Point-of-care urine tenofovir monitoring of adherence to drive interventions for HIV treatment and prevention

References

• Han WM, Law MG, Egger M, et al. Global estimates of viral suppression in children and adolescents and adults on antiretroviral therapy adjusted for missing viral load measurements: a multiregional, retrospective cohort study in 31 countries. Lancet HIV. 2021 Dec;8(12):e766–e775.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention (CDC). Monitoring selected national HIV prevention and care objectives by using HIV surveillance data United States and 6 dependent areas, 2020. [Accessed 2022 Aug 26] https://www.cdc.gov/hiv/library/reports/hiv-surveillance/vol-27-no-3/index.html
   Google Scholar
• UNAIDS. Fact sheet - latest global and regional statistics on the status of the AIDS epidemic. 2023 (Jul 13 [Accessed 2023 Jul 16]. Available from: https://www.unaids.org/en/resources/documents/2023/UNAIDS_FactSheet
   Google Scholar
• Pugh LE, Roberts JS, Viswasam N, et al. Systematic review of interventions aimed at improving HIV adherence to care in low- and middle-income countries in sub-Saharan Africa. J Infect Public Health. 2022 Aug 28;15(10):1053–1060. doi: 10.1016/j.jiph.2022.08.012
   PubMed Web of Science ®Google Scholar
• Locher C, Messerli M, Gaab J, et al. Long-term effects of psychological interventions to improve adherence to antiretroviral treatment in HIV-Infected persons: a systematic review and meta-analysis. AIDS Patient Care STDS. 2019 Mar;33(3):131–144.
   PubMed Web of Science ®Google Scholar
• Zhang J, Li C, Xu J, et al. Discontinuation, suboptimal adherence, and reinitiation of oral HIV pre-exposure prophylaxis: a global systematic review and meta-analysis. Lancet HIV. 2022 Apr;9(4):e254–e268.
   PubMed Web of Science ®Google Scholar
• Spinelli MA, Laborde N, Kinley P, et al. The importance of PrEP persistence in preventing HIV infections on PrEP. J Int AIDS Soc. 2020 Aug;23(8):e25578.
   PubMed Web of Science ®Google Scholar
• Spinelli MA, Laborde N, Kinley P, et al. Missed opportunities to prevent HIV infections among pre-exposure prophylaxis users: a population-based mixed methods study, San Francisco, United States. J Int AIDS Soc. 2020 Apr;23(4):e25472.
   PubMed Web of Science ®Google Scholar
• Spinelli MA, Buchbinder SP. Pre-exposure prophylaxis persistence is a critical issue in PrEP implementation. Clin Infect Dis. 2020 Jul 27;71(3):583–585. doi: 10.1093/cid/ciz896
   PubMed Web of Science ®Google Scholar
• Serota DP, Rosenberg ES, Sullivan PS, et al. Pre-exposure prophylaxis uptake and discontinuation among young black men who have sex with men in Atlanta, Georgia: a prospective cohort study. Clin Infect Dis. 2020 Jul 27;71(3):574–582. doi: 10.1093/cid/ciz894
   PubMed Web of Science ®Google Scholar
• Bavinton BR, Grulich AE. HIV pre-exposure prophylaxis: scaling up for impact now and in the future. Lancet Public Health. 2021 Jul;6(7):e528–e533. doi: 10.1016/S2468-2667(21)00112-2
   PubMed Web of Science ®Google Scholar
• van Zyl G, Jennings L, Kellermann T, et al. Urine tenofovir-monitoring predicts HIV viremia in patients treated with high genetic-barrier regimens. AIDS. 2022 Nov 15;36(14):2057–2062. doi: 10.1097/QAD.0000000000003354
   PubMed Web of Science ®Google Scholar
• Bikinesi L, Spinelli MA, Nyoni N, et al. A low-cost rapid urine test for TFV increases ART adherence and viral suppression. Conference on Retroviruses and Opportunistic Infections (CROI), Feb 19-22, 2023, Seattle, WA; Abstract 1038.5.
