Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring
Abstract Background Confounding introduced by individuals’ sexual risk behavior is potentially a significant source of bias in HIV-1 prevention intervention studies. To more completely account for sexual behaviors when assessing the efficacy of the monthly dapivirine ring, a new longer-acting HIV-1...
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creator | Stalter, Randy M Dong, Tracy Q Hendrix, Craig W Palanee-Phillips, Thesla van der Straten, Ariane Hillier, Sharon L Kiweewa, Flavia M Mgodi, Nyaradzo M Marzinke, Mark A Bekker, Linda-Gail Soto-Torres, Lydia Baeten, Jared M Brown, Elizabeth R |
description | Abstract
Background
Confounding introduced by individuals’ sexual risk behavior is potentially a significant source of bias in HIV-1 prevention intervention studies. To more completely account for sexual behaviors when assessing the efficacy of the monthly dapivirine ring, a new longer-acting HIV-1 prevention option for women, we estimated per-sex-act risk reduction associated with product use.
Methods
We conducted a secondary analysis of data from MTN-020/ASPIRE, a phase 3, randomized, placebo-controlled efficacy trial of the dapivirine ring that recruited HIV-uninfected, African women aged 18–45 years. With cumulative sex acts as the time scale, we used multivariable Cox regression with inverse probability of censoring weights to estimate HIV-1 risk reduction associated with a rate of dapivirine release indicative of consistent product use.
Results
Women in the dapivirine ring group (n = 1187) had an estimated incidence rate of 2.3 (95% confidence interval [CI], 1.8–3.1) HIV-1 acquisition events per 10 000 sex acts versus 3.6 (95% CI, 2.9–4.4) per 10 000 acts in the placebo group (n = 1187). Dapivirine release indicative of consistent ring use was associated with a 63% (95% CI, 33%–80%) per-sex-act HIV-1 risk reduction.
Conclusions
These results support the efficacy of the dapivirine vaginal ring for HIV-1 prevention and help to inform decision-making for women, providers, and policymakers regarding product use.
Clinical Trials Registration
NCT01617096.
Among cisgender African women using the dapivirine vaginal ring for HIV-1 prevention, drug release rates consistent with continuous product use were associated with a 63% (95% CI, 33%–80%) per-sex-act HIV-1 risk reduction, further supporting the product's efficacy. |
doi_str_mv | 10.1093/infdis/jiad550 |
format | Article |
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Background
Confounding introduced by individuals’ sexual risk behavior is potentially a significant source of bias in HIV-1 prevention intervention studies. To more completely account for sexual behaviors when assessing the efficacy of the monthly dapivirine ring, a new longer-acting HIV-1 prevention option for women, we estimated per-sex-act risk reduction associated with product use.
Methods
We conducted a secondary analysis of data from MTN-020/ASPIRE, a phase 3, randomized, placebo-controlled efficacy trial of the dapivirine ring that recruited HIV-uninfected, African women aged 18–45 years. With cumulative sex acts as the time scale, we used multivariable Cox regression with inverse probability of censoring weights to estimate HIV-1 risk reduction associated with a rate of dapivirine release indicative of consistent product use.
Results
Women in the dapivirine ring group (n = 1187) had an estimated incidence rate of 2.3 (95% confidence interval [CI], 1.8–3.1) HIV-1 acquisition events per 10 000 sex acts versus 3.6 (95% CI, 2.9–4.4) per 10 000 acts in the placebo group (n = 1187). Dapivirine release indicative of consistent ring use was associated with a 63% (95% CI, 33%–80%) per-sex-act HIV-1 risk reduction.
Conclusions
These results support the efficacy of the dapivirine vaginal ring for HIV-1 prevention and help to inform decision-making for women, providers, and policymakers regarding product use.
Clinical Trials Registration
NCT01617096.
