Delany-Moretlwe 2022 clinical trial - XML Representation - Evidence Based Medicine on FHIR Implementation Guide v1.0.0-ballot

This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
: Delany-Moretlwe 2022 clinical trial - XML Representation

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    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Citation</b><a name="153881"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Citation &quot;153881&quot; Version &quot;1&quot; Updated &quot;2023-08-10 21:44:41+0000&quot; </p></div><p><b>StructureDefinition Work Group</b>: cds</p><p><b>url</b>: <code>https://fevir.net/resources/Citation/153881</code></p><p><b>identifier</b>: FEvIR Object Identifier: 153881, id: 35378077</p><p><b>version</b>: 1.0.0-ballot</p><p><b>title</b>: Delany-Moretlwe 2022 clinical trial</p><p><b>status</b>: active</p><p><b>date</b>: 2023-12-17 16:55:23+0000</p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href="http://www.hl7.org/Special/committees/dss">http://www.hl7.org/Special/committees/dss</a></p><p><b>description</b>: This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>FEvIR Platform Use (Details: http://hl7.org/fhir/citation-classification-type code fevir-platform-use = 'FEvIR Platform Use', stated as 'FEvIR Platform Use')</td><td>Project Specific <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#project-specific)</span></td></tr></table><p><b>jurisdiction</b>: World <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (m49.htm#001)</span></p><p><b>copyright</b>: https://creativecommons.org/licenses/by-nc-sa/4.0/</p><p><b>approvalDate</b>: 2022-05-10</p><p><b>lastReviewDate</b>: 2023-03-17</p><p><b>author</b>: Brian S. 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--&gt; 2022-02-27</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: PubMed Pubstatus of Revised <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-revised)</span></p><p><b>period</b>: ?? --&gt; 2022-03-12</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: PubMed Pubstatus of Accepted <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-accepted)</span></p><p><b>period</b>: ?? --&gt; 2022-03-14</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: PubMed Pubstatus of Pubmed <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-pubmed)</span></p><p><b>period</b>: ?? --&gt; 2022-04-05 06:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: PubMed Pubstatus of Medline <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-medline)</span></p><p><b>period</b>: ?? --&gt; 2022-05-11 06:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: PubMed Pubstatus of Entrez <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-entrez)</span></p><p><b>period</b>: ?? --&gt; 2022-04-04 20:10:00+0000</p></blockquote><blockquote><p><b>citedArtifact</b></p><p><b>identifier</b>: id: 35378077, id: PMC9077443, id: 10.1016/S0140-6736(22)00538-4, pii: S0140-6736(22)00538-4</p><p><b>relatedIdentifier</b>: id: NCT03164564</p><h3>Titles</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Language</b></td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>Primary title <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-title-type.html">Title Type</a>#primary)</span></td><td>English <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-ietf3066.html">Tags for the Identification of Languages</a>#en)</span></td><td>Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial.</td></tr></table><h3>Abstracts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td><td><b>Copyright</b></td></tr><tr><td style="display: none">*</td><td>**BACKGROUND:** Oral pre-exposure prophylaxis has been introduced in more than 70 countries, including many in sub-Saharan Africa, but women experience considerable barriers to daily pill-taking, such as stigma, judgement, and the fear of violence. Safe and effective long-acting agents for HIV prevention are needed for women. We aimed to evaluate the safety and efficacy of injectable cabotegravir compared with daily oral tenofovir diphosphate plus emtricitabine (TDF-FTC) for HIV prevention in HIV-uninfected women.
