NCT02148276|Completed
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Sponsor study identifier
Secondary identifiers
NIH
observational
79
1 country
1
Study Start
May 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 4, 2017
Actual (reported)Study Completion
April 4, 2017
Actual (reported)This two-phased project will 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-related 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 adoption by HIV researchers. The investigators will then evaluate its feasibility, acceptability, and preliminary utility and construct validity in an ongoing HIV-related trial.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 4, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 23, 2014
Actual (reported)May 28, 2014
Actual (reported)May 2015
Date type not reportedThis date has not been verified as actual or estimated.
April 4, 2017
Actual (reported)April 4, 2017
Actual (reported)Acceptability to participants
Evaluate the acceptability of the ACASI-SHQ to clients using a modified version of the well-validated Client Satisfaction Questionnaire.
3 months
Feasibility and acceptability to research staff
Assess the host study research team's perceptions of the ACASI-SHQ's acceptability and feasibility using the the ACASI-SHQ Feasibility and Acceptability Questionnaire. We will also hold a focus group with the host study research team to collect qualitative data on the feasibility, acceptability, and perceived benefits of the ACASI-SHQ and information to guide its future implementation.
22 Months
Utility and construct validity
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.
We anticipate that the sample will be representative of the populations in our ongoing trials of clients with substance use disorders and of the substance abuse treatment population, which is approximately 70% male, 60% African-American, 35% Caucasian, and 30% Hispanic. This distribution is similar to the gender and racial distributions of publicly funded drug abuse treatment patients in Philadelphia and other large cities located in Mid-Atlantic States.
Treatment Research Institute
Philadelphia, Pennsylvania, 19106, United States
David S Festinger, Ph.D.
Treatment Research Institute
79 participants (actual enrollment reported by the registry).
First Submitted
May 23, 2014
First Posted
May 28, 2014
Study Start
May 2015
Date type not reportedThis date has not been verified as actual or estimated.
12 months
Contact the study team to confirm eligibility.
Primary Completion
April 4, 2017
Actual (reported)Study Completion
April 4, 2017
Actual (reported)Last Updated
March 28, 2023
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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