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Background: Methamphetamine (MA) use has been linked to engaging in sexual risk behaviors (SRBs) that are associated with HIV/STIs, particularly among men who have sex with men (MSM) and men who have sex with men and women (MSMW; hereafter MSM/W). The objectives of this analysis were to determine whether reduced MA is associated with decreases in SRBs in a sample of MSM/W.
Method: Data came from the ADAPT-2 trial, a randomized, double-blind, two-stage sequential parallel design trial evaluating extended-release injectable naltrexone (NTX) and oral bupropion (BUP) vs. placebo for MA use disorder. In the first 6 weeks of the trial (stage 1), participants were randomized to receive NTX-BUP or placebo. In the second 6 weeks, participants in the placebo group who did not have a treatment response were rerandomized (stage 2). For this secondary analysis, the independent variable was the number of MA-negative urine drug screens (UDS). The dependent variables included three different types of SRBs. Regression models of the independent and dependent variables were adjusted for age, race/ethnicity status, marital status, treatment assignment, and baseline SRBs.
Results: Of the 151 participants, median age was 40 years and majority were non-Hispanic white (52%) and completed more than high school education (82%). Each additional MA-negative UDS was associated with a 7% (adjusted rate ratio (aRR) =0.93; 95% CI, 0.87, 0.99) reduction in total number of sex partners in stage 2 only. Each additional MA-negative UDS was associated with a 13% (aRR =0.87 95%; confidence interval (CI), (0.76, 0.98)) and 9% (aRR =0.91; 95% CI, 0.84, 0.99) reduction in number of condomless sexual encounters in stage 1 and stage 2, respectively. Lastly, each additional MA-negative UDS was associated with a 16% (aRR =0.84; 95% (CI), 0.75, 0.94)) and 27% (aRR =0.73; 95% CI, 0.64, 0.84) reduction in number of sexual encounters when high on MA.
Conclusions: Our analysis showed that reductions in MA use was associated with reductions in several sexual risk behaviors associated with HIV/STI. These findings provide further support for exploring reductions in sexual risk behaviors as a clinical endpoint in future treatment interventions for MA use.
Related protocols: CTN-0068
This poster reports on an initiative to implement HIV rapid testing in substance abuse treatment programs in the state of South Carolina. A multi-agency collaboration between the Single State Authority, the state Health Department, the regional Addiction Technology Transfer Center (ATTC), and one substance abuse treatment program (Lexington-Richland Alcohol and Drug Abuse Council (LRADAC)), facilitated state-wide implementation. LRADAC, a community-based treatment program, was one of twelve sites that participated in the CTN trial on HIV rapid testing (protocol CTN-0032). Upon completion of the trial, LRADAC implemented a rapid HIV testing and counseling program as a clinical service. South Carolina’s previous efforts to implement on-site rapid HIV testing in 10 pilot agencies had less than optimal success due to the absence of a successful model on which agencies could base their implementation plan. With support from the collaborating agencies, staff developed and presented a 2 1/2 day HIV testing and counseling curriculum at the annual SC School of Alcohol and Drug Studies in 2010. Following the successful completion of the course, participants were fully certified to conduct testing and counseling in their local programs. Course participants had the opportunity to learn the counseling and testing procedures that LRADAC staff found successful in implementing their program. Although challenging, implementing HIV testing program in substance abuse treatment programs is feasible for agencies. The multi-agency collaboration in South Carolina supported the development of an HIV testing and counseling course that was team taught and showcased a successful model on which implementation could be based. Consequently, this effort increased the likelihood that additional substance abuse agencies within the state would move forward with implementation.
Related protocols: CTN-0032
Although numerous studies have examined sexual and substance use behaviors that put people at risk for sexually transmitted infections including HIV, most focus on an overall measure of aggregate risk or a few simple and particular subtypes of sexual acts assessed in separate analyses. In this article, researchers introduce a more sensitive approach to assess how the relative characteristics of sex acts may determine the level of risk in which an individual chooses to engage.
Project AWARE, a randomized clinical trial conducted among 5012 patients in nine STD clinics across the U.S., is used to illustrate the approach. The study was guided by two aims: (1) describe a new approach to examine the count of sexual acts using a disaggregated repeated measures design and (2) show how this new approach can be used to evaluate interactions among different categories of sexual risk behaviors and other predictors of interest (such as gender/sexual orientation).