**METHODS:** HPTN 084 was a phase 3, randomised, double-blind, double-dummy, active-controlled, superiority trial in 20 clinical research sites in seven countries in sub-Saharan Africa. Participants were eligible for enrolment if they were assigned female sex at birth, were aged 18-45 years, reported at least two episodes of vaginal intercourse in the previous 30 days, were at risk of HIV infection based on an HIV risk score, and agreed to use a long-acting reversible contraceptive method. Participants were randomly assigned (1:1) to either active cabotegravir with TDF-FTC placebo (cabotegravir group) or active TDF-FTC with cabotegravir placebo (TDF-FTC group). Study staff and participants were masked to study group allocation, with the exception of the site pharmacist who was responsible for study product preparation. Participants were prescribed 5 weeks of daily oral product followed by intramuscular injections every 8 weeks after an initial 4-week interval load, alongside daily oral pills. Participants who discontinued injections were offered open-label daily TDF-FTC for 48 weeks. The primary endpoints of the study were incident HIV infection in the intention-to-treat population, and clinical and laboratory events that were grade 2 or higher in all women who had received at least one dose of study product. This study is registered with ClinicalTrials.gov, NCT03164564.
**FINDINGS:** From Nov 27, 2017, to Nov 4, 2020, we enrolled 3224 participants (1614 in the cabotegravir group and 1610 in the TDF-FTC group). Median age was 25 years (IQR 22-30); 1755 (54·7%) of 3209 had two or more partners in the preceding month. 40 incident infections were observed over 3898 person-years (HIV incidence 1·0% [95% CI 0·73-1·40]); four in the cabotegravir group (HIV incidence 0·2 cases per 100 person-years [0·06-0·52]) and 36 in the TDF-FTC group (1·85 cases per 100 person-years [1·3-2·57]; hazard ratio 0·12 [0·05-0·31]; p&amp;lt;0·0001; risk difference -1·6% [-1·0% to -2·3%]. In a random subset of 405 TDF-FTC participants, 812 (42·1%) of 1929 plasma samples had tenofovir concentrations consistent with daily use. Injection coverage was 93% of the total number of person-years. Adverse event rates were similar across both groups, apart from injection site reactions, which were more frequent in the cabotegravir group than in the TDF-FTC group (577 [38·0%] of 1519 vs 162 [10·7%] of 1516]) but did not result in injection discontinuation. Confirmed pregnancy incidence was 1·3 per 100 person-years (0·9-1·7); no congenital birth anomalies were reported.
**INTERPRETATION:** Although both products for HIV prevention were generally safe, well tolerated, and effective, cabotegravir was superior to TDF-FTC in preventing HIV infection in women.
**FUNDING:** National Institute of Allergy and Infectious Diseases, ViiV Healthcare, and the Bill &amp;amp; Melinda Gates Foundation. Additional support was provided through the National Institute of Mental Health, the National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. ViiV Healthcare and Gilead Sciences provided pharmaceutical support.</td><td>Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.</td></tr></table><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>citation</b>: UNAIDS  Confronting inequalities: lessons for pandemic responses from 40 years of AIDS. July 14, 2021. https://www.unaids.org/en/resources/documents/2021/2021-global-aids-update-slideset</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>citation</b>: WHO . World Health Organization; Geneva: 2015. Policy brief: pre-exposure prophylaxis (PrEP): WHO expands recommendation on oral pre-exposure prophylaxis of HIV infection (PrEP)</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: Journal Article <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#D016428)</span></p><p><b>citation</b>: Celum CL, Delany-Moretlwe S, Baeten JM, et al. HIV pre-exposure prophylaxis for adolescent girls and young women in Africa: from efficacy trials to delivery. 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#D000068679)</span>, cabotegravir <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (chemical-substances#HMH0132Z1Q; #C584914)</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: MeSH Heading <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading)</span></p><p><b>artifactAssessment</b>: <a name="meshHeading0"> </a></p><blockquote><p/><p><a name="meshHeading0"> </a></p><p><b>artifact</b>: <a href="#">#</a></p><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Adult <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D000328)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Anti-HIV Agents <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D019380)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is Major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Child <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D002648)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Diketopiperazines <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D054659)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Emtricitabine <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D000068679)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: therapeutic use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000627)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Female <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D005260)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: HIV Infections <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D015658)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: is Major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: chemically induced <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000139)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: epidemiology <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000453)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: prevention &amp; control <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000517)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: HIV Seropositivity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D006679)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: is Major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: drug therapy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000188)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: HIV-1 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D015497)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is Major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Humans <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D006801)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Infant, Newborn <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D007231)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Pregnancy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D011247)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Pyridones <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D011728)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: therapeutic use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000627)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote></blockquote></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Publication Type <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#publication-type)</span></p><p><b>classifier</b>: Clinical Trial, Phase III <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D017428)</span>, Journal Article <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D016428)</span>, Randomized Controlled Trial <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D016449)</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Knowledge Artifact Type <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#knowledge-artifact-type)</span></p><p><b>classifier</b>: Journal Article <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#D016428)</span></p><p><b>artifactAssessment</b>: <span>: Classifier added by Computable Publishing LLC</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Citation Subset <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#citation-subset)</span></p><p><b>classifier</b>: IM <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (elements_descriptions.html#citationsubset#IM)</span></p></blockquote><blockquote><p><b>contributorship</b></p><p><b>complete</b>: true</p><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author0"> </a></p><blockquote><p/><p><a name="author0"> </a></p><p><b>name</b>: Sinead Delany-Moretlwe </p></blockquote><p><b>forenameInitials</b>: S</p><p><b>affiliation</b>: <span>: Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: sdelany@wrhi.ac.za.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author1"> </a></p><blockquote><p/><p><a name="author1"> </a></p><p><b>name</b>: James P Hughes </p></blockquote><p><b>forenameInitials</b>: JP</p><p><b>affiliation</b>: <span>: Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author2"> </a></p><blockquote><p/><p><a name="author2"> </a></p><p><b>name</b>: Peter Bock </p></blockquote><p><b>forenameInitials</b>: P</p><p><b>affiliation</b>: <span>: Desmond Tutu TB Centre, University of Stellenbosch, Stellenbosch, South Africa.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author3"> </a></p><blockquote><p/><p><a name="author3"> </a></p><p><b>name</b>: Samuel Gurrion Ouma </p></blockquote><p><b>forenameInitials</b>: SG</p><p><b>affiliation</b>: <span>: Kisumu Clinical Research Site, Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author4"> </a></p><blockquote><p/><p><a name="author4"> </a></p><p><b>name</b>: Portia Hunidzarira </p></blockquote><p><b>forenameInitials</b>: P</p><p><b>affiliation</b>: <span>: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author5"> </a></p><blockquote><p/><p><a name="author5"> </a></p><p><b>name</b>: Dishiki Kalonji </p></blockquote><p><b>forenameInitials</b>: D</p><p><b>affiliation</b>: <span>: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author6"> </a></p><blockquote><p/><p><a name="author6"> </a></p><p><b>name</b>: Noel Kayange </p></blockquote><p><b>forenameInitials</b>: N</p><p><b>affiliation</b>: <span>: Blantyre Clinical Research Site, College of Medicine, University of Malawi, Blantyre, Malawi.