Tenofovir-induced AKI diagnostic screening tool

The effectiveness of tenofovir-induced tool in improving the diagnosis and early detection of acute kidney injury among female sex workers, North-West Province, South Africa: a framework for scaling up a diagnostic screening tool

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202608871254363

Enrollment

180

Registered

2026-08-04

Start date

2026-08-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS Kidney Disease

Interventions

TDF induced AKI screening tool

Gold Standard

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: HIV-positive On TDF-based ART =18 years North-West Province, >1 year Able to provide informed consent Not pregnant, no known CKD at baseline

Exclusion criteria

Exclusion criteria: HIV-negative Not on TDF-based ART <18 years Resident <1 year Unable to consent Pregnant, known CKD

Design outcomes

Primary

Measure	Time frame
The primary outcome of this study is the clinical detection of TDF-associated nephrotoxicity (acute kidney injury, AKI) among female sex workers on tenofovir-based ART is assessed through specific renal function changes, with the following clinical criteria: A decline in estimated glomerular filtration rate (eGFR) of more than 35% An increase in serum creatinine of more than 50% An eGFR of less than 60 mL/min/1.73m² within three months	—

Measure

Time frame

The primary outcome of this study is the clinical detection of TDF-associated nephrotoxicity (acute kidney injury, AKI) among female sex workers on tenofovir-based ART is assessed through specific renal function changes, with the following clinical criteria: A decline in estimated glomerular filtration rate (eGFR) of more than 35% An increase in serum creatinine of more than 50% An eGFR of less than 60 mL/min/1.73m² within three months

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Secondary

Measure	Time frame
The secondary outcomes in this study focus on various aspects beyond the primary clinical detection of TDF-associated nephrotoxicity, aiming to assess the broader impact and practicality of implementing the TDF-induced AKI screening tool. Specifically, the secondary outcomes include feasibility, acceptability, and usability, diagnostic harmony sensitivity, specificity and predictive values of the screening tool compared to the standard-of-care (creatinine) test. Assesses how reliably the new tool matches established diagnostic standards. Implementation Variables Include: The number of FSWs tested, the Number of healthcare workers (HCWs) trained on the screening protocol, the Number of false positives/negatives observed, and the Number and frequency of follow-up tests conducted. Demographic & Clinical Data - Collection of participant information such as age, sex, education, occupation, BMI, race/ethnicity, and ART duration.	—

Measure

Time frame

The secondary outcomes in this study focus on various aspects beyond the primary clinical detection of TDF-associated nephrotoxicity, aiming to assess the broader impact and practicality of implementing the TDF-induced AKI screening tool. Specifically, the secondary outcomes include feasibility, acceptability, and usability, diagnostic harmony sensitivity, specificity and predictive values of the screening tool compared to the standard-of-care (creatinine) test. Assesses how reliably the new tool matches established diagnostic standards. Implementation Variables Include: The number of FSWs tested, the Number of healthcare workers (HCWs) trained on the screening protocol, the Number of false positives/negatives observed, and the Number and frequency of follow-up tests conducted. Demographic & Clinical Data - Collection of participant information such as age, sex, education, occupation, BMI, race/ethnicity, and ART duration.

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Countries

South Africa

Contacts

Public ContactEdith Phalane

CoSupervisor

edithp@uj.ac.za+27796123754

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026