Among cisgender African women using the dapivirine vaginal ring for HIV-1 prevention, drug release rates consistent with continuous product use were associated with a 63% (95% CI, 33%–80%) per-sex-act HIV-1 risk reduction, further supporting the product's efficacy.</description><identifier>ISSN: 0022-1899</identifier><identifier>ISSN: 1537-6613</identifier><identifier>EISSN: 1537-6613</identifier><identifier>DOI: 10.1093/infdis/jiad550</identifier><identifier>PMID: 38099506</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Adolescent ; Adult ; Anti-HIV Agents - therapeutic use ; Clinical trials ; Contraceptive Devices, Female ; Decision making ; Female ; HIV ; HIV Infections - epidemiology ; HIV Infections - prevention & control ; HIV Seropositivity ; HIV-1 ; Human immunodeficiency virus ; Humans ; Major ; Middle Aged ; Placebos ; Pyrimidines ; Risk Reduction Behavior ; Sex ; Sexual behavior ; Vagina ; Young Adult</subject><ispartof>The Journal of infectious diseases, 2024-04, Vol.229 (4), p.1158-1165</ispartof><rights>The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com 2023</rights><rights>The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.</rights><rights>The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c368t-1626ca6bf677f34c78d25a9e088bae34098b7578deeb69e06a59e6930456d25d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,1584,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38099506$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Stalter, Randy M</creatorcontrib><creatorcontrib>Dong, Tracy Q</creatorcontrib><creatorcontrib>Hendrix, Craig W</creatorcontrib><creatorcontrib>Palanee-Phillips, Thesla</creatorcontrib><creatorcontrib>van der Straten, Ariane</creatorcontrib><creatorcontrib>Hillier, Sharon L</creatorcontrib><creatorcontrib>Kiweewa, Flavia M</creatorcontrib><creatorcontrib>Mgodi, Nyaradzo M</creatorcontrib><creatorcontrib>Marzinke, Mark A</creatorcontrib><creatorcontrib>Bekker, Linda-Gail</creatorcontrib><creatorcontrib>Soto-Torres, Lydia</creatorcontrib><creatorcontrib>Baeten, Jared M</creatorcontrib><creatorcontrib>Brown, Elizabeth R</creatorcontrib><creatorcontrib>MTN-020/ASPIRE Study Team</creatorcontrib><creatorcontrib>for the MTN-020/ASPIRE Study Team</creatorcontrib><title>Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring</title><title>The Journal of infectious diseases</title><addtitle>J Infect Dis</addtitle><description>Abstract
Background
Confounding introduced by individuals’ sexual risk behavior is potentially a significant source of bias in HIV-1 prevention intervention studies. To more completely account for sexual behaviors when assessing the efficacy of the monthly dapivirine ring, a new longer-acting HIV-1 prevention option for women, we estimated per-sex-act risk reduction associated with product use.
Methods
We conducted a secondary analysis of data from MTN-020/ASPIRE, a phase 3, randomized, placebo-controlled efficacy trial of the dapivirine ring that recruited HIV-uninfected, African women aged 18–45 years. With cumulative sex acts as the time scale, we used multivariable Cox regression with inverse probability of censoring weights to estimate HIV-1 risk reduction associated with a rate of dapivirine release indicative of consistent product use.
Results
Women in the dapivirine ring group (n = 1187) had an estimated incidence rate of 2.3 (95% confidence interval [CI], 1.8–3.1) HIV-1 acquisition events per 10 000 sex acts versus 3.6 (95% CI, 2.9–4.4) per 10 000 acts in the placebo group (n = 1187). Dapivirine release indicative of consistent ring use was associated with a 63% (95% CI, 33%–80%) per-sex-act HIV-1 risk reduction.
Conclusions
These results support the efficacy of the dapivirine vaginal ring for HIV-1 prevention and help to inform decision-making for women, providers, and policymakers regarding product use.
Clinical Trials Registration
NCT01617096.
