TABLE 1.

NIDA Clinical Trials Network protocols with HIV/HCV outcomes.

CTN protocol number	Recruitment dates	Subjects: Sites	Study name	Study type	Main outcomes or HIV/AIDS-related outcomes
0010	7/2003–12/2005	152:6	Buprenorphine/Naloxone Facilitated Rehabilitation for Heroin Addicted Adolescents/Young Adults (aged 15–21)	Randomized trial of two outpatient regimens in addition to TAU: BUP: extended treatment consisting of 12 weeks of tapered treatment; and DETOX: short-term detoxification over 14 days	At week 12, BUP patients reported less injection drug use and, within the BUP group females had less injection use than males. Injection risk did not change for persistent injectors. Sexual activity decreased in both genders and conditions, but sexual risk did not.
0012	7/2003–1/2005	269 administrators, 1723 providers, 48 state administrators	Screening, Evaluation, and Treatment of HIV/AIDS, Hepatitis C Viral Infections, and Sexually Transmitted Infections in Substance Abuse Treatment Programs	Survey of treatment program administrators and providers, and state administrators regarding the availability of and factors associated with infection-related health services	There was wide variability in services depending on program type, revenue source, and patient characteristics. Perceived barriers were lack of funding, regulations constraints, and patient attitudes.
0015	1/2004–10/2005	353:7	Women’s Treatment for Trauma and Substance Use Disorders: A Randomized Clinical Trial	Randomized trial of Seeking Safety and TAU versus Women’s Health Education and TAU to reduce posttraumatic stress and substance use symptoms	Among women with higher sexual risk (at least 12 unprotected sexual occasions/month), those in Seeking Safety showed greater reductions in HIV sexual risk behavior versus Women’s Health Education 12 months post-treatment.
0017	11/2004–2/2006	632:8	HIV and HCV Intervention for Injection Drug Users in Inpatient Detoxification	Randomized trial of (1) HIV/HCV testing and counseling (2) Therapeutic Alliance (TA), and (3) TAU to reduce HIV risk behavior and increase entry into ongoing substance abuse treatment	Rates of entry into ongoing treatment were higher for TA than TAU; entry into treatment was faster in TA than TAU. Treatment participation within 2 months after detox predicted reductions in injection risk. Participation in detox was followed by significant decreases in drug injection and risk behaviors for up to 6 months; interventions added to TAU offered no improvement in risk behavior outcomes.
0018	5/2004–10/2005	590:14	Safer Sex Skills Groups for Men: Real Men Are Safe (REMAS)	Randomized trial of a five-session safer sex skills group (REMAS) versus single-session standard HIV education (HE) to reduce sexual risk behavior	There was significantly greater decrease in sexual risk behavior in REMAS versus HE at 3 months and 6 months.
0019	6/2004–10/2005	515:12	Safer Sex Skills Groups for Women: Safer Sex Skills Building (SSSB)	Randomized trial of a five-session SSSB group versus single-session standard HE to reduce sexual risk behaviors	There was significantly greater decrease in sexual risk behavior in SSSB versus HE at 6 months.
0032	1/2009–5/2009	1281:12	HIV Rapid Testing and Counseling	Randomized trial of (1) on-site rapid HIV testing/counseling, (2) on-site rapid HIV testing only, and (3) standard referral to off-site HIV testing to increase rates of HIV testing acceptance and to decrease HIV sexual risk behavior	Primary outcomes pending

Note: NIDA, National Institute on Drug Abuse; CTN, Clinical Trials Network; TAU, treatment as usual.