Feasibility of Identifying a Cohort of US Women at High Risk for HIV Infection for HIV Vaccine Efficacy Trials: Longitudinal Results of HVTN 906

Koblin, Beryl A. PhD*; Metch, Barbara MA, MS; Novak, Richard M. MD; Morgan, Cecilia PhD; Lucy, Debbie MS*; Dunbar, Debora MSN§; Graham, Parrie MSPH; Swann, Edith PhD, RN; Madenwald, Tamra MA, MPH; Escamilia, Gina MS; Frank, Ian MD§,¶; on behalf of the HVTN 906 Study Team

JAIDS Journal of Acquired Immune Deficiency Syndromes: 1 June 2013 - Volume 63 - Issue 2 - p 239–244
doi: 10.1097/QAI.0b013e31828ded1a
Epidemiology and Prevention

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.

*Laboratory of Infectious Disease Prevention, New York Blood Center, New York, NY;

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA;

Section of Infectious Diseases, University of Illinois, Chicago, IL;

§HIV Prevention Division, University of Pennsylvania, Philadelphia, PA;

Division of AIDS, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD; and

Infectious Diseases Division, University of Pennsylvania, Philadelphia, PA.

Correspondence to: Beryl A. Koblin, PhD, Laboratory of Infectious Disease Prevention, New York Blood Center, 310 E.67th Street New York, NY 10065 (e-mail: bkoblin@nybloodcenter.org).

Supported by the Division of AIDS, National Institute of Allergy and Infectious Disease, National Institutes of Health, grants 1UM1AI068614, 1UM1A1069470, 1UM1A1069554, 1UM1A1069534, 1UM1AI068635, and P30AI045008.

The authors have no conflicts of interest to disclose.

Presented in part at AIDS Vaccine 2012, September 9–12, 2012, Boston, MA.

Received October 23, 2012

Accepted February 18, 2013

© 2013 by Lippincott Williams & Wilkins