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APHA Scientific Session and Event Listing

Recorded presentation

Judith Bernstein, PhD, RNC¹, Anne Valentine, MPH², Supriya Mehta, MHS, PhD², and Edward Bernstein, MD¹. (1) Youth Alcohol Prevention Center, Boston University School of Public Health, 715 Albany St., Boston, MA 02118, 617-414-1415, jbernste@bu.edu, (2) Department of Emergency Medicine, Boston University School of Medicine, Boston, Boston, Boston, MO 02118

Stringent protection of human rights was incorporated into the initial design of Project SAFE, a randomized controlled trial in the Emergency Department to reduce sexually transmitted disease (STD) rates among cocaine and heroin users. The objectives were to determine if the level of exposure to individual and environmental risk factors among active drug users justifies especially intensive measures to protect patient autonomy and confidentiality, and to institute a research process that treats participants from diverse communities with dignity and respect. Descriptive data were analyzed from an intake screening survey and baseline assessment tool. Results revealed: the sample was 61% male, 37% African American, 40% non-Hispanic White, and 21% Hispanic. We identified a high level of risk in several categories: socio-economic—not high school graduate 30%, homeless 27%, unemployed 89%, combined household income <$0,000 94%; drug use practices—current injection drug user 47%; sexual health practices—recent exchange of sex for drugs or money 19%, previous STD 43%, HIV positive 10%, no condom use with casual or exchange partner 31%; co-existing health problems—taking psychiatric medications 30%, no regular source of care 53%; exposure to violence— PTSD scale positive 44%, sexual abuse 41%, physical abuse 58%, witness to violence 68%. PTSD positive enrollees were more likely to have had a recent exchange partner. We recommend that at minimum HIV researchers intensify safeguards for assessing comprehension of study elements, provide free testing for STDs, and refer all enrollees for substance abuse and mental health services, regardless of randomization status.

Learning Objectives:

• Identify environmental risk factors that increase the need for stringent monitoring of and protection of participants’ human rights in the research process;
• Describe three areas of increased risk specific to enrollees in an HIV study;
• List five procedures that can be incorporated into study design to act as safeguards for vulnerable populations.

Keywords: Risk Assessment, Research Ethics

Presenting author's disclosure statement:

Any relevant financial relationships? No

Recorded presentation