Profiles of different subtypes of sexual acts in the past 6 months were assessed. Potential interactions of the characteristics associated with each subtype which resulted in up to 48 distinct subtypes of sexual risk behaviors — sex with a primary/non-primary partner; partner’s HIV status; vaginal/anal sex; condom use; and substance use before or during sex act — can be examined. Specifically, researchers chose condom use and primary and non-primary status of partner as an application in this paper to illustrate this method. There were significantly more condomless sex acts (M = 23, SE = 0.9) and sex acts with primary partners (M = 27.1, SE = 0.9) compared to sex acts with condoms (M = 10.9, SE = 0.4, IRR = 2.10, 95% CI 1.91-2.32, p < .001) and sex acts with non-primary partner (M = 10.9, SE = 0.5, IRR = 2.5, 95% CI 2.33-2.78, p < .001). In addition, there were significant differences for the count of sexual risk behaviors among women who have sex with men (WSM), men who have sex with women (MSW) and men who have sex with men (MSM) for sex acts with and without condom use, primary and non-primary partner, and their interaction (ps = .03, < .0001, and .001, respectively).
Conclusions: This approach extends our understanding of how people make choices among sexual behaviors and may be useful in future research on disaggregated characteristics of sex acts.
Related protocols: CTN-0032, Project AWARE
Although HIV risk behaviors such as substance use and condomless sex are prevalent among people currently seeking or receiving services at substance use disorder (SUD) treatment programs, associations with housing status in this population have not been well studied. This study examined the associations between housing status, substance use, and HIV-related sexual risk behaviors among 1281 participants from 12 U.S. community-based SUD programs. In addition, substance use was examined as a potential mediator of the relationship between housing status and sexual risk behaviors.
Researchers conducted Chi-square, univariate, and multivariate logistic regression models on data from the NIDA Clinical Trials Network HIV Rapid Testing and Counseling study (CTN-0032). Path analysis was used to test the mediation and indirect effects.
Unstable housing was significantly associated with having multiple concurrent condomless sex partners, condomless sex with non-primary partners, and partners of unknown HIV serostatus. Homelessness was significantly associated with condomless vaginal sex and condomless sex with any substance use. The path between unstable housing and sexual risk behaviors was mediated by problematic drug use, particularly by cocaine, opioids, and marijuana use.
Conclusions: Because housing status impacts HIV risk behaviors for individuals in SUD treatment programs, both housing status and substance use behaviors should be assessed upon program entry in order to identify and mitigate risk behaviors.
Related protocols: CTN-0032
African Americans who use substances experience a particular risk for HIV. Negative attitudes towards condoms are a strong predictor of risk and can serve as barriers to safe sex. They also vary by gender. In this secondary analysis of data from two NIDA Clinical Trials Network studies, CTN-0018 and CTN-0019, the relationship between gender, unprotected sex, and condom barriers among 203 African Americans in substance use treatment was examined.
Results indicated that no gender differences were present in unprotected sex. Men reported more motivational barriers to condom use and were more likely to believe that condoms would impede sexual experience (the latter not statistically significant). For both genders, the perception that condoms might negatively impact sexual experience was associated with unprotected sex. Gender did not moderate the relationship between condom barriers and unprotected sex.
Conclusions: These findings suggest the need for gender and race-specific prevention strategies that focus on motivation and address pleasure-based concerns regarding condoms. Substance use treatment facilities are well-positioned to support interventions to target these issues.
Related protocols: CTN-0018, CTN-0019
The NIDA National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) is devoted to the development of effective interventions for people who use substances across a variety of populations. When positive outcomes of a particular intervention do not generalize to other groups, adaptation may improve effectiveness for a different target group. However, currently limited information is available for involving community participation in cultural adaptation.
The current paper illustrates the evolution of our methodology for community engaged cultural adaptation by describing a series of sexual health and substance use interventions. We highlight the transition from minimal community involvement (the Delphi process), to moderate community involvement (theater testing), to full community engagement in cultural adaptation. Ultimately, the results of these three projects led to the development of Community Collaborative Cultural Adaptation, a novel and concrete approach to cultural adaptation. This approach emphasizes the advantage of establishing academic/community partnerships for cultural adaptation to increase the effectiveness and sustainability of interventions.
