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Background/objectives: HIV continues to be a significant problem among substance users and their sexual partners in the United States. The National Drug Abuse Treatment Clinical Trials Network (CTN) offers a national platform for effectiveness trials of HIV interventions in community substance abuse treatment programs. This article presents the HIV activities of the CTN during its first 10 years., Results: While emphasizing CTN HIV protocols, this article reviews the (1) HIV context for this work; (2) the collaborative process among providers, researchers, and National Institute on Drug Abuse CTN staff, on which CTN HIV work was based; (3) results of CTN HIV protocols and HIV secondary analyses in CTN non-HIV protocols; and (4) implications for future HIV intervention effectiveness research in community substance abuse treatment programs., Conclusion/significance: While the feasibility of engaging frontline providers in this research is highlighted, the limitations of small to medium effect sizes and weak adoption and sustainability in everyday practice are also discussed.

We sought to identify barriers to offering services for HIV/AIDS, hepatitis C virus, and sexually transmitted infections in substance abuse treatment programs. We surveyed treatment program administrators and clinicians within the National Drug Abuse Treatment Clinical Trials Network to evaluate the availability of medical and non-medical services for patients with or at risk for acquiring these infections. A substantial proportion of programs do not offer services (particularly medical services) for these infections. The most commonly cited barriers were funding, health insurance benefits, patient acceptance, and staff training. The findings highlight a missed opportunity to positively impact these infectious disease epidemics., (© Taylor & Francis Group, LLC)

This report examines associations between the availability of human immunodeficiency virus (HIV)-related health services in substance abuse treatment programs and characteristics of the programs and the patients they serve. In a cross-sectional, descriptive design and via a validated survey, program administrators within the National Drug Abuse Treatment Clinical Trials Network provided information on program characteristics, patient characteristics (rates of risky sexual and drug behaviors and HIV infection), and the availability of 31 different HIV-related health services. Of 319 programs, 84% submitted surveys. Service availability rates ranged from: 10% (pneumococcal vaccination) to 86% (drug testing) for the 6 HIV-related services offered to all patients, 13% (Pap smear for women) to 54% (tuberculin skin testing) for the 6 services offered to new patients, 2% (sterile injection equipment) to 64% (male condoms) for the 4 risk-reduction services, 37% (Pap smear for women) to 61% (tuberculin skin testing) for the 11 biological assessments offered to HIV-positive patients, and 33% (medical treatments) to 52% (counseling) for the 4 other services offered to HIV-positive patients. The availability of these HIV-related services was associated with clinical settings, the types of addiction treatment services, the rates of risky drug and sexual behaviors, and HIV infection rates among patients. Availability of such services was below published guidelines. While the results provide another basis for the infection-related prevention benefits of substance abuse treatment, the variability in the availability of HIV-related health care deserves further study and has health policy implications in determining how to utilize substance abuse treatment in reducing drug-related HIV transmission.

The safety, efficacy, and tolerability of nelfinavir (NFV)-containing antiretroviral therapy were evaluated in patients coinfected with HIV and hepatitis C undergoing methadone maintenance at an urban outpatient opioid treatment program serving a minority adult population. Eligibility covered methadone-maintained patients coinfected with HIV and hepatitis C who had received or were currently receiving NFV. The yield was 51 case patients. Parameters examined looked into safety, efficacy, and tolerability. Nelfinavir was discontinued in 2 patients for liver function abnormalities but resumed in 1 patient. One patient developed laboratory abnormalities during NFV therapy that were not present before NFV therapy; in 12 case patients, pre-NFV therapy liver function abnormalities resolved completely during NFV therapy. There was a statistically significant increase in CD4 count during NFV therapy. Viral load decreased or was unchanged in 10 case patients and increased in 8, of whom 5 had a CD4 count increase during NFV therapy. Three patients had diarrhea and 4 patients had constipation. Nelfinavir was not discontinued -- neither was dose adjusted -- in any of these patients. Patients who had received NFV > or =36 months had a smaller increase in mean methadone dose as compared with patients who had received NFV <36 months. The results show that NFV is safe, efficacious, and well tolerated.

A 24-week open-label clinical trial was conducted in 195 HIV-infected adults commonly underrepresented in research (35% female, 71% African American, 21% Hispanic, and 20% injection drug users [IDUs]) to evaluate the effect of an HIV educational program on efficacy and adherence with a simple, compact, twice-daily triple nucleoside regimen containing a lamivudine (150 mg)/zidovudine (300 mg) combination (COM) tablet plus abacavir (ABC), 300 mg. At baseline, the patients' median plasma HIV-1 RNA level was 4.18 log10 copies/mL and the median CD4+ cell count was 379 cells/mm3. Patients were randomized 1:1 to 4 modules of the Tools for Health and Empowerment HIV education intervention plus routine counseling (EI + RC; n = 96) or to routine counseling alone (RC; n = 99). No differences between the EI + RC and RC treatment arms were observed with respect to the proportion of patients achieving plasma HIV-1 RNA levels <40 copies/mL (60% [33/55] vs. 55% [38/69]; P = 0.529) or <400 copies/mL (80% [44/55] vs. 80% [55/69]; P = 0.689) at week 24 (intent-to-treat observed analysis), increase in median CD4 cell count above baseline at week 24 (78.3 vs. 104.8 cells/mm3; P = 0.498), or mean overall adherence rates as measured by the Medication Event Monitoring System (MEMS) (70% vs. 74%). COM + ABC was generally well tolerated, and no association was observed between interruptions in treatment and the development of ABC hypersensitivity (5 suspected cases). In conclusion, in underrepresented patients, the EI used in this study did not affect the efficacy and adherence results with ABC + COM to any greater degree than did RC.

Abstract: Illicit drug users sustain the epidemics of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), hepatitis C (HCV), and sexually transmitted infections (STIs). Substance abuse treatment programs present a major intervention point in stemming these epidemics. As a part of the “Infections and Substance Abuse” study, established by the National Drug Abuse Treatment Clinical Trials Network, sponsored by National Institute on Drug Abuse, three surveys were developed; for treatment program administrators, for clinicians, and for state and District of Columbia health and substance abuse department administrators, capturing service availability, government mandates, funding, and other key elements related to the three infection groups. Treatment programs varied in corporate structure, source of revenue, patient census, and medical and non-medical staffing; medical services, counseling services, and staff education targeted HIV/AIDS more often than HCV or STIs. The results from this study have the potential to generate hypotheses for further health services research to inform public policy. [Copyright &y& Elsevier]