Evidence map›Paper›PMID 39653676›Full record

Observational studyJournal of the International AIDS Society2024

High recent PrEP adherence with point-of-care urine tenofovir testing and adherence counselling among young African women: results from the INSIGHT cohort.

Brenda Gati Mirembe, Deborah Donnell, Meighan Krows, Zinhle Zwane, Elizabeth Bukusi, Ravindre Panchia, Cheryl Louw, Noluthando Mwelase, Pearl Selepe, Melissa Senne and 24 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in Journal of the International AIDS Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05746065 (A Cohort for Evaluation of Open-label PrEP Delivery and PrEP Preferences Among African Women), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT05746065 completednot on this map

A Cohort for Evaluation of Open-label PrEP Delivery and PrEP Preferences Among African Women

TypeobservationalSponsorUniversity of WashingtonRan2022 to 2023Enrolled3,087ConditionsHIV InfectionsArmsPrEP
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Observational
  6. Review
  7. Article
  8. Article
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

34 authors.

Brenda Gati MirembeMakerere University-Johns Hopkins University, Kampala, Uganda.
Deborah DonnellFred Hutchinson Cancer Center, Seattle, Washington, USA.
Meighan KrowsDepartment of Global Health, University of Washington, Seattle, Washington, USA.
Zinhle ZwaneSetshaba Research Centre, Pretoria, South Africa.
Elizabeth BukusiDepartment of Global Health, University of Washington, Seattle, Washington, USA.
Ravindre PanchiaPerinatal Research HIV Research Unit, Soweto, South Africa.
Cheryl LouwMadibeng Centre for Research, Madibeng South Africa, Brits, South Africa.
Noluthando MwelaseHelen Joseph Hospital Clinical HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
Pearl SelepeAurum Klerksdorp Clinical Research Centre, Klerksdorp, South Africa.
Melissa SenneAurum Rustenburg Clinical Research Centre, Rustenburg, South Africa.
Logashvari NaidooSouth African Medical Research Center Chatsworth Clinical Research Site, Chatsworth, South Africa.
Rachel ChihanaKamuzu University of Health Sciences - Johns Hopkins Research Project, Blantyre, Malawi.
Margaret KasaroUniversity of North Carolina Global Projects Zambia, Lusaka, Zambia.
Harriet Nuwagaba-BiribonwohaInternational Center for AIDS and Treatment Program, Mbabane, eSwatini.ORCID https://orcid.org/0000-0001-5131-3371
Philip KotzeQhakaza Mbokodo Research Clinic, Ladysmith, South Africa.
Katherine GillDesmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.ORCID https://orcid.org/0000-0002-3372-9506
Pippa MacDonaldDesmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Alastair vanHeerdenHuman Sciences Research Council, Center for Community Based Research (CCBR), Pietermaritzburg, South Africa.ORCID https://orcid.org/0000-0003-2530-6885
Shannon BosmanHuman Sciences Research Council, Center for Community Based Research (CCBR), Pietermaritzburg, South Africa.
Manjeetha JaggernathMATCH Research Unit, University of the Witwatersrand, Durban, South Africa.
Phillip du PreezDepartment of Medicine, University of Cape Town, Vuka Research Clinic, Cape Town, South Africa.
Amy WardDepartment of Medicine, University of Cape Town, Vuka Research Clinic, Cape Town, South Africa.
Remco P H PetersFoundation for Professional Development, Pretoria, South Africa.
Sinead Delany-MoretlweWits Reproductive Health and HIV Unit, University of the Witwatersrand, Johannesburg, South Africa.ORCID https://orcid.org/0000-0003-0376-1019
Sue PeacockDepartment of Global Health, University of Washington, Seattle, Washington, USA.
Rachel JohnsonDepartment of Global Health, University of Washington, Seattle, Washington, USA.
Jason CaucuttDepartment of Global Health, University of Washington, Seattle, Washington, USA.
Susan MorrisonDepartment of Global Health, University of Washington, Seattle, Washington, USA.ORCID https://orcid.org/0009-0000-8826-8076
Guohong WangAbottt Research Laboratories, Pomona, California, USA.
Monica GandhiUniversity of California San Franscisco, San Fransisco, California, USA.ORCID https://orcid.org/0000-0002-7025-1994
Jennifer VellozaUniversity of California San Franscisco, San Fransisco, California, USA.ORCID https://orcid.org/0000-0001-7242-7415
Renee HeffronDepartment of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.ORCID https://orcid.org/0000-0001-6039-0352
Connie CelumDepartment of Global Health, University of Washington, Seattle, Washington, USA.ORCID https://orcid.org/0000-0002-8813-3419
INSIGHT Study Team