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author7"> </a></p><blockquote><p/><p><a name="author7"> </a></p><p><b>name</b>: Joseph Makhema </p></blockquote><p><b>forenameInitials</b>: J</p><p><b>affiliation</b>: <span>: Botswana Harvard AIDS Institute Partnership (BHP), Gaborone, Botswana.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author8"> </a></p><blockquote><p/><p><a name="author8"> </a></p><p><b>name</b>: Patricia Mandima </p></blockquote><p><b>forenameInitials</b>: P</p><p><b>affiliation</b>: <span>: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author9"> </a></p><blockquote><p/><p><a name="author9"> </a></p><p><b>name</b>: Carrie Mathew </p></blockquote><p><b>forenameInitials</b>: C</p><p><b>affiliation</b>: <span>: Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author10"> </a></p><blockquote><p/><p><a name="author10"> </a></p><p><b>name</b>: Elizabeth Spooner </p></blockquote><p><b>forenameInitials</b>: E</p><p><b>affiliation</b>: <span>: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author11"> </a></p><blockquote><p/><p><a name="author11"> </a></p><p><b>name</b>: Juliet Mpendo </p></blockquote><p><b>forenameInitials</b>: J</p><p><b>affiliation</b>: <span>: International AIDS Vaccine Initiative, Uganda Virus Research Institute, Entebbe, Uganda.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author12"> </a></p><blockquote><p/><p><a name="author12"> </a></p><p><b>name</b>: Pamela Mukwekwerere </p></blockquote><p><b>forenameInitials</b>: P</p><p><b>affiliation</b>: <span>: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author13"> </a></p><blockquote><p/><p><a name="author13"> </a></p><p><b>name</b>: Nyaradzo Mgodi </p></blockquote><p><b>forenameInitials</b>: N</p><p><b>affiliation</b>: <span>: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author14"> </a></p><blockquote><p/><p><a name="author14"> </a></p><p><b>name</b>: Patricia Nahirya Ntege </p></blockquote><p><b>forenameInitials</b>: PN</p><p><b>affiliation</b>: <span>: Baylor College of Medicine Children's Foundation Uganda, Kampala, Uganda.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author15"> </a></p><blockquote><p/><p><a name="author15"> </a></p><p><b>name</b>: Gonasagrie Nair </p></blockquote><p><b>forenameInitials</b>: G</p><p><b>affiliation</b>: <span>: Desmond Tutu Health Foundation, University of Cape Town, Cape Town, South Africa.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author16"> </a></p><blockquote><p/><p><a name="author16"> </a></p><p><b>name</b>: Clemensia Nakabiito </p></blockquote><p><b>forenameInitials</b>: C</p><p><b>affiliation</b>: <span>: Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author17"> </a></p><blockquote><p/><p><a name="author17"> </a></p><p><b>name</b>: Harriet Nuwagaba-Biribonwoha </p></blockquote><p><b>forenameInitials</b>: H</p><p><b>affiliation</b>: <span>: Eswatini Prevention Center, International Center for AIDS Care and Treatment Program at Columbia University Mailman School of Public Health, New York, NY, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author18"> </a></p><blockquote><p/><p><a name="author18"> </a></p><p><b>name</b>: Ravindre Panchia </p></blockquote><p><b>forenameInitials</b>: R</p><p><b>affiliation</b>: <span>: Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author19"> </a></p><blockquote><p/><p><a name="author19"> </a></p><p><b>name</b>: Nishanta Singh </p></blockquote><p><b>forenameInitials</b>: N</p><p><b>affiliation</b>: <span>: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author20"> </a></p><blockquote><p/><p><a name="author20"> </a></p><p><b>name</b>: Bekezela Siziba </p></blockquote><p><b>forenameInitials</b>: B</p><p><b>affiliation</b>: <span>: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author21"> </a></p><blockquote><p/><p><a name="author21"> </a></p><p><b>name</b>: Jennifer Farrior </p></blockquote><p><b>forenameInitials</b>: J</p><p><b>affiliation</b>: <span>: FHI 360, Durham, NC, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author22"> </a></p><blockquote><p/><p><a name="author22"> </a></p><p><b>name</b>: Scott Rose </p></blockquote><p><b>forenameInitials</b>: S</p><p><b>affiliation</b>: <span>: FHI 360, Durham, NC, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author23"> </a></p><blockquote><p/><p><a name="author23"> </a></p><p><b>name</b>: Peter L Anderson </p></blockquote><p><b>forenameInitials</b>: PL</p><p><b>affiliation</b>: <span>: Anschutz Medical Campus, University of Colorado, Aurora, CO, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author24"> </a></p><blockquote><p/><p><a name="author24"> </a></p><p><b>name</b>: Susan H Eshleman </p></blockquote><p><b>forenameInitials</b>: SH</p><p><b>affiliation</b>: <span>: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author25"> </a></p><blockquote><p/><p><a name="author25"> </a></p><p><b>name</b>: Mark A Marzinke </p></blockquote><p><b>forenameInitials</b>: MA</p><p><b>affiliation</b>: <span>: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author26"> </a></p><blockquote><p/><p><a name="author26"> </a></p><p><b>name</b>: Craig W Hendrix </p></blockquote><p><b>forenameInitials</b>: CW</p><p><b>affiliation</b>: <span>: Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author27"> </a></p><blockquote><p/><p><a name="author27"> </a></p><p><b>name</b>: Stephanie Beigel-Orme </p></blockquote><p><b>forenameInitials</b>: S</p><p><b>affiliation</b>: <span>: Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author28"> </a></p><blockquote><p/><p><a name="author28"> </a></p><p><b>name</b>: Sybil Hosek </p></blockquote><p><b>forenameInitials</b>: S</p><p><b>affiliation</b>: <span>: Department of Psychiatry, Stroger Hospital of Cook County, Chicago, IL, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author29"> </a></p><blockquote><p/><p><a name="author29"> </a></p><p><b>name</b>: Elizabeth Tolley </p></blockquote><p><b>forenameInitials</b>: E</p><p><b>affiliation</b>: <span>: FHI 360, Durham, NC, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author30"> </a></p><blockquote><p/><p><a name="author30"> </a></p><p><b>name</b>: Nirupama Sista </p></blockquote><p><b>forenameInitials</b>: N</p><p><b>affiliation</b>: <span>: FHI 360, Durham, NC, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author31"> </a></p><blockquote><p/><p><a name="author31"> </a></p><p><b>name</b>: Adeola Adeyeye </p></blockquote><p><b>forenameInitials</b>: A</p><p><b>affiliation</b>: <span>: Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author32"> </a></p><blockquote><p/><p><a name="author32"> </a></p><p><b>name</b>: James F Rooney </p></blockquote><p><b>forenameInitials</b>: JF</p><p><b>affiliation</b>: <span>: Gilead Sciences, Foster City, CA, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author33"> </a></p><blockquote><p/><p><a name="author33"> </a></p><p><b>name</b>: Alex Rinehart </p></blockquote><p><b>forenameInitials</b>: A</p><p><b>affiliation</b>: <span>: ViiV Healthcare, Durham, NC, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author34"> </a></p><blockquote><p/><p><a name="author34"> </a></p><p><b>name</b>: William R Spreen </p></blockquote><p><b>forenameInitials</b>: WR</p><p><b>affiliation</b>: <span>: ViiV Healthcare, Durham, NC, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author35"> </a></p><blockquote><p/><p><a name="author35"> </a></p><p><b>name</b>: Kimberly Smith </p></blockquote><p><b>forenameInitials</b>: K</p><p><b>affiliation</b>: <span>: ViiV Healthcare, Durham, NC, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author36"> </a></p><blockquote><p/><p><a name="author36"> </a></p><p><b>name</b>: Brett Hanscom </p></blockquote><p><b>forenameInitials</b>: B</p><p><b>affiliation</b>: <span>: Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author37"> </a></p><blockquote><p/><p><a name="author37"> </a></p><p><b>name</b>: Myron S Cohen </p></blockquote><p><b>forenameInitials</b>: MS</p><p><b>affiliation</b>: <span>: University of North Carolina (UNC) at Chapel Hill, Chapel Hill, NC, USA.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author38"> </a></p><blockquote><p/><p><a name="author38"> </a></p><p><b>name</b>: Mina C Hosseinipour </p></blockquote><p><b>forenameInitials</b>: MC</p><p><b>affiliation</b>: <span>: University of North Carolina (UNC) at Chapel Hill, Chapel Hill, NC, USA; UNC Project-Malawi, Lilongwe, Malawi.</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="author39"> </a></p><blockquote><p/><p><a name="author39"> </a></p><p><b>name</b>: HPTN 084 study group</p></blockquote></blockquote></blockquote></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author0</b><a name="author0"> </a></p><p><b>name</b>: Sinead Delany-Moretlwe </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author1</b><a name="author1"> </a></p><p><b>name</b>: James P Hughes </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author2</b><a name="author2"> </a></p><p><b>name</b>: Peter Bock </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author3</b><a name="author3"> </a></p><p><b>name</b>: Samuel Gurrion Ouma </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author4</b><a name="author4"> </a></p><p><b>name</b>: Portia Hunidzarira </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author5</b><a name="author5"> </a></p><p><b>name</b>: Dishiki Kalonji </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author6</b><a name="author6"> </a></p><p><b>name</b>: Noel Kayange </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author7</b><a name="author7"> </a></p><p><b>name</b>: Joseph Makhema </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author8</b><a name="author8"> </a></p><p><b>name</b>: Patricia Mandima </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author9</b><a name="author9"> </a></p><p><b>name</b>: Carrie Mathew </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author10</b><a name="author10"> </a></p><p><b>name</b>: Elizabeth Spooner </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author11</b><a name="author11"> </a></p><p><b>name</b>: Juliet Mpendo </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author12</b><a name="author12"> </a></p><p><b>name</b>: Pamela Mukwekwerere </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author13</b><a name="author13"> </a></p><p><b>name</b>: Nyaradzo Mgodi </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author14</b><a name="author14"> </a></p><p><b>name</b>: Patricia Nahirya Ntege </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author15</b><a name="author15"> </a></p><p><b>name</b>: Gonasagrie Nair </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author16</b><a name="author16"> </a></p><p><b>name</b>: Clemensia Nakabiito </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author17</b><a name="author17"> </a></p><p><b>name</b>: Harriet Nuwagaba-Biribonwoha </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author18</b><a name="author18"> </a></p><p><b>name</b>: Ravindre Panchia </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author19</b><a name="author19"> </a></p><p><b>name</b>: Nishanta Singh </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author20</b><a name="author20"> </a></p><p><b>name</b>: Bekezela Siziba </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author21</b><a name="author21"> </a></p><p><b>name</b>: Jennifer Farrior </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author22</b><a name="author22"> </a></p><p><b>name</b>: Scott Rose </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author23</b><a name="author23"> </a></p><p><b>name</b>: Peter L Anderson </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author24</b><a name="author24"> </a></p><p><b>name</b>: Susan H Eshleman </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author25</b><a name="author25"> </a></p><p><b>name</b>: Mark A Marzinke </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author26</b><a name="author26"> </a></p><p><b>name</b>: Craig W Hendrix </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author27</b><a name="author27"> </a></p><p><b>name</b>: Stephanie Beigel-Orme </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author28</b><a name="author28"> </a></p><p><b>name</b>: Sybil Hosek </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author29</b><a name="author29"> </a></p><p><b>name</b>: Elizabeth Tolley </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author30</b><a name="author30"> </a></p><p><b>name</b>: Nirupama Sista </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author31</b><a name="author31"> </a></p><p><b>name</b>: Adeola Adeyeye </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author32</b><a name="author32"> </a></p><p><b>name</b>: James F Rooney </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author33</b><a name="author33"> </a></p><p><b>name</b>: Alex Rinehart </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author34</b><a name="author34"> </a></p><p><b>name</b>: William R Spreen </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author35</b><a name="author35"> </a></p><p><b>name</b>: Kimberly Smith </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author36</b><a name="author36"> </a></p><p><b>name</b>: Brett Hanscom </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author37</b><a name="author37"> </a></p><p><b>name</b>: Myron S Cohen </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author38</b><a name="author38"> </a></p><p><b>name</b>: Mina C Hosseinipour </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Organization #author39</b><a name="author39"> </a></p><p><b>name</b>: HPTN 084 study group</p></blockquote><hr/><blockquote><p><b>Generated Narrative: ArtifactAssessment #meshHeading0</b><a name="meshHeading0"> </a></p><p><b>artifact</b>: <a href="#">#</a></p><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Adult <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D000328)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Anti-HIV Agents <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D019380)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is Major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Child <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D002648)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Diketopiperazines <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D054659)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Emtricitabine <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D000068679)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> 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            value="**BACKGROUND:** Oral pre-exposure prophylaxis has been introduced in more than 70 countries, including many in sub-Saharan Africa, but women experience considerable barriers to daily pill-taking, such as stigma, judgement, and the fear of violence. Safe and effective long-acting agents for HIV prevention are needed for women. We aimed to evaluate the safety and efficacy of injectable cabotegravir compared with daily oral tenofovir diphosphate plus emtricitabine (TDF-FTC) for HIV prevention in HIV-uninfected women.
