Behavioral Intervention to Reduce Sexual and Injection Risks Among Female Sex Workers Who Also Inject Drugs in Mexico
FSW-IDU
Epidemiologic Study on Changing HIV Risks Among FSW-IDUs on the Mexico-US Border
3 other identifiers
interventional
584
1 country
2
Brief Summary
The investigators propose a highly efficient four-arm (factorial) trial to simultaneously test the efficacy of two behavioral interventions aimed at:
- increasing condom use in the context of ongoing drug use and
- decreasing needle and paraphernalia sharing among female sex workers who also inject drugs in two Mexican-U.S. border cities: Tijuana and Ciudad Juarez.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv
Started Oct 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 7, 2009
CompletedFirst Posted
Study publicly available on registry
February 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
September 18, 2012
CompletedApril 30, 2020
April 1, 2020
2.7 years
February 7, 2009
July 2, 2012
April 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Combined HIV/STI 12-month Incidence Rates of HIV, Syphilis, Chlamydia, Gonorrhea and Trichomonas Vaginalis.
Combined incidence for HIV/STI was calculated over the 12-month study period and included only those who a) had at least one follow-up visit and b) at baseline tested negative for HIV and any of the aforementioned STIs. In the calculations we accounted for the time each participant spent at risk of HIV/any STI during the follow-up period, by using available information on each participant for each time point (i.e. baseline, 4-, 8-, and 12-months was used). The analytic method used for this outcome analysis was Poisson regression with robust variance estimation. The outcome variable was a binary variable indicating whether a participant has contracted HIV or a new STI during the 12-month follow-up period. The primary factor of interest was the intervention group. The log ("time spent at risk of HIV/any STI") was used as an offset variable in order to account for the time spent at risk of HIV/any STI by each participant.
12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline
Secondary Outcomes (3)
Change (Baseline to 4-, 8-, and 12-months) in the Mean Number of Unprotected Sex Acts With Clients.
12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline
Change (Baseline to 4-, 8-, and 12-months) in the Proportional Odds of Higher Receptive Needle Sharing
12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline
Change (Baseline to 4-, 8-, and 12-months) in the Mean Score of the Injection Risk Index (IRI).
12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline
Study Arms (4)
Group A
PLACEBO COMPARATORDidactic safer injection \& sexual activity education: In each city, 75 women will participate in a 60 minute lecture-format presentation and printed materials on safer sex and safer injection based on CDC guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection.
Group B
ACTIVE COMPARATORInteractive injection risk intervention and didactic safer sex education: In each city, 75 women will participate in the 60 minute "Di No a las Jeringas Contaminadas" \['Say No to Contaminated Syringes'\] counseling session. This one-on-one intervention incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory and Theory of Reasoned Action (SCT/TRA) to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared. In addition, participants will be provided a lecture-format presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex.
Group C
ACTIVE COMPARATORInteractive sexual risk intervention and didactic safer injection education: In each city, 75 women will participate in the 60 minute "Di No Al Sexo Inseguro" \[Say No to Unsafe Sex'\] counseling session. This one on one intervention incorporates elements of MI and principles of Social Cognitive Theory and Theory of Reasoned Action (SCT/TRA) to address the context of unsafe sex and condom use with clients. In addition, participants will be provided a lecture format presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior.
Group D
EXPERIMENTALInteractive injection and sexual risk intervention: In each city, 75 women will participate in the 60 minute "Di No a las Jeringas Contaminadas" \['Say No to Contaminated Syringes'\] and "Di No Al Sexo Inseguro" \[Say No to Unsafe Sex'\] counseling session. This one-on-one intervention incorporates elements of MI and principles of Social Cognitive Theory and Theory of Reasoned Action (SCT/TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., HIV (Human Immuno-deficiency Virus), STIs (Sexually Transmitted Infections), pregnancy).
Interventions
This is a one-on-one intervention that incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory (SCT) and Theory of Reasoned Action (TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., HIV (Human Immuno-deficiency Virus), STIs (Sexually Transmitted Infections), pregnancy).
