Evidence map›Paper›PMID 28542081›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2017

Brief Report: Dapivirine Vaginal Ring Use Does Not Diminish the Effectiveness of Hormonal Contraception.

Jennifer E Balkus, Thesla Palanee-Phillips, Krishnaveni Reddy, Samantha Siva, Ishana Harkoo, Clemensia Nakabiito, Kenneth Kintu, Gonasangrie Nair, Catherine Chappell, Flavia Matovu Kiweewa and 7 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 20% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Elevated Risk of Bacterial Vaginosis Among Users of the Copper Intrauterine Device: A Prospective Longitudinal Cohort Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. 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

17 authors at 11 institutions in 3 countries.

Jennifer E Balkus*Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA; Departments of †Epidemiology; ‡Global Health, University of Washington, Seattle, WA; §Wits Reproductive Health and HIV Institute, Johannesburg, South Africa; ‖South African Medical Research Council, Durban, South Africa; ¶CAPRISA, Durban, South Africa; #Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda; **Emavundleni Research Centre, Cape Town, South Africa; ††Magee-Womens Hospital of UPMC, Pittsburgh, PA; ‡‡Departments of Pathology and Medicine, Johns Hopkins University School of Medicine, Baltimore, MD; §§US National Institutes of Health, Bethesda, MD; and Departments of ‖‖Biostatistics; ¶¶Medicine, University of Washington, Seattle, WA.
Thesla Palanee-Phillips
Krishnaveni Reddy
Samantha Siva
Ishana Harkoo
Clemensia Nakabiito
Kenneth Kintu
Gonasangrie Nair
Catherine Chappell
Flavia Matovu Kiweewa
Samuel Kabwigu
Logashvari Naidoo
Nitesha Jeenarain
Mark Marzinke
Lydia Soto-Torres
Elizabeth R Brown
Jared M Baeten
MUJHU Research Collaboration · UGSouth African Medical Research Council · ZAPerinatal HIV Research Unit · ZAAfrican Organisation for Research and Training in Cancer · ZACentre for the AIDS Programme of Research in South Africa · ZAFred Hutch Cancer Center · USInfectious Disease Research Institute · USJohns Hopkins University · USMagee-Womens Hospital · USNational Institutes of Health · USUniversity of Washington · US

Funding

Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
Statistical and Data Management Center (SDMC): Microbicide Trials NetworkUM1AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BROWN, ELIZABETH RENATA · 2011 to 2021
$66.5M
The Johns Hopkins University - Uganda Clinical Trials UnitUM1AI069530 · NIAID · JOHNS HOPKINS UNIVERSITY · PI MARY Glenn Fowler, Philippa Musoke · 2012 to 2026
$34.8M
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
Laboratory Center (LC): Microbicide Trials NetworkUM1AI106707 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI MELLORS, JOHN W, ROHAN, LISA CENCIA · 2014 to 2021
$27.1M
Building Research Careers in Women's HealthK12HD043441 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI SADOVSKY, YOEL · 2002 to 2023
$10.1M
NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069530NIAID NIH HHS UM1 AI106707NICHD NIH HHS K12 HD043441
6 · The paper itself

Abstract

objectiveTo evaluate the potential for a clinically relevant drug-drug interaction with concomitant use of a dapivirine vaginal ring, a novel antiretroviral-based HIV-1 prevention strategy, and hormonal contraception by examining contraceptive efficacies with and without dapivirine ring use.

designA secondary analysis of women participating in MTN-020/ASPIRE, a randomized, double-blind, placebo-controlled trial of the dapivirine vaginal ring for HIV-1 prevention.

methodsUse of a highly effective method of contraception was an eligibility criterion for study participation. Urine pregnancy tests were performed monthly. Pregnancy incidence by arm was calculated separately for each hormonal contraceptive method and compared using an Andersen-Gill proportional hazards model stratified by site and censored at HIV-1 infection.

resultsOf 2629 women enrolled, 2310 women returned for follow-up and reported using a hormonal contraceptive method at any point during study participation (1139 in the dapivirine arm and 1171 in the placebo arm). Pregnancy incidence in the dapivirine arm versus placebo among women using injectable depot medroxyprogesterone acetate was 0.43% vs. 0.54%, among women using injectable norethisterone enanthate was 1.15% vs. 0%, among women using hormonal implants was 0.22% vs. 0.69%, and among women using oral contraceptive pills was 32.26% vs. 28.01%. Pregnancy incidence did not differ by study arm for any of the hormonal contraceptive methods.

conclusionsUse of the dapivirine ring does not reduce the effectiveness of hormonal contraceptives for pregnancy prevention. Oral contraceptive pill use was associated with high pregnancy incidence, potentially because of poor pill adherence. Injectable and implantable methods were highly effective in preventing pregnancy.

Indexed as

ContraceptionContraceptive Devices, FemaleAdolescentAdultAnti-Retroviral AgentsContraceptive Agents, FemaleContraceptives, Oral, HormonalDouble-Blind MethodDrug InteractionsFemaleFollow-Up StudiesHIV InfectionsHumansIncidenceMedroxyprogesterone AcetateMiddle AgedAnti-Retroviral AgentsContraceptive Agents, FemaleContraceptives, Oral, HormonalDapivirineMedroxyprogesterone AcetateNorethindronenorethindrone enanthatePyrimidines

Identifiers

PMID28542081
PMCPMC5597463
OpenAlexW2619918398

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.