Designing and pilot testing a cohort study of people who inject drugs to assess the effect of opiate agonist therapies on HIV and HCV incidence, Kerman, Iran.
People who inject drugs (PWID) are the most severely affected population for HIV and HCV in Iran. Moreover, Iran, straddling the world’s major supply route of heroin, has the higher per capita opioid users in the world. Combination prevention approaches a have been implemented, including medically assisted drug treatment (mainly opiate agonist therapies [OAT] including clonidine detoxification with or without methadone or buprenorphine maintenance therapy [MMT, BMT, respectively]),needle and syringe exchange, and condom distribution programs. All are provided free of charge. However unsafe injection and unprotected sex are frequently reported among PWID. Remaining questions are what is the impact of OAT interventions in the real world; how available are they to the target PWID; and what effect do they have on injection and sexual risk behaviors for HIV and HCV. Answering these questions requires a rigorous, longitudinal platform for prevention research.
We therefore are proposing to design and pilot a prospective cohort study of PWID in Kerman, Iran. First, we will adapt to our context the approach of the UCSF-created UFO study (www.ufomodel.com), a highly successful epidemiological research study of HCV and HIV infection in young PWID in San Francisco1-3. The current pilot study will validate protocols and instruments for our target site by PWID and expert input. Second, we will recruit a diverse sample of 30 PWID by from outreach workers, public and private sector treatment programs, and referral from experts and key informants to qualitatively measure the acceptability, feasibility, and procedures of our UFO-adapted approaches in assembling and maintaining PWID through follow-up. With the refined protocols and instruments, we will next implement a small-scale pilot study of 99 PWID for a follow-up period of six months with quarterly visits. The primary assessment will be to approximate the effect size of the association between exposure to OAT and HIV and HCV outcomes. The proposed study will lead to an NIH R01 proposal to establish a larger prospective study to assess ongoing risk, HIV and HCV transmission, and the impact of prevention services and interventions in young adult PWID in Iran. We also envision leveraging future funding opportunities in Iran to develop our research site. In brief, the proposed CAPS Innovative Grant will initiate an Iranian UFO sister study to meet the proposed aims, to create platform for future HIV and HCV prevention research, and to ultimately achieve the same positive health impact on young PWID as our UCSF model.