• Evidence of HIV-1 infection or death [ Time Frame: At Week 104 ] [ Designated as safety issue: Yes ]
  

• Self-report of continued injection opiate use [ Time Frame: Measured through Week 156 ] [ Designated as safety issue: No ]
  
• Urinalysis results positive for opiates [ Time Frame: Measured through Week 156 ] [ Designated as safety issue: No ]
  
• Self-reported frequency of injection [ Time Frame: Measured through Week 156 ] [ Designated as safety issue: No ]
  
• Self-reported frequency of injection with previously used injection equipment (needles, syringes, cookers, cottons, and rinse water) [ Time Frame: Measured through Week 156 ] [ Designated as safety issue: No ]
  
• Self-reported frequency of unprotected sex or sex sold/traded for drugs [ Time Frame: Measured through Week 156 ] [ Designated as safety issue: No ]
  
• Self-report of number of days employed in past month [ Time Frame: Measured through Week 156 ] [ Designated as safety issue: No ]
  
• Self-report of incarceration, detention, and jail [ Time Frame: Measured through Week 156 ] [ Designated as safety issue: No ]
  
• Self-report of enrollment into drug treatment programs at the 78 and 104 week visits [ Time Frame: Measured at Weeks 78 and 104 ] [ Designated as safety issue: No ]
  
• Incident hepatitis C infections [ Time Frame: Measured through Week 156 ] [ Designated as safety issue: No ]
  
• Incident hepatitis B infections [ Time Frame: Measured through Week 156 ] [ Designated as safety issue: No ]
  
• Incidence of HIV infections [ Time Frame: Measured through Week 156 ] [ Designated as safety issue: No ]
  
• Death [ Time Frame: Measured through Week 156 ] [ Designated as safety issue: No ]
  
• ALT toxicity grades [ Time Frame: Measured through Week 156 ] [ Designated as safety issue: No ]
  
• Bilirubin toxicity grades [ Time Frame: Measured through Week 156 ] [ Designated as safety issue: No ]
  
• ALT lab values [ Time Frame: Measured through Week 156 ] [ Designated as safety issue: No ]
  
• Bilirubin lab values [ Time Frame: Measured through Week 156 ] [ Designated as safety issue: No ]
  
• Study site confirmed report of incarceration, detention, and jail [ Time Frame: Measured through Week 156 ] [ Designated as safety issue: No ]
  

Effective HIV prevention among injection drug users (IDUs) requires educating the at-risk population about HIV transmission and risky behavior, and providing the means for behavior change. Current treatment for opiate dependence focuses on reducing the frequency of drug use. BUP/NX is a combination pill currently used to treat opiate-dependent individuals. This trial will evaluate the effectiveness of two therapies in preventing HIV transmission among IDUs. Drug and risk reduction counseling combined with either long term medication assisted treatment (LT-MAT) with BUP/NX or short term medication assisted treatment (ST-MAT) with BUP/NX will be compared in preventing the transmission of HIV among opiate-dependent individuals.

This study will last 4.5 years. Participants in this study will be randomly assigned to one of two treatment arms. Group 1 will receive LT-MAT with BUP/NX. Group 2 will receive ST-MAT with BUP/NX. An initial 4-week safety and feasibility phase will involve the first 50 participants at each site and will last approximately 30 weeks. Study visits will occur every week and will include a physical exam and blood and urine collection.

The main treatment phase of the study will last 52 weeks. Participants in Group 1 will receive BUP/NX under the tongue, at first daily and then three times a week for 52 weeks. Participants assigned to Group 1 will take part in a BUP/NX reduction phase, which will occur between Weeks 47 and 52. Participants in Group 2 will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator. Participants assigned to Group 2 will receive BUP/NX for a maximum of 18 days; detoxification may be repeated at Week 26 if the participant is still injecting opiates. After Week 4 of the safety phase and Weeks 26 and 52 of the overall study, participants will complete an intervention acceptability assessment.

In addition, participants in both groups will attend drug and risk reduction counseling weekly. After the first 12 weeks, participants will return every 4 weeks for 10 more counseling sessions. HIV testing, hepatitis C testing, risk assessment, and urine tests for opiates will occur at screening and at Weeks 26, 52, 78, 104, 130 and 156. Plasma from blood samples will be stored at each of these visits. Hepatitis B testing will occur at Week 26. Participants in China will attend study visits through approximately Week 104, and participants in Thailand will attend study visits through approximately Week 156.

Participants in China who have been incarcerated may participate in an optional substudy, which is examining the withdrawal effects from BUP/NX after incarceration. Participants who agree to take part in the substudy will attend one study visit and will complete a questionnaire.