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Improvement of Vaginal Health for Kenyan Women at Risk for Acquisition of Human Immunodeficiency Virus Type 1: Results of a Randomized Trial
Background. Vaginal infections are common and have been associated with increased risk for acquisition of human immunodeficiency virus type 1 (HIV-1). Methods. We conducted a randomized trial of directly observed oral treatment administered monthly to reduce vaginal infections among Kenyan women at...
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| Published in: | The Journal of infectious diseases 2008-05, Vol.197 (10), p.1361-1368 |
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| creator | McClelland, R. Scott Richardson, Barbra A. Hassan, Wisal M. Chohan, Vrasha Lavreys, Ludo Mandaliya, Kishorchandra Kiarie, James Jaoko, Walter Ndinya-Achola, Jeckoniah O. Baeten, Jared M. Kurth, Ann E. Holmes, King K. |
| description | Background. Vaginal infections are common and have been associated with increased risk for acquisition of human immunodeficiency virus type 1 (HIV-1). Methods. We conducted a randomized trial of directly observed oral treatment administered monthly to reduce vaginal infections among Kenyan women at risk for HIV-1 acquisition. A trial intervention of 2 g of metronidazole plus 150 mg of fluconazole was compared with metronidazole placebo plus fluconazole placebo. The primary end points were bacterial vaginosis (BV), vaginal candidiasis, trichomoniasis vaginalis (hereafter, “trichomoniasis”), and colonization with Lactobacillus organisms. Results. Of 310 HIV-1-seronegative female sex workers enrolled (155 per arm), 303 were included in the primary end points analysis. A median of 12 follow-up visits per subject were recorded in both study arms (P = .8). Compared with control subjects, women receiving the intervention had fewer episodes of BV (hazard ratio [HR], 0.55; 95% confidence interval [CI], 0.49–0.63) and more frequent vaginal colonization with any Lactobacillus species (HR, 1.47; 95% CI, 1.19–1.80) and H2O2-producing Lactobacillus species (HR, 1.63; 95% CI, 1.16–2.27). The incidences of vaginal candidiasis (HR, 0.84; 95% CI, 0.67–1.04) and trichomoniasis (HR, 0.55; 95% CI, 0.27–1.12) among treated women were less than those among control subjects, but the differences were not statistically significant. Conclusions. Periodic presumptive treatment reduced the incidence of BV and promoted colonization with normal vaginal flora. Vaginal health interventions have the potential to provide simple, female-controlled approaches for reducing the risk of HIV-1 acquisition. |
| doi_str_mv | 10.1086/587490 |
| format | article |
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Scott ; Richardson, Barbra A. ; Hassan, Wisal M. ; Chohan, Vrasha ; Lavreys, Ludo ; Mandaliya, Kishorchandra ; Kiarie, James ; Jaoko, Walter ; Ndinya-Achola, Jeckoniah O. ; Baeten, Jared M. ; Kurth, Ann E. ; Holmes, King K.</creator><creatorcontrib>McClelland, R. Scott ; Richardson, Barbra A. ; Hassan, Wisal M. ; Chohan, Vrasha ; Lavreys, Ludo ; Mandaliya, Kishorchandra ; Kiarie, James ; Jaoko, Walter ; Ndinya-Achola, Jeckoniah O. ; Baeten, Jared M. ; Kurth, Ann E. ; Holmes, King K.</creatorcontrib><description>Background. Vaginal infections are common and have been associated with increased risk for acquisition of human immunodeficiency virus type 1 (HIV-1). Methods. We conducted a randomized trial of directly observed oral treatment administered monthly to reduce vaginal infections among Kenyan women at risk for HIV-1 acquisition. A trial intervention of 2 g of metronidazole plus 150 mg of fluconazole was compared with metronidazole placebo plus fluconazole placebo. The primary end points were bacterial vaginosis (BV), vaginal candidiasis, trichomoniasis