   Google Scholar
• McCluskey SM, Pepperrell T, Hill A, et al. Adherence, resistance, and viral suppression on dolutegravir in sub-saharan Africa: implications for the TLD era. AIDS. 2021 Dec 15;35(Suppl Supplement 2):S127–S135. doi: 10.1097/QAD.0000000000003082
   PubMedGoogle Scholar
• Berg KM, Arnsten JH. Practical and conceptual challenges in measuring antiretroviral adherence. J Acquir Immune Defic Syndr. 2006 Dec 1;43(Suppl 1):S79–87. doi: 10.1097/01.qai.0000248337.97814.66
   PubMedGoogle Scholar
• Kagee A, Nel A. Assessing the association between self-report items for HIV pill adherence and biological measures. AIDS Care. 2012;24(11):1448–52. doi: 10.1080/09540121.2012.687816
   PubMed Web of Science ®Google Scholar
• Hebel S, Kahn-Woods E, Malone-Thomas S, et al. Brief report: discrepancies between self-reported adherence and a biomarker of adherence in real-world settings. J Acquir Immune Defic Syndr. 2020 Dec 1;85(4):454–457. doi: 10.1097/QAI.0000000000002486
   PubMed Web of Science ®Google Scholar
• Marrazzo JM, Ramjee G, Richardson BA, et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015 Feb 5;372(6):509–518. doi: 10.1056/NEJMoa1402269
   PubMed Web of Science ®Google Scholar
• Koenig HC, Mounzer K, Daughtridge GW, et al. Urine assay for tenofovir to monitor adherence in real time to tenofovir disoproxil fumarate/emtricitabine as pre-exposure prophylaxis. HIV Med. 2017 Jul;18(6):412–418.
   PubMed Web of Science ®Google Scholar
• Gandhi M, Bacchetti P, Rodrigues WC, et al. Development and validation of an immunoassay for tenofovir in urine as a real-time metric of antiretroviral adherence. EClinical Medicine (Published By The Lancet). 2018. doi: 10.2139/ssrn.3234836.
   Google Scholar
• Gandhi M, Bacchetti P, Spinelli IM, et al. Validation of a urine tenofovir immunoassay for adherence monitoring to PrEP and ART and establishing the cut-off for a point-of-care test. J Acquir Immune Defic Syndr. 2019 Jan 11;81(1):72–77. doi: 10.1097/QAI.0000000000001971
   PubMed Web of Science ®Google Scholar
• Spinelli MA, Glidden DV, Rodrigues WC, et al. Low tenofovir level in urine by a novel immunoassay is associated with seroconversion in a PrEP demonstration project. AIDS. 2019 Aug;14(5):867–872. doi: 10.1097/QAD.0000000000002135.
   Google Scholar
• Castillo-Mancilla JR, Zheng JH, Rower JE, et al. Tenofovir, emtricitabine, and tenofovir diphosphate in dried blood spots for determining recent and cumulative drug exposure. AIDS Res Hum Retroviruses. 2013 Feb;29(2):384–390.
   PubMed Web of Science ®Google Scholar
• Gandhi M, Greenblatt RM. Hair it is: the long and short of monitoring antiretroviral treatment. Ann Intern Med. 2002;137(8):696–697. doi: 10.7326/0003-4819-137-8-200210150-00016
   PubMed Web of Science ®Google Scholar
• Spinelli MA, Haberer JE, Chai PR, et al. Approaches to objectively measure antiretroviral medication adherence and drive adherence interventions. Curr HIV/AIDS Rep. 2020 Aug;17(4):301–314.
   PubMed Web of Science ®Google Scholar
• Baxi SM, Greenblatt RM, Bacchetti P, et al. Nevirapine concentration in hair samples is a strong predictor of virologic suppression in a prospective cohort of HIV-Infected patients. PloS One. 2015;10(6):e0129100. doi: 10.1371/journal.pone.0129100
   PubMed Web of Science ®Google Scholar
• Gandhi M, Ofokotun I, Bacchetti P, et al. Antiretroviral concentrations in hair strongly predict virologic response in a large HIV treatment-naive clinical trial. Clin Infect Dis. 2019 Mar;5(6):1044–1047.
   Google Scholar
• Murnane PM, Bacchetti P, Currier JS, et al. Tenofovir concentrations in hair strongly predict virologic suppression in breastfeeding women. AIDS. 2019 Aug 1;33(10):1657–1662. doi: 10.1097/QAD.0000000000002237
   PubMed Web of Science ®Google Scholar
• Niu X, Kubiak RW, Siriprakaisil O, et al. Tenofovir-diphosphate in dried blood spots vs tenofovir in urine/plasma for oral preexposure prophylaxis adherence monitoring. Open Forum Infect Dis. 2022 Aug;9(8):ofac405.
