Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study

Jairam R Lingappa, Erin Kahle, Nelly Mugo, Andrew Mujugira, Amalia Magaret, Jared Baeten, Elizabeth A Bukusi, Craig R Cohen, Elly Katabira, Allan Ronald, James Kiarie, Carey Farquhar, Grace John Stewart, Joseph Makhema, M Essex, Edwin Were, Kenneth Fife, Guy Debruyn, Glenda Gray, James McIntyre, Rachel Manongi, Saidi Kapiga, David Coetzee, Susan Allen, Mubiana Inambao, Kayitesi Kayitenkore, Etienne Karita, William Kanweka, Sinead Delany, Helen Rees, Bellington Vwalika, Robert W Coombs, Rhoda Morrow, William Whittington, Lawrence Corey, Anna Wald, Connie Celum, Partners HSV-2/HIV-1 Transmission Study Team, Jairam R Lingappa, Erin Kahle, Nelly Mugo, Andrew Mujugira, Amalia Magaret, Jared Baeten, Elizabeth A Bukusi, Craig R Cohen, Elly Katabira, Allan Ronald, James Kiarie, Carey Farquhar, Grace John Stewart, Joseph Makhema, M Essex, Edwin Were, Kenneth Fife, Guy Debruyn, Glenda Gray, James McIntyre, Rachel Manongi, Saidi Kapiga, David Coetzee, Susan Allen, Mubiana Inambao, Kayitesi Kayitenkore, Etienne Karita, William Kanweka, Sinead Delany, Helen Rees, Bellington Vwalika, Robert W Coombs, Rhoda Morrow, William Whittington, Lawrence Corey, Anna Wald, Connie Celum, Partners HSV-2/HIV-1 Transmission Study Team

Abstract

Background: The Partners HSV-2/HIV-1 Transmission Study (Partners Study) is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2) suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1 serodiscordant heterosexual couples. We describe the baseline characteristics of this cohort.

Methods: HIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4 count >or=250 cells/mcL and was not on antiretroviral therapy, were enrolled at 14 sites in East and Southern Africa. Demographic, behavioral, clinical and laboratory characteristics were assessed.

Results: Of the 3408 HIV-1 serodiscordant couples enrolled, 67% of the HIV-1 infected partners were women. Couples had cohabitated for a median of 5 years (range 2-9) with 28% reporting unprotected sex in the month prior to enrollment. Among HIV-1 susceptible participants, 86% of women and 59% of men were HSV-2 seropositive. Other laboratory-diagnosed sexually transmitted infections were uncommon (<5%), except for Trichomonas vaginalis in 14% of HIV-1 infected women. Median baseline CD4 count for HIV-1 infected participants was 462cells/mcL and median HIV-1 plasma RNA was 4.2 log(10) copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender (+0.24 log(10) copies/mL; p<0.001) and CD4 count (-0.25 and -0.55 log(10) copies/mL for CD4 350-499 and >500 relative to <350, respectively, p<0.001).

Conclusions: The Partners Study successfully enrolled a cohort of 3408 heterosexual HIV-1 serodiscordant couples in Africa at high risk for HIV-1 transmission. Follow-up of this cohort will evaluate the efficacy of acyclovir for HSV-2 suppression in preventing HIV-1 transmission and provide insights into biological and behavioral factors determining heterosexual HIV-1 transmission.

Trial registration: ClinicalTrials.gov NCT00194519.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1. Prescreening, Screening and Enrollment Flow…
Figure 1. Prescreening, Screening and Enrollment Flow for HIV-1 serodiscordant couples in the Partners Study.

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