A randomized controlled trial utilizing motivational interviewing to reduce HIV risk and drug use in young gay and bisexual men.

OBJECTIVE: Young gay and bisexual men (YGBM) are disproportionally at risk of HIV infection due to sexual risk behaviors, which are often exacerbated by recreational drug use. However, there have been no evidence-based interventions targeting substance-using YGBM. This study was designed to test a brief motivational interviewing (MI) intervention to reduce both risky sex and drug use among HIV-negative YGBM. METHOD: A total of 143 non-treatment-seeking YGBM (ages 18-29 years) who reported recent unprotected anal intercourse (UAI) and recreational drug use were randomized to 4 sessions of MI or 4 sessions of content-matched education. Participants were followed every 3 months for 1 year, and behavior change was examined across conditions and time for aggregated and day-level drug use and UAI. RESULTS: Regardless of condition, participants reported significant reductions in UAI and substance use over time. However, YGBM in the MI condition were 18% less likely to use drugs and 24% less likely to engage in UAI than YGBM in the education condition. CONCLUSIONS: The results support the utility of MI, compared with a content-matched education condition, to significantly reduce both UAI and drug use among YGBM. Interventions may benefit from an emphasis on substance use reductions, which might indirectly lead to less frequent UAI. Future research efforts should examine whether this type of brief MI intervention is effective when delivered by clinic or community settings utilized by YGBM.

Aggregate versus day level association between methamphetamine use and HIV medication non-adherence among gay and bisexual men.

Methamphetamine use is associated with HIV infection, especially among gay and bisexual men. Methamphetamine use contributes to disease progression both directly, by increasing viral load and damaging the immune system, and indirectly, by decreasing medication adherence. Research examining the association of methamphetamine use and non-adherence has traditionally compared groups of users and nonusers on adherence, compared methamphetamine use between participants above or below some threshold level of adherence (e.g. >90 % dose adherence), or examined aggregate relationships. Using Timeline Follow-back procedures, the present study examined aggregate, threshold, and day-level associations of methamphetamine use with non-adherence in 210 HIV-positive gay and bisexual methamphetamine-using men. Methamphetamine use was not associated with adherence behavior at the aggregate-level, but methamphetamine use on a given day was associated with 2.3 times the odds of non-adherence on that day. Threshold results were equivocal. These data suggest that the methamphetamine and non-adherence relationship is complicated: non-adherence is more likely to occur on days in which methamphetamine is used, but participants reported more non-adherence days in which methamphetamine was not used. This seeming paradox generates questions about the selection of analytical techniques and has important implications for behavioral interventions targeting substance use and adherence among HIV-positive individuals.

Predictors of day-level sexual risk for young gay and bisexual men.

As HIV infection rates remain high among young gay and bisexual men, investigations into determinants of sexual risk are paramount. This study examined independent and interactive effects of substance use, mental health, perceived benefits of unprotected sex, and type of sex partner on odds of not using condoms. Analyses included 188 high-risk substance using HIV-negative and unknown status young gay and bisexual men (ages 18-29). Substance use and endorsing favorable attitudes towards unprotected sex strongly predicted sexual risk. Mental health moderated the relationship between partner type (main vs. casual) and condom use such that increased anxiety and depression were associated with increased odds of using condoms with main partners and not using condoms with casual partners. Understanding how these determinants of HIV risk converge to predict unprotected anal sex can identify essential risk relationships for prevention, obtain effects sizes of greater magnitude and prolonged sustainability, and build robust couples-based interventions.

Participant characteristics and HIV risk behaviors among individuals entering integrated buprenorphine/naloxone and HIV care.

