Most clinical trials do not regularly monitor for negative social harms experienced by participants in any systematic way. Participation in HIV trials often places 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 two-phased project aims to improve the collection of social harms among HIV trial participants by developing 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 proposed study will proceed in two phases. In Phase 1, the investigators will develop the ACASI Social Harm Questionnaire (SHQ). In Phase 2, the investigators will conduct a controlled study to evaluate its acceptability, feasibility, and utility and construct validity.

During Phase 1 the investigators will first conduct a systematic literature review to identify existing tools that researchers currently use to measure social harm or impact experienced by research participants. In addition, the investigators will survey 100 researchers who are currently conducting National Institutes of Health (NIH)-funded HIV-related trials involving substance abusers. The sample will be randomly selected from a pool of researchers meeting this criterion identified through the NIH RePORTER database. The brief telephone survey will include questions about methods used to collect data on social harm including specific questions asked, mode of administration, frequency of assessment, perceived ease of data collection, and concerns related to the assessment. During this phase the investigators will also conduct a focus group with 10 former research participants to gather information about their experiences and perceptions of social harm in HIV-related research trials. The research team in collaboration with a multidisciplinary panel of experts will draft a beta-version of the SHQ content and format. The expert panel will also assist in identifying an optimal trial in which to test the finalized instrument in the second phase of the study. Finally, the investigators will conduct a protocol analysis of the beta-version through interviews with 20 individuals who are currently enrolled in an ongoing National Institute of Drug Abuse (NIDA)-funded HIV prevention trial being conducted by the investigators. This is intended to ensure that items are correctly and similarly understood by subjects, and to provide insight into better methods of phrasing or structuring questions and response options to properly convey their meaning. Upon completion of the protocol analysis, the revised instrument will be finalized by the investigators, programmed into the ACASI format, beta-tested by the research team, and critically reviewed by our expert panel before the final programming of the ACASI-SHQ is completed.

During Phase 2, we will conduct a pilot study to evaluate the acceptability, feasibility, and utility and construct validity of the ACASI-SHQ. Individuals consenting to the host study will be offered the opportunity to participate in the pilot study, and they will receive a manualized written informed consent procedure. We will enroll a total of 80 individuals into the pilot study. All participants will complete two measures of social harm at monthly research appointments for a three month period. The social harms assessments will be (1) the ACASI-SHQ that was developed in Phase 1 and (2) the HIV Vaccine Trials Network (HVTN) Social Impact Assessment. At each appointment, the order in which the instruments are delivered will be counterbalanced to control for carryover effects. At the end of Phase 2, host study research team will complete the ACASI-SHQ Feasibility and Acceptability Questionnaire. Additionally, the PI and Co-I will conduct a focus group with the research team to collect qualitative data on the feasibility, acceptability, and perceived benefits of the ACASI-SHQ and information to guide its future implementation.

The recruitment, study design, conditions, arms, interventions, and eligibility criteria sections of this record reflect the involvement of the 80 participants who will participate in Phase 2 pilot testing of the ACASI-SHQ.