Funding

LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI Sinead Delany-Moretlwe, RAPHAEL J LANDOVITZ · 2011 to 2026
$779.5M
University of KwaZulu-Natal - CAPRISA HIV/AIDS Clinical Trials UnitUM1AI069469 · NIAID · UNIVERSITY OF KWAZULU-NATAL · PI QUARRAISHA ABDOOL KARIM · 2012 to 2026
$36.4M
ICAP Clinical Trials UnitUM1AI154468 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI WAFAA M. EL-SADR, JESSICA E. JUSTMAN · 2021 to 2026
$13.0M
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
Gates Foundation INV-004743NIAID NIH HHS R01 AI143340NIAID NIH HHS R37 AI098472NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI069469NIAID NIH HHS UM1 AI154468
6 · The paper itself

Abstract

introductionAdolescent girls and young women (AGYW) account for two-thirds of new HIV infections in Africa. African AGYW have had high uptake of oral HIV pre-exposure prophylaxis (PrEP) but low adherence, which might be improved by point-of-care adherence monitoring with tailored counselling.

methodsFrom August 2022 to July 2023, we conducted a PrEP demonstration project with sexually active AGYW ages 16-30 years from 20 sites in South Africa, Eswatini, Kenya, Malawi, Uganda and Zambia. Participants were offered oral tenofovir-based PrEP at enrolment and followed up at 1, 3 and 6 months. PrEP adherence was assessed by a point-of-care qualitative lateral flow urine tenofovir (TFV) assay indicating PrEP use in the prior 4 days, which accompanied real-time adherence counselling that incorporated urine TFV results when testing was available (70.8% of month 1, 35.3% of month 3 and 83.9% of month 6 visits). We estimated overall adherence, correcting for missing test results, and analysed the association of having received urine TFV results at month 1 or 3 with subsequent urine TFV test positivity, using modified Poisson regression.

resultsOf the 3087 AGYW enrolled, the median age was 24 years (interquartile range 21-27), 75.7% were from South Africa, 2878 (93.2%) initiated PrEP at enrolment and 107 (3.5%) after enrolment. Visit retention was 92.0-96.2% for months 1, 3 and 6, and 2518 (90.1%) exited the study with a PrEP refill. Adherence, based on the point-of-care urine tenofovir test positivity rate, was estimated as 72%, 71% and 65% at months 1, 3 and 6, respectively. Women who received one prior urine TFV test had a 42% higher likelihood of a subsequent positive urine TFV test (adjusted odds ratio, OR = 1.42, 95% confidence interval, CI 1.27-1.60), and those having received two prior tests had a 67% higher likelihood (adjusted OR = 1.67; 95% CI 1.41-1.98). Observed HIV incidence was 1.38/100 person-years (95% CI 0.97-2.08).

conclusionsOral PrEP uptake, recent adherence and persistence were high in a multisite cohort of young African women over 6 months of follow-up. The use of a novel point-of-care tenofovir assay with tailored real-time adherence counselling was associated with increased adherence to PrEP at subsequent visits, warranting further study. CLINICAL TRIALS REGISTRATION: clinicaltrials.gov NCT05746065.

Indexed as

Anti-HIV AgentsCounselingDrug MonitoringHIV InfectionsPre-Exposure ProphylaxisTenofovirAdolescentAdultCohort StudiesFemaleHumansPoint-of-Care SystemsPoint-of-Care TestingYoung AdultAnti-HIV AgentsTenofoviradherenceAfricapoint‐of‐carePrEPtenofovirwomen

Identifiers

PMID39653676
PMCPMC11628190

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.