Evidence map›Paper›PMID 34910143›Full record

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

Incidence of Herpes Simplex Virus Type 2 Infection Among African Women Using Depot Medroxyprogesterone Acetate, a Copper Intrauterine Device, or a Levonorgestrel Implant for Contraception: A Nested Randomized Trial.

Nelly R Mugo, Randy M Stalter, Renee Heffron, Helen Rees, Caitlin W Scoville, Charles Morrison, Athena P Kourtis, Elizabeth Bukusi, Mags Beksinka, Neena M Philip and 6 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
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. An erratum has been issued. It is linked to trial NCT02550067 (A Multi Center, Open-Label, Randomised Clinical Trial Comparing HIV Incidence and Contraceptive Benefits in Women Using Depot Medroxyprogesterone Acetate), 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
0.5field-weighted citation impact, top 34% 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.

NCT02550067 nacompletednot on this map

A Multi Center, Open-Label, Randomised Clinical Trial Comparing HIV Incidence and Contraceptive Benefits in Women Using Depot Medroxyprogesterone Acetate (DMPA), Levonorgestrel (LNG) Implant, and Copper Intrauterine Devices (IUDs)

TypeinterventionalSponsorFHI 360Ran2015 to 2018Enrolled7,830ConditionsHIV, ContraceptionArmsDMPA, LNG, Copper IUD
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. Contraceptive effects on the cervicovaginal microbiome: Recent evidence including randomized trials.American journal of reproductive immunology (New York, N.Y. : 1989) · 2023
    Review
  4. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 7 institutions in 3 countries.

Nelly R MugoCenter for Clinical Research & Center for Microbiology Kenya Medical Research Institute (KEMRI), Kenya.ORCID 0000-0002-2347-006X
Randy M StalterDepartment of Global Health, Seattle, Washington, USA.
Renee HeffronDepartment of Global Health, Seattle, Washington, USA.
Helen ReesUniversity of the Witwatersrand, Wits Reproductive Health and HIV Institute (Wits RHI), Johannesburg, South Africa.
Caitlin W ScovilleDepartment of Global Health, Seattle, Washington, USA.
Charles MorrisonBehavioral, Epidemiologic and Clinical Sciences, FHI 360, Durham, North Carolina, USA.
Athena P KourtisDivision of HIV Prevention, National Center for HIV, Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Elizabeth BukusiCenter for Clinical Research & Center for Microbiology Kenya Medical Research Institute (KEMRI), Kenya.
Mags BeksinkaMatCH Research Unit (MRU), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.
Neena M PhilipICAP at Columbia University, Mailman School of Public Health, Columbia University, New York, New York, USA.
Ivana BeeshamMatCH Research Unit (MRU), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.
Jen DeeseDepartment of Medicine, University of Washington, Seattle, Washington, USA.
Vinodh EdwardThe Aurum Institute, Johannesburg, South Africa.
Deborah DonnellVaccine and Infectious Disease Division, Fred Hutchinson, Seattle, Washington, USA.
Jared M BaetenDepartment of Global Health, Seattle, Washington, USA.
Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial Consortium
University of the Witwatersrand · ZAUniversity of Washington · USKenya Medical Research Institute · KEFred Hutch Cancer Center · USFamily Health International 360 · USCenters for Disease Control and Prevention · USICAP Global Health

Funding

Regulation Paneth cell defensins by bacterial infectionR01AI057757 · NIAID · MEDICAL COLLEGE OF WISCONSIN · PI SALZMAN, NITA H · 2005 to 2009
$1.4M
Regulation Paneth cell defensins by bacterial infectionR21AI057757 · NIAID · MEDICAL COLLEGE OF WISCONSIN · PI SALZMAN, NITA H · 2004 to 2004
$325k
NIAID NIH HHS R01 AI057757NIAID NIH HHS R21 AI057757United States Agency for International Development and the President's Emergency Plan for AIDS Relief AID-OAA-A-15-00045US Centers for Disease Control and Prevention U48 DP 005013 SIP 14-023
6 · The paper itself

Abstract

backgroundGlobally, women have higher herpes simplex virus type 2 (HSV-2) prevalence than men; data from observational studies suggest a possible association of HSV-2 acquisition with use of intramuscular depot medroxyprogesterone acetate (DMPA-IM).

methodsWithin a randomized trial of the effect of 3 contraceptive methods-DMPA-IM, a copper intrauterine device (IUD), and a levonorgestrel (LNG) implant-on human immunodeficiency virus (HIV) acquisition, we assessed HSV-2 acquisition. HSV-2 and HIV seronegative women, aged 16-35 years, and seeking effective contraception were followed for 12-18 months at 12 sites in Eswatini, Kenya, South Africa, and Zambia from 2015 to 2018. HSV-2 serologic testing was done at enrollment and final study visits. Intention-to-treat analysis using Poisson regression with robust standard errors compared HSV-2 incidence by contraceptive method.

resultsAt baseline, 4062 randomized women were HSV-2 seronegative, of whom 3898 (96.0%) had a conclusive HSV-2 result at their final study visit. Of these, 614 (15.8%) acquired HSV-2, at an incidence of 12.4/100 person-years (p-y): 10.9/100 p-y among women assigned DMPA-IM, 13.7/100 p-y the copper IUD, and 12.7/100 p-y the LNG implant. Incidence rate ratios (IRR) for HSV-2 acquisition were 0.80 (95% confidence interval [CI], .65-.97) for DMPA-IM compared with copper IUD, 0.86 (95% CI, .71-1.05) for DMPA-IM compared with LNG implant, and 1.08 (95% CI, .89-1.30) for copper IUD compared with LNG implant. HSV-2 acquisition risk was significantly increased among women who also acquired HIV during follow-up (IRR 3.55; 95% CI, 2.78-4.48).

conclusionsIn a randomized trial, we found no association between HSV-2 acquisition and use of 3 contraceptive methods.

trial registrationClinicalTrials.gov number NCT02550067.

Indexed as

Contraceptive Agents, FemaleHerpes SimplexHIV InfectionsIntrauterine Devices, CopperContraceptionFemaleHerpesvirus 2, HumanHumansIncidenceLevonorgestrelMaleMedroxyprogesterone AcetateContraceptive Agents, FemaleLevonorgestrelMedroxyprogesterone AcetateAfricacontraceptionherpes simplex virus type 2 (HSV-2)HIVwomen

Identifiers

PMID34910143
PMCPMC9464069
OpenAlexW4206093734

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.