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Abstract: 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

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:

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

Abstract:

Current HIV testing guidelines recommend that all adolescents and adults aged 13–64 be routinely screened for HIV in healthcare settings. Sexually transmitted disease (STD) clinic patients represent a population at increased risk for HIV, justifying more frequent risk assessment and testing. This analysis describes missed opportunities for HIV testing among a sample of STD clinic patients to identify areas where HIV testing services may be improved. Secondary analysis was conducted using data from Project AWARE, a randomized trial of 5012 adult patients from 9 STD clinics in the United States, enrolled April–December 2010. HIV testing history, healthcare service utilization, and behavioral risks were obtained through audio computer-assisted self-interview. Missed opportunities for HIV testing, defined as having a healthcare visit but no HIV test in the last 12 months, were characterized by location and frequency. Of 2315 (46.2%) participants not tested for HIV in the last 12 months, 1715 (74.1%) had a missed opportunity for HIV testing. These missed opportunities occurred in both traditional (54.9% at family doctor, 20.3% at other medical doctor visits) and non-traditional (28.5% at dental, 19.0% at eye doctor, 13.9% at correctional facility, and 13.3% at psychology visits) testing settings. Of 53 participants positive for HIV at baseline, 16 (30.2%) had a missed testing opportunity. Missed opportunities for HIV testing were common in this population of STD clinic patients. There is a need to increase routinized HIV screening and expand testing services to a broader range of healthcare settings.

Related protocols: CTN-0032, Project AWARE

Abstract:

HIV testing is the foundation for consolidated HIV treatment and prevention. This study aimed to discover the most relevant variables for predicting HIV testing uptake among substance users in substance use disorder treatment programs by applying random forest (RF), a robust multivariate statistical learning method. It also provides a descriptive introduction to this method for those who are unfamiliar with it. This secondary analysis used data from the NIDA Clinical Trials Network HIV testing and counseling study (CTN-0032). A total of 1281 HIV-negative or status unknown participants from 12 U.S. community-based substance use disorder treatment programs were included and were randomized into three HIV testing and counseling groups. The a priori primary outcomes was self-reported receipt of HIV test results. Classification accuracy of RF was compared to logistic regression, a standard statistical approach for binary outcomes. Variable importance measures for the RF model were used to select the most relevant variables. RF based models produced much higher classification accuracy than those based on logistic regression. Treatment group is the most important predictor among all covariates, with a variable importance index of 12.9%. RF variable importance revealed that several types of condomless sex behaviors, condom use self-efficacy and attitudes towards condom use, and level of depression are the most important predictors of receipt of HIV testing results. There is a non-linear negative relationship between count of condomless sex acts and the receipt of HIV testing.

Conclusions: RF seems promising in discovering important factors related to HIV testing uptake among large numbers of predictors and should be encouraged in future HIV prevention and treatment research and intervention program evaluations.

Related protocols: CTN-0032

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:

Sexually transmitted infections (STIs) are significant public health and financial burdens in the United States. This manuscript examines the relationship between substance use and prevalent and incident STIs in HIV-negative adult patients at STI clinics.

A secondary analysis of Project AWARE was performed based on 5012 patients from 9 STI clinics. STIs were assessed by laboratory assay and substance use by self-report. Patterns of substance use were assessed using latent class analysis. The relationship of latent class to STI rates was investigated using Poisson regression by population groups at high risk for STIs defined by participant’s and partner’s gender.

Drug use patterns differed by risk group and substance use was related to STI rates with the relationships varying by risk behavior group. Substance use treatment participation was associated with increased STI rates.

Conclusion: Substance use focused interventions may be useful in STI clinics to reduce morbidity associated with substance use. Conversely, gender-specific sexual health interventions may be useful in substance use treatment.

Related protocols: CTN-0032, Project AWARE

Abstract:

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.

Abstract:

The NIDA Clinical Trials Network trial of rapid HIV testing/counseling in 1281 patients (protocol CTN-0032) was a unique opportunity to examine relationships among substance use, depressive symptoms, and sex risk behavior. In this ancillary examination of the study data, past 6-month substance use, substance use severity, depressive symptoms, and three types of sex risk behavior (unprotected sex occasions [USOs] with primary partners, with nonprimary partners, and while high/drunk) were assessed. Zero-inflated negative binomial analyses were provided: probability and rate of sex risk behavior (in risk behavior subsample). Levels of sexual risk behavior were high, while variable across the three types of sex risk behaviors. Among the patients, 50.4% has engaged in USOs with primary partners, 42% in sex while drunk or high, and 23.8% in USOs with nonprimary partners. Similar factors were significantly associated with all three types of sex risk behaviors. For all types, problem drinking, cocaine use, and substance use severity had an exacerbating effect. Older age was associated with lower risk behavior, other relationship categories (e.g., married, separated/divorced, cohabitating) were associated with greater risk behavior than was single status. Depressive symptoms were associated with decreased likelihood of USOs with a primary partner.

