Evidence map›Paper›PMID 25259704›Full record

Trial reportAIDS (London, England)2014

Pre-exposure prophylaxis does not affect the fertility of HIV-1-uninfected men.

Edwin O Were, Renee Heffron, Nelly R Mugo, Connie Celum, Andrew Mujugira, Elizabeth A Bukusi, Jared M Baeten, Partners PrEP Study Team

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
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

8 authors at 3 institutions in 2 countries.

Edwin O WereaDepartment of Reproductive Health, Moi University, Eldoret, Kenya bDepartment of Global Health, University of Washington, Seattle, Washington, USA cCentre for Clinical Research dCentre for Microbiology Research, Kenya Medical Research Institute eDepartment of Obstetrics and Gynecology, Kenyatta National Hospital, Nairobi, Kenya fDepartment of Medicine gDepartment of Epidemiology hDepartment of Obstetrics and Gynecology, University of Washington, Seattle, Washington, USA. *Members of the Partners PrEP Study Team are listed in the Acknowledgements section.
Renee Heffron
Nelly R Mugo
Connie Celum
Andrew Mujugira
Elizabeth A Bukusi
Jared M Baeten
Partners PrEP Study Team
University of Washington · USKenyatta National Hospital · KEMoi University · KE

Funding

Pediatric HIV-1 in Africa: Pathogenesis and ManagementK24HD054314 · NICHD · UNIVERSITY OF WASHINGTON · PI JOHN-STEWART, GRACE C. · 2006 to 2016
$1.2M
Hormonal contraception, pre-exposure prophylaxis, and HIV-1 protectionR21HD074439 · NICHD · UNIVERSITY OF WASHINGTON · PI BAETEN, JARED · 2013 to 2014
$432k
Antiretroviral periconception HIV prevention for HIV discordant couplesK99HD076679 · NICHD · UNIVERSITY OF WASHINGTON · PI HEFFRON, RENEE A. · 2013 to 2014
$208k
NICHD NIH HHS K24 HD054314NICHD NIH HHS K99 HD076679NICHD NIH HHS K99HD076679NICHD NIH HHS R21 HD074439NICHD NIH HHS R21HD074439
6 · The paper itself

Abstract

backgroundThere is a paucity of data on the effect of antiretroviral medications on male fertility. Couples affected by HIV-1 often have fertility intentions, and antiretroviral medications, as both treatment of HIV-1-infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons, are part of peri-conception risk reduction.

methodsWithin a randomized, placebo-controlled trial of daily oral tenofovir disoproxil fumarate (TDF) and combination emtricitabine (FTC)/TDF PrEP for HIV-1 prevention conducted among heterosexual HIV-1-serodiscordant couples, we assessed the impact of TDF and FTC/TDF use on male fertility, measured as incident pregnancy in female partners of men assigned to PrEP vs. placebo.

resultsOf the 2962 HIV-1-uninfected men partners, 986 were randomized to TDF, 1013 to FTC/TDF, and 963 to placebo. The overall pregnancy incidence in their HIV-1-infected female partners was 12.9 per 100 person-years and did not differ significantly across the study arms (13.2 TDF, 12.4 FTC/TDF, 13.2 placebo). The frequency of live births, pregnancy losses, and gestational age at birth or loss was also statistically similar in the three randomization groups.

conclusionTDF and FTC/TDF, when used as PrEP by HIV-1-uninfected men, did not adversely affect male fertility or pregnancy outcomes.

Indexed as

AdenineAdultAnti-Retroviral AgentsChemopreventionDeoxycytidineEmtricitabineFemaleFertilityHIV InfectionsHumansMaleOrganophosphonatesPlacebosPre-Exposure ProphylaxisPregnancyTenofovirAdenineAnti-Retroviral AgentsDeoxycytidineEmtricitabineOrganophosphonatesPlacebosTenofovir

Identifiers

PMID25259704
PMCPMC4216472
OpenAlexW2313654022

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.