Table 1.
Summary of the clinical visits and laboratory testing for study groups.
| Visit requirements | Enrollment | Month 3 | Month 6 | Month 9 | Month 12 | ||||||
| Screening and enrollment |
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Review eligibility criteria | ✓ | — | —a | — | — | |||||
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Obtain informed consent | ✓ | — | — | — | — | |||||
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Randomization | ✓ | — | — | — | — | |||||
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Collect sociodemographic information | ✓ | — | — | — | — | |||||
| Research assistant tasks |
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Collect and update contact information | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
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Conduct baseline questionnaire | ✓ | — | — | — | — | |||||
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Conduct quarterly questionnaire | — | ✓ | ✓ | ✓ | — | |||||
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Conduct exit study questionnaire | — | — | — | — | ✓ | |||||
| Clinical visit by nurse or physician |
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Medical history and interval updates | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
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Physical examination (as needed) | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
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Rapid HIV testing | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
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PrEPa or drug side effect screen | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
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Collect/assess pill count for prior PrEP | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
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PrEP dispensing for 3-month supply | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
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Adherence and risk reduction counseling | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| Point-of-care and laboratory testing |
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Serum hemoglobin | ✓ | — | — | — | — | |||||
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Serum creatinine | ✓ | — | ✓ | — | ✓ | |||||
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Urinalysis | ✓ | — | ✓ | — | ✓ | |||||
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POCb urine TFVc assay (intervention arm) | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
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POC urine TFV assay (standard-of-care arm) | — | — | — | — | ✓ | |||||
| Specimen collection and storage |
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Stored plasma | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
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Dried blood spot for TFV-DPd | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
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Hair sample for TFV-DP | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
aNot applicable.
bPrEP: preexposure prophylaxis.
cPOC: point-of-care.
dTFV: tenofovir.
eTFV-DP: tenofovir-diphosphate.