Background
Background and rationale
Overview of study objective and design
Methods
Participants, interventions, and outcomes
Study setting
Eligibility criteria
Interventions
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Step 1 aims to have BI Staff engage clients and help them focus on a primary substance (i.e., one that caused them the most problems) and its relation to HIV. BI Staff try to understand clients’ motivation for stopping substance use and receiving HIV care.
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Step 2 aims to build upon Step 1 by strategically evoking clients’ reasons for change (called change talk). Step 2 provides up to three opportunities (Steps 2a–2c) for motivational enhancement. In Step 2a, BI Staff summarize clients’ arguments for and against change and then have the clients identify additional reasons from a checklist for quitting or cutting down substance use. BI Staff ask clients to elaborate on identified reasons and then ask a key question to determine their substance use goal. If clients commit to quitting or cutting back on substance use, BI Staff proceed to Change Planning (Step 3). If clients remain ambivalent about changing substance use, BI Staff move to Step 2b. In Step 2b, BI Staff offer clients personalized feedback about how their use compares with that of others, the annual cost of their use, and how substance use typically affects Highly Active Antiretroviral Therapy (HAART) adherence, morbidity, and mortality among people infected with HIV. BI Staff summarize and emphasize change talk. If clients remain noncommittal, BI Staff use additional motivational enhancement strategies (e.g., importance or confidence ruler technique) to evoke motivation for change (Step 2c).
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Step 3 involves developing a change plan to strengthen clients’ commitment to cut back or quit substance use. BI Staff cover the following elements: steps clients might take, identification of when each step will be used, review of available substance use treatment services, and identification of social supports and obstacles.
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Step 4 summarizes the MIBI session. For clients who committed to change and developed a change plan, BI Staff use a contract with clients to summarize the change plan and fortify the clients’ commitment to it. For clients who remain unsure about changing their substance use, BI Staff seek to “keep the door open” by thanking clients for talking about their substance use and encouraging them to discuss it again at their next visit.
Outcomes
Instruments (time; compensation) | Collection time-points and procedures | Primary outcome measures | ||
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Enrollment (pre-baseline) | Baseline (t = 0 weeks) | Follow-up (t = 4 weeks) | ||
Substance Use Screener (1–5 min; $0) | Xa,b | |||
Project Introduction Script (1–2 min; $0) | Xa,b | |||
Informed Consent (5–10 min; $0) | Xa,b | |||
Assurance of Consent (1–2 min; $0) | Xa,b | |||
Locator Form (5–10 min; $0) | Xb | |||
Baseline Assessment (20–40 min; $20) | Xb | Baseline measurement of each primary outcome was completed as part of the baseline assessment, which was adapted from the Addiction Severity Index, 5th Edition. [37] Descriptions of the primary outcome measures are provided below | ||
Follow-up Assessment (20–40 min; $20) | Xc |
Days of primary substance use
A continuous measure (ranges from 0 to28) of the number of days participants used their primary substance during the past 28 days
Number of substance-related problems
A continuous measure (ranges from 0 to 11) of the number of substance use disorder symptoms participants had during the past 28 days
Times engaging in risky behaviors
A continuous measure (no specified range) of the number of times participants engaged in unprotected sex, injection drug use, or needle sharing during the past 28 days
Days of substance use treatment
A continuous measure (ranges from 0 to 28) of the number of days participants attended residential treatment, outpatient treatment, or self-help group meetings during the past 28 days
Antiretroviral therapy (ART) medication adherence
A continuous measure (ranges from 0 to 28) of the number of days participants missed at least one dose of their HIV medications during the past 28 days |
Participant timeline
Sample size
Recruitment
Assignment of interventions
Allocation
Blinding (masking)
Data collection, management, and analysis
Data collection methods
Data management
Statistical methods
Monitoring
Data monitoring
Harms
Auditing
Ethics and dissemination
Research ethics approval
Protocol amendments
Consent
Confidentiality
Declaration of interests
Access to data
Ancillary and post-trial care
Dissemination policy
Discussion
Trial-relevant events that have occurred to date
Calendar year | Calendar month | Project year | Project month | Key project-relevant events |
---|---|---|---|---|
2014 | July | YEAR 1 | MONTH 1 | The targeted number of participating organizations and client participants was reduced because the grant received a $565,695 reduction in its total budget |
August | MONTH 2 | |||
September | MONTH 3 | |||
October | MONTH 4 | The Joint United Nations Programme on HIV/AIDS (UNAIDS) released its 90-90-90 treatment targets to help end the AIDS epidemic | ||
November | MONTH 5 | The principal investigator (Dr. Garner) of the grant moved from Chestnut Health Systems to RTI International The grant was relinquished back to the National Institute on Drug Abuse (NIDA) | ||
December | MONTH 6 | |||
2015 | January | MONTH 7 | ||
February | MONTH 8 | The grant award, minus the costs incurred during the first 5 months of the grant, was awarded to RTI International with Dr. Garner again as the principal investigator | ||
March | MONTH 9 | The preparation process for the SAT2HIV Project’s first cohort of AIDS service organizations was initiated | ||
April | MONTH 10 | |||
May | MONTH 11 | |||
June | MONTH 12 | The MIBI Experiment preparation process for the SAT2HIV Project’s first cohort of ASOs was completed | ||
July | YEAR 2 | MONTH 13 | The MIBI Experiment with the SAT2HIV Project’s first cohort was initiated The updated United States National HIV/AIDS Strategy was released | |
August | MONTH 14 | |||
September | MONTH 15 | |||
October | MONTH 16 | |||
November | MONTH 17 | |||
December | MONTH 18 | |||
2016 | January | MONTH 19 | The MIBI Experiment with the SAT2HIV Project’s first cohort was completed | |
February | MONTH 20 | |||
March | MONTH 21 | The MIBI Experiment preparation process for the SAT2HIV Project’s second cohort of ASOs was initiated | ||
April | MONTH 22 | |||
May | MONTH 23 | |||
June | MONTH 24 | The preparation process for the SAT2HIV Project’s second cohort of ASOs was completed | ||
July | YEAR 3 | MONTH 25 | The MIBI Experiment with the SAT2HIV Project’s second cohort was initiated | |
August | MONTH 26 | |||
September | MONTH 27 | |||
October | MONTH 28 | |||
November | MONTH 29 | |||
December | MONTH 30 | The MIBI Experiment with the SAT2HIV Project’s second cohort was completed |