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 McIntyreRachel 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

Research output: Contribution to journalArticle

63 Citations (Scopus)

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 $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 log10 copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender (+0.24 log10 copies/mL; p<0.001) and CD4 count (-0.25 and -0.55 log10 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.

Original languageEnglish
Article numbere5272
JournalPLoS One
Volume4
Issue number4
DOIs
StatePublished - Apr 30 2009

Fingerprint

Human Herpesvirus 2
Human immunodeficiency virus 1
HIV-1
Acyclovir
Heterosexuality
Biological Factors
sexually transmitted diseases
Unsafe Sex
Southern Africa
Herpes Genitalis
Eastern Africa
CD4 Lymphocyte Count
Sexually Transmitted Diseases
genitalia
placebos

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)

Cite this

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

In: PLoS One, Vol. 4, No. 4, e5272, 30.04.2009.

Research output: Contribution to journalArticle

Lingappa, JR, Kahle, E, Mugo, N, Mujugira, A, Magaret, A, Baeten, J, Bukusi, EA, Cohen, CR, Katabira, E, Ronald, A, Kiarie, J, Farquhar, C, Stewart, GJ, Makhema, J, Essex, M, Were, E, Fife, K, deBruyn, G, Gray, G, McIntyre, J, Manongi, R, Kapiga, S, Coetzee, D, Allen, S, Inambao, M, Kayitenkore, K, Karita, E, Kanweka, W, Delany, S, Rees, H, Vwalika, B, Coombs, RW, Morrow, R, Whittington, W, Corey, L, Wald, A & Celum, C 2009, 'Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: The Partners Study', PLoS One, vol. 4, no. 4, e5272. https://doi.org/10.1371/journal.pone.0005272
Lingappa, Jairam R. ; Kahle, Erin ; Mugo, Nelly ; Mujugira, Andrew ; Magaret, Amalia ; Baeten, Jared ; Bukusi, Elizabeth A. ; Cohen, Craig R. ; Katabira, Elly ; Ronald, Allan ; Kiarie, James ; Farquhar, Carey ; Stewart, Grace John ; Makhema, Joseph ; Essex, M. ; Were, Edwin ; Fife, Kenneth ; deBruyn, Guy ; Gray, Glenda ; McIntyre, James ; Manongi, Rachel ; Kapiga, Saidi ; Coetzee, David ; Allen, Susan ; Inambao, Mubiana ; Kayitenkore, Kayitesi ; Karita, Etienne ; Kanweka, William ; Delany, Sinead ; Rees, Helen ; Vwalika, Bellington ; Coombs, Robert W. ; Morrow, Rhoda ; Whittington, William ; Corey, Lawrence ; Wald, Anna ; Celum, Connie. / Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission : The Partners Study. In: PLoS One. 2009 ; Vol. 4, No. 4.
@article{a8cb5232b9604b618c7429d88c75187c,
title = "Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: The Partners Study",
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 $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 log10 copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender (+0.24 log10 copies/mL; p<0.001) and CD4 count (-0.25 and -0.55 log10 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.",
author = "Lingappa, {Jairam R.} and Erin Kahle and Nelly Mugo and Andrew Mujugira and Amalia Magaret and Jared Baeten and Bukusi, {Elizabeth A.} and Cohen, {Craig R.} and Elly Katabira and Allan Ronald and James Kiarie and Carey Farquhar and Stewart, {Grace John} and Joseph Makhema and M. Essex and Edwin Were and Kenneth Fife and Guy deBruyn and Glenda Gray and James McIntyre and Rachel Manongi and Saidi Kapiga and David Coetzee and Susan Allen and Mubiana Inambao and Kayitesi Kayitenkore and Etienne Karita and William Kanweka and Sinead Delany and Helen Rees and Bellington Vwalika and Coombs, {Robert W.} and Rhoda Morrow and William Whittington and Lawrence Corey and Anna Wald and Connie Celum",
year = "2009",
month = "4",
day = "30",
doi = "10.1371/journal.pone.0005272",
language = "English",
volume = "4",
journal = "PLoS One",
issn = "1932-6203",
publisher = "Public Library of Science",
number = "4",

}

TY - JOUR

T1 - Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission

T2 - The Partners Study

AU - Lingappa, Jairam R.

AU - Kahle, Erin

AU - Mugo, Nelly

AU - Mujugira, Andrew

AU - Magaret, Amalia

AU - Baeten, Jared

AU - Bukusi, Elizabeth A.

AU - Cohen, Craig R.

AU - Katabira, Elly

AU - Ronald, Allan

AU - Kiarie, James

AU - Farquhar, Carey

AU - Stewart, Grace John

AU - Makhema, Joseph

AU - Essex, M.

AU - Were, Edwin

AU - Fife, Kenneth

AU - deBruyn, Guy

AU - Gray, Glenda

AU - McIntyre, James

AU - Manongi, Rachel

AU - Kapiga, Saidi

AU - Coetzee, David

AU - Allen, Susan

AU - Inambao, Mubiana

AU - Kayitenkore, Kayitesi

AU - Karita, Etienne

AU - Kanweka, William

AU - Delany, Sinead

AU - Rees, Helen

AU - Vwalika, Bellington

AU - Coombs, Robert W.

AU - Morrow, Rhoda

AU - Whittington, William

AU - Corey, Lawrence

AU - Wald, Anna

AU - Celum, Connie

PY - 2009/4/30

Y1 - 2009/4/30

N2 - 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 $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 log10 copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender (+0.24 log10 copies/mL; p<0.001) and CD4 count (-0.25 and -0.55 log10 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.

AB - 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 $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 log10 copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender (+0.24 log10 copies/mL; p<0.001) and CD4 count (-0.25 and -0.55 log10 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.

UR - http://www.scopus.com/inward/record.url?scp=65549102236&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=65549102236&partnerID=8YFLogxK

U2 - 10.1371/journal.pone.0005272

DO - 10.1371/journal.pone.0005272

M3 - Article

C2 - 19404392

AN - SCOPUS:65549102236

VL - 4

JO - PLoS One

JF - PLoS One

SN - 1932-6203

IS - 4

M1 - e5272

ER -