Trial Outcomes & Findings for Behavioral Intervention to Reduce Sexual and Injection Risks Among Female Sex Workers Who Also Inject Drugs in Mexico (NCT NCT00840658)
NCT ID: NCT00840658
Last Updated: 2020-04-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
584 participants
Primary outcome timeframe
12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline
Results posted on
2020-04-30
Participant Flow
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.
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.
Participant milestones
| Measure |
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).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
144
|
146
|
148
|
146
|
|
Overall Study
COMPLETED
|
139
|
143
|
143
|
142
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
5
|
4
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|---|---|---|
|
Overall Study
Death
|
2
|
2
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
2
|
1
|
Baseline Characteristics
Behavioral Intervention to Reduce Sexual and Injection Risks Among Female Sex Workers Who Also Inject Drugs in Mexico
Baseline characteristics by cohort
| Measure |
A: Didactic Safer Injection & Sexual Activity Education
n=144 Participants
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
n=146 Participants
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
n=148 Participants
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
n=146 Participants
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
n=584 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33 years
INTER_QUARTILE_RANGE 2742 • n=5 Participants
|
32 years
INTER_QUARTILE_RANGE 2740 • n=7 Participants
|
34 years
INTER_QUARTILE_RANGE 2740 • n=5 Participants
|
34 years
INTER_QUARTILE_RANGE 2940 • n=4 Participants
|
33 years
INTER_QUARTILE_RANGE 2740 • n=21 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
584 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Mexico
|
144 participants
n=5 Participants
|
146 participants
n=7 Participants
|
148 participants
n=5 Participants
|
146 participants
n=4 Participants
|
584 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 months, with measuring points at baseline and at 4, 8, and 12 months past baselineCombined 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.
Outcome measures
| Measure |
A: Didactic Safer Injection & Sexual Activity Education
n=139 Participants
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
n=143 Participants
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
n=143 Participants
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
n=142 Participants
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).
|
|---|---|---|---|---|
|
Combined HIV/STI 12-month Incidence Rates of HIV, Syphilis, Chlamydia, Gonorrhea and Trichomonas Vaginalis.
|
65.02 incidence density per 100 person years
|
67.66 incidence density per 100 person years
|
35.02 incidence density per 100 person years
|
54.04 incidence density per 100 person years
|
SECONDARY outcome
Timeframe: 12 months, with measuring points at baseline and at 4, 8, and 12 months past baselinePopulation: 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).
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.
Outcome measures
| Measure |
A: Didactic Safer Injection & Sexual Activity Education
n=294 Participants
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
n=290 Participants
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).
|
|---|---|---|---|---|
|
Change (Baseline to 4-, 8-, and 12-months) in the Mean Number of Unprotected Sex Acts With Clients.
Ciudad Juarez (4-months)
|
18.63 Number of unprotected sex acts
Standard Deviation 25.14
|
24.09 Number of unprotected sex acts
Standard Deviation 41.50
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Mean Number of Unprotected Sex Acts With Clients.
Ciudad Juarez (8-months)
|
15.98 Number of unprotected sex acts
Standard Deviation 21.92
|
20.77 Number of unprotected sex acts
Standard Deviation 42.23
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Mean Number of Unprotected Sex Acts With Clients.
Tijuana (Baseline)
|
37.91 Number of unprotected sex acts
Standard Deviation 46.79
|
34.76 Number of unprotected sex acts
Standard Deviation 36.63
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Mean Number of Unprotected Sex Acts With Clients.
Tijuana (4-months)
|
13.83 Number of unprotected sex acts
Standard Deviation 25.81
|
11.94 Number of unprotected sex acts
Standard Deviation 23.15
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Mean Number of Unprotected Sex Acts With Clients.
Tijuana (8-months)
|
5.27 Number of unprotected sex acts
Standard Deviation 16.28
|
5.99 Number of unprotected sex acts
Standard Deviation 16.18
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Mean Number of Unprotected Sex Acts With Clients.
Tijuana (12-months)
|
5.60 Number of unprotected sex acts
Standard Deviation 14.58
|
5.38 Number of unprotected sex acts
Standard Deviation 16.35
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Mean Number of Unprotected Sex Acts With Clients.
Ciudad Juarez (Baseline)
|
46.67 Number of unprotected sex acts
Standard Deviation 43.48
|
54.10 Number of unprotected sex acts
Standard Deviation 94.38
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Mean Number of Unprotected Sex Acts With Clients.
Ciudad Juarez (12-months)
|
11.89 Number of unprotected sex acts
Standard Deviation 20.29
|
18.76 Number of unprotected sex acts
Standard Deviation 26.53
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months, with measuring points at baseline and at 4, 8, and 12 months past baselinePopulation: 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.
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.
