Generated Narrative: PublicationRecord 153881 version: 11; Last updated: 2025-10-12 18:47:15+0000 ArtifactPublicationStatus: Active url: https://fevir.net/resources/PublicationRecord/153881 identifier: FEvIR Object Identifier/153881, https://pubmed.ncbi.nlm.nih.gov/35378077 title: Delany-Moretlwe 2022 clinical trial status: Active author: Brian S. Alper: , Computable Publishing®: MEDLINE-to-FEvIR Converter: publisher: Computable Publishing LLC contact: support@computablepublishing.com description: This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide. UseContexts - Code Value[x] * Citation Classification Type: fevir-platform-use (FEvIR Platform Use) Project Specific copyright: https://creativecommons.org/licenses/by-nc-sa/4.0/ approvalDate: 2022-05-10 lastReviewDate: 2023-03-17 Summaries - Style Text * Computable Publishing Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial [Journal Article]. Contributors: Delany-Moretlwe S, Hughes JP, Bock P, Ouma SG, Hunidzarira P, Kalonji D, Kayange N, Makhema J, Mandima P, Mathew C, Spooner E, Mpendo J, Mukwekwerere P, Mgodi N, Ntege PN, Nair G, Nakabiito C, Nuwagaba-Biribonwoha H, Panchia R, Singh N, Siziba B, Farrior J, Rose S, Anderson PL, Eshleman SH, Marzinke MA, Hendrix CW, Beigel-Orme S, Hosek S, Tolley E, Sista N, Adeyeye A, Rooney JF, Rinehart A, Spreen WR, Smith K, Hanscom B, Cohen MS, Hosseinipour MC, HPTN 084 study group. In: Lancet (London, England), PMID 35378077. Published May 07, 2022. Available at: https://pubmed.ncbi.nlm.nih.gov/35378077/. classification type: Citation Source classifier: MEDLINE classification type: MEDLINE Citation Owner classifier: National Library of Medicine, Index Section currentState: Medline Citation Status of MEDLINE, PubMed PublicationStatus of ppublish statusDate activity: PubMed Pubstatus of Received period: ?? --> 2022-02-27 statusDate activity: PubMed Pubstatus of Revised period: ?? --> 2022-03-12 statusDate activity: PubMed Pubstatus of Accepted period: ?? --> 2022-03-14 statusDate activity: PubMed Pubstatus of PubMed period: ?? --> 2022-04-05 06:00:00+0000 statusDate activity: PubMed Pubstatus of Medline period: ?? --> 2022-05-11 06:00:00+0000 statusDate activity: PubMed Pubstatus of Entrez period: ?? --> 2022-04-04 20:10:00+0000 citedArtifact identifier: https://pubmed.ncbi.nlm.nih.gov/35378077, https://www.ncbi.nlm.nih.gov/pmc//PMC9077443, https://doi.org/10.1016/S0140-6736(22)00538-4, pii/S0140-6736(22)00538-4 relatedIdentifier: <a href="http://terminology.hl7.org/7.3.0/NamingSystem-ClinicalTrialsGov.html" title="RETIREMENT INFO: This entry was incorrectly added as a code system record, however, ClinicalTrials.gov is an identifier system. That entry should be referenced instead at [https://terminology.hl7.org/NamingSystem-ClinicalTrials-Gov.html](https://terminology.hl7.org/NamingSystem-ClinicalTrials-Gov.html).#xD;#xA;#xD;#xA;The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed [ClinicalTrials.gov](http://clinicaltrials.gov) to provide patients, family members, and members of the public current information about clinical research studies. [ClinicalTrials.gov](http://clinicaltrials.gov) contains summary information about clinical studies being conducted throughout the United States and in many countries throughout the world. These data are provided to the National Library of Medicine by organizations and institutions that sponsor and implement the studies.#xD;#xA;#xD;#xA;[ClinicalTrials.gov](http://clinicaltrials.gov) is updated daily. You should check [ClinicalTrials.gov](http://clinicaltrials.gov) frequently for updated information.#xD;#xA;#xD;#xA;More information about ClinicalTrials.gov can be found [here](https://clinicaltrials.gov/about-site/about-ctg).">ClinicalTrials.gov/NCT03164564 Titles - Type Language Text * Primary title English Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. Abstracts - Text Copyright * 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<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 & 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. 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. relatesTo type: Cites citation: UNAIDS Confronting inequalities: lessons for pandemic responses from 40 years of AIDS. 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CAB-LA PrEP: early detection of HIV infection may reduce InSTI resistance risk. 29th Conference on Retroviruses and Opportunistic Infections; Feb 12–16, 2022 (abstr Oral-08). relatesTo type: Has Comment In classifier: Comment citation: Lancet. 