Evidence map›Paper›PMID 23262497›Full record

ReviewAIDS (London, England)2013

Recommendations for the follow-up of study participants with breakthrough HIV infections during HIV/AIDS biomedical prevention studies.

Paige Etter, Raphael Landovitz, Sengeziwe Sibeko, Magdalena E Sobieszczyk, Sharon A Riddler, Carissa Karg, Athe Tsibris, Jeffrey Schouten

Abstract readReview
In one paragraph

Review in AIDS (London, England), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

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

1 citing paper in PubMed.

  1. Trial
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.

Paige EtterOffice of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Raphael Landovitz
Sengeziwe Sibeko
Magdalena E Sobieszczyk
Sharon A Riddler
Carissa Karg
Athe Tsibris
Jeffrey Schouten

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
Leadership Group for a Global HIV Vaccine Clinical Trials NetworkU01AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI COREY, LAWRENCE · 2006 to 2010
$181.5M
Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
Microbicide Trials NetworkU01AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2006 to 2010
$77.0M
UCLA Rapid, Relevant, Rigorous Implementation Science HubP30MH058107 · NIMH · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Cathy J Reback · 1997 to 2026
$53.5M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024156 · NCRR · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2006 to 2011
$53.0M
WOMEN'S INTERAGENCY HIV STUDY (WIHS) ORGANIZATION AND MANAGEMENTU01AI034994 · NIAID · GEORGETOWN UNIVERSITY · PI KASSAYE, SEBLE G · 1993 to 2018
$52.0M
University of Pittsburgh Clinical Trials UnitUM1AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SUSAN L KOLETAR, John W Mellors · 2012 to 2026
$38.0M
Clinical and Translational Science AwardUL1TR000040 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2012 to 2015
$26.2M
Columbia Collaborative HIV/AIDS Clinical Trials UnitU01AI069470 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI HAMMER, SCOTT M · 2007 to 2011
$15.4M
Biomedical Prevention for HIV in High-risk Populations with ComorbiditiesK23DA026308 · NIDA · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI LANDOVITZ, RAPHAEL J · 2009 to 2013
$790k
NCATS NIH HHS UL1 TR000040NCRR NIH HHS UL1 RR024156NIAID NIH HHS 5 UM1 AI068614NIAID NIH HHS 5 UM1 AI068633NIAID NIH HHS U01 AI034994NIAID NIH HHS U01AI034994NIAID NIH HHS U01 AI068614NIAID NIH HHS U01 AI068633NIAID NIH HHS U01 AI069470NIAID NIH HHS U01-AI069470NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI069494NIDA NIH HHS K23 DA026308NIDA NIH HHS K23DA026308NIMH NIH HHS P30 MH058107PHS HHS U01 A1068614
6 · The paper itself

Abstract

objectiveTo facilitate collection of cumulative data on longitudinal HIV disease outcomes during HIV prevention studies by developing recommendations for follow-up of the relatively few study participants with breakthrough infections.

designWe formed a working group to compare and contrast the various approaches taken in recent HIV prevention trials, to summarize the advantages and disadvantages associated with each, and to explore the feasibility of developing protocols for the long-term follow-up of seroconverters.

methodsWe reviewed study designs, objectives, and assessments in 15 interventional studies that followed HIV seroconverters. Protocol team members joined discussions of the various approaches and developed recommendations.

resultsMost HIV prevention clinical trials share a core set of objectives, including the description/comparison of virological, immunological, and clinical course of HIV, and sometimes a comparison of preseroconversion and postseroconversion behavior. Long-term follow-up of seroconverters can be conducted in separate studies if the transition from parent protocol is effectively managed.

conclusionWe recommend the development of harmonized seroconverter protocols. Although specific research questions in the postseroconversion period may differ depending on prevention modality, harmonizing key evaluations would create an opportunity to ask overarching questions that inform the prevention field with respect to design and implementation of future combination prevention studies. Follow-up immediately postseroconversion should be conducted in the parent protocol before roll over into a follow-up protocol. Development of specimen repositories with ample volumes for future assays, standardized definitions of infection, diagnosis and seroconversion dates, and harmonization of study objectives and sample collections at key time points are important.

Indexed as

Acquired Immunodeficiency SyndromeCD4 Lymphocyte CountClinical Trials as TopicData CollectionDelivery of Health CareDisease ProgressionFemaleFollow-Up StudiesGuidelines as TopicHIV SeropositivityHumansMaleSexual BehaviorUnited StatesViral Load

Identifiers

PMID23262497
PMCPMC4286368

What OpenQuestion holds

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Registered trials

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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.