Clinical trial NCT00840658: Behavioral Intervention to Reduce Sexual and Injection Risks Among Female Sex Workers Who Also Inject Drugs in Mexico
Official title: Epidemiologic Study on Changing HIV Risks Among FSW-IDUs on the Mexico-US Border
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
HIV Infections
Keywords: HIV
Injection drug users
Female sex workers
STIs
HIV Seronegativity
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of California, San Diego
name: ISSESALUD
name: Universidad Autonoma de Ciudad Juarez
name: Northeastern University
name: San Diego State University
name: University of California, Los Angeles
First posted: 2009-02-10
Enrollment: 584
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: Combined HIV/STI 12-month Incidence Rates of HIV, Syphilis, Chlamydia, Gonorrhea and Trichomonas Vaginalis.
timeFrame: 12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline
Secondary outcomes:
measure: Change (Baseline to 4-, 8-, and 12-months) in the Mean Number of Unprotected Sex Acts With Clients.
timeFrame: 12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline
measure: Change (Baseline to 4-, 8-, and 12-months) in the Proportional Odds of Higher Receptive Needle Sharing
timeFrame: 12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline
measure: Change (Baseline to 4-, 8-, and 12-months) in the Mean Score of the Injection Risk Index (IRI).
timeFrame: 12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: PrevenCasa, AC
state: Baja California
city: Ciudad Juarez
country: Mexico
facility: Sadec-Femap
state: Chihuahua
Study officials:
affiliation: University of California, San Diego
name: Steffanie A Strathdee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Strathdee 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.
citation: Vera 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.