   PubMed Web of Science ®Google Scholar
• Rao PS, Modi N, Nguyen NT, et al. Alternative methods for therapeutic drug monitoring and dose adjustment of tuberculosis treatment in clinical settings: a systematic review. Clin Pharmacokinet. 2023 Mar 4;62(3):375–398. doi: 10.1007/s40262-023-01220-y
   PubMed Web of Science ®Google Scholar
• Gandhi M, Wang G, King R, et al. Development and validation of the first point-of-care assay to objectively monitor adherence to HIV treatment and prevention in real-time in routine settings. AIDS. 2020 Feb 1;34(2):255–260. doi: 10.1097/QAD.0000000000002395
   PubMed Web of Science ®Google Scholar
• Cressey TR, Siriprakaisil O, Kubiak RW, et al. Plasma pharmacokinetics and urinary excretion of tenofovir following cessation in adults with controlled levels of adherence to tenofovir disoproxil fumarate. Int J Infect Dis. 2020 Aug;97:365–370.
   PubMed Web of Science ®Google Scholar
• Drain PK, Bardon AR, Simoni JM, et al. Point-of-care and near real-time testing for antiretroviral adherence monitoring to HIV treatment and prevention. Curr HIV/AIDS Rep. 2020 Oct;17(5):487–498.
   PubMed Web of Science ®Google Scholar
• Drain P, Ngure K, Mugo N, et al. Testing a real-time tenofovir urine adherence assay for monitoring and providing feedback to preexposure prophylaxis in Kenya (PUMA): protocol for a pilot randomized controlled trial. JMIR Res Protoc. 2020 Apr 2;9(4):e15029. doi: 10.2196/15029
   PubMed Web of Science ®Google Scholar
• Drain PK, Kubiak RW, Siriprakaisil O, et al. Urine tenofovir concentrations correlate with plasma and relate to tenofovir disoproxil fumarate adherence: a randomized, directly observed pharmacokinetic trial (TARGET study). Clin Infect Dis. 2020 May 6;70(10):2143–2151. doi: 10.1093/cid/ciz645
   PubMed Web of Science ®Google Scholar
• Johnson KA, Niu X, Glidden DV, et al. Lower urine tenofovir concentrations among individuals taking tenofovir alafenamide versus tenofovir disoproxil fumarate: implications for point-of-care testing. Open Forum Infect Dis. 2021 Jul;8(7):ofab200.
   PubMed Web of Science ®Google Scholar
• Spinelli MA, Glidden DV, Rodrigues WC, et al. Low tenofovir level in urine by a novel immunoassay is associated with seroconversion in a preexposure prophylaxis demonstration project. AIDS. 2019 Apr 1;33(5):867–872. doi: 10.1097/QAD.0000000000002135
   PubMed Web of Science ®Google Scholar
• Spinelli MA, Glidden DV, Anderson PL, et al. Brief report: short-term adherence marker to PrEP predicts future nonretention in a large PrEP demo project: implications for point-of-care adherence testing. J Acquir Immune Defic Syndr. 2019 Jun 1;81(2):158–162. doi: 10.1097/QAI.0000000000002005
   PubMed Web of Science ®Google Scholar
• Stalter RM, Baeten JM, Donnell D, et al. Urine tenofovir levels measured using a novel immunoassay predict human immunodeficiency virus protection. Clin Infect Dis. 2021 Feb 1;72(3):486–489. doi: 10.1093/cid/ciaa785
   PubMed Web of Science ®Google Scholar
• Mustanski B, Ryan DT, Spinelli MA, et al. Urine point-of-care tenofovir test demonstrates strong predictive clinical and research utility. AIDS. 2023 Dec 1;37(15):2381–2387. Epub 2023 Sep 5. PMID: 37696260. doi: 10.1097/QAD.0000000000003710
   PubMed Web of Science ®Google Scholar
• McCluskey SM, Govender K, Adamson J, et al. Point-of-care urine tenofovir testing to predict HIV drug resistance among individuals with virologic failure. AIDS. 2023 Feb 17;37(7):1109–1113. doi: 10.1097/QAD.0000000000003520
   PubMed Web of Science ®Google Scholar
• Jennings L, Kellermann T, Spinelli M, et al. Drug resistance, rather than low tenofovir levels in blood or urine, is associated with tenofovir, emtricitabine, and efavirenz failure in resource-limited settings. AIDS Res Hum Retroviruses. 2022 Jun;38(6):455–462.
