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

Steffanie Strathdee

Status and phase: Completed; Phase 2

Conditions: HIV; HIV Infections

Treatments: Behavioral: Interactive Injection Risk Intervention; Behavioral: Interactive injection and sexual risk intervention; Behavioral: Lecture-format presentation; Behavioral: Interactive Sexual Risk Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00840658

R01DA023877 (U.S. NIH Grant/Contract)

5R01DA023877-02 (U.S. NIH Grant/Contract)

DESPR R01DA023877

Details and patient eligibility

About

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.

Full 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.

Enrollment: 584 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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584 participants in 4 patient groups, including a placebo group

Group A

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Lecture-format presentation

Group B

Active Comparator group

Description:

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.

Treatment:

Behavioral: Interactive Injection Risk Intervention

Group C

Active Comparator group

Description:

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.

Treatment:

Behavioral: Interactive Sexual Risk Intervention

Group D

Experimental group

Description:

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).

Treatment:

Behavioral: Interactive injection and sexual risk intervention