Safety, acceptability and adherence of dapivirine vaginal ring in a microbicide clinical trial conducted in multiple countries in sub-Saharan Africa

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dc.contributor.authorNel, Annaleneen_ZA
dc.contributor.authorBekker, Linda-Gailen_ZA
dc.contributor.authorBukusi, Elizabethen_ZA
dc.contributor.authorHellstrӧm, Elizabethen_ZA
dc.contributor.authorKotze, Philipen_ZA
dc.contributor.authorLouw, Cherylen_ZA
dc.contributor.authorMartinson, Francisen_ZA
dc.contributor.authorMasenga, Gilearden_ZA
dc.contributor.authorMontgomery, Elizabethen_ZA
dc.contributor.authorNdaba, Nelisiween_ZA
dc.contributor.authorVan der Straten, Arianeen_ZA
dc.contributor.authorVan Niekerk, Neliëtteen_ZA
dc.contributor.authorWoodsong, Cynthiaen_ZA
dc.date.accessioned2016-04-13T12:34:34Z
dc.date.available2016-04-13T12:34:34Z
dc.date.issued2016en_ZA
dc.description.abstractBACKGROUND: This was the first microbicide trial conducted in Africa to evaluate an antiretroviral-containing vaginal ring as an HIV prevention technology for women. Objectives The trial assessed and compared the safety, acceptability and adherence to product use of a 4-weekly administered vaginal ring containing the antiretroviral microbicide, dapivirine, with a matching placebo ring among women from four countries in sub-Saharan Africa. METHODS: 280 Healthy, sexually active, HIV-negative women, aged 18 to 40 years were enrolled with 140 women randomised to a dapivirine vaginal ring (25 mg) and 140 women to a matching placebo ring, inserted 4-weekly and used over a 12-week period. Safety was evaluated by pelvic examination, colposcopy, clinical laboratory assessments, and adverse events. Blood samples for determination of plasma concentrations of dapivirine were collected at Weeks 0, 4 and 12. Residual dapivirine levels in returned rings from dapivirine ring users were determined post-trial. Participant acceptability and adherence to ring use were assessed by self-reports. RESULTS: No safety concerns or clinically relevant differences were observed between the dapivirine and placebo ring groups. Plasma dapivirine concentrations immediately prior to ring removal were similar after removal of the first and third ring, suggesting consistent ring use over the 12-week period. No clear relationship was observed between the residual amount of dapivirine in used rings and corresponding plasma concentrations. Self-reported adherence to daily use of the vaginal rings over the 12-week trial period was very high. At the end of the trial, 96% of participants reported that the ring was usually comfortable to wear, and 97% reported that they would be willing to use it in the future if proven effective. CONCLUSIONS: The dapivirine vaginal ring has a favourable safety and acceptability profile. If proven safe and effective in large-scale trials, it will be an important component of combination HIV prevention approaches for women. Trial Registration ClinicalTrials.gov NCT01071174en_ZA
dc.identifier.apacitationNel, A., Bekker, L., Bukusi, E., Hellstrӧm, E., Kotze, P., Louw, C., ... Woodsong, C. (2016). Safety, acceptability and adherence of dapivirine vaginal ring in a microbicide clinical trial conducted in multiple countries in sub-Saharan Africa. <i>PLoS One</i>, http://hdl.handle.net/11427/18850en_ZA
dc.identifier.chicagocitationNel, Annalene, Linda-Gail Bekker, Elizabeth Bukusi, Elizabeth Hellstrӧm, Philip Kotze, Cheryl Louw, Francis Martinson, et al "Safety, acceptability and adherence of dapivirine vaginal ring in a microbicide clinical trial conducted in multiple countries in sub-Saharan Africa." <i>PLoS One</i> (2016) http://hdl.handle.net/11427/18850en_ZA
dc.identifier.citationNel, A., Bekker, L. G., Bukusi, E., Hellstrӧm, E., Kotze, P., Louw, C., ... & van der Straten, A. (2016). Safety, acceptability and adherence of dapivirine vaginal ring in a microbicide clinical trial conducted in multiple countries in sub-Saharan Africa. PloS one, 11(3), e0147743. doi:10.1371/journal.pone.0147743en_ZA
