Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT00840658
Status:
COMPLETED
Last Update Posted:
2020-04-30
First Post:
2009-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Behavioral Intervention to Reduce Sexual and Injection Risks Among Female Sex Workers Who Also Inject Drugs in Mexico
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004347', 'term': 'Drug Interactions'}, {'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D000069437', 'term': 'Pharmacological Phenomena'}, {'id': 'D002620', 'term': 'Pharmacological and Toxicological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sstrathdee@ucsd.edu', 'phone': '(858) 822-1952', 'title': 'Steffanie Strathdee, PhD', 'organization': 'University of California, San Diego'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Observed important site differences at enrollment need to be considered in outcome analysis.'}}, 'adverseEventsModule': {'timeFrame': 'October 2008 through July 2010.', 'description': 'Participant reports; death certificates', 'eventGroups': [{'id': 'EG000', 'title': 'A: Didactic Safer Injection and Sexual Activity Education', 'description': "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.", 'otherNumAtRisk': 144, 'otherNumAffected': 0, 'seriousNumAtRisk': 144, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'B: Interactive Injection Risk Intervention and Didactic Safer', 'description': '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.', 'otherNumAtRisk': 146, 'otherNumAffected': 0, 'seriousNumAtRisk': 146, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'C:Interactive Sexual Risk Intervention & Didactic Safer', 'description': '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.', 'otherNumAtRisk': 148, 'otherNumAffected': 0, 'seriousNumAtRisk': 148, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'D: Interactive Injection and Sexual Risk Intervention', 'description': '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).', 'otherNumAtRisk': 146, 'otherNumAffected': 0, 'seriousNumAtRisk': 146, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'Participants Affected/at risk', 'notes': 'Deceased and lost to follow up due to circumstances beyond study participation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 146, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Serious and other'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Combined HIV/STI 12-month Incidence Rates of HIV, Syphilis, Chlamydia, Gonorrhea and Trichomonas Vaginalis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Didactic Safer Injection & Sexual Activity Education', 'description': "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).\n\nIn this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection."}, {'id': 'OG001', 'title': 'B: Interactive Injection Risk & Didactic Safer Sex Education', 'description': 'In each city, 75 women will participate in the 60 minute "Di No a las Jeringas Contaminadas" \\[\'Say No to Contaminated Syringes\'\\] counseling session.\n\nThis 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.\n\nIn 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.'}, {'id': 'OG002', 'title': 'C:Interactive Sexual Risk & Didactic Safer Injection Eductatio', 'description': 'In each city, 75 women will participate in the 60 minute "Di No Al Sexo Inseguro" \\[Say No to Unsafe Sex\'\\] counseling session.\n\nThis 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.\n\nIn 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.'}, {'id': 'OG003', 'title': 'D: Interactive Injection & Sexual Risk Intervention', 'description': '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.\n\nThis 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '65.02', 'groupId': 'OG000'}, {'value': '67.66', 'groupId': 'OG001'}, {'value': '35.02', 'groupId': 'OG002'}, {'value': '54.04', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline', 'description': '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.\n\nIn 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).\n\nThe 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.', 'unitOfMeasure': 'incidence density per 100 person years', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change (Baseline to 4-, 8-, and 12-months) in the Mean Number of Unprotected Sex Acts With Clients.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group (Arm C+Arm D)', 'description': 'The intervention group was created by combining Arm C (i.e., interactive sexual risk and didactic safer injection education) and Arm D (i.e., interactive sexual risk and interactive injection risk)'}, {'id': 'OG001', 'title': 'Control Group (Arm A+Arm B)', 'description': 'The control group was created by combining Arm A (i.e., didactic sexual risk and didactic safer injection education) and Arm B (i.e., didactic sexual risk and interactive injection risk).'