Evidence map›Paper›PMID 25415290›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2015

High HIV, HPV, and STI prevalence among young Western Cape, South African women: EVRI HIV prevention preparedness trial.

Anna R Giuliano, Matthys H Botha, Michele Zeier, Martha E Abrahamsen, Richard H Glashoff, Louvina E van der Laan, Mary Papenfuss, Susan Engelbrecht, Maarten F Schim van der Loeff, Staci L Sudenga and 3 more

Erratum issuedOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2015. 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 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
2.8field-weighted citation impact, top 10% 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.

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

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.

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  7. Sociodemographics, behaviour and knowledge of first South African HPV-vaccine recipients.South African family practice : official journal of the South African Academy of Family Practice/Primary Care · 2024
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4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

13 authors at 5 institutions in 3 countries.

Anna R Giuliano*Center for Infection Research in Cancer, Moffitt Cancer Center, Tampa, FL; †Department of Obstetrics and Gynaecology and Unit for Gynaecological Oncology, Tygerberg Hospital, Stellenbosch University, Cape Town, South Africa; ‡Department of Medicine and Centre for Infectious Diseases, Stellenbosch University, Cape Town, South Africa; §Division of Medical Virology, Stellenbosch University and NHLS Tygerberg, Cape Town, South Africa; ‖Department of Research, Cluster Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, the Netherlands; ¶Department of Internal Medicine, Center for Infection and Immunity Amsterdam (CINIMA), Academic Medical Center, Amsterdam, the Netherlands; and #FHI 360, Durham, NC.
Matthys H Botha
Michele Zeier
Martha E Abrahamsen
Richard H Glashoff
Louvina E van der Laan
Mary Papenfuss
Susan Engelbrecht
Maarten F Schim van der Loeff
Staci L Sudenga
Benji N Torres
Siegfried Kipping
Douglas Taylor
Moffitt Cancer Center · USStellenbosch University · ZAFamily Health International 360 · USGGD Amsterdam · NLTygerberg Hospital · ZA

Funding

Integrative Molecular Epidemiology WorkshopR25CA174664 · NCI · AMERICAN ASSOCIATION FOR CANCER RESEARCH · PI Shelley S Tworoger · 2013 to 2026
$2.8M
Moffitt Postdoctoral Training Program in Molecular & Genetic EpidemiologyR25CA147832 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI EGAN, KATHLEEN M. · 2010 to 2014
$2.0M
NCI NIH HHS R25 CA147832NCI NIH HHS R25 CA174664PHS HHS R25TCA147832Wellcome Trust 097410
6 · The paper itself

Abstract

backgroundThis study sought to assess the feasibility of conducting a phase III HIV prevention trial using a multivalent human papillomavirus (HPV) vaccine (Gardasil; Merck, Whitehouse Station, NJ).

methodsA total of 479 sexually active women aged 16-24 years in the Western Cape, South Africa, were enrolled in the Efficacy of HPV Vaccine to Reduce HIV Infection (EVRI) Trial. Of these, 402 were HIV negative, nonpregnant, and randomized 1:1 to receive Gardasil or a saline placebo vaccine. Vaccine doses were administered at enrollment, month 2, and month 6, and participants were followed for 1 month after the third dose. Enrollment HIV, HPV, other sexually transmitted infections (STIs), and cervical cytology were evaluated. Rates of accrual, vaccine compliance, and adherence to protocol were monitored.

resultsHigh rates of accrual of eligible females to study (93%) and completion of the 3-dose vaccine series (91%) were noted, with few protocol violations. Ineligibility due to reported HIV positivity was 19%, and another 12% of those enrolled tested HIV positive. STI prevalence was high, with 6.2%, 10.9%, and 32.8% testing positive for syphilis, gonorrhea, and chlamydia, respectively. Cervical prevalence of ≥1 of 37 HPV types was 71%. STI and HPV prevalence was highest among the youngest women (<19 years).

conclusionsFeasibility (successful accrual, retention, and vaccination) of conducting randomized placebo-controlled trials of HPV vaccines among HIV high-risk women in South Africa was demonstrated. This work demonstrates that phase III HIV prevention trials need to intervene at young ages and screen and treat multiple STIs concurrently to have a measurable impact on HIV acquisition.

Indexed as

AdolescentFemaleHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18HumansPapillomavirus VaccinesPlacebosPrevalenceSexually Transmitted DiseasesSouth AfricaYoung AdultHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18Papillomavirus VaccinesPlacebos

Identifiers

PMID25415290
PMCPMC4378717
OpenAlexW2017166510

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.