OBJECTIVE: This study was part of a national, multisite demonstration project evaluating the impact of integrated buprenorphine/naloxone treatment and HIV care. The goals of this study were to describe the baseline demographic, clinical, and substance use characteristics of the participants and to explore HIV transmission risk behaviors in this group. METHODS: Nine sites across the United States participated. Data obtained by interview and chart review included demographic information, medical history, substance use, and risk behaviors.We performed a descriptive analysis of patient characteristics at entry and used logistic regression to evaluate factors associated with 1) unprotected anal or vaginal sex; and 2) needle-sharing within the previous 90 days. RESULTS: Three hundred eighty-six individuals were included in the study: 303 (78.5%) received buprenorphine/naloxone; 41 (10.6%) received methadone; and 42 (10.9%) received another form of treatment. The analysis of risk behaviors was limited to those in the buprenorphine group (n = 303). Among those reporting vaginal or anal sex in the previous 90 days, 24% had sex without a condom. Factors significantly associated with unprotected sex were: having a partner; female gender; and alcohol use in previous 30 days. A total of 8.9% of participants shared needles in the previous 90 days. Factors significantly associated with needle-sharing were: amphetamine use; marijuana use; homelessness; and anxiety. CONCLUSIONS: Addressing transmission risk behaviors is an important secondary HIV prevention strategy. In addition to treatment for opioid dependence, addressing other substance use, social issues, particularly housing, and mental health may have important implications for reducing HIV transmission in HIV-infected opioid-dependent patients.

HIV treatment outcomes among HIV-infected, opioid-dependent patients receiving buprenorphine/naloxone treatment within HIV clinical care settings: results from a multisite study.

BACKGROUND: Having opioid dependence and HIV infection are associated with poor HIV-related treatment outcomes. METHODS: HIV-infected, opioid-dependent subjects (N = 295) recruited from 10 clinical sites initiated buprenorphine/naloxone (BUP/NX) and were assessed at baseline and quarterly for 12 months. Primary outcomes included receiving antiretroviral therapy (ART), HIV-1 RNA suppression, and mean changes in CD4 lymphocyte count. Analyses were stratified for the 119 subjects not on ART at baseline. Generalized estimating equations were deployed to examine time-dependent correlates for each outcome. RESULTS: At baseline, subjects on ART (N = 176) were more likely than those not on ART (N = 119) to be older, heterosexual, have lower alcohol addiction severity scores, and lower HIV-1 RNA levels; they were less likely to be homeless and report sexual risk behaviors. Subjects initiating BUP/NX (N = 295) were significantly more likely to initiate or remain on ART and improve CD4 counts over time compared with baseline; however, these improvements were not significantly improved by longer retention on BUP/NX. Retention on BUP/NX for three or more quarters was, however, significantly associated with increased likelihood of initiating ART (ß = 1.34 [1.18, 1.53]) and achieve viral suppression (ß = 1.25 [1.10, 1.42]) for the 64 of 119 (54%) subjects not on ART at baseline compared with the 55 subjects not retained on BUP/NX. In longitudinal analyses, being on ART was positively associated with increasing time of observation from baseline and higher mental health quality of life scores (ß = 1.25 [1.06, 1.46]) and negatively associated with being homo- or bisexual (ß = 0.55 [0.35, 0.97]), homeless (ß = 0.58 [0.34, 0.98]), and increasing levels of alcohol addiction severity (ß = 0.17 [0.03, 0.88]). The strongest correlate of achieving viral suppression was being on ART (ß = 10.27 [5.79, 18.23]). Female gender (ß = 1.91 [1.07, 3.41]), Hispanic ethnicity (ß = 2.82 [1.44, 5.49]), and increased general health quality of life (ß = 1.02 [1.00,1.04]) were also independently correlated with viral suppression. Improvements in CD4 lymphocyte count were significantly associated with being on ART and increased over time. CONCLUSIONS: Initiating BUP/NX in HIV clinical care settings is feasible and correlated with initiation of ART and improved CD4 lymphocyte counts. Longer retention on BPN/NX was not associated with improved prescription of ART, viral suppression, or CD4 lymphocyte counts for the overall sample in which the majority was already prescribed ART at baseline. Among those retained on BUP/NX, HIV treatment outcomes did not worsen and were sustained. Increasing time on BUP/NX, however, was especially important for improving HIV treatment outcomes for those not on ART at baseline, the group at highest risk for clinical deterioration. Retaining subjects on BUP/NX is an important goal for sustaining HIV treatment outcomes for those on ART and improving them for those who are not. Comorbid substance use disorders (especially alcohol), mental health problems, and quality-of-life indicators independently contributed to HIV treatment outcomes among HIV-infected persons with opioid dependence, suggesting the need for multidisciplinary treatment strategies for this population.

