Evidence map›Paper›PMID 23446497›Full record

ArticleJournal of acquired immune deficiency syndromes (1999)2013

Feasibility of identifying a cohort of US women at high risk for HIV infection for HIV vaccine efficacy trials: longitudinal results of HVTN 906.

Beryl A Koblin, Barbara Metch, Richard M Novak, Cecilia Morgan, Debbie Lucy, Debora Dunbar, Parrie Graham, Edith Swann, Tamra Madenwald, Gina Escamilia and 2 more

Abstract readMulticenter Study
In one paragraph

Article in Journal of acquired immune deficiency syndromes (1999), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 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.

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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  8. HIV Sexual Risk and Syndemics among Women in Three Urban Areas in the United States: Analysis from HVTN 906.Journal of urban health : bulletin of the New York Academy of Medicine · 2015
    Article
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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

12 authors.

Beryl A KoblinLaboratory of Infectious Disease Prevention, New York Blood Center, New York, NY 10065, USA. bkoblin@nybloodcenter.org
Barbara Metch
Richard M Novak
Cecilia Morgan
Debbie Lucy
Debora Dunbar
Parrie Graham
Edith Swann
Tamra Madenwald
Gina Escamilia
Ian Frank
HVTN 906 Study Team

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI DAVID S METZGER · 1999 to 2026
$78.6M
University of Pennsylvania HIV Clinical Trials UnitUM1AI069534 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI Ian Frank, PABLO TEBAS · 2012 to 2026
$33.0M
NIAID NIH HHS 1UM1AI068614NIAID NIH HHS 1UM1AI068635NIAID NIH HHS P30 AI045008NIAID NIH HHS P30AI045008NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069534PHS HHS 1UM1A1069470PHS HHS 1UM1A1069534PHS HHS 1UM1A1069554
6 · The paper itself

Abstract

backgroundIdentifying cohorts of US women with HIV infection rates sufficient for inclusion in vaccine efficacy trials has been challenging. Using geography and sexual network characteristics to inform recruitment strategies, HVTN 906 determined the feasibility of recruiting a cohort of women at high risk for HIV acquisition.

methodsHIV uninfected women who reported unprotected sex in the prior 6 months, resided or engaged in risk behavior in local geographical high-risk pockets and/or had a male partner who had been incarcerated, injected drugs, or had concurrent partners were eligible. Behavioral risk assessment, HIV counseling and testing, and pregnancy testing were done at baseline, 6, 12, and 18 months.

resultsAmong 799 women, 71% were from local high-risk pockets and had high-risk male partners. Median age was 37 years; 79% were Black; and 15% Latina. Over half (55%) reported a new partner in the prior 6 months, 57% reported a male partner who had concurrent female sexual partners, and 37% reported a male partner who had been incarcerated. Retention at 18 months was 79.5%. Annual pregnancy incidence was 12%. Annual HIV incidence was 0.31% (95% confidence interval: 0.06% to 0.91%). Risk behaviors decreased between screening and 6 months with smaller changes thereafter. DISCUSSION: This cohort of women recruited using new strategies based on geography and sexual network characteristics did not have an HIV incidence high enough for HIV vaccine efficacy trials, despite high baseline levels of risk and a high pregnancy rate. New strategies to identify cohorts of US women for efficacy trials are needed.

Indexed as

Clinical Trials as TopicPatient SelectionAdultAIDS VaccinesCohort StudiesFeasibility StudiesFemaleHIV InfectionsHumansPregnancyRisk-TakingSexual PartnersSurveys and QuestionnairesUnited StatesUnsafe SexYoung AdultAIDS Vaccines

Identifiers

PMID23446497
PMCPMC3671573

What OpenQuestion holds

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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.