Plasma and endocervical swab samples were collected every six months, irrespective of ART initiation, and included in this analysis if they were collected after ART initiation. The samples were linked to the contraceptive method reported as being used at the sample collection visit. Plasma and genital viral detection was conducted using COBAS AmpliPrep/COBAS TaqMan Real-Time HIV-1 RNA assay (Roche Diagnostics, Indianapolis, IN) for Partners in Prevention and Couples Observational Studies and Abbott RealTime HIV-1 assay (Abbott Laboratories, Des Plains, IL) for Partners PrEP Study, as previously detailed.11 (link),18 The lower limits of quantification for HIV-1 RNA assays in both undiluted plasma and endocervical samples were 40–48 copies/mL of fluid tested. Plasma viral suppression was considered <400 copies/mL and genital shedding as any detectable genital viral RNA. We defined isolated genital shedding as any detectable genital viral RNA in the setting of plasma viral suppression at the same visit.
Protocol detail
HIV Viral Suppression Monitoring
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Corresponding Organization : Kenya Medical Research Institute
Other organizations : Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Family Health International 360
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Variable analysis
independent variables
- Contraceptive method reported as being used at the sample collection visit
- Plasma viral suppression (<400 copies/mL)
- Genital shedding (any detectable genital viral RNA)
- Isolated genital shedding (any detectable genital viral RNA in the setting of plasma viral suppression at the same visit)
- Plasma and endocervical swab samples were collected every six months, irrespective of ART initiation, and included in this analysis if they were collected after ART initiation
- No positive or negative controls were explicitly mentioned in the input text.
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