vaginalis (hereafter, “trichomoniasis”), and colonization with Lactobacillus organisms. Results. Of 310 HIV-1-seronegative female sex workers enrolled (155 per arm), 303 were included in the primary end points analysis. A median of 12 follow-up visits per subject were recorded in both study arms (P = .8). Compared with control subjects, women receiving the intervention had fewer episodes of BV (hazard ratio [HR], 0.55; 95% confidence interval [CI], 0.49–0.63) and more frequent vaginal colonization with any Lactobacillus species (HR, 1.47; 95% CI, 1.19–1.80) and H2O2-producing Lactobacillus species (HR, 1.63; 95% CI, 1.16–2.27). The incidences of vaginal candidiasis (HR, 0.84; 95% CI, 0.67–1.04) and trichomoniasis (HR, 0.55; 95% CI, 0.27–1.12) among treated women were less than those among control subjects, but the differences were not statistically significant. Conclusions. Periodic presumptive treatment reduced the incidence of BV and promoted colonization with normal vaginal flora. Vaginal health interventions have the potential to provide simple, female-controlled approaches for reducing the risk of HIV-1 acquisition.</description><identifier>ISSN: 0022-1899</identifier><identifier>EISSN: 1537-6613</identifier><identifier>DOI: 10.1086/587490</identifier><identifier>PMID: 18444793</identifier><language>eng</language><publisher>United States: The University of Chicago Press</publisher><subject><![CDATA[Adolescent ; Adult ; Anti-Infective Agents - administration & dosage ; Anti-Infective Agents - therapeutic use ; Antifungal Agents - administration & dosage ; Antifungal Agents - therapeutic use ; Candidiasis, Vulvovaginal - epidemiology ; Candidiasis, Vulvovaginal - prevention & control ; Female ; Fluconazole - administration & dosage ; Fluconazole - therapeutic use ; HIV Infections - epidemiology ; HIV Infections - prevention & control ; HIV Infections - virology ; HIV-1 - isolation & purification ; Human immunodeficiency virus 1 ; Humans ; Incidence ; Kenya - epidemiology ; Lactobacillus ; Lactobacillus - growth & development ; Metronidazole - administration & dosage ; Metronidazole - therapeutic use ; Middle Aged ; Placebos - administration & dosage ; Sex Work ; Trichomonas Vaginitis - epidemiology ; Trichomonas Vaginitis - prevention & control ; Vagina - microbiology ; Vagina - parasitology ; Vagina - physiology ; Vaginosis, Bacterial - epidemiology ; Vaginosis, Bacterial - prevention & control]]></subject><ispartof>The Journal of infectious diseases, 2008-05, Vol.197 (10), p.1361-1368</ispartof><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c409t-7d3330153877a99a7dcdda1e57a6c98b272cd26c0ee8cfb440c643fc892089cf3</citedby><cites>FETCH-LOGICAL-c409t-7d3330153877a99a7dcdda1e57a6c98b272cd26c0ee8cfb440c643fc892089cf3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,786,790,27957,27958</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18444793$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>McClelland, R. Scott</creatorcontrib><creatorcontrib>Richardson, Barbra A.</creatorcontrib><creatorcontrib>Hassan, Wisal M.</creatorcontrib><creatorcontrib>Chohan, Vrasha</creatorcontrib><creatorcontrib>Lavreys, Ludo</creatorcontrib><creatorcontrib>Mandaliya, Kishorchandra</creatorcontrib><creatorcontrib>Kiarie, James</creatorcontrib><creatorcontrib>Jaoko, Walter</creatorcontrib><creatorcontrib>Ndinya-Achola, Jeckoniah O.</creatorcontrib><creatorcontrib>Baeten, Jared M.</creatorcontrib><creatorcontrib>Kurth, Ann E.</creatorcontrib><creatorcontrib>Holmes, King K.