Quantification of HIV-1 RNA Among Men Who Have Sex With Men Using an At-Home Self-Collected Dried Blood Spot Specimen: Feasibility Study

Abstract

BackgroundSuboptimal antiretroviral therapy (ART) adherence and disengagement in care present significant public health challenges because of the increased probability of HIV transmission. In the United States, men who have sex with men (MSM) continue to be disproportionately affected by HIV, highlighting a critical need to engage high-risk MSM living with HIV who are not engaged or retained in care.ObjectiveThe aim of the study was to assess the feasibility of at-home blood self-collection and laboratory quantification of HIV-1 RNA viral load (VL) to report laboratory-based VL outcomes and compare self-reported and laboratory-reported VLMethodsBetween 2016 and 2017, 766 US HIV-positive MSM enrolled in a Web-based behavioral intervention were invited to participate in an at-home dried blood spot (DBS) collection study using HemaSpot-HF kits (Spot On Sciences, Inc, Austin, TX) for laboratory-quantified VL.ResultsOf those invited to participate, 72.3% (554/766) enrolled in the DBS study. Most (79.2%, 439/554) men enrolled reported attempting to collect their blood, 75.5% (418/554) of participants mailed a DBS specimen to the research laboratory, and 60.8% (337/554) had an adequate blood sample for VL testing. Of the 337 specimens tested for VL by the laboratory, 52.5% (177/337) had detectable VL (median: 3508 copies/mL; range: 851-1,202,265 copies/mL). Most men (83.9%, 135/161) who returned a DBS specimen with laboratory-quantified detectable VL self-reported an undetectable VL during their last clinical visit.ConclusionsHome collection of DBS samples from HIV-positive MSM is feasible and has the potential to support clinical VL monitoring. Discrepant laboratory HIV-1 RNA values and self-reported VL indicate a need to address perceived VL status, especially in the era of treatment as prevention. Most participants were willing to use an at-home DBS kit in the future, signaling an opportunity to engage high-risk MSM in long-term HIV care activities.

Longitudinal Viral Load Monitoring Using Home-Collected Dried Blood Spot Specimens of MSM Living with HIV: Results from a Feasibility Pilot Study

“…The M-Spot 2 study is part of a sequence of studies following participants from the Sex Positive! Study (parent study) and the first M-Spot study [4,5]. Briefly, eligible participants in the parent study self-reported being biologically male and identified as male or genderqueer; ≥ 18 years old; White, Black, or Hispanic; able to read and respond in English; a United States (U.S.) resident; living with HIV; virally unsuppressed (≥ 200 copies/mL) in the past year or reported past-month suboptimal ART adherence; and reported condomless anal sex (CAS) with an HIV-discordant or unknown status male partner in the past 6 months.…”

“…For this pilot study, a different research assay was used to test DBS specimens than the research assay used for the first M-Spot study [4]. The purpose of the new research assay was to obtain a lower limit of quantification (500 copies/mL vs. 832 copies/mL).…”

Achieve Research Continuity During Social Distancing by Rapidly Implementing Individual and Group Videoconferencing with Participants: Key Considerations, Best Practices, and Protocols

“…This strategy could be adopted for analyses involving other specimens. For example, a video-call could be used to support participants in collecting dried blood spots for analysis [11,12].…”

Evaluation of Rapid Testing Algorithms for Venue-based Anonymous HIV Testing among Non-HIV-Positive Men Who Have Sex with Men, National HIV Behavioral Surveillance (NHBS), 2017

“…CDC used previously published protocols for GS HIV Combo Ag/Ab EIA (BRC; Bio-Rad Laboratories) and Geenius HIV-1/2 supplemental assay (Geenius; Bio-Rad Laboratories) which were validated for use with DBS in the CDC laboratory [ 18 ]. All samples received viral load (VL) testing using a modified protocol (HIV-1 RNA 1.0 mL extraction protocol) on the Abbott Real Time m2000sp HIV-1 VL kit (Abbott Molecular Inc., Des Plaines, IL) optimized for 70 µL of whole blood [ 19 , 20 ]. Because DBS collected during the study may have limited quantity of blood, four 6 mm punches (~ 50 µL of whole blood) were used in a laboratory-validated protocol [ 21 ].…”