Behavioral Intervention to Reduce Sexual and Injection Risks Among Female Sex Workers Who Also Inject Drugs in Mexico (FSW-IDU)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of California, San Diego
ISSESALUD
Universidad Autonoma de Ciudad Juarez
Northeastern University
San Diego State University
University of California, Los Angeles
Information provided by (Responsible Party):
Steffanie Strathdee, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00840658
First received: February 7, 2009
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
HIV
HIV Infections
Behavioral: Interactive injection and sexual risk intervention
Behavioral: Interactive Sexual Risk Intervention
Behavioral: Interactive Injection Risk Intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Epidemiologic Study on Changing HIV Risks Among FSW-IDUs on the Mexico-US Border

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Combined HIV/STI 12-month Incidence Rates of HIV, Syphilis, Chlamydia, Gonorrhea and Trichomonas Vaginalis. [ Time Frame: 12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Change (Baseline to 4-, 8-, and 12-months) in the a)Mean Number of Unprotected Sex Acts With Clients and b)Ratio of Unprotected Sex Acts With Clients (Relative to the Number of Sex Acts With Clients. [ Time Frame: 12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline ] [ Designated as safety issue: No ]
    The analytic method used for a) was negative binomial regression with the number of unprotected sex acts with clients as the outcome variable and intervention group, time point (baseline, 4-, 8-, and 12-months), and the interaction between the two as the main effects of interest. Similarly, for part b) we used negative binomial regression, except that in this case log(total number of sex acts with clients) was used as an offset variable in order to create the ratio of unprotected sex acts (relative to total number of sex acts).

  • Change (Baseline to 4-, 8-, and 12-months) in the a) Proportional Odds of Higher Receptive Needle Sharing and b) Mean Score of the Injection Risk Index (IRI). [ Time Frame: 12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline ] [ Designated as safety issue: No ]

    For a) we asked: "In the past month, how often have you used a needle or syringe that you knew or suspected had been used before by someone else?" (possible responses: 1=never, 2=sometimes, 3=about half the time, 4=often, 5=always), with a higher response indicating a higher risk.

    Analyzed using ordinal logistic regression with frequency of receptive needle sharing as outcome variable and intervention group, time point, and interaction between the two as main effects of interest.

    For b)IRI calculated based on: receptive needle sharing, sharing a bottlecap/spoon/cooker, sharing cotton filter for a needle, or rinse water after someone else has used it, and using a used syringe to divide drugs. Score constructed by calculating average score between responses to injection risk indicators, with higher score representing higher risk. We analyzed using gamma regression with IRI as outcome and intervention group, time point and interaction between the two as main effects of interest



Enrollment: 584
Study Start Date: October 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group A
Didactic 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.
Active Comparator: Group B
Interactive 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.
Behavioral: Interactive Injection Risk Intervention
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.
Other Name: Motivational interviewing
Active Comparator: Group C
Interactive 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.
Behavioral: Interactive Sexual Risk Intervention
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).
Other Name: Motivational interviewing
Experimental: Group D
Interactive 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).
Behavioral: Interactive injection and sexual risk intervention
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).
Other Name: Motivational Interviewing

Detailed Description:

Our specific aims are:

  • Aim 1: To evaluate the efficacy of a behavioral intervention to decrease sharing of syringes and injection paraphernalia among FSW-IDUs. We hypothesize that FSW-IDUs in the active experimental injection risk reduction condition will report: (a) less receptive and distributive needle sharing; (b) less sharing of injection paraphernalia; (c) obtaining syringes and injection paraphernalia from safer sources.
  • Aim 2: To evaluate the efficacy of a behavioral intervention to increase condom use among FSW-IDUs in the context of ongoing drug use. We hypothesize that FSW-IDUs in the active experimental sexual risk reduction condition will: (a) report less unprotected vaginal and anal sex; and (b) have fewer incident cases of specific STIs.
  • Aim 3: To evaluate the joint effects of these two behavioral interventions to increase condom use and reduce sharing of needles and syringes/injection paraphernalia among FSW-IDUs. We hypothesize that the joint effect of these interventions will generate greater risk reductions compared to either intervention alone.
  • Aim 4: To determine the extent to which theoretically-important components of our interventions (i.e., self-efficacy, outcome expectancies, attitudes, intentions) represent underlying mechanisms of change in primary outcomes (i.e., sexual- and injection-related risk reductions).
  • Aim 5: To explore subgroup differences in the efficacy of: a) the sexual risk reduction, and b) the injection risk reduction intervention based on background characteristics, contextual factors, social factors and intrapersonal factors.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840658

Locations
Mexico
PrevenCasa, AC
Tijuana, Baja California, Mexico, 22000
Sadec-Femap
Ciudad Juarez, Chihuahua, Mexico
Sponsors and Collaborators
Steffanie Strathdee
University of California, San Diego
ISSESALUD
Universidad Autonoma de Ciudad Juarez
Northeastern University
San Diego State University
University of California, Los Angeles
Investigators
Principal Investigator: Steffanie A Strathdee, PhD University of California, San Diego
  More Information

Additional Information:
No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steffanie Strathdee, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00840658     History of Changes
Obsolete Identifiers: NCT01719939
Other Study ID Numbers: DESPR R01DA023877, R01DA023877, 5R01DA023877-02
Study First Received: February 7, 2009
Results First Received: July 2, 2012
Last Updated: January 16, 2013
Health Authority: United States: Federal Government
Mexico: Ministry of Health

Keywords provided by University of California, San Diego:
HIV
Injection drug users
Female sex workers
STIs
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 29, 2014