Enrollment Characteristics and Risk Behaviors of Injection Drug Users Participating in the Bangkok Tenofovir Study, Thailand
Open Access
- 28 September 2011
- journal article
- research article
- Published by Public Library of Science (PLoS) in PLOS ONE
- Vol. 6 (9), e25127
- https://doi.org/10.1371/journal.pone.0025127
Abstract
The Bangkok Tenofovir Study was launched in 2005 to determine if pre-exposure prophylaxis with tenofovir will reduce the risk of HIV infection among injecting drug users (IDUs). We describe recruitment, screening, enrollment, and baseline characteristics of study participants and contrast risk behavior of Tenofovir Study participants with participants in the 1999–2003 AIDSVAX B/E Vaccine Trial. The Bangkok Tenofovir Study is an ongoing, phase-3, randomized, double-blind, placebo-controlled, HIV pre-exposure prophylaxis trial of daily oral tenofovir. The Tenofovir Study and the Vaccine Trial were conducted among IDUs at 17 drug-treatment clinics in Bangkok. Tenofovir Study sample size was based on HIV incidence in the Vaccine Trial. Standardized questionnaires were used to collect demographic, risk behavior, and incarceration data. The Tenofovir Study is registered with ClinicalTrials.gov, number-NCT00119106. From June 2005 through July 2010, 4094 IDUs were screened and 2413 enrolled in the Bangkok Tenofovir Study. The median age of enrolled participants was 31 years (range, 20–59), 80% were male, and 63% reported they injected drugs during the 3 months before enrollment. Among those who injected, 53% injected methamphetamine, 37% midazolam, and 35% heroin. Tenofovir Study participants were less likely to inject drugs, inject daily, or share needles (all, p<0.001) than Vaccine Trial participants. The Bangkok Tenofovir Study has been successfully launched and is fully enrolled. Study participants are significantly less likely to report injecting drugs and sharing needles than participants in the 1999–2003 AIDSVAX B/E Vaccine Trial suggesting HIV incidence will be lower than expected. In response, the Bangkok Tenofovir Study enrollment was increased from 1600 to 2400 and the study design was changed from a defined 1-year follow-up period to an endpoint-driven design. Trial results demonstrating whether or not daily oral tenofovir reduces the risk of HIV infection among IDUs are expected in 2012.Keywords
This publication has 35 references indexed in Scilit:
- Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with MenNew England Journal of Medicine, 2010
- Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in WomenScience, 2010
- Prevention of Rectal SHIV Transmission in Macaques by Daily or Intermittent Prophylaxis with Emtricitabine and TenofovirPLoS Medicine, 2008
- Randomized, Double‐Blind, Placebo‐Controlled Efficacy Trial of a Bivalent Recombinant Glycoprotein 120 HIV‐1 Vaccine among Injection Drug Users in Bangkok, ThailandThe Journal of Infectious Diseases, 2006
- Palmtop-assisted Self-Interviewing for the Collection of Sensitive Behavioral Data: Randomized Trial with Drug Use Urine TestingAmerican Journal of Epidemiology, 2005
- Efficacy and Safety of Tenofovir DF vs Stavudine in Combination Therapy in Antiretroviral-Naive PatientsA 3-Year Randomized TrialPublished by American Medical Association (AMA) ,2004
- Recruitment, screening and characteristics of injection drug users participating in the AIDSVAX®B/E HIV vaccine trial, Bangkok, ThailandAIDS, 2004
- Lack of increased HIV risk behavior among injection drug users participating in the AIDSVAX®B/E HIV vaccine trial in Bangkok, ThailandAIDS, 2004
- A Case–Control Study of HIV Seroconversion in Health Care Workers after Percutaneous ExposureNew England Journal of Medicine, 1997
- Validating population surveys for the measurement of HIV/STD prevention indicatorsAIDS, 1995