Quantification of Tenofovir Alafenamide Adherence (QUANTI-TAF)

PLWH taking or initiating/re-initiating TAF will be recruited for a 16-week study. Upon entering the study, participants will be trained on the use the digital pill to objectively quantify adherence. Study participants already taking TAF will return every 4 weeks for a study visit where blood for drug concentrations will be obtained. Participants initiating/re-initiating TAF will return weekly for the first 4 weeks, at weeks 6 and 8, and every 4 weeks thereafter for a study visit where drug concentrations will be obtained.

Inclusion criteria

• Females or males with HIV, able to give informed consent and comply with study procedures.
• Currently on (> 6 months), or planning to initiate/re-initiate TAF.

Exclusion criteria

• For females of childbearing age, active pregnancy or any intent to become pregnant
• Hepatitis C (HCV) infection for which treatment is anticipated within the next 16 weeks after enrollment. Treated HCV with sustained virologic response is allowable if last dose of HCV antivirals was >12 months prior to enrollment
• Advanced renal (eGFR <30 mL/min/1.73m**2) or liver (Child-Pugh B or C) disease
• History of extensive bowel surgery, gastric bypass, or gastroparesis
• Concomitant use of any prescription or non-prescription drug known (or with the potential) to significantly influence the PK of TAF (e.g. rifamycins, carbamazepine, phenytoin, St. John's Wort, tipranavir)