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Abstract: Men who have sex with men who use substances (SU-MSM) can benefit from pre-exposure prophylaxis (PrEP) for HIV prevention, especially in Southern US cities where HIV incidence is high; however, uptake remains low. Identifying barriers and facilitators is crucial for developing and implementing strategies to enhance uptake. Few studies of PrEP barriers and facilitators have focused on Southern SU-MSM, and most existing studies have not robustly measured such barriers and facilitators. In this study, 225 SU-MSM were recruited from community STI clinics, syringe services programs, or substance use treatment programs in eight Southern cities. Using structural equation modeling, we examined latent variable constructs of barriers and facilitators (i.e., affordability, burden, risk compensation, side effects, and stigma) and their associations with both willingness to take PrEP and length of PrEP use. Greater concern over affordability was robustly associated with more willingness to take PrEP under a variety of conditions. Risk compensation was associated with greater length of PrEP use, suggesting a major motivator to remain on PrEP was the perceived freedom to forego condoms during sex. Findings advance research on measurement of barriers and facilitators of PrEP willingness and uptake and highlight the importance of addressing affordability in PrEP implementation. Related protocols: CTN-0082

Abstract:

This is one of the primary outcomes articles for CTN-0082.

In Southern U.S. states with high HIV incidence and low HIV Pre-Exposure Prophylaxis (PrEP) uptake, enhanced efforts to increase interest in and willingness to use PrEP are needed. This implementation survey examined the associations of sociodemographic background, substance use, and sexual risk behaviors with willingness to use daily oral and long-acting injectable (LAI) PrEP among substance using men who have sex with men (SU-MSM). Participants were 225 SU-MSM recruited from sexually transmitted infection (STI) clinics, syringe services programs (SSPs), and substance use treatment programs (SUTPs) in eight Southern U.S. cities. Rates of willingness were high for both daily oral PrEP (78%) and LAI PrEP (66%). In multivariable analyses, distinct factors were associated with willingness towards each. For daily oral PrEP, greater willingness was associated with condomless anal sex, less frequent non-injection opioid use, prior PrEP awareness, and past use of PrEP. For LAI PrEP, greater willingness was associated with Black race, identifying as gay, being single, and higher injection drug use frequency. Lower willingness to use LAI PrEP was associated with higher non-injection opioid use frequency. Findings about willingness to use LAI PrEP, as a relatively newer modality, and greater willingness among Black SU-MSM as a disproportionately HIV-impacted population, are especially important.

Conclusions: These findings argue for the necessity to enhance PrEP promotion efforts that distinguish between oral and LAI PrEP and that are specifically tailored to major SU-MSM subgroups in the Southern U.S.

Related protocols: CTN-0082

Abstract:

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

Abstract:

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

Abstract:

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

Abstract:

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

Abstract:

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

Abstract:

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

Abstract:

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

Abstract:

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

Abstract:

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

Abstract:

In the U.S., women who use drugs are at heightened susceptibility to HIV/STD heterosexual transmission. Drug treatment is a critical juncture at which to provide HIV/STD risk assessment, testing, risk reduction interventions, and linkage to treatment, as needed. To effectively implement interventions in busy drug treatment programs, it is important to have a rapid and accurate measure of sexual risk. This study compared 2 dichotomous ratings of unprotected sex among women in substance abuse treatment who participated in NIDA Clinical Trials Network study CTN-0019, “Reducing HIV/STD Risk Behaviors: A Research Study for Women in Drug Abuse Treatment”: (1) any unprotected vaginal/anal sex occasions in the last 3 months, versus (2) unprotected vaginal/anal sex at last sexual occasion (LSO). The two measures were derived from the Sexual Experiences and Risk Behavior Assessment Schedule (SERBAS). Sexually active women from 12 methadone maintenance or psychosocial outpatient programs who had a main (n = 363) or other male partner(s) (n = 117) were assessed at baseline for unprotected sex in the last 3 months and at LSO. These 2 measures were compared for congruence.

Analyses found that participants who reported unprotected sex at LSO consistently reported at least 1 unprotected sex occasion in the last 3 months: 99.1% for main male partner sex and 93.8% for other male partner sex. Participants who reported using a condom at LSO, however, were less consistent in terms of their behavior over the past 3 months: only 30.3% also reported protected sex at all sex occasions in the last 3 months with main male partner, with 67.6% reporting the same for other male partner(s).

Conclusions: This study suggests that use of one question about condom protected sex at LSO is a good indicator of the presence of sexual risk behavior during the past 3 months. If participants report unprotected sex at LSO, they are likely to have had at least one other unprotected encounter in the prior 3 months. Those reporting condom use at LSO may or may not have consistently used condoms over the prior 3 months; follow-up questions with this group will be necessary to adequately gauge risk.

