TOPLINE:

Adding laboratory-based HIV viral load (VL) test results — with a median turnaround time of 26 hours — to standard-of-care testing did not improve overall linkage to care compared with standard-of-care test results alone but was associated with faster linkage to antiretroviral therapy (ART) among people living with HIV.

METHODOLOGY:

• Researchers conducted a randomized clinical trial to assess whether next-day, laboratory-based HIV VL test results improved linkage to ART among people with HIV infection or linkage to preexposure prophylaxis (PrEP) among at-risk participants not receiving either therapy.
• Overall, 195 participants (median age, 36 years; 39.0% women) were randomly assigned to the intervention group (n = 98), which received standard-of-care HIV antigen/antibody testing plus plasma HIV VL testing with next-day results, or the control group (n = 97), which received standard-of-care testing alone.
• The primary outcome was linkage to care, defined as having at least one telehealth or in-person conversation about HIV PrEP or ART with a healthcare professional, within 12 weeks of enrollment.
• Secondary outcomes included time to linkage to care and differences by HIV infection status.
• The median turnaround times were 6.4 hours for HIV antigen/antibody test results and 26.0 hours for VL test results.

TAKEAWAY:

• By 12 weeks, 35.4% of the participants were linked to care, with 55.1% in the intervention group vs 44.9% in the control group linked to care; no significant difference was found between groups (hazard ratio [HR], 1.28; P = .31).
• Among people with HIV infection, in a modified intention-to-treat analysis that excluded one control participant who received a clinician-ordered VL test, time to ART linkage was significantly reduced with the intervention, with 76.2% of participants in the intervention group vs 25.0% in the control group linked by day 50 (log-rank P = .03).
• Participants who were not sexually active had significantly higher rates of linkage to care in the intervention group than in the control group (HR, 2.56; P = .04).
• Among PrEP-eligible participants, the intervention was not associated with linkage to care (P = .83).

IN PRACTICE:

“Further, more comprehensive, packaged interventions, such as rapid VL testing with immediate initiation or reinitiation of ART or PrEP, may be beneficial for HIV treatment and prevention,” the authors wrote.

SOURCE:

This study was led by Matthew M. Hamill, MBChB, PhD, Johns Hopkins School of Medicine, Baltimore. It was published online on December 16, 2025, in JAMA Network Open.

LIMITATIONS:

Turnaround times for VL testing exceeded 24 hours; thus, same-day initiation of ART or PrEP was not possible, and opportunities for rapid linkage may have been missed. Only about half of the participants completed the final visit, which may have led to an underestimation of actual linkage to care. Cost, feasibility, and infrastructure requirements limited the generalizability of the results to settings without on-site laboratory capacity.

DISCLOSURES:

This study was funded by the CDC. Several authors reported receiving nonfinancial support and/or personal fees from Roche Diagnostics, Biosynex, and/or Cepheid, and one author reported receiving grants from Baltimore City Health Department, AbbVie Inc., and Gilead Sciences.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.