Outcome measures
| Measure |
A: Didactic Safer Injection & Sexual Activity Education
n=292 Participants
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
n=292 Participants
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).
|
|---|---|---|---|---|
|
Change (Baseline to 4-, 8-, and 12-months) in the Proportional Odds of Higher Receptive Needle Sharing
Tijuana (4 Months)
|
0.32 Odds Receptive Needle Sharing
Interval 0.23 to 0.46
|
0.26 Odds Receptive Needle Sharing
Interval 0.18 to 0.38
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Proportional Odds of Higher Receptive Needle Sharing
Tijuana (8 Months)
|
0.18 Odds Receptive Needle Sharing
Interval 0.12 to 0.27
|
0.16 Odds Receptive Needle Sharing
Interval 0.11 to 0.25
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Proportional Odds of Higher Receptive Needle Sharing
Tijuana (12 months)
|
0.15 Odds Receptive Needle Sharing
Interval 0.1 to 0.23
|
0.13 Odds Receptive Needle Sharing
Interval 0.08 to 0.21
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Proportional Odds of Higher Receptive Needle Sharing
Tijuana (Baseline)
|
3.01 Odds Receptive Needle Sharing
Interval 2.18 to 4.15
|
2.83 Odds Receptive Needle Sharing
Interval 2.14 to 3.74
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Proportional Odds of Higher Receptive Needle Sharing
Ciudad Juarez (baseline)
|
2.45 Odds Receptive Needle Sharing
Interval 1.79 to 3.35
|
1.911 Odds Receptive Needle Sharing
Interval 1.4 to 2.6
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Proportional Odds of Higher Receptive Needle Sharing
Ciudad Juarez (4 months)
|
0.85 Odds Receptive Needle Sharing
Interval 0.59 to 1.23
|
0.69 Odds Receptive Needle Sharing
Interval 0.47 to 1.02
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Proportional Odds of Higher Receptive Needle Sharing
Ciudad Juarez (8 months)
|
0.53 Odds Receptive Needle Sharing
Interval 0.37 to 0.77
|
0.71 Odds Receptive Needle Sharing
Interval 0.49 to 1.03
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Proportional Odds of Higher Receptive Needle Sharing
Ciudad Juarez (12 months)
|
0.38 Odds Receptive Needle Sharing
Interval 0.27 to 0.55
|
0.56 Odds Receptive Needle Sharing
Interval 0.39 to 0.79
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months, with measuring points at baseline and at 4, 8, and 12 months past baselinePopulation: 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.
The injection risk index (IRI) was calculated by averaging the responses to the following five questions: 1. 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? 2. In the past month, how often was a new syringe used to divide the drug? 3. In the past month, how often did you use a bottle-cap/spoon/cooker after someone else had used it? 4. In the past month, how often did you use a cotton filter for a needle after someone else had used it? 5. 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.
Outcome measures
| Measure |
A: Didactic Safer Injection & Sexual Activity Education
n=292 Participants
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
n=292 Participants
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).
|
|---|---|---|---|---|
|
Change (Baseline to 4-, 8-, and 12-months) in the Mean Score of the Injection Risk Index (IRI).
Tijuana (Baseline)
|
3.393 IRI Score
Interval 3.24 to 3.553
|
3.358 IRI Score
Interval 3.203 to 3.52
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Mean Score of the Injection Risk Index (IRI).
Tijuana (4 Months)
|
1.916 IRI Score
Interval 1.723 to 2.131
|
1.855 IRI Score
Interval 1.673 to 2.057
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Mean Score of the Injection Risk Index (IRI).
Tijuana (8 months)
|
1.697 IRI Score
Interval 1.508 to 1.91
|
1.648 IRI Score
Interval 1.474 to 1.844
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Mean Score of the Injection Risk Index (IRI).
Tijuana (12 months)
|
1.551 IRI Score
Interval 1.382 to 1.741
|
1.542 IRI Score
Interval 1.368 to 1.737
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Mean Score of the Injection Risk Index (IRI).
Ciudad Juarez (baseline)
|
3.236 IRI Score
Interval 3.045 to 3.439
|
3.07 IRI Score
Interval 2.889 to 3.267
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Mean Score of the Injection Risk Index (IRI).
Ciudad Juarez (4 months)
|
2.418 IRI Score
Interval 2.2 to 2.658
|
2.362 IRI Score
Interval 2.142 to 2.606
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Mean Score of the Injection Risk Index (IRI).
Ciudad Juarez (8 months)
|
2.146 IRI Score
Interval 1.937 to 2.378
|
2.311 IRI Score
Interval 2.095 to 2.549
|
—
|
—
|
|
Change (Baseline to 4-, 8-, and 12-months) in the Mean Score of the Injection Risk Index (IRI).
Ciudad Juarez (12 months)
|
1.827 IRI Score
Interval 1.657 to 2.015
|
2.070 IRI Score
Interval 1.879 to 2.282
|
—
|
—
|
Adverse Events
A: Didactic Safer Injection and Sexual Activity Education
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
B: Interactive Injection Risk Intervention and Didactic Safer
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
C:Interactive Sexual Risk Intervention & Didactic Safer
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
D: Interactive Injection and Sexual Risk Intervention
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A: Didactic Safer Injection and Sexual Activity Education
n=144 participants at risk
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
n=146 participants at risk
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
n=148 participants at risk
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
n=146 participants at risk
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).
|
|---|---|---|---|---|
|
Social circumstances
Participants Affected/at risk
|
3.5%
5/144 • Number of events 5 • October 2008 through July 2010.
Participant reports; death certificates
|
2.1%
3/146 • Number of events 3 • October 2008 through July 2010.
Participant reports; death certificates
|
5.4%
8/148 • Number of events 8 • October 2008 through July 2010.
Participant reports; death certificates
|
2.7%
4/146 • Number of events 4 • October 2008 through July 2010.
Participant reports; death certificates
|
Other adverse events
Adverse event data not reported
Additional Information
Steffanie Strathdee, PhD
University of California, San Diego
Phone: (858) 822-1952
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place