Evidence map›Paper›PMID 35294524›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022

A Randomized Clinical Trial of Human Papillomavirus Test-and-Treat as Compared to Cytology-Based Screening for Prevention of Cervical Cancer Among Women With Human Immunodeficiency Virus: AIDS Clinical Trials Group Protocol A5282.

Timothy Wilkin, Huichao Chen, Vikrant Sahasrabuddhe, Roy Matining, Rosie Mngqibisa, Lameck Chinula, Yamikani Mbilizi, Tsitsi Magure, Ayotunde E Omoz-Oarhe, Mohammed Rassool and 8 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01315363, which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 33% of its field
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.

NCT01315363 no registry record found
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. 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

18 authors at 17 institutions in 7 countries.

Timothy WilkinDivision of Infectious Diseases, Weill Cornell Medicine, New York, New York, USA.
Huichao ChenCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts, USA.
Vikrant SahasrabuddheDivision of Cancer Prevention, National Cancer Institute, Rockville, Maryland, USA.
Roy MatiningCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts, USA.
Rosie MngqibisaDurban International Clinical Research Site, Enhancing care Foundation, King Edward Hospital, Durban, South Africa.
Lameck ChinulaUniversity of North Carolina Project-Malawi, Lilongwe, Malawi.
Yamikani MbiliziJohns Hopkins Research Project, Blantyre, Malawi.
Tsitsi MagureUniversity of Zimbabwe Faculty of Medicine and Health Sciences, Harare, Zimbabwe.
Ayotunde E Omoz-OarheBotswana Harvard AIDS Institute Partnership, Gaborone, Botswana.
Mohammed RassoolClinical HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa.
Cynthia RiviereClinical Research Department, Les Centres GHESKIO, Port-au-Prince, Haiti.
Rhamesh BhosaleDepartment of Obstetrics and Gynecology, Byramjee Jeejeebhoy Government Medical College, Pune, India.
Sheela GodboleDivision of Epidemiology, ICMR-National AIDS Research Unit, Pune, India.
Reena NaranjoPublic Health & Scientific Research, Social & Scientific Systems, Inc, A DLH Holdings Company, Silver Spring, Maryland, USA.
Robert CoombsDepartments of Laboratory Medicine & Pathology and Medicine, University of Washington, Seattle, Washington, USA.
Pamela MichelowNational Health Laboratory Service, Johannesburg, South Africa.
Catherine GodfreyOffice of the Global AIDS Coordinator, Department of State, Washington D.C., USA.
Cynthia FirnhaberDivision of Infectious Disease, Department of Medicine, University of Colorado Medical School, Aurora, Colorado, USA.
Cancer Research And Biostatistics · USBlantyre Institute for Community Ophthalmology · MWBotswana Harvard AIDS Institute Partnership · BWGheskio Centers · HTGovernment Medical College · INKing Edward VIII Hospital · ZANational AIDS Research Institute · INNational Cancer Institute · USNational Health Laboratory Service · ZASocial and Scientific Systems (United States) · USUnited States Department of State · USUniversity of Colorado Denver · USUniversity of Malawi · MWUniversity of the Witwatersrand · ZAUniversity of Washington · USUniversity of Zimbabwe · ZWWeill Cornell Medicine · US

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
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
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
The Malawi Clinical Trials UnitU01AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI TAHA, TAHA E · 2007 to 2011
$46.7M
The Malawi Clinical Trials UnitUM1AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JACKY M JENNINGS, TAHA E TAHA · 2012 to 2026
$43.8M
THE IMPACTA PERU CLINICAL TRIALS UNITUM1AI069438 · NIAID · ASOCIACION CIVIL IMPACTA SALUD Y EDUCACN · PI Alberto La Rosa, Jorge Luis Sanchez · 2012 to 2026
$43.2M
Soweto Clinical Trials UnitUM1AI069453 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI Glenda E Gray, Lerato Mohapi · 2012 to 2026
$40.9M
The Johns Hopkins Baltimore-Washington-India Clinical Trials Unit (BWI CTU)UM1AI069465 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Charles W. Flexner, Amita Gupta · 2012 to 2026
$34.1M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
Botswana-Harvard T.H. Chan School of Public Health AIDS Initiative Partnership CTU Y18 SupplementUM1AI069456 · NIAID · THE BOTSWANA HARVARD HEALTH PARTNERSHIP · PI SHAHIN LOCKMAN, Joseph Moeketsi Makhema · 2012 to 2026
$29.4M
NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069417NIAID NIH HHS U01 AI069421NIAID NIH HHS U01 AI069423NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069438NIAID NIH HHS U01 AI069453NIAID NIH HHS U01 AI069456NIAID NIH HHS U01 AI069463NIAID NIH HHS U01 AI069465NIAID NIH HHS U01 AI069471NIAID NIH HHS U01 AI069497NIAID NIH HHS U01 AI069518NIAID NIH HHS U01 AI069521NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069417NIAID NIH HHS UM1 AI069421NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069438NIAID NIH HHS UM1 AI069453NIAID NIH HHS UM1 AI069456NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069465NIAID NIH HHS UM1 AI069471NIAID NIH HHS UM1 AI069497NIAID NIH HHS UM1 AI069518NIAID NIH HHS UM1 AI069521
6 · The paper itself

Abstract

backgroundCytology-based cervical cancer screening followed by confirmation and treatment of biopsy-proven high-grade squamous intraepithelial lesions (bHSIL) is difficult to implement in resource-constrained settings. We hypothesized that high-risk human papillomavirus (hrHPV) testing followed by immediate cryotherapy of women with hrHPV (HPV screen-and-treat) may improve outcomes.

methodsRandomized, open-label, phase 2, multinational clinical trial enrolling women with human immunodeficiency virus (HIV) age 18 or older with cervical hrHPV and having no cervical lesions or lesions appropriate for cryotherapy. Women were randomized to immediate cryotherapy (Arm A) or cytology-based screening (Arm B). For Arm A, cervical biopsies were obtained followed by cervical cryotherapy, and in Arm B, women with abnormal cytology underwent colposcopy followed by loop electroexcision procedure (LEEP) if bHSIL was detected. Women were followed through 30 months. The primary outcome was time to bHSIL detected from Month 6 through study completion.

resultsIn total, 288 women (145 in Arm A, 143 in Arm B) were randomized: median age 35 years, 84% on antiretroviral therapy, median CD4 501 cells/mm3. In Arm A, 39 (27%) of women had bHSIL at entry, and in Arm B, 88 (62%) had abnormal cytology, 22 (15%) were diagnosed with bHSIL, 12 (8%) underwent LEEP. In follow-up, 30 (21%) and 31 (22%) developed bHSIL; time to bHSIL was similar between arms (P=.94). The prevalence of hrHPV at Month 6 was similar between arms (61% and 70%, P=.13).

conclusionsHPV test-and-treat was not associated with improved bHSIL outcomes as compared to cytology-based screening. More effective treatment options are required to improve outcomes from screen-and-treat programs. CLINICAL TRIALS REGISTRATION: NCT01315363.

Indexed as

Acquired Immunodeficiency SyndromeAlphapapillomavirusHIV InfectionsPapillomavirus InfectionsSquamous Intraepithelial LesionsUterine Cervical DysplasiaUterine Cervical NeoplasmsAdolescentAdultEarly Detection of CancerFemaleHIVHumansMass ScreeningPapillomaviridaeVaginal Smearscervical cancercytologyHIVHPVwomen

Identifiers

PMID35294524
PMCPMC9555836
OpenAlexW4221073059

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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.