HIVPhase 2FSW-IDUNCT00840658
Behavioral Intervention to Reduce Sexual and Injection Risks Among Female Sex Workers Who Also Inject Drugs in Mexico
A Phase 2 study testing Interactive injection and sexual risk intervention, Interactive Sexual Risk Intervention and Interactive Injection Risk Intervention in people with HIV and HIV Infections, run by Steffanie Strathdee at 2 sites in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, HIV Infections
- What is being tested?
- Interactive injection and sexual risk intervention, Interactive Sexual Risk Intervention and Interactive Injection Risk Intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 584 participants
- Where
- 2 sitesMexico
- Study dates
- Oct 2008to Jul 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Mexico2 sites
Sadec-Femap
Ciudad Juárez, Chihuahua
PrevenCasa, AC
Tijuana, Estado de Baja California, 22000
About this study
Official title: Epidemiologic Study on Changing HIV Risks Among FSW-IDUs on the Mexico-US Border
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.
Read the 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.
- Conditions
- HIV, HIV Infections
- Being tested
- Interactive injection and sexual risk intervention, Interactive Sexual Risk Intervention, Interactive Injection Risk Intervention, Lecture-format presentation
- Keywords
- HIV, Injection drug users, Female sex workers, STIs, HIV Seronegativity
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive injection and sexual risk interventionBehavioural
Also called Motivational Interviewing
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).
Interactive Sexual Risk InterventionBehavioural
Also called Motivational interviewing
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).
Interactive Injection Risk InterventionBehavioural
Also called Motivational interviewing
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.
Lecture-format presentationBehavioural
Also called Control
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | 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. Receives: Behavioral: Lecture-format presentation |
| Group B | Active comparator | 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. Receives: Behavioral: Interactive Injection Risk Intervention |
| Group C | Active comparator | 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. Receives: Behavioral: Interactive Sexual Risk Intervention |
| Group D | Experimental | 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). Receives: Behavioral: Interactive injection and sexual risk intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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
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. The intervention effect was evaluated by conducting ordinal logistic regression, with the frequency of receptive needle sharing as the outcome variable and Group (Intervention vs. Control), Visit (Baseline, 4-months, 8-months, and 12-months) and the interaction term between the two (Visit*Group) as the main effects. Our primary interest was the Visit*Group interaction, with a significant corresponding p-value being indicative of an intervention effect.
Measured: 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).
The injection risk index (IRI) was calculated by averaging the responses to the following five questions:
- 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?
- In the past month, how often was a new syringe used to divide the drug?
- In the past month, how often did you use a bottle-cap/spoon/cooker after someone else had used it?
- In the past month, how often did you use a cotton filter for a needle after someone else had used it?
- In the past month, how often did you use rinse water to clean needles after someone else had used it? The possible responses to the questions were coded as follows: 0=never, 1=sometimes, 2=about half the time, 3=often, 4=always. Before averaging the responses to the five questions, the responses to the second question were reversed coded to yield the same direction as the responses to the other four questions. IRI range: 0-20. Higher IRI-->higher risk.
Measured: 12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startOct 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steffanie Strathdee
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of California, San Diego, ISSESALUD, Universidad Autonoma de Ciudad Juarez, Northeastern University, San Diego State University, University of California, Los Angeles
- Responsible party
- Sponsor-investigator, Steffanie Strathdee, University of California, San Diego
- Investigators
- Steffanie A Strathdee, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840658
- Sponsor's protocol ID
- DESPR R01DA023877
- Other IDs
- R01DA023877, 5R01DA023877-02
- Acronym
- FSW-IDU
- Status last verified
- Apr 2020
- First submitted
- 7 Feb 2009
- Last updated
- 30 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 30126411Strathdee 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.
PubMed 23785451Vera 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.
PubMed 22891807
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Study on Changing HIV Risks Among FSW-IDUs on the Mexico-US Border
- ClinicalTrials.gov ID
- NCT00840658
- Acronym / sponsor ID
- FSW-IDU / DESPR R01DA023877
- Conditions
- HIV, HIV Infections
- Keywords
- HIV, Injection drug users, Female sex workers, STIs, HIV Seronegativity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- Steffanie StrathdeeUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of California, San Diego, ISSESALUD, Universidad Autonoma de Ciudad Juarez, Northeastern University, San Diego State University, University of California, Los Angeles
- Study start
- Oct 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 Feb 2009 (estimated)
- Results
- Posted 18 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Behavioral: Lecture-format presentationDidactic 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 comparator | Behavioral: Interactive Injection Risk InterventionInteractive 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 comparator | Behavioral: Interactive Sexual Risk InterventionInteractive 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 | Experimental | Behavioral: Interactive injection and sexual risk interventionInteractive 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive injection and sexual risk interventionAlso: Motivational InterviewingThis 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). | Behavioural | Group D |
| Interactive Sexual Risk InterventionAlso: Motivational interviewingThis 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). | Behavioural | Group C |
| Interactive Injection Risk InterventionAlso: Motivational interviewingThis 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. | Behavioural | Group B |
| Lecture-format presentationAlso: Control60 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. | Behavioural | Group A |
Primary outcome
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
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.
3 secondary outcomes
Change (Baseline to 4-, 8-, and 12-months) in the Mean Number of Unprotected Sex Acts With Clients.
Time frame: 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
Time frame: 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).
Time frame: 12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30126411Jain 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.
- Derived from this study: PubMed 23785451Strathdee 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.
- Derived from this study: PubMed 22891807Vera 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.
- Division of Global Public Health, Department of Medicine, University of California, San DiegoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffanie A Strathdee, PhD principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interactive injection and sexual risk intervention, Interactive Sexual Risk Intervention and Interactive Injection Risk Intervention in people with HIV and HIV Infections, run by Steffanie Strathdee at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00840658, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020; AzTrials last refreshed its copy on 6 Nov 2026.