Phase 2
N=584
Behavioral Intervention to Reduce Sexual and Injection Risks Among Female Sex Workers Who Also Inject Drugs in Mexico
HIV · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00840658 ↗Enrolled (actual)
584
Serious AEs
3.4%
Results posted
Sep 2012
Primary outcome: Primary: Combined HIV/STI 12-month Incidence Rates of HIV, Syphilis, Chlamydia, Gonorrhea and Trichomonas Vaginalis. — 65.02; 67.66; 35.02; 54.04 incidence density per 100 person years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Interactive injection and sexual risk intervention (Behavioral); Interactive Sexual Risk Intervention (Behavioral); Interactive Injection Risk Intervention (Behavioral); Lecture-format presentation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Steffanie Strathdee
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined HIV/STI 12-month Incidence Rates of HIV, Syphilis, Chlamydia, Gonorrhea and Trichomonas Vaginalis. |
65.02; 67.66; 35.02; 54.04 | — |
| SECONDARY Change (Baseline to 4-, 8-, and 12-months) in the Mean Number of Unprotected Sex Acts With Clients. |
37.91; 34.76; 13.83; 11.94; 5.27; 5.99 | — |
| SECONDARY Change (Baseline to 4-, 8-, and 12-months) in the Proportional Odds of Higher Receptive Needle Sharing |
3.01; 2.83; 0.32; 0.26; 0.18; 0.16 | 0.036 sig |
| SECONDARY Change (Baseline to 4-, 8-, and 12-months) in the Mean Score of the Injection Risk Index (IRI). |
3.393; 3.358; 1.916; 1.855; 1.697; 1.648 | 0.013 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00840658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.