}], 'classes': [{'title': 'Tijuana (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.91', 'spread': '46.79', 'groupId': 'OG000'}, {'value': '34.76', 'spread': '36.63', 'groupId': 'OG001'}]}]}, {'title': 'Tijuana (4-months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.83', 'spread': '25.81', 'groupId': 'OG000'}, {'value': '11.94', 'spread': '23.15', 'groupId': 'OG001'}]}]}, {'title': 'Tijuana (8-months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.27', 'spread': '16.28', 'groupId': 'OG000'}, {'value': '5.99', 'spread': '16.18', 'groupId': 'OG001'}]}]}, {'title': 'Tijuana (12-months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.60', 'spread': '14.58', 'groupId': 'OG000'}, {'value': '5.38', 'spread': '16.35', 'groupId': 'OG001'}]}]}, {'title': 'Ciudad Juarez (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.67', 'spread': '43.48', 'groupId': 'OG000'}, {'value': '54.10', 'spread': '94.38', 'groupId': 'OG001'}]}]}, {'title': 'Ciudad Juarez (4-months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.63', 'spread': '25.14', 'groupId': 'OG000'}, {'value': '24.09', 'spread': '41.50', 'groupId': 'OG001'}]}]}, {'title': 'Ciudad Juarez (8-months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.98', 'spread': '21.92', 'groupId': 'OG000'}, {'value': '20.77', 'spread': '42.23', 'groupId': 'OG001'}]}]}, {'title': 'Ciudad Juarez (12-months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.89', 'spread': '20.29', 'groupId': 'OG000'}, {'value': '18.76', 'spread': '26.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline', 'description': '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.', 'unitOfMeasure': 'Number of unprotected sex acts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The data was analyzed by study location. In Tijuana, there were 284 participants (143 in the intervention and 141 in the control group) and in Ciudad Juarez there were 300 participants (151 in the intervention and 149 in the control group).'}, {'type': 'SECONDARY', 'title': 'Change (Baseline to 4-, 8-, and 12-months) in the Proportional Odds of Higher Receptive Needle Sharing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group (Arm B+Arm D)', 'description': 'The Intervention Group was created by combining those who received Arm B (i.e., Interactive Injection Risk \\& Didactic Safer Sex Education) and Arm D(i.e., Interactive Injection \\&Sexual Risk Intervention).'}, {'id': 'OG001', 'title': 'Control Group (Arm A+ Arm C)', 'description': 'The Control Group was created by combining Arm A( i.e., those who received the Didactic Safer Injection \\& Sexual Activity Education) and Arm C (i.e., those who received Interactive Sexual Risk \\& Didactic Safer Injection Education).'}], 'classes': [{'title': 'Tijuana (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.01', 'groupId': 'OG000', 'lowerLimit': '2.18', 'upperLimit': '4.15'}, {'value': '2.83', 'groupId': 'OG001', 'lowerLimit': '2.14', 'upperLimit': '3.74'}]}]}, {'title': 'Tijuana (4 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.32', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '0.46'}, {'value': '0.26', 'groupId': 'OG001', 'lowerLimit': '0.18', 'upperLimit': '0.38'}]}]}, {'title': 'Tijuana (8 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.27'}, {'value': '0.16', 'groupId': 'OG001', 'lowerLimit': '0.11', 'upperLimit': '0.25'}]}]}, {'title': 'Tijuana (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.23'}, {'value': '0.13', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '0.21'}]}]}, {'title': 'Ciudad Juarez (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.45', 'groupId': 'OG000', 'lowerLimit': '1.79', 'upperLimit': '3.35'}, {'value': '1.911', 'groupId': 'OG001', 'lowerLimit': '1.40', 'upperLimit': '2.60'}]}]}, {'title': 'Ciudad Juarez (4 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '0.59', 'upperLimit': '1.23'}, {'value': '0.69', 'groupId': 'OG001', 'lowerLimit': '0.47', 'upperLimit': '1.02'}]}]}, {'title': 'Ciudad Juarez (8 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.53', 'groupId': 'OG000', 'lowerLimit': '0.37', 'upperLimit': '0.77'}, {'value': '0.71', 'groupId': 'OG001', 'lowerLimit': '0.49', 'upperLimit': '1.03'}]}]}, {'title': 'Ciudad Juarez (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.38', 'groupId': 'OG000', 'lowerLimit': '0.27', 'upperLimit': '0.55'}, {'value': '0.56', 'groupId': 'OG001', 'lowerLimit': '0.39', 'upperLimit': '0.79'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'P-value is for the Ciudad Juarez site and it corresponds to the interaction between group (Intervention vs. Control) and study visit (12-months vs. baseline).', 'groupDescription': 'Alternative hypothesis: There is a difference between the intervention and the control group with respect to the change in the odds of higher receptive needle sharing. (i.e., The interaction between study visit (baseline, 4-, 8-, and 12-months) and intervention group will be significant at 0.05 significance level. Over time, the intervention group will experience a significant decline in receptive needle sharing but the control group will not.)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'To examine the receptive needle sharing outcome, we used ordinal logistic regression for correlated data via GEE with the correlation matrix estimated empirically from the data. The final analyses were stratified by site. The final ordinal logistic regression models included the following main effects: Group, Visit, and Visit\\*Group interaction, with our primary interest in the Visit\\*Group interaction, as a significant p-value would be indicative of an intervention effect.'