Search

Objective To describe the design, methods and baseline findings of a multi-level prevention intervention to increase consistent condom use among persons at public social sites in Kingston, Jamaica, who have new or concurrent sexual partnerships. Methods A two-arm randomized controlled trial (RCT) of 147 sites where persons meet new sex partners. Sites were identified by community informants as places where people meet new sexual partners, which include bars, street locations, bus stops, malls and others. Sites were sorted into 50 clusters based on geographic proximity and type of site and randomized to receive a multi-level site-based intervention or not. Intervention components include on-site HIV testing, condom promotion and peer education. Effectiveness of the intervention will be measured by comparing the proportion of persons with new or multiple partners in the past year who report recent inconsistent condom use at intervention vs. control sites. Results Baseline surveys were conducted at 66 intervention (711 men, 845 women) and 65 control sites (654 men, 738 women). Characteristics of intervention and control sites as well as the characteristics of patrons at these sites were similar. The outcome variable was balanced with approximately 30% of men and 25% of women at intervention and control sites reporting a new partner or more than one partner in the past year and recent inconsistent condom use. Conclusions The baseline findings confirm that the population is an appropriate target group for HIV prevention and that randomization will provide the means to estimate programme effectiveness. [ABSTRACT FROM AUTHOR]

The randomized controlled trial has been used in medical research for a little over half a century. This manuscript provides an overview of some of the history and evolution of the randomized controlled trial during this period. There exists hierarchies of evidence for therapeutic, diagnostic and prognostic questions, and the randomized controlled trial is at the top of the therapeutic hierarchy. Despite being at the top of the therapeutic hierarchy randomization in itself does not guarantee the trial results approximate the true effect. Issues that result in systematic and nonsystematic deviations from the truth in randomized controlled trials must also be considered. We present a model for evidence-based decision making that includes the following components; the clinical state, patient preferences, research evidence from a range of studies and clinical expertise. We discuss the role of the randomized controlled trial within evidence based decision making. [ABSTRACT FROM AUTHOR]