Drug treatment outcomes among HIV-infected opioid-dependent patients receiving buprenorphine/naloxone.

BACKGROUND: Buprenorphine/naloxone allows the integration of opioid dependence and HIV treatment. METHODS: We conducted a prospective study in HIV-infected opioid-dependent patients to investigate the impact of buprenorphine/naloxone treatment on drug use. Self-report and chart review assessments were conducted every 3 months (quarters 1-4) for 1 year. Outcomes were buprenorphine/naloxone treatment retention, drug use, and addiction treatment processes. RESULTS: Among 303 patients enrolled between July 2005 and December 2007, retention in buprenorphine/naloxone treatment was 74%, 67%, 59%, and 49% during Quarters 1, 2, 3, and 4, respectively. Past 30-day illicit opioid use decreased from 84% of patients at baseline to 42% in retained patients over the year. Patients were 52% less likely to use illicit opioids for each quarter in treatment (Odds ratio = 0.66; 95% CI: 0.61 to 0.72). Buprenorphine/naloxone doses and office visits approximated guidelines published by the United States Department of Health and Human Services. Urine toxicology monitoring was less frequent than recommended. CONCLUSIONS: Buprenorphine/naloxone provided in HIV treatment settings can decrease opioid use. Strategies are needed to improve retention and address ongoing drug use in this treatment population.

Improved quality of life for opioid-dependent patients receiving buprenorphine treatment in HIV clinics.

BACKGROUND: Opioid dependence and HIV infection are associated with poor health-related quality of life (HRQOL). Buprenorphine/naloxone (bup/nx) provided in HIV care settings may improve HRQOL. METHODS: We surveyed 289 HIV-infected opioid-dependent persons treated with clinic-based bup/nx about HRQOL using the Short Form Health Survey (SF-12) administered at baseline, 3, 6, 9, and 12 months. We used normalized SF-12 scores, which correspond to a mean HRQOL of 50 for the general US population (SD 10, possible range 0-100). We compared mean normalized mental and physical composite and component scores in quarters 1, 2, 3, and 4 with baseline scores using generalized estimating equation models. We assessed the effect of clinic-based bup/nx prescription on HRQOL composite scores using mixed effects regression with site as random effect and time as repeated effect. RESULTS: Baseline normalized SF-12 scores were lower than the general US population for all HRQOL domains. Average composite mental HRQOL improved from 38.3 (SE 12.5) to 43.4 (SE 13.2) [ß 1.13 (95% CI: 0.72 to 1.54)] and composite physical HRQOL remained unchanged [ß 0.21 (95% CI: -0.16 to 0.57)] over 12 months follow-up. Continued bup/nx treatment across all 4 quarters was associated with improvements in both physical [ß 2.38 (95% CI: 0.63 to 4.12)] and mental [ß 2.51 (95% CI: 0.42 to 4.60)] HRQOL after adjusting for other contributors to HRQOL. CONCLUSIONS: Clinic-based bup/nx maintenance therapy is potentially effective in ameliorating some of the adverse effects of opioid dependence on HRQOL for HIV-infected populations.

Hepatic safety and lack of antiretroviral interactions with buprenorphine/naloxone in HIV-infected opioid-dependent patients.

BACKGROUND: The safety of buprenorphine/naloxone (bup/nx) in HIV-infected patients has not been established. Prior reports raise concern about hepatotoxicity and interactions with atazanavir. METHODS: We conducted a prospective cohort study of 303 opioid-dependent HIV-infected patients initiating bup/nx treatment. We assessed changes in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) over time. We compared bup/nx doses in patients receiving the antiretroviral atazanavir to those not receiving atazanavir. We conducted surveillance for pharmacodynamic interactions. RESULTS: Median AST [37.0 vs. 37.0 units/liter (U/L) respective interquartile ranges (IQRs) 26-53 and 26-59] and ALT (33.0 vs. 33.0 U/L, respective IQRs 19-50 and 18-50) values did not change over time among 141 patients comparing pre-bup/nx exposure with post-bup/nx exposure measures. During bup/nx exposure, 207 subjects demonstrated no significant change in median AST (36.0 vs. 35.0 U/L, respective IQRs 25-57 and 25-61) and ALT (29.0 vs. 31.0 U/L, respective IQRs 19-50 and 18-50) values collected a median of 6 months apart. Analyses restricted to patients with hepatitis C and HIV co-infection yielded similar results, except a small but significant decrease in first to last AST, during treatment with bup/nx (P = 0.048). Mean bup/nx dose, ranging 16.0-17.8 mg, did not differ over time or with co-administration of atazanavir. No pharmacodynamic interactions were noted. CONCLUSIONS: Buprenorphine/naloxone did not produce measurable hepatic toxicity or pharmacodynamic interaction with atazanavir in HIV-infected opioid-dependent patients.