Related protocols: CTN-0018
HIV prevention for women with substance use disorders is a public health priority. To identify characteristics associated with sexual risk among women in outpatient substance abuse treatment, this study categorized 809 screened women who participated in CTN-0019 into 3 groups: sexually inactive, sexually active with consistent condom use, and sexually active with inconsistent condom use.
Multinomial logistic regression analyses were used to examine demographics, substance use and treatment characteristics, and regional HIV seroprevalence as predictors of sexual risk behavior.
Younger age and attending psychosocial treatment for primary cocaine use (versus attending methadone maintenance treatment for primary opioid use) were significantly associated with being at higher HIV risk.
Conclusions: Grounded in data from a large, geographically heterogeneous, national sample of substance using women in substance abuse treatment, this study identified demographic and clinical characteristics among women with differing levels of HIV risk. Analyses examined established predictors of HIV risk behavior of enduring importance, including: (younger) age; having multiple partners; primary stimulant use; alcohol use; and community HIV risk (as indicated by estimated IDU HIV seroprevalence). HIV prevention should be tailored to address HIV risk in younger women in psychosocial treatment.
Related protocols: CTN-0019
The extent to which behavioral drug abuse treatments affect sexual risk behaviors is largely unknown. This study examined the impact of behavioral drug abuse treatments on sexual risk behaviors using an integrative data analysis approach across eight trials conducted within the NIDA Clinical Trials Network (CTN-0004, 0005, 0006, 0007, 0009, 0013, 0015, and 0021). Participants (N=1305) from eight randomized controlled trials who were sexually active at baseline were included in the pooled dataset; 48.7% were female, 64.1% self-identified as a racial/ethnic minority, with M (SD) age of 34.9 (9.6). Longitudinal logistic regression estimated the probability of risky sexual behavior (i.e., inconsistent condom use and/or > 1 sexual partner in past 30 days) post-intervention with an indicator variable (1 for post-intervention), study condition (control, intervention), and their interaction as predictors; the analysis employed random effects for each trial and included relevant control variables. Time-varying differences in effects based on weeks post-intervention were incorporated using interacted linear and quadratic terms with condition status. Approximately 84.2% reported risky sexual behaviors at baseline. The control and intervention conditions were 18.5 and 17.3 percentage points less likely to report risky sexual behavior post-intervention, respectively.
Conclusions: Results suggest decreasing rates of risky sex engagement until 8 weeks (control) or 9 weeks (intervention post-intervention; risky sexual behavior subsequently increased. Behavioral CTN trial participation was associated with decreased sexual risk behaviors in both the intervention and control trial conditions. Given the heterogeneity of treatment approaches employed across the 8 CTN trials, these results point to the effectiveness of behavioral drug abuse treatment to reduce sexual risk behaviors. To bolster further reductions in sexual risk behavior engagement, there is a need to identify HIV risk reduction interventions that can best be integrated within existing resource-limited substance use disorder treatment programs.
Related protocols: CTN-0004, CTN-0005, CTN-0006, CTN-0007, CTN-0009, CTN-0013, CTN-0015, CTN-0021
Sex risk behaviors and substance use are intertwined. Many men continue to engage in high-risk sexual behaviors even when enrolled in substance use disorder (SUD) treatment. We hypothesized that changes in sex risk behaviors would coincide with changes in drug/alcohol use severity among men in SUD treatment. During an HIV risk-reduction trial, CTN-0018, men in methadone maintenance and outpatient drug-free treatment (N=359) completed assessments at baseline and six months after. Changes in sex risk and substance use severity were assessed using the Addiction Severity Index-Lite (ASI-Lite), controlling for treatment condition.
In multinomial logistic regressions, decreased alcohol severity was significantly associated with decreases in reported sex partners, and increased alcohol severity was significantly associated with increases in reported sex partners. Increasing drug use severity was significantly associated with maintaining and initiating sex with a high-risk partner, while decreasing alcohol use severity was significantly associated with discontinuing sex under the influence. However, changes in drug/alcohol use severity were not associated with changes in unprotected sex.