Conclusions: Sexual risk behavior is common among individuals in outpatient substance abuse treatment. Results highlight the roles of problem drinking (e.g., up to three-fold) and cocaine (e.g., up to twice) in increasing sex risk behavior. They also demonstrate the utility of distinguishing between partner types and presence/absence of alcohol/drugs during sex. Findings argue for the need to integrate sex risk reduction into drug treatment, in both the assessment and counseling process. Addressing sexual risk behavior may enhance relapse prevention in this vulnerable population.

Related protocols: CTN-0032

Abstract:

Substance users are at increased risk for HIV and HCV infection. Still, many substance use treatment programs (SUTP) fail to offer HIV/HCV testing. This secondary analysis of data from the National Drug Abuse Treatment Clinical Trials Network study CTN-0032, a multi-site randomized trial of rapid HIV testing, examines self-reported HIV/HCV testing patterns and serostatus of 2473 SUTP patients in 12 community-based sites that had not previously offered on-site testing. Results indicate that most respondents screened for the randomized trial tested more than a year prior to intake for HIV (52%) and HCV (38%). Prevalence rates were 3.6 and 30% for HIV and HCV, respectively. The majority of participants that were HIV (52.2%) and HCV-positive (40.5%) reported having been diagnosed within the last 1-5 years. Multivariable logistic regression showed that members of high-risk groups were more likely to have been tested.

Conclusions: This analysis demonstrates the potential for community-based substance use treatment programs to identify substance users at-risk for HIV and HCV infection. Access to high quality care and service attentive to the unique needs of substance users is vital to realizing optimal results in both HIV and HCV, reducing the incidence of late diagnosis, extending life expectancy, improving health outcomes and overall quality of life, and decreasing the use of costly medical services. Bundled HIV/HCV testing and linkage to care issues are recommended for expanding testing in community-based SUTP settings.

Related protocols: CTN-0032

Abstract:

There are an estimated 3.2 million individuals in the United States who are chronically infected with hepatitis C virus (HCV), of whom only have had an HCV antibody test and less than a quarter have had a confirmatory HCV RNA test. The US Centers for Disease Control and Prevention (CDC) has set a goal to reduce the proportion of HCV-infected individuals unaware of their status from 55% to 33%. This analysis of data from the National Drug Abuse Treatment Clinical Trials Network, study CTN-0032 (HIV Rapid Testing and Counseling), aimed to evaluate the cost-effectiveness of rapid HCV and simultaneous HCV/HIV antibody testing in substance abuse treatment programs. Researcher used a decision analytic model to compare the cost-effectiveness of no HCV testing referral or offer, off-site HCV testing referral, on-site rapid HCV testing offer, and on-site rapid HCV and HIV testing offer. Base case inputs included 11% undetected chronic HCV, 0.4% undetected HIV, 35% HCV co-infection among HIV-infected, 53% linked to HCV care after testing antibody positive, and 67% linked to HIV care. Disease outcomes were estimated from established computer simulation models of HCV (HEP-CE) and HIV (CEPAC). Measurements included lifetime costs (2011 US dollars) and quality-adjusted life years (QALYs) discounted at 3% annually and incremental cost-effective ratios (ICERs).

On-site rapid HCV testing had an ICER of $18,300/QALY compared with no testing, and was more efficient than (dominated) off-site HCV testing referral. On-site rapid HCV and HIV testing had an ICER of $64,500/QALY compared with on-site rapid HCV testing alone. In one and two-way sensitivity analyses, the ICER of on-site rapid HCV and HIV testing remained <$100,000/QALY, except when undetected HIV prevalence was <0.1% or when we assumed frequent HIV testing elsewhere. The ICER remained <$100,000/QALY in approximately 90% of probabilistic sensitivity analyses.

Conclusions: On-site rapid hepatitis C and HIV testing in substance abuse treatment programs is cost-effective at a <$100,000/quality-adjusted life years threshold. On-site rapid HCV and HIV testing in substance abuse treatment programs represents good value as a public health investment. Policymakers should identify ways to improve the capacity of substance abuse treatment programs to implement on-site HCV and HIV testing, bill for these services, and ensure that individuals testing positive for either virus receive further evaluation and treatment.

Related protocols: CTN-0032, CTN-0032-A-1

Abstract:

Rapid HIV testing in high-risk populations can increase the number of persons who learn their HIV status and avoid spending clinic resources to locate persons identified as HIV infected. For this analysis, the authors determined the cost to sexually transmitted disease (STD) clinics of point-of-care rapid HIV testing using data from 7 public clinics that participated in a randomized trial of rapid testing with and without brief patient-centered risk reduction counseling in 2010. Costs included counselor and trainer time, supplies, and clinic overhead. National labor rates and test costs were applied, and the authors also calculated median clinic start-up costs and mean cost per patient tested, as well as projecting incremental annual costs of implementing universal rapid HIV testing compared with current testing practices.