2022 May 7;399(10337):1754-1755 target: https://pubmed.ncbi.nlm.nih.gov/35378079/ relatesTo type: Correction In classifier: Published Erratum citation: Lancet. 2022 May 7;399(10337):1778 target: https://pubmed.ncbi.nlm.nih.gov/35526551/ relatesTo type: Has Comment In classifier: Comment citation: Nat Med. 2022 Aug;28(8):1542-1543 target: https://pubmed.ncbi.nlm.nih.gov/35869309/ relatesTo type: Has Comment In classifier: Comment citation: Nature. 2022 Aug;608(7923):460-461 target: https://pubmed.ncbi.nlm.nih.gov/35931763/ relatesTo type: Has Comment In classifier: Comment citation: Nature. 2022 Aug;608(7922):239 target: https://pubmed.ncbi.nlm.nih.gov/35945377/ publicationForm publishedIn type: Periodical identifier: Electronic ISSN Type/1474-547X, ISOAbbreviation/Lancet, ISSN Linking/0140-6736, Medline Title Abbreviation/Lancet, NLM Unique ID/2985213R title: Lancet (London, England) publisherLocation: England citedMedium: Internet volume: 399 issue: 10337 articleDate: 2022-05-07 language: English pageString: 1779-1789 publicationForm citedMedium: Internet without issue articleDate: 2022-04-01 webLocation classifier: Abstract url: https://pubmed.ncbi.nlm.nih.gov/35378077/ webLocation classifier: DOI Based url: https://doi.org/10.1016/S0140-6736(22)00538-4 classification type: Publishing Model classifier: Print Electronic classification type: Chemical classifier: Anti-HIV Agents, Diketopiperazines, Pyridones, Emtricitabine, cabotegravir classification type: Publication type classifier: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial classification type: Citation subset classifier: IM classification type: MeSH Heading artifactAssessment: ArtifactAssessment: artifact[x] = this resource classification type: Knowledge Artifact Type classifier: Journal Article artifactAssessment: Classifier added by Computable Publishing LLC contributorship complete: true entry contributor: Delany-Moretlwe S forenameInitials: S affiliation: Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: sdelany@wrhi.ac.za. entry contributor: Hughes JP forenameInitials: JP affiliation: Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. entry contributor: Bock P forenameInitials: P affiliation: Desmond Tutu TB Centre, University of Stellenbosch, Stellenbosch, South Africa. entry contributor: Ouma SG forenameInitials: SG affiliation: Kisumu Clinical Research Site, Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya. entry contributor: Hunidzarira P forenameInitials: P affiliation: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe. entry contributor: Kalonji D forenameInitials: D affiliation: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa. entry contributor: Kayange N forenameInitials: N affiliation: Blantyre Clinical Research Site, College of Medicine, University of Malawi, Blantyre, Malawi. entry contributor: Makhema J forenameInitials: J affiliation: Botswana Harvard AIDS Institute Partnership (BHP), Gaborone, Botswana. entry contributor: Mandima P forenameInitials: P affiliation: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe. entry contributor: Mathew C forenameInitials: C affiliation: Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa. entry contributor: Spooner E forenameInitials: E affiliation: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa. entry contributor: Mpendo J forenameInitials: J affiliation: International AIDS Vaccine Initiative, Uganda Virus Research Institute, Entebbe, Uganda. entry contributor: Mukwekwerere P forenameInitials: P affiliation: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe. entry contributor: Mgodi N forenameInitials: N affiliation: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe. entry contributor: Ntege PN forenameInitials: PN affiliation: Baylor College of Medicine Children's Foundation Uganda, Kampala, Uganda. entry contributor: Nair G forenameInitials: G affiliation: Desmond Tutu Health Foundation, University of Cape Town, Cape Town, South Africa. entry contributor: Nakabiito C forenameInitials: C affiliation: Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda. entry contributor: Nuwagaba-Biribonwoha H forenameInitials: H affiliation: Eswatini Prevention Center, International Center for AIDS Care and Treatment Program at Columbia University Mailman School of Public Health, New York, NY, USA. entry contributor: Panchia R forenameInitials: R affiliation: Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa. entry contributor: Singh N forenameInitials: N affiliation: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa. entry contributor: Siziba