The impact of cocaine use on outcomes in HIV-infected patients receiving buprenorphine/naloxone.

BACKGROUND: Cocaine use is common in opioid-dependent HIV-infected patients, but its impact on treatment outcomes in these patients receiving buprenorphine/naloxone is not known. METHODS: We conducted a prospective study in 299 patients receiving buprenorphine/naloxone who provided baseline cocaine data and a subset of 266 patients who remained in treatment for greater than or equal to one quarter. Assessments were conducted at baseline and quarterly for 1 year. We evaluated the association between baseline and in-treatment cocaine use on buprenorphine/naloxone retention, illicit opioid use, antiretroviral adherence, CD4 counts, HIV RNA, and risk behaviors. RESULTS: Sixty-six percent (197 of 299) of patients reported baseline cocaine use and 65% (173 of 266) of patients with follow-up data reported in-treatment cocaine use. Baseline and in-treatment cocaine use did not impact buprenorphine/naloxone retention, antiretroviral adherence, CD4 lymphocytes, or HIV risk behaviors. However, baseline cocaine use was associated with a 14.8 (95% confidence interval [CI], 9.0-24.2) times greater likelihood of subsequent cocaine use (95% CI, 9.0-24.2), a 1.4 (95% CI, 1.02-2.00) times greater likelihood of subsequent opioid use, and higher log10 HIV RNA (P < 0.016) over time. In-treatment cocaine use was associated with a 1.4 (95% CI, 1.01-2.00) times greater likelihood of concurrent opioid use. CONCLUSIONS: Given cocaine use negatively impacts opioid and HIV treatment outcomes, interventions to address cocaine use in HIV-infected patients receiving buprenorphine/naloxone treatment are warranted.

The BHIVES collaborative: organization and evaluation of a multisite demonstration of integrated buprenorphine/naloxone and HIV treatment.

Substance abuse is associated with poor medical and quality-of-life outcomes among HIV-infected individuals. Although drug treatment may reduce these negative consequences, for many patients, options are limited. Buprenorphine/naloxone, an opioid agonist treatment that can be prescribed in the United States in office-based settings, can be used to expand treatment capacity and integrate substance abuse services into HIV care. Recognizing this potential, the US Health Resources and Services Administration funded the development and implementation of demonstration projects that integrated HIV care and buprenorphine/naloxone treatment at 10 sites across the country. An Evaluation and Technical Assistance Center provided programmatic and clinical support as well as oversight for an evaluation that examined the processes for and outcomes of integrated care. The evaluation included patient-level self-report and chart abstractions as well as provider and site level data collected through surveys and in-depth interviews. Although multisite demonstrations pose implementation and evaluation challenges, our experience demonstrates that these can, in part, be addressed through ongoing communication and technical assistance as well as a comprehensive evaluation design that incorporates multiple research methods and data sources. Although limitations to evaluation findings persist, they may be balanced by the scope and "real-world" context of the initiative.

Improving adherence to HIV quality of care indicators in persons with opioid dependence: the role of buprenorphine.