</creatorcontrib><title>Improvement of Vaginal Health for Kenyan Women at Risk for Acquisition of Human Immunodeficiency Virus Type 1: Results of a Randomized Trial</title><title>The Journal of infectious diseases</title><addtitle>The Journal of Infectious Diseases</addtitle><description>Background. Vaginal infections are common and have been associated with increased risk for acquisition of human immunodeficiency virus type 1 (HIV-1). Methods. We conducted a randomized trial of directly observed oral treatment administered monthly to reduce vaginal infections among Kenyan women at risk for HIV-1 acquisition. A trial intervention of 2 g of metronidazole plus 150 mg of fluconazole was compared with metronidazole placebo plus fluconazole placebo. The primary end points were bacterial vaginosis (BV), vaginal candidiasis, trichomoniasis vaginalis (hereafter, “trichomoniasis”), and colonization with Lactobacillus organisms. Results. Of 310 HIV-1-seronegative female sex workers enrolled (155 per arm), 303 were included in the primary end points analysis. A median of 12 follow-up visits per subject were recorded in both study arms (P = .8). Compared with control subjects, women receiving the intervention had fewer episodes of BV (hazard ratio [HR], 0.55; 95% confidence interval [CI], 0.49–0.63) and more frequent vaginal colonization with any Lactobacillus species (HR, 1.47; 95% CI, 1.19–1.80) and H2O2-producing Lactobacillus species (HR, 1.63; 95% CI, 1.16–2.27). The incidences of vaginal candidiasis (HR, 0.84; 95% CI, 0.67–1.04) and trichomoniasis (HR, 0.55; 95% CI, 0.27–1.12) among treated women were less than those among control subjects, but the differences were not statistically significant. Conclusions. Periodic presumptive treatment reduced the incidence of BV and promoted colonization with normal vaginal flora. Vaginal health interventions have the potential to provide simple, female-controlled approaches for reducing the risk of HIV-1 acquisition.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Anti-Infective Agents - administration & dosage</subject><subject>Anti-Infective Agents - therapeutic use</subject><subject>Antifungal Agents - administration & dosage</subject><subject>Antifungal Agents - therapeutic use</subject><subject>Candidiasis, Vulvovaginal - epidemiology</subject><subject>Candidiasis, Vulvovaginal - prevention & control</subject><subject>Female</subject><subject>Fluconazole - administration & dosage</subject><subject>Fluconazole - therapeutic use</subject><subject>HIV Infections - epidemiology</subject><subject>HIV Infections - prevention & control</subject><subject>HIV Infections - virology</subject><subject>HIV-1 - isolation & purification</subject><subject>Human immunodeficiency virus 1</subject><subject>Humans</subject><subject>Incidence</subject><subject>Kenya - epidemiology</subject><subject>Lactobacillus</subject><subject>Lactobacillus - growth & development</subject><subject>Metronidazole - administration & dosage</subject><subject>Metronidazole - therapeutic use</subject><subject>Middle Aged</subject><subject>Placebos - administration & dosage</subject><subject>Sex Work</subject><subject>Trichomonas Vaginitis - epidemiology</subject><subject>Trichomonas Vaginitis - prevention & control</subject><subject>Vagina - microbiology</subject><subject>Vagina - parasitology</subject><subject>Vagina - physiology</subject><subject>Vaginosis, Bacterial - epidemiology</subject><subject>Vaginosis, Bacterial - prevention & control</subject><issn>0022-1899</issn><issn>1537-6613</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><recordid>eNqF0ctu1DAUBmALgehQ4BGQV-wCvsUXdlUFZERVYDQUxMby2CdgGjvTOEEMz8BDk2FGdNnVWZzvP9LRj9BTSl5QouXLWithyD20oDVXlZSU30cLQhirqDbmBD0q5QchRHCpHqITqoUQyvAF-rNM26H_CQnyiPsWX7lvMbsON-C68Ttu-wG_g7xzGX_uZ4PdiFexXP9bnPmbKZY4xj7vo82UZrZMacp9gDb6CNnv8FUcpoLXuy1g-gqvoEzdWPbe4ZXLoU_xNwS8HqLrHqMHresKPDnOU_Tpzev1eVNdvH-7PD-7qLwgZqxU4JyT-VGtlDPGqeBDcBRq5aQ3esMU84FJTwC0bzdCEC8Fb702jGjjW36Knh_uzq_fTFBGm2Lx0HUuQz8VKw2tGZszd0FGWC04o3dCauYWlDa30A99KQO0djvE5IadpcTum7SHJmf47Hhx2iQIt-xY3QyqA4hlhF__9264tlJxVdvmy1fbfCTi8sOltjX_C9uWp4g</recordid><startdate>20080515</startdate><enddate>20080515</enddate><creator>McClelland, R. Scott</creator><creator>Richardson, Barbra A.