}], 'paramType': 'MEAN', 'timeFrame': '12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline', 'description': '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.', 'unitOfMeasure': 'Odds Receptive Needle Sharing', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses for the secondary outcomes were stratified by site. Of the total 292 participants in the Intervention Group, 142 were in Tijuana and 150 in Cd. Juarez. Similarly, of the 292 participants in the Control Group, 142 were in Tijuana and 150 in Cd Juarez.'}, {'type': 'SECONDARY', 'title': 'Change (Baseline to 4-, 8-, and 12-months) in the Mean Score of the Injection Risk Index (IRI).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group (Arm B+Arm D)', 'description': 'The Intervention Group was created by combining those who received Arm B (i.e., Interactive Injection Risk \\& Didactic Safer Sex Education) and Arm D(i.e., Interactive Injection \\&Sexual Risk Intervention).'}, {'id': 'OG001', 'title': 'Control Group (Arm A+ Arm C)', 'description': 'The Control Group was created by combining Arm A( i.e., those who received the Didactic Safer Injection \\& Sexual Activity Education) and Arm C (i.e., those who received Interactive Sexual Risk \\& Didactic Safer Injection Education).'}], 'classes': [{'title': 'Tijuana (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.393', 'groupId': 'OG000', 'lowerLimit': '3.240', 'upperLimit': '3.553'}, {'value': '3.358', 'groupId': 'OG001', 'lowerLimit': '3.203', 'upperLimit': '3.520'}]}]}, {'title': 'Tijuana (4 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.916', 'groupId': 'OG000', 'lowerLimit': '1.723', 'upperLimit': '2.131'}, {'value': '1.855', 'groupId': 'OG001', 'lowerLimit': '1.673', 'upperLimit': '2.057'}]}]}, {'title': 'Tijuana (8 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.697', 'groupId': 'OG000', 'lowerLimit': '1.508', 'upperLimit': '1.910'}, {'value': '1.648', 'groupId': 'OG001', 'lowerLimit': '1.474', 'upperLimit': '1.844'}]}]}, {'title': 'Tijuana (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.551', 'groupId': 'OG000', 'lowerLimit': '1.382', 'upperLimit': '1.741'}, {'value': '1.542', 'groupId': 'OG001', 'lowerLimit': '1.368', 'upperLimit': '1.737'}]}]}, {'title': 'Ciudad Juarez (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.236', 'groupId': 'OG000', 'lowerLimit': '3.045', 'upperLimit': '3.439'}, {'value': '3.07', 'groupId': 'OG001', 'lowerLimit': '2.889', 'upperLimit': '3.267'}]}]}, {'title': 'Ciudad Juarez (4 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.418', 'groupId': 'OG000', 'lowerLimit': '2.200', 'upperLimit': '2.658'}, {'value': '2.362', 'groupId': 'OG001', 'lowerLimit': '2.142', 'upperLimit': '2.606'}]}]}, {'title': 'Ciudad Juarez (8 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.146', 'groupId': 'OG000', 'lowerLimit': '1.937', 'upperLimit': '2.378'}, {'value': '2.311', 'groupId': 'OG001', 'lowerLimit': '2.095', 'upperLimit': '2.549'}]}]}, {'title': 'Ciudad Juarez (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.827', 'groupId': 'OG000', 'lowerLimit': '1.657', 'upperLimit': '2.015'}, {'value': '2.070', 'groupId': 'OG001', 'lowerLimit': '1.879', 'upperLimit': '2.282'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'P-value is for the Ciudad Juarez site and it corresponds to the interaction between group (Intervention vs. Control) and study visit (12-months vs. baseline).', 'groupDescription': 'Alternative hypothesis: There is a difference between the intervention and the control group with respect to the change in the mean score IRI (i.e., The interaction between study visit (baseline, 4-, 8-, and 12-months) and intervention group will be significant at 0.05 significance level. Over time, the intervention group will experience a significant decline in the IRI but the control group will not.)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'We used gamma regression for correlated data via GEE, with the correlation matrix estimated empirically from the data. The final analyses were stratified by site. The final gamma regression models included the following main effects: Group, Visit, and Visit\\*Group interaction, with our primary interest in the Visit\\*Group interaction, as a significant p-value would be indicative of an intervention effect.'}], 'paramType': 'MEAN', 'timeFrame': '12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline', 'description': 'The injection risk index (IRI) was calculated by averaging the responses to the following five questions:\n\n1. 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?\n2. In the past month, how often was a new syringe used to divide the drug?\n3. In the past month, how often did you use a bottle-cap/spoon/cooker after someone else had used it?\n4. In the past month, how often did you use a cotton filter for a needle after someone else had used it?\n5. 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.', 'unitOfMeasure': 'IRI Score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses for the secondary outcomes were stratified by site. Of the total 292 participants in the Intervention Group, 142 were in Tijuana and 150 in Cd. Juarez. Similarly, of the 292 participants in the Control Group, 142 were in Tijuana and 150 in Cd Juarez.