Most clinical trials do not regularly monitor for negative social harms experienced by participants in any systematic way. Participation in HIV trials often place participants at a heightened risk of oppression, discrimination, and victimization. These risks may be compounded when participants are substance abusers. Although foreseen risks are generally outlined in the consent form and monitored throughout the study, many social harms are unforeseen and, consequently, are not discussed or monitored. Without systematic monitoring, the majority of social harms likely go undetected. Recognizing the high level of social harm that may arise as a result of participation in HIV vaccine trials, several National Institute of Allergy and Infectious Diseases (NIAID)-sponsored groups began to incorporate general assessments to measure the social impact of research participation in HIV vaccine trials. Although this has provided a preliminary model for monitoring social harms in clinical research, the assessments have several shortcomings that limit their reliability, validity and utility. In general, they are administered in an interview format that may be cumbersome to the research team. Furthermore, participants may feel uncomfortable or reluctant to report social harms directly to the interviewer, resulting in inaccuracies or underreporting of negative events. Interview items generally address large classes of behavior rather than specific behaviors, reducing the sensitivity and construct validity of the assessments, and questions used across agencies are not standardized. Finally, these assessments do not include harms specific to substance use, a major risk factor for HIV/AIDS transmission. The proposed two- phased project seeks to develop a comprehensive, audio computer assisted self-administered interview social harm questionnaire (ACASI-SHQ) that will allow researchers to more easily identify and monitor social harms experienced by substance abusers participating in HIV trials. The ACASI-SHQ will (1) reduce the likelihood of socially desirable responding, (2) include items with high levels of specificity to increase the likelihood of identifying social harms (construct validity), and (3) utilize a self-interview format that will increase the likelihood of its adoptio by HIV researchers. We will then evaluate its feasibility, acceptability, and preliminary utility and construct validity in an ongoing HIV trial. Findings from this innovative and significant R21 application will serve as the basis for a future R01 application to examine the utility and validit of the social harm assessment in a larger sample of research trials.

Public Health Relevance

Participation in HIV trials often place participants at a heightened risk of oppression, discrimination, and victimization, particularly when participants are substance abusers. Although foreseen risks are generally outlined in the consent form and monitored throughout the study, many social harms are unforeseen and, consequently, are not discussed or monitored. The proposed two-phased project seeks to develop and evaluate the feasibility and acceptability of a comprehensive, audio computer assisted self-administered interview social harm questionnaire (ACASI-SHQ) that will allow researchers to more easily identify and monitor social harms experienced by substance abusers participating in HIV trials.

Agency
National Institute of Health (NIH)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21DA036407-01A1
Application #
8789549
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Kahana, Shoshana Y
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Treatment Research Institute, Inc. (TRI)
Department
Type
DUNS #
City
Philadelphia
State
PA
Country
United States
Zip Code
19106