**METHODS:** HPTN 084 was a phase 3, randomised, double-blind, double-dummy, active-controlled, superiority trial in 20 clinical research sites in seven countries in sub-Saharan Africa. Participants were eligible for enrolment if they were assigned female sex at birth, were aged 18-45 years, reported at least two episodes of vaginal intercourse in the previous 30 days, were at risk of HIV infection based on an HIV risk score, and agreed to use a long-acting reversible contraceptive method. Participants were randomly assigned (1:1) to either active cabotegravir with TDF-FTC placebo (cabotegravir group) or active TDF-FTC with cabotegravir placebo (TDF-FTC group). Study staff and participants were masked to study group allocation, with the exception of the site pharmacist who was responsible for study product preparation. Participants were prescribed 5 weeks of daily oral product followed by intramuscular injections every 8 weeks after an initial 4-week interval load, alongside daily oral pills. Participants who discontinued injections were offered open-label daily TDF-FTC for 48 weeks. The primary endpoints of the study were incident HIV infection in the intention-to-treat population, and clinical and laboratory events that were grade 2 or higher in all women who had received at least one dose of study product. This study is registered with ClinicalTrials.gov, NCT03164564.
**FINDINGS:** From Nov 27, 2017, to Nov 4, 2020, we enrolled 3224 participants (1614 in the cabotegravir group and 1610 in the TDF-FTC group). Median age was 25 years (IQR 22-30); 1755 (54·7%) of 3209 had two or more partners in the preceding month. 40 incident infections were observed over 3898 person-years (HIV incidence 1·0% [95% CI 0·73-1·40]); four in the cabotegravir group (HIV incidence 0·2 cases per 100 person-years [0·06-0·52]) and 36 in the TDF-FTC group (1·85 cases per 100 person-years [1·3-2·57]; hazard ratio 0·12 [0·05-0·31]; p&amp;lt;0·0001; risk difference -1·6% [-1·0% to -2·3%]. In a random subset of 405 TDF-FTC participants, 812 (42·1%) of 1929 plasma samples had tenofovir concentrations consistent with daily use. Injection coverage was 93% of the total number of person-years. Adverse event rates were similar across both groups, apart from injection site reactions, which were more frequent in the cabotegravir group than in the TDF-FTC group (577 [38·0%] of 1519 vs 162 [10·7%] of 1516]) but did not result in injection discontinuation. Confirmed pregnancy incidence was 1·3 per 100 person-years (0·9-1·7); no congenital birth anomalies were reported.
**INTERPRETATION:** Although both products for HIV prevention were generally safe, well tolerated, and effective, cabotegravir was superior to TDF-FTC in preventing HIV infection in women.
**FUNDING:** National Institute of Allergy and Infectious Diseases, ViiV Healthcare, and the Bill &amp;amp; Melinda Gates Foundation. Additional support was provided through the National Institute of Mental Health, the National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. ViiV Healthcare and Gilead Sciences provided pharmaceutical support."/>
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