</creator><creator>Hassan, Wisal M.</creator><creator>Chohan, Vrasha</creator><creator>Lavreys, Ludo</creator><creator>Mandaliya, Kishorchandra</creator><creator>Kiarie, James</creator><creator>Jaoko, Walter</creator><creator>Ndinya-Achola, Jeckoniah O.</creator><creator>Baeten, Jared M.</creator><creator>Kurth, Ann E.</creator><creator>Holmes, King K.</creator><general>The University of Chicago Press</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>7X8</scope></search><sort><creationdate>20080515</creationdate><title>Improvement of Vaginal Health for Kenyan Women at Risk for Acquisition of Human Immunodeficiency Virus Type 1: Results of a Randomized Trial</title><author>McClelland, R. Scott ; Richardson, Barbra A. ; Hassan, Wisal M. ; Chohan, Vrasha ; Lavreys, Ludo ; Mandaliya, Kishorchandra ; Kiarie, James ; Jaoko, Walter ; Ndinya-Achola, Jeckoniah O. ; Baeten, Jared M. ; Kurth, Ann E. ; Holmes, King K.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c409t-7d3330153877a99a7dcdda1e57a6c98b272cd26c0ee8cfb440c643fc892089cf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Anti-Infective Agents - administration & dosage</topic><topic>Anti-Infective Agents - therapeutic use</topic><topic>Antifungal Agents - administration & dosage</topic><topic>Antifungal Agents - therapeutic use</topic><topic>Candidiasis, Vulvovaginal - epidemiology</topic><topic>Candidiasis, Vulvovaginal - prevention & control</topic><topic>Female</topic><topic>Fluconazole - administration & dosage</topic><topic>Fluconazole - therapeutic use</topic><topic>HIV Infections - epidemiology</topic><topic>HIV Infections - prevention & control</topic><topic>HIV Infections - virology</topic><topic>HIV-1 - isolation & purification</topic><topic>Human immunodeficiency virus 1</topic><topic>Humans</topic><topic>Incidence</topic><topic>Kenya - epidemiology</topic><topic>Lactobacillus</topic><topic>Lactobacillus - growth & development</topic><topic>Metronidazole - administration & dosage</topic><topic>Metronidazole - therapeutic use</topic><topic>Middle Aged</topic><topic>Placebos - administration & dosage</topic><topic>Sex Work</topic><topic>Trichomonas Vaginitis - epidemiology</topic><topic>Trichomonas Vaginitis - prevention & control</topic><topic>Vagina - microbiology</topic><topic>Vagina - parasitology</topic><topic>Vagina - physiology</topic><topic>Vaginosis, Bacterial - epidemiology</topic><topic>Vaginosis, Bacterial - prevention & control</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>McClelland, R. Scott</creatorcontrib><creatorcontrib>Richardson, Barbra A.</creatorcontrib><creatorcontrib>Hassan, Wisal M.</creatorcontrib><creatorcontrib>Chohan, Vrasha</creatorcontrib><creatorcontrib>Lavreys, Ludo</creatorcontrib><creatorcontrib>Mandaliya, Kishorchandra</creatorcontrib><creatorcontrib>Kiarie, James</creatorcontrib><creatorcontrib>Jaoko, Walter</creatorcontrib><creatorcontrib>Ndinya-Achola, Jeckoniah O.</creatorcontrib><creatorcontrib>Baeten, Jared M.</creatorcontrib><creatorcontrib>Kurth, Ann E.</creatorcontrib><creatorcontrib>Holmes, King K.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>The Journal of infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>McClelland, R. Scott</au><au>Richardson, Barbra A.</au><au>Hassan, Wisal M.</au><au>Chohan, Vrasha</au><au>Lavreys, Ludo</au><au>Mandaliya, Kishorchandra</au><au>Kiarie, James</au><au>Jaoko, Walter</au><au>Ndinya-Achola, Jeckoniah O.</au><au>Baeten, Jared M.</au><au>Kurth, Ann E.</au><au>Holmes, King K.