BACKGROUND: Opioid-dependent HIV-infected patients are less likely to receive HIV quality of care indicators (QIs) compared with nondependent patients. Buprenorphine/naloxone maintenance therapy (bup/nx) could affect the quality of HIV care for opioid-dependent patients. METHODS: We abstracted 16 QIs from medical records at nine HIV clinics 12 months before and after initiation of bup/nx versus other treatment for opioid dependence. Summary quality scores (number of QIs received/number eligible × 100) were calculated. We compared change in QIs and summary quality scores in patients receiving bup/nx versus other participants. RESULTS: One hundred ninety-four of 268 participants (72%) received bup/nx and 74 (28%) received other treatment. Mean summary quality scores increased over 12 months for participants receiving bup/nx (45.6% to 51.6%, P < 0.001) but not other treatment (48.6% to 47.8%, P = 0.788). Bup/nx participants experienced improvements in six of 16 HIV QIs versus three of 16 QIs in other participants. Improvements were mostly in preventive and monitoring care domains. In multivariable analysis, bup/nx was associated with improved summary quality score (ß 8.55; 95% confidence interval, 2.06-15.0). CONCLUSIONS: In this observational cohort study, HIV-infected patients with opioid dependence received approximately half of HIV QIs at baseline. Buprenorphine treatment was associated with improvement in HIV QIs at 12 months. Integration of bup/nx into HIV clinics may increase receipt of high-quality HIV care. Further research is required to assess the effect of improved quality of HIV care on clinical outcomes.

Opioid-prescribing practices and provider confidence recognizing opioid analgesic abuse in HIV primary care settings.

BACKGROUND: Pain syndromes are common in HIV-infected patients, who also are commonly affected by opioid-use disorders. Although opioids can treat pain, prescribers must consider the consequences of iatrogenic or missed addiction diagnoses. METHODS: In an anonymous online survey, we asked a national sample of HIV providers about their demographics, experience, and patients, and their practices and attitudes about chronic opioid therapy, addiction, and confidence recognizing opioid analgesic abuse. RESULTS: One hundred six providers reported 28% of their patients had chronic pain; 21% received opioid analgesics; 37% were HIV infected by injecting drug use; and 12% were addicted to prescription opioids. Few providers followed recommended guidelines for chronic opioid therapy in nonmalignant pain. Mean provider confidence was 6.3 on a scale of 10. Higher confidence was associated with provider sex (P < 0.05), patient volume (P < 0.03), discussing substance use, (P < 0.05), urine toxicology (P < 0.01), prescribing longer acting opioids (P = 0.005), and prescribing buprenorphine (P = 0.009). CONCLUSIONS: HIV providers seldom follow recommended guidelines for opioid prescribing and have limited confidence in their ability to recognize opioid analgesic abuse. Clinical practices developed to reduce misuse and increase early detection and treatment of opioid dependence are associated with higher confidence. The implementation of guidelines to improve the quality of opioid prescribing in HIV clinics may aid in the diagnosis of addictive disorders and prevent their adverse outcomes.

The cost of integrated HIV care and buprenorphine/naloxone treatment: results of a cross-site evaluation.

BACKGROUND: Implementing integrated HIV and buprenorphine/naloxone treatment requires cost estimates to plan and obtain funding. METHODS: We identified costs incurred at HIV clinical sites participating in a cross-site evaluation of integrated care that followed patients for 1 year. Costs include labor, overhead, and urine toxicology analyses (clinic perspective), buprenorphine/naloxone (payer perspective) and patient time and transportation (patient perspective). Sites provided resource utilization quarterly, and providers estimated time required for each activity. With site as the unit of analysis, results are reported as median (range) of average site costs in 2008 US dollars. RESULTS: The median number of monthly provider encounters for integrated care patients was 3.2 (1.5-13.3) compared with 1.7 (1.1-4.2) for similar patients not in integrated care, but integrated care patients had fewer physician encounters. Median monthly clinic costs per integrated care patient were $136 ($67-$677) for labor and overhead and $8 ($2-$23) for toxicology analyses, $22 higher than clinic costs for patients not in integrated care. Median monthly costs for buprenorphine/naloxone were $209 ($165-$272), and monthly patient costs in integrated care were $11 ($1-$54) higher. CONCLUSIONS: Integrated HIV and buprenorphine/naloxone treatment requires different resources, including costs that are not third-party reimbursed. Implementing integrated care will require funding for training and for new staff such as buprenorphine coordinators, in addition to reimbursement for buprenorphine/naloxone. Further research is needed to identify potential cost offsets outside of the clinic setting.

