Related Experiment Video
Updated: Apr 29, 2026
Humanized NOG Mice for Intravaginal HIV Exposure and Treatment of HIV Infection
Published on: January 31, 2020
Prospective HIV RNA screening with long-acting cabotegravir pre-exposure prophylaxis in HPTN 083
Raphael J Landovitz1, Jessica M Fogel2, Fei Gao3
1Center for Clinical AIDS Research & Education, University of California Los Angeles, Los Angeles, California, USA.
Background:
Pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention. However, breakthrough infections can occur, even with optimal adherence. We evaluated the performance of prospective HIV RNA screening in cisgender men and transgender women who have sex with men using long-acting injectable cabotegravir (CAB-LA) pre-exposure prophylaxis (PrEP) in HPTN 083.
Methods:
In the Open Label Extension of HPTN 083, sites performed HIV rapid, antigen/antibody (Ag/Ab) and RNA testing at each visit. Results from site testing and retrospective HIV testing were used to determine final HIV status and identify the first HIV positive visit.
Results:
HIV RNA screening was associated with fewer diagnostic delays (7% vs. 47% of cases, p=0.02) and earlier treatment initiation (median 15 vs. 62 days, p=0.02). Drug resistance was less frequent with RNA screening (15% vs. 31% of cases, p=0.22). Five cases were first detected with RNA testing only. Sensitivity and specificity of RNA testing were 93% (95% CI: 76, 99) and 99.92% (95% CI: 99.88, 99.95), respectively. However, positive predictive value (PPV) was low overall (55%; 95% CI: 40, 69) and was lower if CAB-LA was administered <6 months earlier (29%; 95% CI: 13, 49). Some false positive RNA test results led to delay or discontinuation of CAB-LA injections.
Conclusions:
HIV RNA screening improved clinical outcomes in the setting of CAB-LA PrEP, but the PPV for RNA screening was low which could compromise patient care.