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Improvement of Vaginal Health for Kenyan Women at Risk for Acquisition of Human Immunodeficiency Virus Type 1: Results of a Randomized Trial</atitle><jtitle>The Journal of infectious diseases</jtitle><addtitle>The Journal of Infectious Diseases</addtitle><date>2008-05-15</date><risdate>2008</risdate><volume>197</volume><issue>10</issue><spage>1361</spage><epage>1368</epage><pages>1361-1368</pages><issn>0022-1899</issn><eissn>1537-6613</eissn><notes>ark:/67375/HXZ-HQ04NPN8-5</notes><notes>istex:998A658B0911A7086FA824D2B9D9DD4F5C0F68BD</notes><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>content type line 23</notes><notes>ObjectType-Undefined-3</notes><abstract>Background. Vaginal infections are common and have been associated with increased risk for acquisition of human immunodeficiency virus type 1 (HIV-1). Methods. We conducted a randomized trial of directly observed oral treatment administered monthly to reduce vaginal infections among Kenyan women at risk for HIV-1 acquisition. A trial intervention of 2 g of metronidazole plus 150 mg of fluconazole was compared with metronidazole placebo plus fluconazole placebo. The primary end points were bacterial vaginosis (BV), vaginal candidiasis, trichomoniasis vaginalis (hereafter, “trichomoniasis”), and colonization with Lactobacillus organisms. Results. Of 310 HIV-1-seronegative female sex workers enrolled (155 per arm), 303 were included in the primary end points analysis. A median of 12 follow-up visits per subject were recorded in both study arms (P = .8). Compared with control subjects, women receiving the intervention had fewer episodes of BV (hazard ratio [HR], 0.55; 95% confidence interval [CI], 0.49–0.63) and more frequent vaginal colonization with any Lactobacillus species (HR, 1.47; 95% CI, 1.19–1.80) and H2O2-producing Lactobacillus species (HR, 1.63; 95% CI, 1.16–2.27). The incidences of vaginal candidiasis (HR, 0.84; 95% CI, 0.67–1.04) and trichomoniasis (HR, 0.55; 95% CI, 0.27–1.12) among treated women were less than those among control subjects, but the differences were not statistically significant. Conclusions. Periodic presumptive treatment reduced the incidence of BV and promoted colonization with normal vaginal flora. Vaginal health interventions have the potential to provide simple, female-controlled approaches for reducing the risk of HIV-1 acquisition.</abstract><cop>United States</cop><pub>The University of Chicago Press</pub><pmid>18444793</pmid><doi>10.1086/587490</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | The Journal of infectious diseases, 2008-05, Vol.197 (10), p.1361-1368 |
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| source | Oxford Academic Journals (OUP); JSTOR |
| subjects | Adolescent Adult Anti-Infective Agents - administration & dosage Anti-Infective Agents - therapeutic use Antifungal Agents - administration & dosage Antifungal Agents - therapeutic use Candidiasis, Vulvovaginal - epidemiology Candidiasis, Vulvovaginal - prevention & control Female Fluconazole - administration & dosage Fluconazole - therapeutic use HIV Infections - epidemiology HIV Infections - prevention & control HIV Infections - virology HIV-1 - isolation & purification Human immunodeficiency virus 1 Humans Incidence Kenya - epidemiology Lactobacillus Lactobacillus - growth & development Metronidazole - administration & dosage Metronidazole - therapeutic use Middle Aged Placebos - administration & dosage Sex Work Trichomonas Vaginitis - epidemiology Trichomonas Vaginitis - prevention & control Vagina - microbiology Vagina - parasitology Vagina - physiology Vaginosis, Bacterial - epidemiology Vaginosis, Bacterial - prevention & control |
| title | Improvement of Vaginal Health for Kenyan Women at Risk for Acquisition of Human Immunodeficiency Virus Type 1: Results of a Randomized Trial |
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