   PubMed Web of Science ®Google Scholar
• Sharma A, Gandhi M, Sallabank G, et al. Perceptions and experiences of returning self-collected specimens for HIV, bacterial STI and potential PrEP adherence testing among sexual minority men in the United States. AIDS Behav. 2022 Sep;12(4):1–15.
   Google Scholar
• McInziba A, Wademan D, Viljoen L, et al. Perspectives of people living with HIV and health workers about a point-of-care adherence assay: a qualitative study on acceptability. AIDS Care. 2023 Feb;13:1–7.
   Google Scholar
• Blair CS, Gandhi M, Shoptaw S, et al. Contingency management for integrated harm reduction among men who have sex with men who use methamphetamine in los angeles: a pilot assessment. AIDS Behav. 2022 Nov 21;27(6):1962–1971. doi: 10.1007/s10461-022-03929-6
   PubMed Web of Science ®Google Scholar
• Thuo N, Polay M, Leddy AM, et al. Point-of-care test for assessing tenofovir adherence: feasibility and recommendations from women in an oral PrEP program in Kenya and their healthcare providers. AIDS Behav. 2021 Apr 24;25(11):3617–3629. doi: 10.1007/s10461-021-03255-3
   PubMed Web of Science ®Google Scholar
• Sheira LA, Kwena ZA, Charlebois ED, et al. Testing a social network approach to promote HIV self-testing and linkage to care among fishermen at lake Victoria: study protocol for the owete cluster randomized controlled trial. Trials. 2022 Jun 6;23(1):463. doi: 10.1186/s13063-022-06409-3
   PubMedGoogle Scholar
• Ngure K, Okello P, Ogello V, et al. Acceptability and feasibility of a New Urine-based tenofovir adherence test in Kenya, Conference on Retroviruses and Opportunistic Infections (CROI), Feb 19-23, 2023, Seattle, WA.
   Google Scholar
• Spinelli MA, Rodrigues WC, Wang G, et al. Brief report: high accuracy of a real-time urine antibody-based tenofovir point-of-care test compared with laboratory-based ELISA in diverse populations. J Acquir Immune Defic Syndr. 2020 Jun 1;84(2):149–152. doi: 10.1097/QAI.0000000000002322
   PubMed Web of Science ®Google Scholar
• Gandhi M, Bacchetti P, Rodrigues WC, et al. Development and validation of an immunoassay for tenofovir in urine as a real-time metric of antiretroviral adherence. EClinical Medicine. 2018 Aug;2-3:22–28.
   PubMedGoogle Scholar
• Gandhi M, Bacchetti P, Spinelli MA, et al. Brief report: validation of a urine tenofovir immunoassay for adherence monitoring to PrEP and ART and establishing the cutoff for a point-of-care test. J Acquir Immune Defic Syndr. 2019 May 1;81(1):72–77. doi: 10.1097/QAI.0000000000001971
   PubMed Web of Science ®Google Scholar
• Johnson KA, Okochi H, Glidden DV, et al. Brief report: no difference in urine tenofovir levels in patients living with HIV on unboosted versus dose-adjusted boosted tenofovir alafenamide. J Acquir Immune Defic Syndr. 2021 Sep 1;88(1):57–60. doi: 10.1097/QAI.0000000000002727
   PubMed Web of Science ®Google Scholar
• Johnson KA, Okochi H, Arreguin M, et al. Urine tenofovir levels strongly correlate with virologic suppression in patients with human immunodeficiency virus on tenofovir alafenamide-based antiretroviral therapy. Clin Infect Dis. 2023 Mar 4;76(5):930–933. doi: 10.1093/cid/ciac828
   PubMed Web of Science ®Google Scholar
• Hermans LE, Umunnakwe CN, Lalla-Edward ST, et al. Point-of-care tenofovir urine testing for the prediction of treatment failure and drug resistance during initial treatment for human immunodeficiency virus type 1 (HIV-1) infection. Clin Infect Dis. 2023 Feb 8;76(3):e553–e560. doi: 10.1093/cid/ciac755
   PubMed Web of Science ®Google Scholar
• Morrow M, MaWhinney S, Coyle RP, et al. Emtricitabine triphosphate in dried blood spots predicts future viremia in persons with HIV and identifies mismatch with self-reported adherence. AIDS. 2021 Oct 1;35(12):1949–1956. doi: 10.1097/QAD.0000000000002981
   PubMed Web of Science ®Google Scholar
• Blair CS, Beymer MR, Kofron RM, et al. PrEP nonadherence, white coat dosing, and HIV risk among a cohort of MSM. Open Forum Infect Dis. 2020 Aug;7(8):ofaa329.