Criteria for offering rapid HIV testing and methods for delivering nonrapid test results varied among clinics before the trial. Rapid HIV testing cost an average of US$22/patient without brief risk reduction counseling and US$46/patient with counseling in these 7 clinics. Median start-up costs per clinic were US$1,100 and US$16,100 without and with counseling, respectively. Estimated incremental annual costs per clinic of implementing universal rapid HIV testing varied by whether or not brief counseling is conducted and by current clinic testing practices, ranging from a savings of US$19,500 to a cost of US$40,700 without counseling and a cost of US$98,000 to US$153,900 with counseling.

Conclusions: Universal rapid HIV testing in STD clinics with same-day results can be implemented at relatively low cost to STD clinics if brief risk reduction counseling is not offered. STD clinics may be able to reallocate savings from less case finding for newly identified HIV-positive individuals lost to follow-up to offset some of these incremental costs. The benefits to patients may be substantial, including more rapid identification and linkage to care of HIV-infected individuals, avoiding return visits to receive results, and less emotional stress waiting for results.

Related protocols: CTN-0032, Project AWARE

Abstract:

This is the Results Article for Project AWARE.

To increase human immunodeficiency virus (HIV) testing rates, many institutions and jurisdictions have revised policies to make the testing process rapid, simple, and routine. A major issue for testing scale-up efforts is the effectiveness of HIV risk-reduction counseling, which has historically been an integral part of the HIV testing process. The objective of Project AWARE, an adaptation of CTN-0032, was to assess the effect of brief patient-centered risk-reduction counseling at the time of a rapid HIV test on the subsequent acquisition of sexually transmitted infections (STIs). From April to December 2010, Project AWARE randomized 5012 patients from 9 sexually transmitted disease (STD) clinics in the United States to receive either brief patient-centered HIV risk-reduction counseling with a rapid HIV test or the rapid HIV test with information only. Participants were assessed for multiple STIs at both baseline and 6-month follow-up. Participants randomized to counseling received individual patient-centered risk-reduction counseling based on an evidence-based model. The core elements included a focus on the patient’s specific HIV/STI risk behavior and negotiation of realistic and achievable risk-reduction steps. All participants received a rapid HIV test.

The prespecified outcome was a composite end point of cumulative incidence of any of the measure STIs over 6 months. All participants were tested for Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum (syphilis), herpes simplex virus 2, and HIV. Women were also tested for Trichomonas vaginalis. Results found no significant difference in 6-month composite STI incidence by study group (adjusted risk ratio, 1.12; 95% CI, 0.94-1.33). There were 250 of 2039 incident cases (12.3%) in the counseling group and 226 of 2032 (11.1%) in the information-only group.

Conclusions: Risk-reduction counseling in conjunction with a rapid HIV test did not significantly affect STI acquisition among STD clinic patients, suggesting no added benefit from brief patient-centered risk-reduction counseling. These study findings lend support for reconsidering the role of counseling as an essential adjunct to HIV testing. This inference is further buttressed by the additional costs associated with counseling at the time of testing; without evidence of effectiveness, counseling cannot be considered an effective use of resources. Posttest counseling for patients testing HIV-positive remains essential, however, both for addressing psychological needs and for providing and ensuring follow-through with medical care and support.

Comment: Haukoos JS, Thrun MW. Eliminating prevention counseling to improve HIV screening. JAMA 2013;310(16):1679-1680.

Related protocols: CTN-0032, Project AWARE

Abstract:

This research brief describes the outcomes from National Drug Abuse Treatment Clinical Trials Network protocol CTN-0032, “HIV Rapid Testing and Counseling,” which found that patients offered HIV testing at centers where they received treatment for substance abuse were four times as likely to be tested as patients referred offsite. The study also supported current CDC advice to omit pretest risk reduction counseling — study participants whose test offer was prefaced with 5 minutes of information about the procedure, and those who received 30 minutes of risk reduction counseling, accepted testing at roughly equal rates. Both groups also reported similar frequencies of sexual risk behaviors during the 6 months subsequent to their test offers. Twelve CTN-affiliated treatment centers throughout the US took part in the trial, with researchers concluding that brief procedural information with an offer of onsite testing was the intervention of choice. With less expenditure of staff time and resources, it yielded rates of test completion and sexual risk reduction that were equal to those obtained with counseling and an offer of onsite testing, and greater than those obtained with offsite referral.

Related protocols: CTN-0032

Abstract:

Social workers are often on the front lines of the HIV/AIDS epidemic delivering prevention education and interventions, offering or linking individuals to HIV testing, and working to improve treatment access, retention, and adherence, especially among vulnerable populations. Individuals with substance use disorders face additional challenges to reducing sexual and drug risk behaviors, as well as barriers to testing, treatment, and antiretroviral therapy adherence.

This article presents current data on HIV transmission and research evidence on prevention and interventions with substance abusers, and highlights how individual social workers can take advantage of this knowledge in practice and through adoption and implementation with organizations. Research from the National Drug Abuse Treatment Clinical Trials Network (CTN) about rapid HIV testing and gender-specific HIV risk reduction interventions is described.

Related protocols: CTN-0018, CTN-0019, CTN-0032