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
Results First Received: July 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: HIV
HIV Infections
Interventions: Behavioral: Interactive injection and sexual risk intervention
Behavioral: Interactive Sexual Risk Intervention
Behavioral: Interactive Injection Risk Intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Study recruitment took place between October 28, 2008 through May 31, 2010 in Tijuana and November 15, 2008 through July 30, 2010 in Ciudad Juarez.

Data Collection for this study has been completed and the study is in the analysis phase.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Targeted sampling techniques were used. Potential participants were approached at venues such as motels, hotels, brothels, shooting galleries, bars, alleys and street corners in both cities. Interested parties were referred to the project offices or a mobile unit for eligibility screening.

Reporting Groups
  Description
A: Didactic Safer Injection & Sexual Activity Education

In each city, 75 women will participate in a 60 minute didactic presentation and printed materials on safer sex and safer injection based on Centers for Disease Control and Prevention (CDC) guidelines for Human Immuno-deficiency Virus (HIV) counseling, testing, and referral and materials from Mexico's National Center for AIDS (Acquired Immuno-Deficiency Syndrome)Studies (CENSIDA).

In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection.

B: Interactive Injection Risk & 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-type presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex.

C:Interactive Sexual Risk & Didactic Safer Injection Eductatio

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-type presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior.

D: Interactive Injection & 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., Human Immuno-deficiency Virus (HIV)infection,Sexually Transmitted Infections (STIs, pregnancy).


Participant Flow:   Overall Study
    A: Didactic Safer Injection & Sexual Activity Education     B: Interactive Injection Risk & Didactic Safer Sex Education     C:Interactive Sexual Risk & Didactic Safer Injection Eductatio     D: Interactive Injection & Sexual Risk Intervention  
STARTED     144     146     148     146  
COMPLETED     139 [1]   143 [1]   143 [1]   142 [1]
NOT COMPLETED     5     3     5     4  
Death                 2                 2                 3                 3  
Lost to Follow-up                 3                 1                 2                 1  
[1] We defined "completed" as having at least one follow-up visit



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
B: Interactive Injection Risk & 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 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 didactic presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex.
C:Interactive Sexual Risk & 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 motivational interviewing (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.
D: Interactive Injection & 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 motivational interviewing (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, STIs, pregnancy).
Total Total of all reporting groups

Baseline Measures
    A: Didactic Safer Injection & Sexual Activity Education     B: Interactive Injection Risk & Didactic Safer Sex Education     C:Interactive Sexual Risk & Didactic Safer Injection Education     D: Interactive Injection & Sexual Risk Intervention     Total  
Number of Participants  
[units: participants]
  144     146     148     146     584  
Age  
[units: years]
Median ( Inter-Quartile Range )
  33  
  ( 27 to 42 )  
  32  
  ( 27 to 40 )  
  34  
  ( 29 to 40 )  
  34  
  ( 28 to 40 )  
  33  
  ( 27 to 40 )  
Gender  
[units: participants]
         
Female     144     146     148     146     584  
Male     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
Mexico     144     146     148     146     584  



  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   11/2012   Safety Issue:   No

3.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   11/2012   Safety Issue:   No


  Serious Adverse Events
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Time Frame October 2008 through July 2010.
Additional Description Participant reports; death certificates

Reporting Groups
  Description
A: Didactic Safer Injection and Sexual Activity Education In each city, 75 women will participate in a 60 minute didactic 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.
B: Interactive Injection Risk Intervention and Didactic Safer 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 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 didactic presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex.
C:Interactive Sexual Risk Intervention & Didactic Safer 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 SCT/TRA to address the context of unsafe sex and condom use with clients. In addition, participants will be provided a didactic presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior.
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 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, STIs, pregnancy).

Serious Adverse Events
    A: Didactic Safer Injection and Sexual Activity Education     B: Interactive Injection Risk Intervention and Didactic Safer     C:Interactive Sexual Risk Intervention & Didactic Safer     D: Interactive Injection and Sexual Risk Intervention  
Total, serious adverse events          
# participants affected / at risk     5/144 (3.47%)     3/146 (2.05%)     8/148 (5.41%)     4/146 (2.74%)  
Social circumstances          
Participants Affected/at risk * 1 [3]        
# participants affected / at risk     5/144 (3.47%)     3/146 (2.05%)     8/148 (5.41%)     4/146 (2.74%)  
# events     5     3     8     4  
* Events were collected by non-systematic assessment
1 Term from vocabulary, Serious and other
[3] Deceased and lost to follow up due to circumstances beyond study participation




  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Observed important site differences at enrollment need to be considered in outcome analysis.


  More Information