Among cisgender African women using the dapivirine vaginal ring for HIV-1 prevention, drug release rates consistent with continuous product use were associated with a 63% (95% CI, 33%–80%) per-sex-act HIV-1 risk reduction, further supporting the product's efficacy.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Clinical trials</subject><subject>Contraceptive Devices, Female</subject><subject>Decision making</subject><subject>Female</subject><subject>HIV</subject><subject>HIV Infections - epidemiology</subject><subject>HIV Infections - prevention & control</subject><subject>HIV Seropositivity</subject><subject>HIV-1</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Major</subject><subject>Middle Aged</subject><subject>Placebos</subject><subject>Pyrimidines</subject><subject>Risk Reduction Behavior</subject><subject>Sex</subject><subject>Sexual behavior</subject><subject>Vagina</subject><subject>Young Adult</subject><issn>0022-1899</issn><issn>1537-6613</issn><issn>1537-6613</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkUFP3DAQha2qqCxLrxxRpF7gEBjHiROf0AooICFRQXfbm-Ukk8VLYi92sqL_Hre7IODS00gz33uap0fIHoUjCoIda9PU2h8vtKqzDD6REc1YHnNO2WcyAkiSmBZCbJMd7xcAkDKefyHbrAAhMuAj8nviPXqvzTz6gS6-w6d4UvXR5dUsptGt9g_RLdZD1WtroklnA_bLdmii6T9Jf4_RmVrqlXbaYDRTc21UG3Rmvku2GtV6_LqZYzL9fv7z9DK-vrm4Op1cxxXjRR9TnvBK8bLhed6wtMqLOsmUQCiKUiFLQRRlnoUtYsnDmqtMIBcM0owHsmZjcrL2XQ5lh3WFpneqlUunO-X-SKu0fH8x-l7O7UpSCpTSPA0OBxsHZx8H9L3stK-wbZVBO3iZCEgET2kBAf32AV3YwYXIXoaPKHABPAnU0ZqqnPXeYfP6DQX5tzW5bk1uWguC_bcZXvGXmgJwuAbssPyf2TMw3qJp</recordid><startdate>20240412</startdate><enddate>20240412</enddate><creator>Stalter, Randy M</creator><creator>Dong, Tracy Q</creator><creator>Hendrix, Craig W</creator><creator>Palanee-Phillips, Thesla</creator><creator>van der Straten, Ariane</creator><creator>Hillier, Sharon L</creator><creator>Kiweewa, Flavia M</creator><creator>Mgodi, Nyaradzo M</creator><creator>Marzinke, Mark A</creator><creator>Bekker, Linda-Gail</creator><creator>Soto-Torres, Lydia</creator><creator>Baeten, Jared M</creator><creator>Brown, Elizabeth R</creator><general>Oxford University Press</general><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>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20240412</creationdate><title>Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring</title><author>Stalter, Randy M ; Dong, Tracy Q ; Hendrix, Craig W ; Palanee-Phillips, Thesla ; van der Straten, Ariane ; Hillier, Sharon L ; Kiweewa, Flavia M ; Mgodi, Nyaradzo M ; Marzinke, Mark A ; Bekker, Linda-Gail ; Soto-Torres, Lydia ; Baeten, Jared M ; Brown, Elizabeth R</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c368t-1626ca6bf677f34c78d25a9e088bae34098b7578deeb69e06a59e6930456d25d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Clinical trials</topic><topic>Contraceptive Devices, Female</topic><topic>Decision making</topic><topic>Female</topic><topic>HIV</topic><topic>HIV Infections - epidemiology</topic><topic>HIV Infections - prevention & control</topic><topic>HIV Seropositivity</topic><topic>HIV-1</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Major</topic><topic>Middle Aged</topic><topic>Placebos</topic><topic>Pyrimidines</topic><topic>Risk Reduction Behavior</topic><topic>Sex</topic><topic>Sexual behavior</topic><topic>Vagina</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Stalter, Randy M</creatorcontrib><creatorcontrib>Dong, Tracy Q</creatorcontrib><creatorcontrib>Hendrix, Craig W</creatorcontrib><creatorcontrib>Palanee-Phillips, Thesla</creatorcontrib><creatorcontrib>van der Straten, Ariane</creatorcontrib><creatorcontrib>Hillier, Sharon L</creatorcontrib><creatorcontrib>Kiweewa, Flavia M</creatorcontrib><creatorcontrib>Mgodi, Nyaradzo M</creatorcontrib><creatorcontrib>Marzinke, Mark