Multi-level assessment protocol (MAP) for adoption in multi-site clinical trials.

The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) is intended to test promising drug abuse treatment models in multi-site clinical trials, and to support adoption of new interventions into clinical practice. Using qualitative research methods we asked: How might the technology of multi-site clinical trials be modified to better support adoption of tested interventions? A total of 42 participants, representing 8 organizational levels ranging from clinic staff to clinical trial leaders, were interviewed about their role in the clinical trial, its interactions with clinics, and intervention adoption. Among eight clinics participating in the clinical trial, we found adoption of the tested intervention in one clinic only. In analysis of interview data we identified four conceptual themes which are likely to affect adoption and may be informative in future multi-site clinical trials. We offer the conclusion that planning for adoption in the early stages of protocol development will better serve the aim of integrating new interventions into practice.

Does centralized intake improve drug abuse treatment outcomes?

This study was designed to assess whether centralized intake and assessment in a drug abuse treatment system would lead to improved outcomes. Clients entering treatment through a centralized intake unit (CIU) or through individual programs (non-CIU) were interviewed at admission, and at 1 month and 1 year postadmission. Interviews included measures of treatment access and satisfaction, psychiatric symptoms, social support, and Addiction Severity Index composite scores. At treatment entry, CIU participants had more employment and psychological problems and lower social support, were more often required to be in treatment, and were more often placed on a waiting list. In analyses controlling for baseline differences between groups, there were main effects of time, but no CIU status effects or CIU status by time interactions. The CIU may have improved access to treatment for a more disabled population; however, clients entering treatment through the CIU did not have better outcomes than those entering treatment directly.

Gender differences in income after substance abuse treatment.

This study asked whether men and women who enrolled in substance use treatment reported similar changes in income from work, public assistance, and crime over time. Income data were analyzed for 261 substance users (77 women, 184 men) who entered day or residential treatment, and completed Addiction Severity Index measures at treatment entry and up to 18 months later. Over time, respondents reported increases in employment income. People whose main source of income at baseline had been crime or public assistance showed significant decreases respectively in income from crime or public assistance. Men made greater gains in work income than women did. Across time, men were more likely to be employed than women were. Findings show the economic value of substance use treatment, but less improvement in employment outcomes for women than men.

Investigation of a secondary syringe exchange program for homeless young adult injection drug users in San Francisco, California, U.S.A.

This study investigated an HIV prevention program for homeless young adult injection drug users (IDUs) that combined a secondary syringe exchange program (SEP) with community-level activities. Homeless young IDUs were recruited from street-based settings in San Francisco, and a structured questionnaire was administered. The secondary SEP operated in a circumscribed geographic area, and for analytic purposes respondents were assigned to the intervention site group if they primarily spent time in this area (n = 67), or the comparison site group if they primarily spent time elsewhere (n = 55). Almost all (96%) intervention site youth had used the secondary SEP in the past 30 days and were significantly more likely to regularly use SEP. In bivariate analysis, comparison site IDUs were more likely to share syringes, reuse syringes, share the cotton used to filter drugs, and use condoms with casual sex partners only inconsistently. In multivariate analysis, comparison site remained positively associated with sharing syringes (adjusted odds ratio [AOR], 3.748; 95% confidence interval [CI], 1.406-9.988), reusing syringes (AOR, 2.769; 95% CI,1.120-6.847), and inconsistent condom use with casual sex partners (AOR, 4.825; 95% CI, 1.392- 16.721). This suggests that the intervention was effective in delivering SEP services to homeless young adult IDUs, and that IDUs who frequented the intervention site had a lower HIV risk than comparison group IDUs.

Relapse outcomes in a randomized trial of residential and day drug abuse treatment.

Relapse outcomes at 6-, 12-, and 18-month intervals were compared between clients randomly assigned to day (n=114) versus residential (n=147) drug abuse treatment. Day clients were more likely than residential clients to relapse 6 months post-admission (OR=3.06, p<0.001); however, no setting differences at 12 or 18 months were found. Few baseline predictors were prospectively related to relapse at 12 and 18 months. These predictors were usual employment status (part-time OR=17.47, p<0.001; full-time OR=2.54, p<0.001), history of drug injecting (OR=5.39, p<0.01), multiple sex partners (OR=1.16, p<0.01), and not having a gay sexual partner (OR=0.05, p<0.03) during 6 months prior to admission. Still, these baseline predictors, together with the existing literature, could be used by drug treatment professionals to identify individuals who may be at high risk for relapse over time, and to offer specialized treatment and aftercare resources as intervention and prevention measures.