Conclusions: Substance use reductions may decrease HIV risk behaviors among male substance users. Our findings highlight the importance of integrating interventions in SUD treatment settings that address the intersection of sex risk behaviors and substance use.
Related protocols: CTN-0018
The aim of this research was to explore the association of abuse experiences (child sexual abuse and adult physical/sexual violence) to sexual relationship power among Black substance-abusing women. The study was a secondary analysis of baseline data collected from 124 Black women in 12 drug treatment programs across the United States who initially participated in an HIV risk reduction trial conducted within the NIDA Clinical Trials Network. The findings revealed that adult sexual abuse, but not childhood sexual or adult physical abuse, was associated with lower relationship control and decision-making dominance as measured by the Sexual Relationship Power Scale.
Conclusions: These findings suggest that a history of adult sexual abuse may disempower Black substance-abusing women from negotiating for safer sex. That argues for addressing a history of adult sexual abuse as a strategy for empowering women to advocate for their sexual health. Designing and implementing sexual risk reduction interventions that address adult sexual violence may enhance the relationship power of Black substance-abusing women and in turn may promote safer sex practices.
Related protocols: CTN-0019
Sexual risk behavior is now the primary vector of HIV transmission among substance users in the United States with gender as a crucial moderator of risk behavior. This study examined gender differences in factors (age, race/ethnicity, education) that predict main-partner unprotected sexual occasions (USO) using the unique platform of two parallel NIDA Clinical Trials Network gender-specific safer sex intervention trials. Baseline assessments of male (N=430) and female (N=377) participants included demographic characteristics; past 3-month sexual activity; and a diagnostic assessment for alcohol, cocaine/stimulant, and opioid use disorders. Using mixed effects generalized linear modeling of the main outcome USO, two-way interactions of gender with age, race/ethnicity, and education were evaluated and adjusted by alcohol, cocaine/stimulant, or opioid use disorder.
When adjusted for alcohol use disorder, the interaction of education and gender was significant. For men, a high school or greater education was significantly associated with more USO compared to men with less than high school. For women, greater than high school education was significantly associated with less USO compared to women with a high school education. None of the other interactions were significant when adjusted for cocaine/stimulant or opioid use disorder.
Conclusions: This study demonstrates gender differences in the relationship of education, alcohol use disorder, and main-partner USO in individuals in substance abuse treatment. This underscores the importance of considering demographic and substance use factors in HIV sexual risk behavior and in crafting prevention messages for this population.
Related protocols: CTN-0018, CTN-0019
This study examined differences in sexual risk behaviors by gender and over time among 1281 patients (777 males and 504 females) from 12 community-based substance use disorder treatment programs throughout the United States participating in CTN-0032, a randomized controlled trial conducted within the NIDA Clinical Trials Network. Zero-inflated negative binomial and negative binomial models were used in the statistical analysis. Results indicated significant reductions in most types of sexual risk behaviors among substance users regardless of the intervention arms. There were also significant gender differences in sexual risk behaviors. Men (compared with women) reported more condomless sex acts with their non-primary partners (IRR=1.80, 95% CI 1.21–2.69) and condomless anal sex acts (IRR=1.74, 95% CI 1.11–2.72), but fewer condomless sex partners (IRR=0.87, 95% CI 0.77–0.99), condomless vaginal sex acts (IRR=0.83, 95%CI 0.69–1.00), and condomless sex acts within 2 hours of using drugs or alcohol (IRR=0.70, 95%CI 0.53–0.90).
Conclusions: Significant reductions in most types of sexual risk behaviors were observed among participants in substance use disorder treatment, in the forms of increased abstinence and decreased number of condomless sex acts. These findings provide evidence that substance use disorder treatment may lead to HIV risk reduction. For the most part, gender differences showed women to have higher levels of risk than men, having more unprotected sex with primary partners and partners of unknown HIV status than men. Women also reported 30% more condomless sex acts within two hours of using drugs or alcohol compared to men in the study group. Gender-specific intervention approaches are called for in substance use disorder treatment.
