Evidence map›Paper›PMID 39736742›Full record

Trial reportAIDS research and therapy2024

Extensive cervical lesion and treatment outcomes in women with HIV/HPV co-infection.

Rosie Mngqibisa, Huichao Chen, Catherine Godfrey, Motshedisi Sebitloane, Unoda Chakalisa, Sharlaa Badal-Faesen, Gaerolwe Masheto, Frank Taulo, Wadzanai Samaneka, Jennifer Tiu and 3 more

Erratum issuedAbstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in AIDS research and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Rosie MngqibisaDurban International Clinical Research Site, King Edward Hospital, Enhancing Care Foundation, Durban, South Africa. rosie@ecarefoundation.com.
Huichao ChenCenter for Biostatistics in AIDS Research, Harvard University T H Chan School of Public Health, Boston, USA.
Catherine GodfreyOffice of the Global AIDS Coordinator, Department of State, Washington, DC, USA.
Motshedisi SebitloaneDepartment of Obstetrics and Gynaecology, University of KwaZulu Natal, Durban, South Africa.
Unoda ChakalisaGaborone CRS, Princess Marina Hospital, Gaborone, Botswana.
Sharlaa Badal-FaesenClinical HIV Research Unit, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
Gaerolwe MashetoPrevention/Treatment Trials CRS Scottish Livingstone Hospital, Molepolole, Gaborone, Botswana.
Frank TauloBotswana Johns Hopkins Research Project, Blantyre, Malawi.
Wadzanai SamanekaParirenyatwa Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.
Jennifer TiuDurban International Clinical Research Site, King Edward Hospital, Enhancing Care Foundation, Durban, South Africa.
Cynthia FirnhaberJennifer Tiu, ACTG Network Coordinating Center, Bethesda, USA.
Timothy WilkinJennifer Tiu, ACTG Network Coordinating Center, Bethesda, USA.
AIDS Clinical Trials Group A5282 Study Team

Funding

Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
UZ-UCSF CTUUM1AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ZVAVAHERA MIKE CHIRENJE, LYNDA STRANIX-CHIBANDA · 2012 to 2026
$75.9M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069436
6 · The paper itself

Abstract

backgroundCervical cancer is a common cancer worldwide, with > 85% of deaths occurring in Lower- and Middle-Income Countries where resources for screening programs are limited. Women living with HIV (WLHIV) are at increased risk. HPV test-and-treat is a screening strategy where women with HPV are offered ablative treatment of the cervix to reduce the risk of invasive cancer. WLHIV tend to have more extensive cervical lesions, necessitating more specialised surgical treatments.

methodACTG A5282 was a randomised, open-label, Phase 2 trial conducted in seven countries that compared a cytology-based screening strategy to HPV test-and-treat for cervical cancer prevention in WLHIV. Women with cervical lesions inappropriate for ablative treatment were assigned to Arm C and underwent colposcopy and directed biopsies. Loop electro-excision procedure was performed if high-grade lesions (bHSIL) were present on cervical biopsies. Women were followed 26 weeks later for repeat evaluations. The Clopper-Pearson exact method was used to construct the 95% confidence interval for the proportion of WLHIV with lesions inappropriate for cryotherapy. Logistic regression models were used to assess the factors associated with these lesions.

resultsOf 1046 women screened, 156 (88%) were Black/Non-Hispanic, with a median age of 36 years; 80% were on ART, and 73% had an HIV-1 RNA < 200 copies/mL. On cervical colposcopy, 17% (179/1046, 95% CI 14.9-19.4%) had cervical lesions inappropriate for cervical ablation. Among 428 (44%) women with High-risk HPV (hrHPV) detected, 112 (26%, 95% CI 22.2%, 30.5%) had cervical lesions inappropriate for ablative therapy. hrHPV was found more commonly among women having lesions inappropriate for ablative therapy as compared to lesions appropriate for ablative therapy (70% vs 54%, p < .001). Among 128 women with extensive cervical lesions undergoing colposcopic biopsies, 43 (34%) had bHSIL detected. Among women undergoing LEEP treatment of bHSIL, 24% had bHSIL detected 26 weeks later.

conclusionCervical lesions inappropriate for ablative therapy were common among WLHIV. This has implications for cervical cancer programs as these lesions can only be optimally treated with surgical therapies such as loop electroexcision procedures, and the capacity for this procedure should be increased to maximise cervical cancer prevention outcomes.

Indexed as

CoinfectionColposcopyHIV InfectionsPapillomavirus InfectionsUterine Cervical NeoplasmsAdultBiopsyCervix UteriFemaleHumansMiddle AgedTreatment OutcomeUterine Cervical DysplasiaCervical cancerCo-infectionCytologyHIV care continuumHPVWomen

Identifiers

PMID39736742
PMCPMC11684313

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Registered trials

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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.