   PubMed Web of Science ®Google Scholar
• Landovitz RJ, Beymer M, Kofron R, et al. Plasma tenofovir levels to support adherence to TDF/FTC preexposure prophylaxis for HIV prevention in MSM in Los Angeles, California. J Acquir Immune Defic Syndr. 2017 Dec 15;76(5):501–511. doi: 10.1097/QAI.0000000000001538
   PubMed Web of Science ®Google Scholar
• Celum C, Hosek S, Tsholwana M, et al. PrEP uptake, persistence, adherence, and effect of retrospective drug level feedback on PrEP adherence among young women in southern Africa: results from HPTN 082, a randomized controlled trial. PLOS Med. 2021 Jun;18(6):e1003670.
   PubMed Web of Science ®Google Scholar
• Velloza J, Poovan N, Ndlovu N, et al. Adaptive HIV pre-exposure prophylaxis adherence interventions for young South African women: study protocol for a sequential multiple assignment randomized trial. PloS One. 2022;17(4):e0266665. doi: 10.1371/journal.pone.0266665
   PubMed Web of Science ®Google Scholar
• Velloza J, Poovan N, Meisner A, et al. Evaluating adaptive HIV pre-exposure prophylaxis adherence interventions for young South African women: results from a sequential multiple assignment randomized trial. Oral presentation at the 24th International AIDS Conference (AIDS 2022) Montreal, Canada, 29 Jul – 2 Aug, 2022.
   Google Scholar
• Ferraris CM, D’Avanzo PA, Jennings L, et al. Acceptability and feasibility of providing adherence feedback based on tenofovir diphosphate in dried blood spots: results from a Pilot study among patients and providers in Cape Town, South Africa. AIDS Behav. 2023 Apr 12;27(10):3478–3486. doi: 10.1007/s10461-023-04063-7
   PubMed Web of Science ®Google Scholar
• Nyoni N, Maya S, Mouton D, et al. Cost-effectiveness of urine tenofovir point-of-care assay for ART adherence feedback in Namibia. Conference on Retroviruses and Opportunistic infections. Denver, CO, U.S. Mar 3. 2024.
   Google Scholar
• Spinelli MS, Ngure K, Biwott C, et al. A point-of-care urine tenofovir adherence feedback intervention improved PrEP adherence among Kenyan women. Adherence 2023. 2023 Jun 11–13. El Conquistador in Puerto Rico, Abstract 1302 (oral presentation).
   Google Scholar
• Gandhi M, Glidden DV, Spinelli MS, et al. Use of a tenofovir urine assay for PrEP counseling among Kenyan women decreases non-adherence. Conference on Retroviruses and Opportunistic Infections (CROI); 2024 March 3–6; Denver, Colorado. 2024.
   Google Scholar
• Okello P, Ngure K, Ogello V, et al. Preferences regarding a real-time urine assay for monitoring and providing feedback on pre-exposure prophylaxis adherence among women in Kenya. Adherence 2023. 2023 Jun 11–13. El Conquistador in Puerto Rico, Abstract 1093 (oral presentation).
   Google Scholar
• Spinelli MA, Grinsztejn B, Landovitz RJ. Promises and challenges: cabotegravir for preexposure prophylaxis. Curr Opin HIV AIDS. 2022 Jul 1;17(4):186–191. doi: 10.1097/COH.0000000000000733
   PubMed Web of Science ®Google Scholar