Document Detail


Feasibility of identifying a cohort of US women at high risk for HIV infection for HIV vaccine efficacy trials: longitudinal results of HVTN 906.
MedLine Citation:
PMID:  23446497     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Identifying 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.
METHODS: HIV 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.
RESULTS: Among 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.
Authors:
Beryl A Koblin; Barbara Metch; Richard M Novak; Cecilia Morgan; Debbie Lucy; Debora Dunbar; Parrie Graham; Edith Swann; Tamra Madenwald; Gina Escamilia; Ian Frank;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  Journal of acquired immune deficiency syndromes (1999)     Volume:  63     ISSN:  1944-7884     ISO Abbreviation:  J. Acquir. Immune Defic. Syndr.     Publication Date:  2013 Jun 
Date Detail:
Created Date:  2013-05-13     Completed Date:  2013-07-08     Revised Date:  2014-06-03    
Medline Journal Info:
Nlm Unique ID:  100892005     Medline TA:  J Acquir Immune Defic Syndr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  239-44     Citation Subset:  IM; X    
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MeSH Terms
Descriptor/Qualifier:
AIDS Vaccines / therapeutic use*
Adult
Clinical Trials as Topic*
Cohort Studies
Feasibility Studies
Female
HIV Infections / epidemiology,  prevention & control*
Humans
Patient Selection*
Pregnancy
Questionnaires
Risk-Taking
Sexual Partners
United States / epidemiology
Unsafe Sex
Young Adult
Grant Support
ID/Acronym/Agency:
1UM1A1069470//PHS HHS; 1UM1A1069534//PHS HHS; 1UM1A1069554//PHS HHS; 1UM1AI068614/AI/NIAID NIH HHS; 1UM1AI068635/AI/NIAID NIH HHS; P30AI045008/AI/NIAID NIH HHS; UM1 AI068614/AI/NIAID NIH HHS; UM1 AI068635/AI/NIAID NIH HHS
Chemical
Reg. No./Substance:
0/AIDS Vaccines
Comments/Corrections

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