1. Patients in routine HIV clinical care at-risk for potentially transmitting HIV in the “test and treat” era of HIV prevention Crane, HM, Mimiaga, M, Feldman, BJ, Fredericksen, R, Mugavero, MJ, Willig, JH, Safren, S, Mathews, WC, Christopoulos, K, Boswell, S, Kitahata, MM, Saag, MS, Mayer, K for the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) Cohort,

2. Background  Sexual risk behavior is the main transmission mode in US and globally  US prevention policies currently moving to “test and treat”, getting patients with HIV diagnosed and into care  Despite earlier initiation of ART, many patients are still at-risk for transmitting HIV even after diagnosis and initiation of care  We therefore conducted this study to better understand HIV transmission risk behavior among patients in clinical care in the US in the current treatment era

3. CNICS

4. Methods  HIV-infected adults, 5 sites, clinical assessment  CNICS data repository captures longitudinal comprehensive clinical data including demographic, clinical, medication, and laboratory data  Primary outcome: being at-risk for potentially transmitting HIV, defined as current sexual risk behavior (sexual activity with incomplete/no condom use in the prior 6 months) with detectable viral load.  Generalized estimating equations adjusting for age, race, sex, and site to examine predictors such as drug and alcohol use, depression

5. Patient Based Instruments DomainInstrument ARV adherenceACTU-4, VAS, 30-day rating DepressionPHQ-9 from PRIME-MD AnxietyPHQ-4 Alcohol useAUDIT-C Substance useASSIST Health related quality of lifeEuroQOL-5D Symptom burdenHIV Symptoms Index (HIV-SI) Body morphologyAdapted from FRAM instrument HIV Risk BehaviorHRAP HRAP includes sexual risk behaviors with both male and female partners in the prior 6 months, including number of partners, serostatus of partners, and condom use Touch screen based assessment completion

6. Results  5,411 patients completed 13,592 assessments and had viral load results  Mean baseline age was 44 years  Mean CD4+ cell count nadir was 284 cells/mm 3  Rate of unsafe sex (incomplete condom use) was 22%  Rate of primary at-risk outcome (incomplete condom use and detectable viral load) was 7%, ranging from 5-11% by site

7. Clinical and demographic characteristics by risk for potential HIV transmission status (based on sexual risk behavior) and viral load (N=5411)

8. Substance use by risk for potential HIV transmission status (based on sexual risk behavior) and viral load (N=5411)

9. Sexual risk behavior by risk for potential HIV transmission (based on sexual risk behavior) and viral load (N=5411)

10. Individual adjusted models to assess potential HIV transmission risk and inadequate medication adherence

11. Odds ratios of substance use associated with being at-risk for potential HIV transmission *adjusted for sex, age, race, site, depression score

12. Discussion  Strengths: large diverse cohort  multiple sites across US  thorough sexual risk behavior assessment  ability to examine impact of individual drugs and alcohol, current treatment era  Limitations: sexual risk behavior by self-report, underestimate  Similarity of associations between being at-risk for potential HIV transmission and inadequate medication adherence  Patients in care may engage in risky sexual behavior with detectable viremia, and substance use, particularly amphetamines, may be one important factor

13. Conclusions  ~1/4 of participants in clinical care were currently engaged in sexual risk behaviors that could potentially transmit HIV. A third of these participants had a detectable viral load.  Findings suggest ongoing need for positive prevention programs, particularly those focused on younger patients, MSM, and especially those with substance use issues  Test and treat policies do not eliminate the need to focus on prevention of potential HIV transmission risk with diagnosed patients in care  Getting patients to non-infectious status is a complex and difficult task for many individuals with HIV; behavioral interventions are needed in conjunction with test and treat approach

14. Acknowledgements  Patients, staff, and providers  Fenway  UAB  UCSD  UCSF  UW  NIH funding: CNICS, ARCH-ERA, PROMIS, NIMH Adherence RO1