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'A: Didactic Safer Injection & Sexual Activity Education', 'description': "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).\n\nIn this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection."}, {'id': 'FG001', 'title': 'B: Interactive Injection Risk & Didactic Safer Sex Education', 'description': 'In each city, 75 women will participate in the 60 minute "Di No a las Jeringas Contaminadas" \\[\'Say No to Contaminated Syringes\'\\] counseling session.\n\nThis 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.\n\nIn 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.'}, {'id': 'FG002', 'title': 'C:Interactive Sexual Risk & Didactic Safer Injection Eductatio', 'description': 'In each city, 75 women will participate in the 60 minute "Di No Al Sexo Inseguro" \\[Say No to Unsafe Sex\'\\] counseling session.\n\nThis 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.\n\nIn 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.'}, {'id': 'FG003', 'title': 'D: Interactive Injection & Sexual Risk Intervention', 'description': '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.\n\nThis 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).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '146'}, {'groupId': 'FG002', 'numSubjects': '148'}, {'groupId': 'FG003', 'numSubjects': '146'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'We defined "completed" as having at least one follow-up visit', 'groupId': 'FG000', 'numSubjects': '139'}, {'comment': 'We defined "completed" as having at least one follow-up visit', 'groupId': 'FG001', 'numSubjects': '143'}, {'comment': 'We defined "completed" as having at least one follow-up visit', 'groupId': 'FG002', 'numSubjects': '143'}, {'comment': 'We defined "completed" as having at least one follow-up visit', 'groupId': 'FG003', 'numSubjects': '142'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '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.\n\nData Collection for this study has been completed and the study is in the analysis phase.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}, {'value': '584', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'A: Didactic Safer Injection & Sexual Activity Education', 'description': "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."}, {'id': 'BG001', 'title': 'B: Interactive Injection Risk & Didactic Safer Sex Education', 'description': '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.'}, {'id': 'BG002', 'title': 'C:Interactive Sexual Risk & Didactic Safer Injection Education', 'description': '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.'}, {'id': 'BG003', 'title': 'D: Interactive Injection & Sexual Risk Intervention', 'description': '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).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '2742', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '42'}, {'value': '32', 'spread': '2740', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '40'}, {'value': '34', 'spread': '2740', 'groupId': 'BG002', 'lowerLimit': '29', 'upperLimit': '40'}, {'value': '34', 'spread': '2940', 'groupId': 'BG003', 'lowerLimit': '28', 'upperLimit': '40'}, {'value': '33', 'spread': '2740', 'groupId': 'BG004', 'lowerLimit': '27', 'upperLimit': '40'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}, {'value': '584', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}, {'value': '584', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 584}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-17', 'studyFirstSubmitDate': '2009-02-07', 'resultsFirstSubmitDate': '2012-07-02', 'studyFirstSubmitQcDate': '2009-02-09', 'lastUpdatePostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-08-18', 'studyFirstPostDateStruct': {'date': '2009-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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.\n\nIn 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).\n\nThe 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.'}], 'secondaryOutcomes': [{'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', 'description': '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.'}, {'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', 'description': '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.'}, {'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', 'description': 'The injection risk index (IRI) was calculated by averaging the responses to the following five questions:\n\n1. 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?\n2. In the past month, how often was a new syringe used to divide the drug?\n3. In the past month, how often did you use a bottle-cap/spoon/cooker after someone else had used it?\n4. In the past month, how often did you use a cotton filter for a needle after someone else had used it?\n5. 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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Injection drug users', 'Female sex workers', 'STIs', 'HIV Seronegativity'], 'conditions': ['HIV', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '30126411', 'type': 'DERIVED', '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.'}, {'pmid': '23785451', 'type': 'DERIVED', '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.'