiding or reducing the risk of infection. Based on a counseling manual disseminated by CENSIDA, Mexico's federal HIV-AIDS prevention agency.
| Study group | Role | What they receive |
|---|---|---|
| Theory-based counseling (Mujer Segura) | Experimental | Will consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants. Receives: Behavioral: Mujer Segura |
| CENSIDA counseling program (didactic) | Active comparator | Will consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants. Receives: Behavioral: CENSIDA counseling program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in HIV and STI incidence relative to control group
Female sex worker (FSW) participants will be tested at baseline and 6-month follow-up for HIV, syphilis, gonorrhea, and Chlamydia. Incidence rates for all infections at 6-month follow-up will be compared between the theory-based Mujer Segura group (N=40 per clinic) and the standard counseling group (N=40 per clinic).
Measured: 6 months
Reduction in number of unprotected sex acts relative to control group
Female sex worker (FSW) participants will be assessed at baseline and 6-month follow-up using self-report measures of frequency of protected and unprotected sex acts with male clients. Changes in frequency at 6-month follow-up will be compared between the theory-based Mujer Segura group (N=40 per clinic) and the standard counseling group (N=40 per clinic).
Measured: 6 months
Secondary outcomes (1)
Fidelity to Mujer Segura intervention model
Counselors at each CBO will be assessed for their fidelity to the intervention protocol and assigned a numerical score. This number will be used to determine possible correlations between levels of fidelity and the efficacy of the Mujer Segura intervention at each clinic.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,228 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, Ph.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465607
- Sponsor's protocol ID
- R01MH087054
- Other IDs
- R01MH087054
- Status last verified
- May 2015
- First submitted
- 2 Nov 2011
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pitpitan EV, Semple SJ, Aarons GA, Palinkas LA, Chavarin CV, Mendoza DV, Magis-Rodriguez C, Staines H, Patterson TL. Factors associated with program effectiveness in the implementation of a sexual risk reduction intervention for female sex workers across Mexico: Results from a randomized trial. PLoS One. 2018 Sep 11;13(9):e0201954. doi: 10.1371/journal.pone.0201954. eCollection 2018.
PubMed 30204761Patterson TL, Semple SJ, Chavarin CV, Mendoza DV, Santos LE, Chaffin M, Palinkas LA, Strathdee SA, Aarons GA. Implementation of an efficacious intervention for high risk women in Mexico: protocol for a multi-site randomized trial with a parallel study of organizational factors. Implement Sci. 2012 Oct 29;7:105. doi: 10.1186/1748-5908-7-105.
PubMed 23107285
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
- Implementation of an Efficacious Intervention for High Risk Women in Mexico
- ClinicalTrials.gov ID
- NCT01465607
- Acronym / sponsor ID
- R01MH087054
- Keywords
- Condom use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,228 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 Nov 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.
This project seeks to determine the personal and organizational conditions that are most conducive to the widespread adoption by community-based organizations (CBOs) of effective programs for reducing the spread of HIV and other sexually transmitted infections (STIs). Taking a brief, single-session counseling program (called "Mujer Segura") that has been proven effective in reducing HIV and STIs in female sex workers who work in Mexican cities along the U.S. border, this project will study the implementation of the program in CBOs in 12 additional cities throughout Mexico to determine how best to ensure that the program remains true to the original model and retains its effectiveness. Mexico has been chosen because HIV is a global problem that respects no international borders, and because HIV prevention programs that can be implemented in settings with limited resources are urgently needed in many parts of the world.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theory-based counseling (Mujer Segura) | Experimental | Behavioral: Mujer SeguraWill consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants. |
| CENSIDA counseling program (didactic) | Active comparator | Behavioral: CENSIDA counseling programWill consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- Self-identify as female sex worker
- Exchanged sex for money, drugs, shelter, or other benefit in last 2 months
- Had unprotected anal or vaginal sex with male client at least once in last 2 months
- Agree to be tested for HIV \& STIs at baseline and 6-month follow-u0
Key exclusion criteria (1 listed)
- Previous positive HIV test result
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 |
|---|---|---|
| Mujer SeguraBrief (35-minute) counseling intervention using techniques from Motivational Interviewing and principles of social cognitive theory (SCT) and theory of reasoned action (TRA). | Behavioural | Theory-based counseling (Mujer Segura) |
| CENSIDA counseling programDidactic HIV and STI counseling involving some personal risk assessment and presenting appropriate information on methods of transmission and for avoiding or reducing the risk of infection. Based on a counseling manual disseminated by CENSIDA, Mexico's federal HIV-AIDS prevention agency. | Behavioural | CENSIDA counseling program (didactic) |
Primary outcome
Reduction in HIV and STI incidence relative to control group
Time frame: 6 months
Female sex worker (FSW) participants will be tested at baseline and 6-month follow-up for HIV, syphilis, gonorrhea, and Chlamydia. Incidence rates for all infections at 6-month follow-up will be compared between the theory-based Mujer Segura group (N=40 per clinic) and the standard counseling group (N=40 per clinic).
Reduction in number of unprotected sex acts relative to control group
Time frame: 6 months
Female sex worker (FSW) participants will be assessed at baseline and 6-month follow-up using self-report measures of frequency of protected and unprotected sex acts with male clients. Changes in frequency at 6-month follow-up will be compared between the theory-based Mujer Segura group (N=40 per clinic) and the standard counseling group (N=40 per clinic).
1 secondary outcome
Fidelity to Mujer Segura intervention model
Time frame: 6 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 30204761Pitpitan EV, Semple SJ, Aarons GA, Palinkas LA, Chavarin CV, Mendoza DV, Magis-Rodriguez C, Staines H, Patterson TL. Factors associated with program effectiveness in the implementation of a sexual risk reduction intervention for female sex workers across Mexico: Results from a randomized trial. PLoS One. 2018 Sep 11;13(9):e0201954. doi: 10.1371/journal.pone.0201954. eCollection 2018.
- Derived from this study: PubMed 23107285Patterson TL, Semple SJ, Chavarin CV, Mendoza DV, Santos LE, Chaffin M, Palinkas LA, Strathdee SA, Aarons GA. Implementation of an efficacious intervention for high risk women in Mexico: protocol for a multi-site randomized trial with a parallel study of organizational factors. Implement Sci. 2012 Oct 29;7:105. doi: 10.1186/1748-5908-7-105.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mujer Segura and CENSIDA counseling program in people with HIV and Syphilis, run by University of California, San Diego at 4 sites 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 1 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 4 sites 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?
Reduction in HIV and STI incidence relative to control group (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT01465607, which also lists 2 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 27 May 2015.