More than ancillary: HIV social services, intermediate outcomes and quality of life.

In HIV care, the use of social or "ancillary" services to stabilize life situations and remove barriers to care is often seen as a means to the end of ensuring more consistent participation in medical care. By examining the impact of HIV social services on the achievement of intermediate outcomes (i.e., ceasing substance use, initiating anti-retroviral therapy (ART), and entering stable housing) and the relationship between intermediate outcome status and quality of life (QOL), our analysis aims to demonstrate the importance of achieving intermediate outcomes in and of themselves and thereby the importance of the ancillary services that assist clients in attaining desired intermediate outcomes. Our analysis relies on baseline and follow-up data from 1646 HIV-positive participants collected during a longitudinal outcome evaluation of 23 HIV social service programs in the New York metropolitan area. Multivariate linear regression modeling was used to assess the impact of achieving intermediate outcomes on QOL at follow-up, controlling for baseline QOL, and demographic factors. The greatest improvements in QOL were found in individuals who changed their intermediate outcome status from using drugs to not using, from not using ART to using ART, and from being unstably housed to being stably housed. Our analysis strongly suggests the importance of achieving intermediate outcomes in improving QOL, and thereby the importance of social services that facilitate the achievement of these intermediate outcomes. The analysis also provides further validation of a QOL measure, by showing that it varies in systematic and expected ways with the achievement of intermediate outcomes. Our study suggests that social services are not merely ancillary in HIV care but rather crucial for achieving both intermediate outcomes as well as the final outcome of improved QOL.

Factors affecting willingness to provide buprenorphine treatment.

Buprenorphine is an effective long-term opioid agonist treatment. As the only pharmacological treatment for opioid dependence readily available in office-based settings, buprenorphine may facilitate a historic shift in addiction treatment from treatment facilities to general medical practices. Although many patients have benefited from the availability of buprenorphine in the United States, almost half of current prescribers are addiction specialists suggesting that buprenorphine treatment has not yet fully penetrated general practice settings. We examined factors affecting willingness to offer buprenorphine treatment among physicians with different levels of prescribing experience. Based on their prescribing practices, physicians were classified as experienced, novice, or as a nonprescriber and asked to assess the extent to which a list of factors impacted their prescription of buprenorphine. Several factors affected willingness to prescribe buprenorphine for all physicians: staff training; access to counseling and alternate treatment; visit time; buprenorphine availability; and pain medications concerns. Compared with other physicians, experienced prescribers were less concerned about induction logistics and access to expert consultation, clinical guidelines, and mental health services. They were more concerned with reimbursement. These data provide important insight into physician concerns about buprenorphine and have implications for practice, education, and policy change that may effectively support widespread adoption of buprenorphine.

The CASE adherence index: A novel method for measuring adherence to antiretroviral therapy.

The Center for Adherence Support Evaluation (CASE) Adherence Index, a simple composite measure of self-reported antiretroviral therapy (ART) adherence, was compared to a standard three-day self-reported adherence measure among participants in a longitudinal, prospective cross-site evaluation of 12 adherence programs throughout the United States. The CASE Adherence Index, consisting of three unique adherence questions developed for the cross-site study, along with a three-day adherence self-report were administered by interviews every three months over a one-year period. Data from the three cross-site adherence questions (individually and in combination) were compared to three -day self-report data and HIV RNA and CD4 outcomes in cross-sectional analyses. The CASE Adherence Index correlated strongly with the three-day self-reported adherence data (p < 0.001) and was more strongly associated with HIV outcomes, including a 1-log decline in HIV RNA level (maximum OR = 2.34; p < 0.05), HIV RNA < 400 copies/ml (maximum OR = 2.33; p < 0.05) and performed as well as the three-day self-report when predicting CD4 count status. Participants with a CASE Index score >10 achieved a 98 cell mean increase in CD4 count over 12 months, compared to a 41 cell increase for those with scores < or =10 (p < 0.05). The CASE Adherence Index is an easy to administer instrument that provides an alternative method for assessing ART adherence in clinical settings.