2178. Metrics and perspectives on implementation of the electronic Columbia Suicide Severity Rating scale (eC-SSRs)™ across four Phase IIIB/IV clinical trials (ARIA, STRIIVING, DAWNING and INSPIRING)
Session: Poster Abstract Session: HIV Psychiatry
Saturday, October 29, 2016
Room: Poster Hall
Background: Increased rates of suicidal ideation/behavior have been reported in individuals with HIV/AIDS. FDA guidance endorses routine monitoring for suicidality in clinical trials of HIV. The electronic Columbia Suicidality Severity Rating scale (eC SSRs) is recommended as a validated tool for prospective assessment of suicidal risk in clinical trials. We evaluated the perception of the eC-SSRs by investigators/site staff in active clinical studies, and determined if the eC-SSRs results correlated with the clinical assessment. This is the first assessment by ViiV of site perspectives on implementation of the e-CSSRs.

Methods: The self-reported eC-SSRs administered by EResearch Technology (ERT) was included in four Phase IIIb/IV studies of dolutegravir. Administration was by telephone (2 studies) and by telephone or internet (2 studies). ViiV administered the “eC-SSRs Metrics and Perspectives Site Questionnaire” (VEQ) as a web-based survey to sites enrolling at least one subject. Topics included ease of eC-SSRs administration, first time use, agreement with clinical assessment, unreported risk, and confidence in utility of the eC-SSRs. Clinical assessment data from ARIA and STRIIVING were reviewed for correlation with the eC-SSRs results.

Results: Overall VEQ response rate was 83% (181/218) from 13 countries. Approximately 1/3 of respondents were investigators. 85% of respondents administered the eC-SSRs by phone, and 34% reported their patients would be unable to complete a web survey. 64% were first time eC-SSRs users; among these, 85% said implementation became easier over time. Half of respondents said the eC-SSRs accurately predicted the risk for suicidality and 14% said the eC-SSRs identified a previously unreported risk. 65% of respondents were somewhat/very confident their patients are being assessed accurately for suicidal risk and the eC-SSRs helps manage this risk appropriately. EC-SSRs results from ARIA and STRIIVING were consistent with the clinical assessment data.

Conclusion: The eC-SSRs identified previous unreported risk for suicidality and provided physicians opportunity for follow up. Overall, respondents feel the eC-SSRs helps them manage suicide risk. The eC-SSRs is considered a useful tool in this setting.

Clare Brennan, DPT, MSPH1, Hannah Whillis, BS2, Choy Man, BSc1, Brian Wynne, MD1 and Vani Vannappagari, MBBS, MPH, PhD1, (1)ViiV Healthcare, Research Triangle Park, NC, (2)GlaxoSmithKline, London, United Kingdom

Disclosures:

C. Brennan, ViiV Healthcare: Employee , GSK stock as part of compensation and Salary

H. Whillis, GlaxoSmithKline: Employee , Salary

C. Man, ViiV Healthcare: Employee , GSK stock as part of compensation and Salary

B. Wynne, ViiV Healthcare: Employee , GSK stock as part of compensation and Salary

V. Vannappagari, ViiV Healthcare: Employee , GSK stock as part of compensation and Salary

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