Drug court effectiveness: a review of California evaluation reports, 1995-1999.

Over the past two decades, drug courts have emerged as a viable alternative for addressing drug cases within the criminal justice system. In California, the Drug Court Partnership Program (DCPP) was created in 1998 and has supported and funded the development of drug courts throughout the State. This article reports on a review of California drug court evaluations through January 2000 conducted as part of an evaluation of the California DCPP. A total of 23 evaluations were collected. Seventeen were reviewed in detail, and six were excluded because they were internal reports rather than evaluations. A standardized review process was initiated which led to a scored rating of the evaluation reports. Results of this review support previous findings that drug court participants may experience reduced rearrest rates by 11% to 14% compared to nonparticipants. The largest reduction in rearrest rates appears among graduates. The graduation rates were between 19% and 54%. Costs and savings associated with drug courts were discussed but no conclusions were possible based on the findings from these evaluations. The evaluation of the effectiveness of drug courts presents unique challenges. This review concludes with a discussion of evaluation methods (e.g. standardizing rate calculations, term definitions) that would strengthen drug court research.

Drug abuse treatment on demand in San Francisco: preliminary findings.

This article reports on a process and capacity evaluation of San Francisco's Treatment on Demand Initiative, which was launched in 1997 to increase availability of publicly-funded substance abuse treatment. For the process evaluation, data from public documents, interviews with community key informants, and newspaper articles were analyzed. For the capacity evaluation, budget documents and admissions data for publicly-funded substance abuse treatment in San Francisco for fiscal years 1995-1998 were analyzed. Results from the process evaluation document the development of the community-oriented Treatment on Demand Planning Council, and its efforts to not only expand treatment, but to create a continuum of services to address the needs of San Francisco's richly diverse communities, to provide service enhancements, and to prioritize service needs. Process evaluation results also highlight the complexities of implementing treatment on demand, including the difficulty of opening new programs. Results from the capacity evaluation indicate that the San Francisco budget supporting publicly-funded treatment increased from $32 million to $45.2 million over four years. During the same period, the number of persons entering the system in a single year increased by 18%, and the number of admissions in a single year increased by 15%. Implications of these findings are discussed.

Changes in HIV-related risk behaviors following drug abuse treatment.

OBJECTIVES: To measure changes in HIV-related injection drug and sexual risk behaviors following drug treatment in a therapeutic community program. METHODS: We conducted a prospective cohort study of 261 drug users, randomly assigned to day or residential treatment. Participants were interviewed 2 weeks after entering treatment and 6, 12 and 18 months later (follow-up rate: 83%). RESULTS: Greater reductions in injection risk behaviors were associated with more time in treatment and the later waves of measurement. Wave was also associated with a reduction of sexual risk behavior. CONCLUSIONS: Drug abuse treatment was associated with a decrease in HIV-related risk behavior.

A randomized trial comparing day and residential drug abuse treatment: 18-month outcomes.

Extending an earlier report of 6-month outcomes, this study reports 12- and 18-month follow-up data for clients (N = 188) entering a therapeutic community drug treatment program who were randomly assigned to day or residential treatment conditions. Outcomes included Addiction Severity Index composite scores and measures of depression, psychiatric symptoms, and social support. Both groups showed significant change over time. The pattern of change indicated decreased problem severity in the 1st 6 months and then maintenance of lowered problem severity. Comparisons between groups indicated greater improvement for residential treatment clients on social problems and psychiatric symptoms but no differences on the remaining outcomes. Although residential treatment may offer some specific advantages, the conclusion here is that improvement among day treatment clients was not significantly different from that of residential treatment clients.

Syringe use and reuse: effects of syringe exchange programs in four cities.

