A Multi-Center Randomized Controlled Trial of Adding Brief Skill-Based Psychoeducation to Primary Needle and Syringe Programs to prevent Human Immunodeficiency Virus: Study Protocol

OBJECTIVES: Our objective was to design an RCT in order to assess the effects of adding a brief skill-based psychoeducation (PE) to routine Needle and Syringe Programs to reduce injection and high risk sexual behaviors associated with Human Immunodeficiency Virus (HIV) infection among referrals of Drop-in Centers (DICs). METHOD/DESIGN: This was a randomized control trial with the primary hypothesis that adding skill-based PE to the routine needle syringe program (NSP) provided in the DICs would be more effective in reducing injection and high risk sexual behaviors associated with HIV infection compared to the routine programs. We intended to randomly allocate 60 patients per group after obtaining informed written consent,. The intervention group receive a combination of brief psychoeducation consisting two individual sessions of skill-based education concerning blood borne viral infection, specifically HIV. The control group received the routine primary NSP services provided in DIC. Study assessments were undertaken by a psychologist at baseline, 1 and 3 months after recruitment. The primary outcome measure was the comparison of the trend of alterations in high risk sexual and injection behaviors associated with HIV infection during 3 months after the initiation of the intervention between the two groups. Secondary outcome measures included the comparison of HIV/AIDS related knowledge and client satisfaction in the participants. DISCUSSION: This paper presents a protocol for an RCT of brief skill-based PE by a trained psychologist to reduce the sexual and injection related high risk behaviors among drug users who received primary NSP services in DIC. This trial tried to investigate the efficacy of the intervention on increasing HIV/AIDS related knowledge and client satisfaction. The results of different indicators of high risk behaviors will be discussed.