Evidence map›Paper›PMID 33149114›Full record

Trial reportNature communications2020

Hormonal contraception alters vaginal microbiota and cytokines in South African adolescents in a randomized trial.

Christina Balle, Iyaloo N Konstantinus, Shameem Z Jaumdally, Enock Havyarimana, Katie Lennard, Rachel Esra, Shaun L Barnabas, Anna-Ursula Happel, Zoe Moodie, Katherine Gill and 10 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02404038 (An Open-Label, Randomized Crossover Study to Evaluate the Acceptability and Preference for Contraceptive Options in Healthy HIV-Uninfected Female Adolescents, 16-17 Years of Age, as Proxy for HIV Prevention Methods), which is not on this map. Cited by 42 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 5% 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.

NCT02404038 naunknown statusnot on this map

An Open-Label, Randomized Crossover Study to Evaluate the Acceptability and Preference for Contraceptive Options in Healthy HIV-Uninfected Female Adolescents, 16-17 Years of Age, as Proxy for HIV Prevention Methods

TypeinterventionalSponsorDesmond Tutu HIV CentreRan2015 to 2020Enrolled131ConditionsHIVArmsNur-Isterate, Nuvaring, Triphasil
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.

  1. The Effect of Exogenous Sex Steroids on the Vaginal Microbiota: A Systematic Review.Frontiers in cellular and infection microbiology · 2021
    Pooled it
  2. Trial
  3. Trial
  4. Persistent, Asymptomatic Colonization withMicrobiology spectrum · 2022
    Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Review
  11. Article
  12. Insights into fungal diversity and dynamics of vaginal mycobiota.Brazilian journal of microbiology : [publication of the Brazilian Society for Microbiology] · 2025
    Article
  13. Observational
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
  20. 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

20 authors at 7 institutions in 2 countries.

Christina BalleDepartment of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Iyaloo N KonstantinusDepartment of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Shameem Z JaumdallyDepartment of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Enock HavyarimanaDepartment of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0001-6185-8607
Katie LennardDepartment of Integrative Biomedical Sciences, University of Cape Town, Cape Town, South Africa.
Rachel EsraDepartment of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Shaun L BarnabasDepartment of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Anna-Ursula HappelDepartment of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Zoe MoodieVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.ORCID 0000-0001-8701-2001
Katherine GillDesmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-3372-9506
Tanya PidwellDesmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Ulas KaraozEarth and Environmental Science, Lawrence Berkeley National Laboratories, Berkeley, CA, 94720, USA.ORCID 0000-0002-8238-6757
Eoin BrodieEarth and Environmental Science, Lawrence Berkeley National Laboratories, Berkeley, CA, 94720, USA.ORCID 0000-0002-8453-8435
Venessa MasekoNational Institute for Communicable Diseases, Sandringham, Johannesburg, South Africa.
Hoyam GamieldienDepartment of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Steven E BosingerDepartment of Pathology & Laboratory Medicine, Emory University School of Medicine; Division of Microbiology and Immunology, Yerkes National Primate Research Center, Atlanta, GA, USA.ORCID 0000-0002-2116-5061
Landon MyerDivision of Epidemiology, Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.
Linda-Gail BekkerDesmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Jo-Ann S PassmoreDepartment of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-1471-4245
Heather B JaspanDepartment of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa. hbjaspan@gmail.com.ORCID 0000-0002-0745-6073
University of Cape Town · ZADesmond Tutu HIV Foundation · ZALawrence Berkeley National Laboratory · USEmory University · USFred Hutch Cancer Center · USNational Health Laboratory Service · ZARespiratory and Meningeal Pathogens Research Unit · ZA

Funding

CHAMPS: Choices for Adolescent Methods of Prevention in South AfricaR01AI094586 · NIAID · DESMOND TUTU HIV FOUNDATION · PI BEKKER, LINDA-GAIL GAIL · 2011 to 2014
$2.5M
Hormone induced mucosal susceptibility and HIV risk in South African adolescentsR01HD083040 · NICHD · UNIVERSITY OF CAPE TOWN · PI JASPAN, HEATHER BERYL, PASSMORE, JO-ANN SHELLEY · 2015 to 2019
$1.9M
NIAID NIH HHS R01 AI094586NICHD NIH HHS R01 HD083040
6 · The paper itself

Abstract

Young women in sub-Saharan Africa are disproportionally affected by HIV infection and unintended pregnancies. However, hormonal contraceptive (HC) use may influence HIV risk through changes in genital tract microbiota and inflammatory cytokines. To investigate this, 130 HIV negative adolescent females aged 15-19 years were enrolled into a substudy of UChoose, an open-label randomized crossover study (NCT02404038), comparing acceptability and contraceptive product preference as a proxy for HIV prevention delivery methods. Participants were randomized to injectable norethisterone enanthate (Net-En), combined oral contraceptives (COC) or etonorgesterol/ethinyl estradiol combined contraceptive vaginal ring (CCVR) for 16 weeks, then crossed over to another HC for 16 weeks. Cervicovaginal samples were collected at baseline, crossover and exit for characterization of the microbiota and measurement of cytokine levels; primary endpoints were cervical T cell activation, vaginal microbial diversity and cytokine concentrations. Adolescents randomized to COCs had lower vaginal microbial diversity and relative abundance of HIV risk-associated taxa compared to Net-En or CCVR. Cervicovaginal inflammatory cytokine concentrations were significantly higher in adolescents randomized to CCVR compared to COC and Net-En. This suggests that COC use may induce an optimal vaginal ecosystem by decreasing bacterial diversity and inflammatory taxa, while CCVR use is associated with genital inflammation.

Indexed as

AdolescentAfrica South of the SaharaContraceptive Devices, FemaleContraceptives, Oral, CombinedCross-Over StudiesCytokinesFemaleHIV InfectionsHormonal ContraceptionHumansMicrobiotaNorethindroneRNA, Ribosomal, 16ST-LymphocytesVaginaYoung AdultContraceptives, Oral, CombinedCytokinesNorethindronenorethindrone enanthateRNA, Ribosomal, 16S

Identifiers

PMID33149114
PMCPMC7643181
OpenAlexW3095559978

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.