B forenameInitials: B affiliation: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe. entry contributor: Farrior J forenameInitials: J affiliation: FHI 360, Durham, NC, USA. entry contributor: Rose S forenameInitials: S affiliation: FHI 360, Durham, NC, USA. entry contributor: Anderson PL forenameInitials: PL affiliation: Anschutz Medical Campus, University of Colorado, Aurora, CO, USA. entry contributor: Eshleman SH forenameInitials: SH affiliation: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. entry contributor: Marzinke MA forenameInitials: MA affiliation: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. entry contributor: Hendrix CW forenameInitials: CW affiliation: Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. entry contributor: Beigel-Orme S forenameInitials: S affiliation: Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. entry contributor: Hosek S forenameInitials: S affiliation: Department of Psychiatry, Stroger Hospital of Cook County, Chicago, IL, USA. entry contributor: Tolley E forenameInitials: E affiliation: FHI 360, Durham, NC, USA. entry contributor: Sista N forenameInitials: N affiliation: FHI 360, Durham, NC, USA. entry contributor: Adeyeye A forenameInitials: A affiliation: Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA. entry contributor: Rooney JF forenameInitials: JF affiliation: Gilead Sciences, Foster City, CA, USA. entry contributor: Rinehart A forenameInitials: A affiliation: ViiV Healthcare, Durham, NC, USA. entry contributor: Spreen WR forenameInitials: WR affiliation: ViiV Healthcare, Durham, NC, USA. entry contributor: Smith K forenameInitials: K affiliation: ViiV Healthcare, Durham, NC, USA. entry contributor: Hanscom B forenameInitials: B affiliation: Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. entry contributor: Cohen MS forenameInitials: MS affiliation: University of North Carolina (UNC) at Chapel Hill, Chapel Hill, NC, USA. entry contributor: Hosseinipour MC forenameInitials: MC affiliation: University of North Carolina (UNC) at Chapel Hill, Chapel Hill, NC, USA; UNC Project-Malawi, Lilongwe, Malawi. entry contributor: HPTN 084 study group Generated Narrative: ArtifactAssessment #meshHeading0 artifact: PublicationRecord Delany-Moretlwe 2022 clinical trial content type: components (if present) include qualifier codings classifier: Adult freeToShare: true Components - Type Classifier * qualifier is not 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major topic component type: qualifier classifier: therapeutic use Components - Type Classifier * is Major topic No content type: components (if present) include qualifier codings classifier: HIV Infections freeToShare: true component type: qualifier classifier: is Major topic component type: qualifier classifier: chemically induced Components - Type Classifier * is Major topic No component type: qualifier classifier: epidemiology Components - Type Classifier * is Major topic No component type: qualifier classifier: prevention & control Components - Type Classifier * is Major topic No content type: components (if present) include qualifier codings classifier: HIV Seropositivity freeToShare: true component type: qualifier classifier: is Major topic component type: qualifier classifier: drug therapy Components - Type Classifier * is Major topic No content type: components (if present) include qualifier codings classifier: HIV-1 freeToShare: true Components - Type Classifier * qualifier is 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Sinead Delany-Moretlwe Generated Narrative: Practitioner #contributor1 name: James P Hughes Generated Narrative: Practitioner #contributor2 name: Peter Bock Generated Narrative: Practitioner #contributor3 name: Samuel Gurrion Ouma Generated Narrative: Practitioner #contributor4 name: Portia Hunidzarira Generated Narrative: Practitioner #contributor5 name: Dishiki Kalonji Generated Narrative: Practitioner #contributor6 name: Noel Kayange Generated Narrative: Practitioner #contributor7 name: Joseph Makhema Generated Narrative: Practitioner #contributor8 name: Patricia Mandima Generated Narrative: Practitioner #contributor9 name: Carrie Mathew Generated Narrative: Practitioner #contributor10 name: Elizabeth Spooner Generated Narrative: Practitioner #contributor11 name: Juliet Mpendo Generated Narrative: Practitioner #contributor12 name: Pamela Mukwekwerere Generated Narrative: Practitioner #contributor13 name: Nyaradzo Mgodi Generated Narrative: Practitioner #contributor14 name: Patricia Nahirya Ntege Generated Narrative: