Background:
Innovative approaches are needed to achieve the third UNAIDS 95-95-95 target, to sustain virologic suppression (VS) in patients on ART. Tenofovir (TFV)-dolutegravir (DTG)-lamivudine (TLD) is first-line ART recommended by the World Health Organization (WHO). Virologic failure in patients on TLD is likely due to non-adherence because of DTG’s high barrier to resistance. Identifying non-adherence to TLD with an objective measure of adherence may help patients achieve VS, while saving on costly repeated viral load (VL) testing and more expensive second-line ART. We integrated a low-cost, point-of-care (POC) urine test to detect TFV into standard enhanced adherence counseling (EAC) to improve VS in adults with high VL on first-line TLD in Namibia.
Methods:
Patients on TLD with persistent non-VS (VL >1000 copies/mL) even after completing 3-months or more of EAC were enrolled from 38 clinics across Namibia. At each monthly ART pick-up, participants completed the POC urine test and received EAC informed by POC test results. After 3 months, participants received a VL test. If VS (the primary outcome) was not achieved, a second round of POC urine testing with EAC was provided. Acceptability of the urine assay was assessed via oral surveys administered to participants and providers.
Results:
Of 127 participants enrolled (median age 33 years, interquartile range 22-46, 61% female) with virologic failure, 109 achieved the primary outcome with the urine assay: VS at month 3 (86%, p < 0.001). An additional 2 participants achieved VS at month 6 (87%). Positive TFV in urine increased from 81% to 97% in clients that achieved VS and 31% to 50% in those who did not. Overall, 86% of participants and 91% of 51 interviewed providers agreed/strongly agreed that the urine test should be incorporated into clinical care.
Conclusions:
Nearly 90% of patients on TLD who were not virally suppressed at baseline despite counseling achieved VS within 3 months following EAC that incorporated feedback from a urine-based POC TFV test. While EAC alone did not achieve VS in this group, EAC that incorporated an objective patient-viewed metric of adherence in the clinic was successful for the vast majority of participants. Encouraging results of this pre-post intervention should be rigorously tested in a future randomized clinical trial. Given the cost of VL and resistance testing in lower-and middle-income countries, this POC urine test has great potential to help achieve the third 95-95-95 target in a low-cost, scalable manner.