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 ,

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

CNICS

MethodsHIV-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

Patient Based Instruments

Domain Instrument

ARV adherence ACTU-4, VAS, 30-day rating

Depression PHQ-9 from PRIME-MD

Anxiety PHQ-4

Alcohol use AUDIT-C

Substance use ASSISTHealth related quality of life

EuroQOL-5D

Symptom burden HIV Symptoms Index (HIV-SI)

Body morphology Adapted from FRAM instrument

HIV Risk Behavior HRAPHRAP 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

Results5,411 patients completed 13,592

assessments and had viral load results Mean baseline age was 44 yearsMean CD4+ cell count nadir was 284

cells/mm3

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 

Clinical and demographic characteristics by risk for potential HIV transmission status (based on sexual risk behavior) and viral

load (N=5411)

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

Sexual risk behavior by risk for potential HIV transmission (based on sexual risk behavior) and viral

load (N=5411)

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

Odds ratios of substance use associated with being at-risk for potential HIV transmission

*adjusted for sex, age, race, site, depression score

DiscussionStrengths: large diverse cohort

multiple sites across US thorough sexual risk behavior assessment ability to examine impact of individual drugs and alcohol,

current treatment eraLimitations: sexual risk behavior by self-report,

underestimateSimilarity 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

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

Acknowledgements Patients, staff, and providers

Fenway UAB UCSD UCSF UW

NIH funding: CNICS, ARCH-ERA, PROMIS, NIMH Adherence RO1