We determined the effect of syringe exchange programs (SEPs) on syringe reuse patterns. Five methods were employed to estimate injections per syringe made by exchange clients in four cities. In San Francisco, Chicago, and Baltimore, self-reported data on the number of injections per syringe were obtained. In New Haven, self-reported injection frequencies were combined with syringe tracking data to derive two methods for estimating the mean injections per syringe. The average number of injections per syringe declined by at least half after establishment of SEPs in New Haven, Baltimore, and Chicago, all cities where such an analysis could be made. There were significant increases in the percentages of exchangers reporting once-only use of their syringes in San Francisco, Baltimore, and Chicago, all cities where the data were amenable to this form of analysis. Self-report and syringe tracking estimates were in agreement that SEP participation was associated with decreases in syringe reuse by drug injectors. SEP participation was associated with increases in the once-only use of syringes. These findings add to earlier studies supporting the role of SEPs in reducing the transmission of syringe-borne infections such as HIV and hepatitis.

Evaluating needle exchange: a description of client characteristics, health status, program utilization, and HIV risk behavior.

This study was designed to describe demographic and drug use characteristics, health status, and HIV-related risk behavior among clients attending the San Francisco needle exchange program (NEP), and to assess the relationship between NEP utilization and risk behavior. Randomly selected clients were interviewed when they visited the NEP. Participants were of diverse ethnicity, had a mean age of 38.2, and 72% were male. Many reported being homeless (25%), unemployed (34%), uninsured (52%), and having an episode of infectious disease in the past 2 years (36%). Clients who received a higher proportion of their needles from the exchange were less likely to report sharing of needles or rinse water. Clients who attended the exchange more frequently were more likely to clean their skin prior to injecting and less likely to use the same needle repeatedly. Frequency of visiting the NEP was not associated with the likelihood of sharing needles or rinse water. Efforts to evaluate needle exchange in the United States will benefit from descriptive reports from other NEP programs, and the use of nonexchange comparison groups.

Drug abuse day treatment: a randomized clinical trial comparing day and residential treatment programs.

Clients entering a therapeutic community (TC)-oriented drug treatment program were randomly assigned to day or residential conditions and interviewed at 2 weeks and 6 months after admission. Outcomes included Addiction Severity Index composite scores and summary scores for the Beck Depression Inventory, Symptom Checklist-90-R, and a social support scale. Only clients who remained in treatment for at least 2 weeks were included. The mean age of the sample (N = 261) was 32.9 (SD = 6.7 years) and the mean education level was 12.1 years (SD = 1.9 years); 30% were women. Comparison of outcome scores at 6 months between groups, while controlling for baseline values, indicated greater improvement for residential clients on social problems and psychiatric symptoms. The groups were similar on the 8 remaining outcomes, including measures of alcohol and drug problems. Overall, the level of improvement among day treatment clients was not significantly different from that of residential clients.

Risk behavior and HIV seroprevalence among injecting drug users in Rio de Janeiro, Brazil.

OBJECTIVE: To characterize HIV seroprevalence and risk behavior among injecting drug users (IDUs) in Rio de Janeiro, Brazil, between 1990 and 1996. DESIGN: We report data from three separate cross-sectional samples of IDUs in Rio de Janeiro: the World Health Organization (WHO) sample (n = 479), the Proviva sample (n = 138) and the Brasil sample (n = 110). These data provide the most comprehensive view available, to date, of this understudied population in Rio. METHODS: Demographic characteristics, HIV/AIDS risk behavior and HIV seroprevalence were compared across the three samples and combined analyses were performed to determine the factors associated with injecting risk behavior, sexual risk behavior and HIV seropositivity. RESULTS: The overall HIV seroprevalence among IDUs was 25%. Two encouraging findings of the present analysis were the lower levels of needle-sharing among participants recruited in the latest years (1995-1996) and the lower HIV seroprevalence in the Proviva sample composed mainly of less educated, poorer IDUs living in deprived neighborhoods. No trends toward safer behavior were found for sexual risk, younger age being the principal factor associated with high risk. CONCLUSIONS: Levels of needle-sharing and sexual risk among IDUs in Rio remain high, demonstrating the urgent need to increase the limited preventive measures undertaken so far. Seroprevalence levels for HIV remain significantly lower in the most deprived sample, arguing for the fundamental importance of prompt and effective prevention strategies to keep infection rates from rising among the poorest and largest strata of Rio's IDUs.

