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Table 2 Effectiveness trial measures

From: The effectiveness of a group-based computerized HIV/STI prevention intervention for black women who use drugs in the criminal justice system: study protocol for E-WORTH (Empowering African-American Women on the Road to Health), a Hybrid Type 1 randomized controlled trial

Variable type

Construct

Description

Timeline

Primary outcome

Reduced incidence of biologically confirmed STIs (i.e., chlamydia, gonorrhea, and trichomoniasis)

Biological assay for infection by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis

Baseline, 12-month follow-up

Secondary outcomes

HIV risk behaviors (number of unprotected sex acts; self-reported condom use)

Measured using NIDA’s Seek, Test, Treat and Retain for Vulnerable Populations: Data Harmonization Measure

Sexual risk behavior items are based on the Women’s Health CoOp Baseline Questionnaire

Baseline, 3-month, 6-month, 12-month follow-up

Viral load

Written confirmation of viral load information for HIV-positive participants provided by participant’s medical provider

Baseline, 3-month, 6-month, 12-month follow-up

Drug use

Measured using NIDA’s Seek, Test, Treat and Retain for Vulnerable Populations Data Harmonization Measure

Injection risk behavior items are taken from the STTR Criminal Justice instrument

Baseline, 3-month, 6-month, 12-month follow-up

Use of drug treatment

Single-item question that inquires about participant’s current legal criminal justice status

Participants are asked to select all responses that apply, including mandated drug treatment court sentence.

Baseline, 3-month, 6-month, 12-month follow-up

Intimate partner violence

IPV was assessed using three subscales from the Revised Conflict Tactics Scale (CTS2) (physical, sexual, and injury-related) [71].

Baseline, 3-month, 6-month, 12-month follow-up

We also used the four-item Jellinek Inventory for assessing Partner Violence [72].

Baseline

Last, we assessed IPV using a two-item self-efficacy inventory that gauges participants’ attempts to make or update a safety plan, or obtain either an order of protection or a restraining order.

Baseline, 3-month, 6-month, 12-month follow-up

Linkage to and retention in HIV and STI treatment

We assessed linkage to and retention in HIV and STI treatment using self-reported items gauging the receipt of medical care for HIV.

Baseline, 3-month, 6-month, 12-month follow-up

ART adherence

We also assessed linkage to and retention in HIV and STI treatment using self-reported items inquiring about the use of ART

Baseline, 3-month, 6-month, 12-month follow-up

Criminal justice involvement and recidivism

Self-reported items assessing number of times stopped, detained, arrested, and convicted of a crime during assessment time frames.

Baseline, 3-month, 6-month, 12-month follow-up

Moderators

Sociodemographics

Self-reported data collected on age, gender, race/ethnicity, education, income, and marital status.

Baseline

Psychosocial characteristics

Depression is assessed using the four-item Center for Epidemiologic Studies Depression Scale.

Baseline, 3-month, 6-month, 12-month follow-up

Posttraumatic stress experienced in the past month was assessed using the PCL-C [73], a standardized self-report rating 17-item scale that corresponds to the key symptoms of PTSD.

Baseline, 12-month follow-up

We use the Stressful Life Events Screening Questionnaire to assess lifetime exposure to traumatic events [74].

Baseline

CFIR construct: outer setting (Environmental-level characteristics)

Questions that focus on the external environment of all recruitment and intervention locations (i.e., probation sites, NGO community reentry provider locations, recruitment locations, strategies and techniques). Assessed using structured qualitative interviews and computerized surveys administered to NGO community reentry facilitators at repeated time points.

Ongoing

CFIR construct: inner setting (organization-level characteristics)

Items inquiring about the feasibility of implementing the intervention in all identified locations; the structural characteristics, networks and communication, culture, climate and readiness for implementation of the implementation organization, recruitment sites and probation locations. Also assessed using structured qualitative interviews and computerized surveys administered to NGO community reentry facilitators at repeated time points.

Baseline, repeated assessments

CFIR construct: individuals setting (staff-level characteristics)

Self-reported questions that capture NGO community reentry facilitators’ readiness to adopt the intervention; knowledge and beliefs about the intervention that might influence adoption; self-efficacy regarding ability to deliver the intervention; individual identification with organization; attitudes about technology (e.g., perception about how hard it is to use, how hard to administer to participants); and other personal attributes.

Baseline, repeated assessments

CFIR construct: intervention characteristics

Determined using self-reported survey questions, this construct examines: community reentry facilitators’ and organizational providers’ attitudes towards the intervention; and features of the intervention itself (the use of a tablet to deliver the intervention, adaptability, complexity, design) that might compromise or facilitate implementation.

Baseline, repeated assessments

CFIR construct: process

These self-reported inventory items captures and processes activities associated with preplanning and early engagement and implementation, supervision of intervention, and evaluation of the intervention.

Baseline, repeated assessments

  1. Abbreviations: ART Antiretroviral therapy, CFIR Consolidated Framework for Implementation Research, HIV Human immunodeficiency virus, IPV Intimate partner violence, NGO Nongovernmental organization, NIDA National Institute on Drug Abuse, PCL-C Posttraumatic Stress Disorder Checklist–Civilian version, PTSD Posttraumatic stress disorder, STI Sexually transmitted infection, STTR Seek, Test, Treat and Retain