This is a one-on-one intervention that incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory (SCT) and Theory of Reasoned Action (TRA) to address the context of unsafe sex and condom use with clients, and associated risks (e.g., HIV (Human Immuno-deficiency Virus), STIs (Sexually Transmitted Infections), pregnancy).
This is a one-on-one intervention that incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory (SCT) and Theory of Reasoned Action (TRA) to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared.
60 minute lecture-format presentation on safer sex and safer injection based on CDC guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). There are no theory-driven active skill building elements oriented towards safer sex or safer injection.
Eligibility Criteria
You may qualify if:
- be biologically female
- be at least 18 years old
- report having exchanged sex for money, goods or drugs within the last month
- report having injected drugs within the last month
- report having unprotected vaginal or anal sex at least once in last 30 days
- report sharing needles/syringes or other injection paraphernalia (i.e., cottons, cookers, water) at least once in the last month
- live in Tijuana, Ciudad Juarez or its suburbs, as determined through municipal boundaries in each city
- test HIV-negative at baseline
- agree to receive antibiotic treatment for chlamydia, gonorrhea, syphilis trichomonas vaginalis or bacterial vaginosis if they test positive at baseline.
You may not qualify if:
- If women report:
- consistent use of condoms for vaginal and anal sex with all male partners during the previous month
- not being able to provide verification of injection drug use (i.e. track marks)
- not sharing needles/syringes or paraphernalia at least once in the last month
- being under 18 years of age
- being male or transgender
- being incapable of giving informed consent
- planning to permanently move outside of the municipal boundaries of Tijuana or Ciudad Juarez within the next year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Steffanie Strathdeelead
- National Institute on Drug Abuse (NIDA)collaborator
- University of California, San Diegocollaborator
- ISSESALUDcollaborator
- Universidad Autonoma de Ciudad Juarezcollaborator
- Northeastern Universitycollaborator
- San Diego State Universitycollaborator
- University of California, Los Angelescollaborator
Study Sites (2)
Sadec-Femap
Ciudad Juárez, Chihuahua, Mexico
PrevenCasa, AC
Tijuana, Estado de Baja California, 22000, Mexico
Related Publications (3)
Jain JP, Bristow CC, Pines HA, Harvey-Vera A, Rangel G, Staines H, Patterson TL, Strathdee SA. Factors in the HIV risk environment associated with bacterial vaginosis among HIV-negative female sex workers who inject drugs in the Mexico-United States border region. BMC Public Health. 2018 Aug 20;18(1):1032. doi: 10.1186/s12889-018-5965-9.
PMID: 30126411DERIVEDStrathdee SA, Abramovitz D, Lozada R, Martinez G, Rangel MG, Vera A, Staines H, Magis-Rodriguez C, Patterson TL. Reductions in HIV/STI incidence and sharing of injection equipment among female sex workers who inject drugs: results from a randomized controlled trial. PLoS One. 2013 Jun 13;8(6):e65812. doi: 10.1371/journal.pone.0065812. Print 2013.
PMID: 23785451DERIVEDVera A, Abramovitz D, Lozada R, Martinez G, Rangel MG, Staines H, Patterson TL, Strathdee SA. Mujer Mas Segura (Safer Women): a combination prevention intervention to reduce sexual and injection risks among female sex workers who inject drugs. BMC Public Health. 2012 Aug 14;12:653. doi: 10.1186/1471-2458-12-653.
PMID: 22891807DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Observed important site differences at enrollment need to be considered in outcome analysis.
Results Point of Contact
- Title
- Steffanie Strathdee, PhD
- Organization
- University of California, San Diego
Study Officials
- PRINCIPAL INVESTIGATOR
Steffanie A Strathdee, PhD
University of California, San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 7, 2009
First Posted
February 10, 2009
Study Start
October 1, 2008
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
April 30, 2020
Results First Posted
September 18, 2012
Record last verified: 2020-04