Related protocols: CTN-0019

Abstract:

Although HIV prevention during substance abuse treatment is ideal, existing HIV risk-reduction interventions are less effective among Black and other ethnic minority substance abusers. The Sexual Health Model (SHM) and Person, Extended Family and Neighborhood-3 model (PEN-3) both highlight the importance of increasing our understanding of the relationship of sociocultural factors to sexual decision-making as a step towards developing more HIV prevention interventions for ethnic minorities. However, few studies examine sociocultural factors in the sexual decision-making process of Black substance abusing men. This secondary analysis of data collected in an evaluation of Real Men Are Safe (REMAS), an HIV prevention intervention, in the NIDA Clinical Trials Network (CTN) addressed this gap by examining the relation of two specific sociocultural factors (i.e., masculinity and perceived barriers to condom use) to the self-reported sexual behaviors of Black substance abusing men with their main and casual female partners.

Analyses of the baseline data of 126 Black men entering substance abuse treatment revealed that the endorsement of both personal and social masculinity predicted more unprotected sexual occasions (USO) with casual partners. The perception that condoms decreased sexual pleasure also predicted higher USO rates with casual partners. However, fewer partner barriers was not associated with USO among casual partners as expected. Neither the endorsement of social or personal masculinity or perceived condom barriers predicted USO with main partners.

Conclusions: These findings suggest that interventions that depict condom use as both pleasurable and congruent with Black male perceptions of masculinity may be more effective with Black substance abusing men than interventions focusing solely on health beliefs or education. Future research should continue to investigate the influence of other sociocultural factors, especially those that influence the sexual decision-making process, on sexual risk behaviors among Black men, as well as other groups.

Related protocols: CTN-0018

Abstract:

Sexual risk is an important, oft-neglected area in addiction treatment. This report examines computerized sexual risk assessment and client feedback at intake as a means of enhancing counselor awareness of client risk behavior during early treatment, as well as any clinical impact of that counselor awareness. In 2009-2011, new clients at two treatment programs participating in the Pacific Northwest Node of the National Drug Abuse Treatment Clinical Trials Network (one an opiate treatment program, the other drug-free) used a computer-assisted assessment at intake to endorse 90-day retrospective indices for: being sexually active, having multiple partners, having sex under drug influence, and inconsistently using condoms. Clients were randomly assigned in a 2:1 ratio to receive or not receive a personal feedback report, and those receiving a report chose if a counselor copy was also distributed. Ninety days later, retained clients (N=79) repeated the assessment and their counselors concurrently reported perceptions of recent client risk behavior.

Based on client reports, pretreatment risk behaviors were prevalent among men and women and remained so during treatment. A general linear model revealed greater counselor awareness of subsequent client risk behavior with mutual distribution of intake feedback reports to client and counselor, and at the opiate treatment program. A repeated-measures analysis of variance indicated that counselor awareness did not predict change in temporally stable patterns of sexual risk behavior.

Conclusions: Findings document that computerized intake assessment of sexual risk and mutually distributed feedback reports prompt greater counselor awareness of clients’ subsequent risk behavior. Future research is needed to determine how best to prepare counselors to use such awareness to effectively prompt risk reduction in routine care.

Abstract:

This CTN ancillary investigation aimed to examine predictors and moderators of response to two HIV sexual risk interventions of different content and duration for individuals in substance abuse treatment programs. Participants were recruited from community drug treatment programs participating in the National Drug Abuse Treatment Clinical Trials Network (CTN). Data were pooled from two parallel randomized controlled CTN studies, CTN-0018 and CTN-0019 (“Reducing HIV/STD Risk Behaviors: A Research Study for Men/Women in Drug Abuse Treatment”), each examining the impact of a multi-session HIV education intervention, on the degree of reduction in unprotected sex from baseline to 3- and 6-month follow-ups. The findings were analyzed using a zero-inflated negative binomial (ZINB) model.

Severity of drug use, gender, and age were significant main effect predictors of number of unprotected sexual occasions (USOs) at follow-up in the non-zero portion of the ZINB model (men, younger participants, and those with greater severity of drug/alcohol abuse have more USOs). Monogamous relationship status and race/ethnicity were significant predictors of having at least one USO vs. none (monogamous individuals and African Americans were more likely to have at least one USO). Significant moderators of intervention effectiveness included recent sex under the influence of drugs/alcohol, duration of abuse of the primary drug, and Hispanic ethnicity.

Conclusions: These predictor findings and moderator findings point to ways in which patients may be selected for the different HIV sexual risk reduction interventions and suggest potential avenues for further development of the interventions for increasing their effectiveness within certain subgroups, with particular attention to cultural sensitivity.

Related protocols: CTN-0018, CTN-0019