Related protocols: CTN-0032
Receptive anal sex has high human immunodeficiency virus (HIV) transmission risk, and heterosexual substance-abusing individuals report higher anal sex rates compared to their counterparts in the general population. This secondary analysis of two NIDA Clinical Trials Network studies (CTN-0018 and CTN-0019) evaluated the effectiveness of two gender-specific, evidence-based HIV prevention interventions (Real Men are Safe, or REMAS, for men; Safer Sex Skill Building, or SSSB, for women) against an HIV education (HIV-Ed) control condition on decreasing unprotected heterosexual anal sex (HAS) among substance abuse treatment-seeking men (n=171) and women (n=105). Two variables, engagement in any HAS and engagement in unprotected HAS, were assessed at baseline and three months post-intervention.
Compared to the control group, women in the gender-specific intervention did not differ on rates of any HAS at follow-up but significantly decreased their rates of unprotected HAS. Men in both the gender-specific and the control interventions reported less HAS and unprotected HAS at three-month follow-up compared to baseline, with no treatment condition effect.
Conclusions: Women and men showed different patterns when it came to unprotected HAS. For men, rates of unprotected HAS decreased overall in the sample, and patterns suggest the reduction may, at least partly, reflect their decreased rates of engaging in any HAS. On the other hand, SSSB women did show a decrease in unprotected HAS compared to controls despite no significant difference in overall HAS rates. For them, the results suggest the SSSB intervention did produce intentional action toward risk reduction. The mechanism of action for SSSB compared to REMAS in decreasing unprotected HAS is unclear. More attention to HAS in HIV-prevention interventions for heterosexual men and women in substance abuse treatment is warranted.
Related protocols: CTN-0018, CTN-0019
HIV counseling with testing has been part of HIV prevention in the U.S. since the 1980s. Despite the long-standing history of HIV testing with prevention counseling, the CDC released HIV testing recommendations for health care settings contesting benefits of prevention counseling with testing in reducing sexual risk behaviors among HIV-negatives in 2006. Efficacy of brief HIV risk-reduction counseling (RRC) in decreasing sexual risk among subgroups of substance use treatment clients was examined using multi-site, randomized controlled trial data from NIDA Clinical Trials Network protocol CTN-0032.
Interaction tests between RRC and subgroups were performed; multivariable regression evaluated the relationship between RRC (with rapid testing) and sex risk. Subgroups were defined by demographics, risk type and level, attitudes/perceptions, and behavioral history. There was an effect (p < .0028) of counseling on number of sex partners among some subgroups.
Conclusions: Results of the analyses on total number of partners suggest that brief, client-centered HIV risk-reduction counseling may be efficacious in reducing total number of sex partners among low-risk participants (e.g., those with no baseline risky sex and those already consistently using condoms) in substance use treatment. However, because the majority of subgroups investigated did not report fewer sexual risk behaviors (acts or partners), the overall findings of this study lend support to the CDC’s 2006 recommendation to provide routine HIV testing without requiring HIV risk-reduction counseling at the time of testing. Findings should be viewed with caution given the number of post hoc subgroup analyses that were performed.
HIV transmission often occurs through heterosexual high-risk sex. Even in the era of HIV combination prevention, promoting condom use and understanding barriers to consistent condom use remain priorities, especially among substance-dependent individuals.
This secondary analysis used data from CTN-0018 and CTN-0019, two NIDA Clinical Trials Network studies that compared a five-session gender-specific risk reduction group (Real Men Are Safe for men, Safer Sex Skills Building for women) to a one-session HIV Education Group for men and women (N=729) in outpatient drug treatment. Condom barriers (Motivation, Partner-Related, Access/Availability, Sexual Experience) were assessed at baseline and 6-month follow-up.
Intervention condition was not associated with condom barriers across any of the four domains; however, individuals who attended at least three of the five SSSB/REMAS sessions or the single session of HIV Education were more likely to report fewer motivation and partner-related barriers. Among women, reductions in motivation and sexual experience barriers were associated with less sexual risk with primary partners. For both men and women, reductions in partner-related barriers were associated with fewer unprotected vaginal/anal sex acts with primary partners.
Conclusions: Condom barriers are important to gender-specific HIV prevention; given limited resources, brief interventions maximizing active components are needed.
Related protocols: CTN-0018, CTN-0019