Practitioner #contributor15 name: Gonasagrie Nair Generated Narrative: Practitioner #contributor16 name: Clemensia Nakabiito Generated Narrative: Practitioner #contributor17 name: Harriet Nuwagaba-Biribonwoha Generated Narrative: Practitioner #contributor18 name: Ravindre Panchia Generated Narrative: Practitioner #contributor19 name: Nishanta Singh Generated Narrative: Practitioner #contributor20 name: Bekezela Siziba Generated Narrative: Practitioner #contributor21 name: Jennifer Farrior Generated Narrative: Practitioner #contributor22 name: Scott Rose Generated Narrative: Practitioner #contributor23 name: Peter L Anderson Generated Narrative: Practitioner #contributor24 name: Susan H Eshleman Generated Narrative: Practitioner #contributor25 name: Mark A Marzinke Generated Narrative: Practitioner #contributor26 name: Craig W Hendrix Generated Narrative: Practitioner #contributor27 name: Stephanie Beigel-Orme Generated Narrative: Practitioner #contributor28 name: Sybil Hosek Generated Narrative: Practitioner #contributor29 name: Elizabeth Tolley Generated Narrative: Practitioner #contributor30 name: Nirupama Sista Generated Narrative: Practitioner #contributor31 name: Adeola Adeyeye Generated Narrative: Practitioner #contributor32 name: James F Rooney Generated Narrative: Practitioner #contributor33 name: Alex Rinehart Generated Narrative: Practitioner #contributor34 name: William R Spreen Generated Narrative: Practitioner #contributor35 name: Kimberly Smith Generated Narrative: Practitioner #contributor36 name: Brett Hanscom Generated Narrative: Practitioner #contributor37 name: Myron S Cohen Generated Narrative: Practitioner #contributor38 name: Mina C Hosseinipour Generated Narrative: Organization #contributor39 name: HPTN 084 study group
components (if present) include qualifier codings
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Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial [Journal Article]. Contributors: Delany-Moretlwe S, Hughes JP, Bock P, Ouma SG, Hunidzarira P, Kalonji D, Kayange N, Makhema J, Mandima P, Mathew C, Spooner E, Mpendo J, Mukwekwerere P, Mgodi N, Ntege PN, Nair G, Nakabiito C, Nuwagaba-Biribonwoha H, Panchia R, Singh N, Siziba B, Farrior J, Rose S, Anderson PL, Eshleman SH, Marzinke MA, Hendrix CW, Beigel-Orme S, Hosek S, Tolley E, Sista N, Adeyeye A, Rooney JF, Rinehart A, Spreen WR, Smith K, Hanscom B, Cohen MS, Hosseinipour MC, HPTN 084 study group. In: Lancet (London, England), PMID 35378077. Published May 07, 2022. Available at: https://pubmed.ncbi.nlm.nih.gov/35378077/.
National Library of Medicine, Index Section
Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial.
**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<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 & 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.
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.
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Classifier added by Computable Publishing LLC
Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: sdelany@wrhi.ac.za.
Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Desmond Tutu TB Centre, University of Stellenbosch, Stellenbosch, South Africa.
Kisumu Clinical Research Site, Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.
Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.
HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.
Blantyre Clinical Research Site, College of Medicine, University of Malawi, Blantyre, Malawi.
Botswana Harvard AIDS Institute Partnership (BHP), Gaborone, Botswana.
Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.
International AIDS Vaccine Initiative, Uganda Virus Research Institute, Entebbe, Uganda.
Baylor College of Medicine Children's Foundation Uganda, Kampala, Uganda.
Desmond Tutu Health Foundation, University of Cape Town, Cape Town, South Africa.
Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.
Eswatini Prevention Center, International Center for AIDS Care and Treatment Program at Columbia University Mailman School of Public Health, New York, NY, USA.
Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
Anschutz Medical Campus, University of Colorado, Aurora, CO, USA.
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Department of Psychiatry, Stroger Hospital of Cook County, Chicago, IL, USA.
Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
University of North Carolina (UNC) at Chapel Hill, Chapel Hill, NC, USA.
University of North Carolina (UNC) at Chapel Hill, Chapel Hill, NC, USA; UNC Project-Malawi, Lilongwe, Malawi.