Clients entering drug abuse day treatment: 18-month outcomes.

Clients who entered and remained in day treatment for at least 2 weeks (N = 66) were interviewed at 6, 12, and 18 months after baseline. Follow-up rates for each time point ranged from 58% to 68%, and 30 clients (45%) were interviewed at every time point. Those who were consistently followed (N = 30) did not differ from those who were not consistently followed (N = 36) on demographics or on outcome variables measured at baseline. Comparison of mean outcome scores across time using MANOVA indicated significant changes from baseline to 6 months in the areas of alcohol, drug, legal, and social problem severity, and these changes were maintained up to 18 months postadmission. Outcomes reflecting psychiatric symptoms and employment also changed over time, but exhibited different patterns of change. Results are confounded by treatment received, since many respondents also participated in residential treatment during follow-up. Day treatment can serve clients having a range of substance abuse problems, and can act as a bridge to traditional residential treatment. Randomized clinical trials, where clients receive only one or the other type of treatment, are needed to assess the effectiveness of day treatment alone.

A day treatment program in a therapeutic community setting: six-month outcomes. The Walden House Day Treatment Program.

Although not well represented in the literature, day treatment programs targeting substance abuse problems have increased in both number and acceptability in recent years. This article reports on a day treatment program based on the Therapeutic Community (TC), and on outcomes for a sample of substance abuse clients (n = 66) entering the program. Participants were interviewed early in treatment and 6 months after admission using the Addiction Severity Index (ASI) and other measures. Clients entering day treatment were demographically diverse, with serious substance-abuse problems and psychiatric morbidity. Median retention in day treatment was about 5 weeks, but many clients received a contiguous episode of residential treatment, so that the median for total time in treatment was 18 weeks. Clients located and interviewed at 6-month follow-up (n = 38) showed significant improvement in alcohol and drug use, legal and social problems, and psychiatric symptoms. Findings suggest that day treatment can be used effectively as a precursor to residential treatment and that some clients applying for residential treatment can be treated effectively in day treatment alone.

A visual inspection protocol for measuring characteristics of used syringes.

This article reports on the use of a Visual Inspection Protocol (VIP) to measure observable characteristics of syringes deposited at the San Francisco needle exchange program. Syringes received by the program were evaluated by several inspectors using the VIP, and interrater reliability was assessed for each item. In Study I, syringes bearing individual markings made by the user (n = 568) were more likely to be capped at the point end and plunger end, and more often were new in appearance when compared with unmarked syringes (n = 2,820). In Study II, syringes with a short street life (n = 250) were more often new in appearance and were less likely to contain blood than syringes with a long street life (n = 246). Syringes having individual markings also show signs of more careful use, and marking syringes may represent an ad hoc HIV prevention strategy for some injection drug users.

Are bisexually identified men in San Francisco a common vector for spreading HIV infection to women?

OBJECTIVES: This article examines sexual risk taking among self-identified bisexual men in San Francisco and whether risk reduction has occurred, with respect to both homosexual and heterosexual behaviors, among human immunodeficiency virus (HIV) antibody-positive and HIV antibody-negative men. It also examines psychosocial correlates of unprotected anal and vaginal intercourse. METHODS: The participants were members of a population-based longitudinal cohort of 1034 single men aged 25 through 54 years recruited from the 19 census tracts in San Francisco that had the greatest prevalence of the acquired immunodeficiency syndrome in 1984. Of the total sample, 140 subjects initially identified themselves as bisexual; 85% of these men remained in the study. RESULTS: The participants reported dramatic reductions in sexual risk taking. Prevalences of unprotected anal sex with men were similar among HIV-positive bisexual men (89% in 1984-1985 and 18% in 1988-1989) and those who were HIV negative (65% and 20%). The prevalence of unprotected vaginal sex was much lower for HIV-positive men (16% in 1984-1985 and 2% in 1988-1989) than for HIV-negative men (35% and 20%). Unprotected intercourse was associated primarily with situational and interpersonal factors. CONCLUSIONS: Striking reductions in risk behaviors were reported. This subgroup of single, bisexually identified men appears unlikely to be a common vector for spreading HIV infection to women.