}, {'pmid': '22891807', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose a highly efficient four-arm (factorial) trial to simultaneously test the efficacy of two behavioral interventions aimed at:\n\n* increasing condom use in the context of ongoing drug use and\n* decreasing needle and paraphernalia sharing\n\namong female sex workers who also inject drugs in two Mexican-U.S. border cities: Tijuana and Ciudad Juarez.', 'detailedDescription': 'Our specific aims are:\n\n* 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.\n* 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.\n* 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.\n* 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).\n* 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be biologically female\n* be at least 18 years old\n* report having exchanged sex for money, goods or drugs within the last month\n* report having injected drugs within the last month\n* report having unprotected vaginal or anal sex at least once in last 30 days\n* report sharing needles/syringes or other injection paraphernalia (i.e., cottons, cookers, water) at least once in the last month\n* live in Tijuana, Ciudad Juarez or its suburbs, as determined through municipal boundaries in each city\n* test HIV-negative at baseline\n* agree to receive antibiotic treatment for chlamydia, gonorrhea, syphilis trichomonas vaginalis or bacterial vaginosis if they test positive at baseline.\n\nExclusion Criteria:\n\nIf women report:\n\n* consistent use of condoms for vaginal and anal sex with all male partners during the previous month\n* not being able to provide verification of injection drug use (i.e. track marks)\n* not sharing needles/syringes or paraphernalia at least once in the last month\n* being under 18 years of age\n* being male or transgender\n* being incapable of giving informed consent\n* planning to permanently move outside of the municipal boundaries of Tijuana or Ciudad Juarez within the next year.'}, 'identificationModule': {'nctId': 'NCT00840658', 'acronym': 'FSW-IDU', 'briefTitle': 'Behavioral Intervention to Reduce Sexual and Injection Risks Among Female Sex Workers Who Also Inject Drugs in Mexico', 'nctIdAliases': ['NCT01719939'], 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Epidemiologic Study on Changing HIV Risks Among FSW-IDUs on the Mexico-US Border', 'orgStudyIdInfo': {'id': 'DESPR R01DA023877'}, 'secondaryIdInfos': [{'id': 'R01DA023877', 'link': 'https://reporter.nih.gov/quickSearch/R01DA023877', 'type': 'NIH'}, {'id': '5R01DA023877-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01DA023877-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group A', '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.", 'interventionNames': ['Behavioral: Lecture-format presentation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', '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.', 'interventionNames': ['Behavioral: Interactive Injection Risk Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', '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.', 'interventionNames': ['Behavioral: Interactive Sexual Risk Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Group D', '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).', 'interventionNames': ['Behavioral: Interactive injection and sexual risk intervention']}], 'interventions': [{'name': 'Interactive injection and sexual risk intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Motivational Interviewing'], 'description': '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).', 'armGroupLabels': ['Group D']}, {'name': 'Interactive Sexual Risk Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Motivational interviewing'], 'description': '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).', 'armGroupLabels': ['Group C']}, {'name': 'Interactive Injection Risk Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Motivational interviewing'], 'description': '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.', 'armGroupLabels': ['Group B']}, {'name': 'Lecture-format presentation', 'type': 'BEHAVIORAL', 'otherNames': ['Control'], 'description': "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.", 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ciudad Juárez', 'state': 'Chihuahua', 'country': 'Mexico', 'facility': 'Sadec-Femap', 'geoPoint': {'lat': 31.72024, 'lon': -106.46084}}, {'zip': '22000', 'city': 'Tijuana', 'state': 'Estado de Baja California', 'country': 'Mexico', 'facility': 'PrevenCasa, AC', 'geoPoint': {'lat': 32.5027, 'lon': -117.00371}}], 'overallOfficials': [{'name': 'Steffanie A Strathdee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steffanie Strathdee', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'University of California, San Diego', 'class': 'OTHER'}, {'name': 'ISSESALUD', 'class': 'UNKNOWN'}, {'name': 'Universidad Autonoma de Ciudad Juarez', 'class': 'OTHER'}, {'name': 'Northeastern University', 'class': 'OTHER'}, {'name': 'San Diego State University', 'class': 'OTHER'}, {'name': 'University of California, Los Angeles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Steffanie Strathdee', 'investigatorAffiliation': 'University of California, San Diego'}}}}