A</creatorcontrib><creatorcontrib>Bekker, Linda-Gail</creatorcontrib><creatorcontrib>Soto-Torres, Lydia</creatorcontrib><creatorcontrib>Baeten, Jared M</creatorcontrib><creatorcontrib>Brown, Elizabeth R</creatorcontrib><creatorcontrib>MTN-020/ASPIRE Study Team</creatorcontrib><creatorcontrib>for the MTN-020/ASPIRE Study Team</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The Journal of infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Stalter, Randy M</au><au>Dong, Tracy Q</au><au>Hendrix, Craig W</au><au>Palanee-Phillips, Thesla</au><au>van der Straten, Ariane</au><au>Hillier, Sharon L</au><au>Kiweewa, Flavia M</au><au>Mgodi, Nyaradzo M</au><au>Marzinke, Mark A</au><au>Bekker, Linda-Gail</au><au>Soto-Torres, Lydia</au><au>Baeten, Jared M</au><au>Brown, Elizabeth R</au><aucorp>MTN-020/ASPIRE Study Team</aucorp><aucorp>for the MTN-020/ASPIRE Study Team</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring</atitle><jtitle>The Journal of infectious diseases</jtitle><addtitle>J Infect Dis</addtitle><date>2024-04-12</date><risdate>2024</risdate><volume>229</volume><issue>4</issue><spage>1158</spage><epage>1165</epage><pages>1158-1165</pages><issn>0022-1899</issn><issn>1537-6613</issn><eissn>1537-6613</eissn><abstract>Abstract
Background
Confounding introduced by individuals’ sexual risk behavior is potentially a significant source of bias in HIV-1 prevention intervention studies. To more completely account for sexual behaviors when assessing the efficacy of the monthly dapivirine ring, a new longer-acting HIV-1 prevention option for women, we estimated per-sex-act risk reduction associated with product use.
Methods
We conducted a secondary analysis of data from MTN-020/ASPIRE, a phase 3, randomized, placebo-controlled efficacy trial of the dapivirine ring that recruited HIV-uninfected, African women aged 18–45 years. With cumulative sex acts as the time scale, we used multivariable Cox regression with inverse probability of censoring weights to estimate HIV-1 risk reduction associated with a rate of dapivirine release indicative of consistent product use.
Results
Women in the dapivirine ring group (n = 1187) had an estimated incidence rate of 2.3 (95% confidence interval [CI], 1.8–3.1) HIV-1 acquisition events per 10 000 sex acts versus 3.6 (95% CI, 2.9–4.4) per 10 000 acts in the placebo group (n = 1187). Dapivirine release indicative of consistent ring use was associated with a 63% (95% CI, 33%–80%) per-sex-act HIV-1 risk reduction.
Conclusions
These results support the efficacy of the dapivirine vaginal ring for HIV-1 prevention and help to inform decision-making for women, providers, and policymakers regarding product use.
Clinical Trials Registration
NCT01617096.
Among cisgender African women using the dapivirine vaginal ring for HIV-1 prevention, drug release rates consistent with continuous product use were associated with a 63% (95% CI, 33%–80%) per-sex-act HIV-1 risk reduction, further supporting the product's efficacy.</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>38099506</pmid><doi>10.1093/infdis/jiad550</doi><tpages>8</tpages></addata></record> |
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source | MEDLINE; Oxford University Press Journals All Titles (1996-Current) |
subjects | Adolescent Adult Anti-HIV Agents - therapeutic use Clinical trials Contraceptive Devices, Female Decision making Female HIV HIV Infections - epidemiology HIV Infections - prevention & control HIV Seropositivity HIV-1 Human immunodeficiency virus Humans Major Middle Aged Placebos Pyrimidines Risk Reduction Behavior Sex Sexual behavior Vagina Young Adult |
title | Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring |
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