Evidence map›Paper›PMID 25118795›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2014

High medication adherence during periconception periods among HIV-1-uninfected women participating in a clinical trial of antiretroviral pre-exposure prophylaxis.

Lynn T Matthews, Renee Heffron, Nelly R Mugo, Craig R Cohen, Craig W Hendrix, Connie Celum, David R Bangsberg, Jared M Baeten, Partners PrEP Study Team

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03030768 (Pilot of an mHealth-enhanced, Safer Conception Intervention to Reduce HIV-1 Risk Among Kenyan HIV-1 Serodiscordant Couples), which is not on this map. Cited by 22 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT03030768 completednot on this mapstarted 2016, after this paper: background citation

Pilot of an mHealth-enhanced, Safer Conception Intervention to Reduce HIV-1 Risk Among Kenyan HIV-1 Serodiscordant Couples

TypeobservationalSponsorUniversity of WashingtonRan2016 to 2018Enrolled74ConditionsHIV Seropositivity, Pregnancy, High-RiskArmsPrEP, Counseling on timed condomless sex, ART and PrEP adherence
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Dual contraceptive method use in HIV-serodiscordant Kenyan couples.The journal of family planning and reproductive health care · 2016
    Article
  15. Article
  16. Article
  17. Review
  18. What people want from sex and preexposure prophylaxis.Current opinion in HIV and AIDS · 2016
    Review
  19. Review
  20. 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

9 authors.

Lynn T Matthews*Division of Infectious Disease and Center for Global Health, Massachusetts General Hospital, Boston, MA; †Division of Infectious Disease, Beth Israel Deaconess Medical Center, Boston, MA; ‡Department of Global Health, University of Washington, Seattle, WA; §Kenya Medical Research Institute, Nairobi, Kenya; ‖Department of Obstetrics, Gynecology and Reproductive Sciences, Bixby Center for Global Reproductive Health, University of California San Francisco, San Francisco, CA; ¶Department of Medicine, Johns Hopkins University, Baltimore, MD; #Department of Medicine, University of Washington, Seattle, WA; and **Department of Epidemiology, University of Washington, Seattle, WA.
Renee Heffron
Nelly R Mugo
Craig R Cohen
Craig W Hendrix
Connie Celum
David R Bangsberg
Jared M Baeten
Partners PrEP Study Team

Funding

Ujima Mentoring ProgramP30MH062246 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MALLORY O JOHNSON · 2001 to 2026
$57.4M
Optimizing Antiretroviral-Based HIV Prevention for HIV Serodiscordant CouplesR01MH095507 · NIMH · UNIVERSITY OF WASHINGTON · PI BAETEN, JARED · 2011 to 2020
$6.1M
Periconception HIV risk reduction for HIV-discordant couples in UgandaK23MH095655 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · PI MATTHEWS, LYNN T · 2011 to 2015
$854k
Mentoring Patient Oriented Adherence Research in UgandaK24MH087227 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · PI BANGSBERG, DAVID ROY · 2009 to 2013
$776k
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 K99 HD076679NICHD NIH HHS K99HD076679NICHD NIH HHS R21 HD074439NICHD NIH HHS R21HD074439NIMH NIH HHS K23 MH095655NIMH NIH HHS K23MH095655NIMH NIH HHS K24 MH087227NIMH NIH HHS K24MH87227NIMH NIH HHS P30 MH062246NIMH NIH HHS R01 MH095507NIMH NIH HHS R01MH095507
6 · The paper itself

Abstract

introductionPre-exposure prophylaxis (PrEP) may be an important safer conception strategy for HIV-1-uninfected women with HIV-1-infected partners. Understanding medication adherence in this population may inform whether PrEP is a feasible safer conception strategy.

methodsWe evaluated predictors of pregnancy and adherence to study medication among HIV-1-uninfected women enrolled in a randomized placebo-controlled trial of PrEP among African HIV-1-serodiscordant couples. Participants were counseled on HIV-1 risk reduction, contraception, and adherence and tested for pregnancy at monthly study visits. Pill counts of dispensed drug were performed and, at a subset of visits, plasma was collected to measure active drug concentration.

resultsAmong 1785 women, pregnancy incidence was 10.2 per 100 person-years. Younger age, not using contraception, having an additional sexual partner, and reporting unprotected sex were associated with increased likelihood of pregnancy. Monthly clinic pill counts estimated that women experiencing pregnancy took 97% of prescribed doses overall, with at least 80% pill adherence for 98% of study months, and no difference in adherence in the periconception period compared with previous periods (P = 0.98). Tenofovir was detected in plasma at 71% of visits where pregnancy was discovered. By multiple measures, adherence was similar for women experiencing and not experiencing pregnancy (P ≥ 0.1).

conclusionsIn this clinical trial of PrEP, pregnancy incidence was 10% per year despite excellent access to effective contraception. Women experiencing pregnancy had high medication adherence, suggesting that PrEP may be an acceptable and feasible safer conception strategy for HIV-1-uninfected women with HIV-1-serodiscordant partners.

Indexed as

Medication AdherenceAdenineAdolescentAdultAnti-HIV AgentsCohort StudiesDouble-Blind MethodFemaleFertilizationHIV InfectionsHumansKenyaOrganophosphonatesPre-Exposure ProphylaxisPregnancyPregnancy Complications, InfectiousAdenineAnti-HIV AgentsOrganophosphonatesTenofovir

Identifiers

PMID25118795
PMCPMC4149628

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.