Evidence map›Paper›PMID 39733245›Full record

Trial reportAIDS care2025

Acceptability and feasibility of a urine-based tenofovir adherence assay for monitoring and providing feedback on PrEP adherence in Kenya.

Phelix Okello, Jennifer Velloza, Vallery Ogello, Emmah Owidi, Peter Mogere, Stephen Gakuo, Deepalika Chakravarty, Charlene Biwott, Purba Chatterjee, Nelly Mugo and 2 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in AIDS care, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03935464 (Pilot Trial to Examine the Feasibility, Acceptability and Impact of an Intervention Using a New Urine-based Tenofovir Adherence Assay), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03935464 nacompletednot on this map

Pilot Trial to Examine the Feasibility, Acceptability and Impact of an Intervention Using a New Urine-based Tenofovir Adherence Assay

TypeinterventionalSponsorUniversity of California, San FranciscoRan2021 to 2024Enrolled100ConditionsRisk ReductionArmsPUMA
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Phelix OkelloPartners in Health Research and Development, Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
Jennifer VellozaDepartment of Medicine, University of California, San Franscisco (UCSF), San Franscisco, CA, USA.
Vallery OgelloPartners in Health Research and Development, Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
Emmah OwidiPartners in Health Research and Development, Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
Peter MogerePartners in Health Research and Development, Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
Stephen GakuoPartners in Health Research and Development, Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
Deepalika ChakravartyDepartment of Medicine, University of California, San Franscisco (UCSF), San Franscisco, CA, USA.
Charlene BiwottPartners in Health Research and Development, Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
Purba ChatterjeeDepartment of Medicine, University of California, San Franscisco (UCSF), San Franscisco, CA, USA.
Nelly MugoPartners in Health Research and Development, Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
Monica GandhiDepartment of Medicine, University of California, San Franscisco (UCSF), San Franscisco, CA, USA.
Kenneth NgureSchool of Public Health, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.

Funding

Randomized Trial to Optimize Virologic Suppression Rates Using a Point-of-Care Urine Monitoring Assay (ROVING-PUMA)R01AI143340 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Monica Gandhi · 2018 to 2026
$5.6M
“Hair Lengthening”: Using Hair Levels to Interpret Long-Acting PrEP Studies.R37AI098472 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Monica Gandhi · 2023 to 2026
$3.2M
Urine tenofovir point-of-care test to identify patients in need of ART adherence supportR01AI152119 · NIAID · STELLENBOSCH UNIVERSITY · PI GANDHI, MONICA, ORRELL, CATHERINE · 2020 to 2024
$1.7M
NIAID NIH HHS R01 AI143340NIAID NIH HHS R01 AI152119NIAID NIH HHS R37 AI098472
6 · The paper itself

Abstract

Objective measures of oral PrEP adherence - especially point-of-care (POC) measures that enable real-time assessment, intervention, and feedback - have the potential to improve adherence. Our team previously developed and validated a novel urine-based POC metric of PrEP adherence. In this study, we sought to determine whether this assay is acceptable and feasible among women taking PrEP and PrEP providers in Kenya. We conducted a trial comparing PrEP adherence counseling using the assay (intervention) versus standard-of-care counseling. We conducted in-depth interviews (IDIs) with intervention-arm participants (n = 20), and focus group discussions (n = 18) after the final (12-month) follow-up visit. We also conducted IDIs with purposively-sampled healthcare providers (HCPs) (n = 8) who administered the assay. The assay was highly acceptable among participants and HCPs as it was perceived to be accurate, could provide evidence of adherence, provides real-time results, and improves participant and provider relationship. HCPs reported that the assay facilitated counseling, seemed to increase adherence, and would be feasible to implement in routine care settings. Both participants and HCPs reported concerns about the assay related to the fear of being stigmatized for negative results, and test accessibility. Future studies should evaluate the impact of this novel test on adherence patterns over time in diverse populations.Trial registration: ClinicalTrials.gov identifier: NCT03935464.

Indexed as

Anti-HIV AgentsHIV InfectionsMedication AdherencePre-Exposure ProphylaxisTenofovirAdultCounselingFeasibility StudiesFemaleFocus GroupsHumansInterviews as TopicKenyaMaleMiddle AgedYoung AdultAnti-HIV AgentsTenofovirHIV preventionKenyaPoint-of-care urine assayPre-exposure prophylaxisSGD 3: Good health and well-being

Identifiers

PMID39733245
PMCPMC12363193

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.