NCT02148276

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2017

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

May 23, 2014

Last Update Submit

March 27, 2023

Conditions

Social Harms in Substance Users in HIV TrialsAudio Computer Assisted Self-administered Questionnaire

Keywords

Social harm detectionInstrument developmentHIV-related clinical trialsSubstance abuseResearch participation

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (1)

  • Utility and construct validity

    12 months

Study Arms (1)

Research Participants

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • Currently participating in an HIV-related trial
  • Current or former substance abusers
  • years of age or older

You may not qualify if:

  • Unable to give competent informed consent
  • Involvement in the study would negatively affect the participant's health or safety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Treatment Research Institute

Philadelphia, Pennsylvania, 19106, United States

Location

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • David S Festinger, Ph.D.

    Treatment Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2014

First Posted

May 28, 2014

Study Start

May 1, 2015

Primary Completion

April 4, 2017

Study Completion

April 4, 2017

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations

US(1)