| ID | Type | Description | Link |
|---|---|---|---|
| R01DA023877 | U.S. NIH Grant/Contract | View source | |
| 5R01DA023877-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| University of California, San Diego | OTHER |
| ISSESALUD | UNKNOWN |
| Universidad Autonoma de Ciudad Juarez |
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The investigators propose a highly efficient four-arm (factorial) trial to simultaneously test the efficacy of two behavioral interventions aimed at:
among female sex workers who also inject drugs in two Mexican-U.S. border cities: Tijuana and Ciudad Juarez.
Our specific aims are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive injection and sexual risk intervention | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline |
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Inclusion Criteria:
Exclusion Criteria:
If women report:
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| Name | Affiliation | Role |
|---|---|---|
| Steffanie A Strathdee, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sadec-Femap | Ciudad Juárez | Chihuahua | Mexico | |||
| PrevenCasa, AC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30126411 | Derived | 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. | |
| 23785451 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| OTHER |
| Northeastern University | OTHER |
| San Diego State University | OTHER |
| University of California, Los Angeles | OTHER |
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|
| 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). |
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|
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| Interactive Sexual Risk Intervention | Behavioral | 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). |
|
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| Interactive Injection Risk Intervention | Behavioral | 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. |
|
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| Lecture-format presentation | Behavioral | 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. |
|
|
| 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. | 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:
| 12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline |
| Tijuana |
| Estado de Baja California |
| 22000 |
| Mexico |
| 22891807 | Derived | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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). |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | incidence density per 100 person years | 12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline |
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| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | Number of unprotected sex acts | 12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline |
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| Secondary | 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. | 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. | Posted | Mean | 95% Confidence Interval | Odds Receptive Needle Sharing | 12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline |
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| Secondary | 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:
| 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. | Posted | Mean | 95% Confidence Interval | IRI Score | 12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline |
|
October 2008 through July 2010.
Participant reports; death certificates
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 5 | 144 | 0 | 144 | ||
| EG001 | 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. | 3 | 146 | 0 | 146 | ||
| EG002 | 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. | 8 | 148 | 0 | 148 | ||
| EG003 | 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). | 4 | 146 | 0 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Participants Affected/at risk | Social circumstances | Serious and other | Non-systematic Assessment | Deceased and lost to follow up due to circumstances beyond study participation |
|
Not provided
Observed important site differences at enrollment need to be considered in outcome analysis.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steffanie Strathdee, PhD | University of California, San Diego | (858) 822-1952 | sstrathdee@ucsd.edu |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Not provided
| ID | Term |
|---|---|
| D004347 | Drug Interactions |
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D000069437 | Pharmacological Phenomena |
| D002620 | Pharmacological and Toxicological Phenomena |
| D010829 | Physiological Phenomena |
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
| Male |
|
| Units | Counts |
|---|
| Participants |
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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). |
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| OG001 | Control Group (Arm A+ Arm C) | 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). |
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