dc.identifier.ris TY - Journal Article AU - Nel, Annalene AU - Bekker, Linda-Gail AU - Bukusi, Elizabeth AU - Hellstrӧm, Elizabeth AU - Kotze, Philip AU - Louw, Cheryl AU - Martinson, Francis AU - Masenga, Gileard AU - Montgomery, Elizabeth AU - Ndaba, Nelisiwe AU - Van der Straten, Ariane AU - Van Niekerk, Neliëtte AU - Woodsong, Cynthia AB - BACKGROUND: This was the first microbicide trial conducted in Africa to evaluate an antiretroviral-containing vaginal ring as an HIV prevention technology for women. Objectives The trial assessed and compared the safety, acceptability and adherence to product use of a 4-weekly administered vaginal ring containing the antiretroviral microbicide, dapivirine, with a matching placebo ring among women from four countries in sub-Saharan Africa. METHODS: 280 Healthy, sexually active, HIV-negative women, aged 18 to 40 years were enrolled with 140 women randomised to a dapivirine vaginal ring (25 mg) and 140 women to a matching placebo ring, inserted 4-weekly and used over a 12-week period. Safety was evaluated by pelvic examination, colposcopy, clinical laboratory assessments, and adverse events. Blood samples for determination of plasma concentrations of dapivirine were collected at Weeks 0, 4 and 12. Residual dapivirine levels in returned rings from dapivirine ring users were determined post-trial. Participant acceptability and adherence to ring use were assessed by self-reports. RESULTS: No safety concerns or clinically relevant differences were observed between the dapivirine and placebo ring groups. Plasma dapivirine concentrations immediately prior to ring removal were similar after removal of the first and third ring, suggesting consistent ring use over the 12-week period. No clear relationship was observed between the residual amount of dapivirine in used rings and corresponding plasma concentrations. Self-reported adherence to daily use of the vaginal rings over the 12-week trial period was very high. At the end of the trial, 96% of participants reported that the ring was usually comfortable to wear, and 97% reported that they would be willing to use it in the future if proven effective. CONCLUSIONS: The dapivirine vaginal ring has a favourable safety and acceptability profile. If proven safe and effective in large-scale trials, it will be an important component of combination HIV prevention approaches for women. Trial Registration ClinicalTrials.gov NCT01071174 DA - 2016 DB - OpenUCT DO - 10.1371/journal.pone.0147743 DP - University of Cape Town J1 - PLoS One LK - https://open.uct.ac.za PB - University of Cape Town PY - 2016 T1 - Safety, acceptability and adherence of dapivirine vaginal ring in a microbicide clinical trial conducted in multiple countries in sub-Saharan Africa TI - Safety, acceptability and adherence of dapivirine vaginal ring in a microbicide clinical trial conducted in multiple countries in sub-Saharan Africa UR - http://hdl.handle.net/11427/18850 ER - en_ZA
dc.identifier.urihttp://dx.doi.org/10.1371/journal.pone.0147743en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/18850
dc.identifier.vancouvercitationNel A, Bekker L, Bukusi E, Hellstrӧm E, Kotze P, Louw C, et al. Safety, acceptability and adherence of dapivirine vaginal ring in a microbicide clinical trial conducted in multiple countries in sub-Saharan Africa. PLoS One. 2016; http://hdl.handle.net/11427/18850.en_ZA
dc.language.isoengen_ZA
dc.publisherPublic Library of Scienceen_ZA
dc.publisher.departmentDesmond Tutu HIV Centreen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.en_ZA
dc.rights.holder© 2016 Nel et alen_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/4.0en_ZA
dc.sourcePLoS Oneen_ZA
dc.source.urihttp://journals.plos.org/plosoneen_ZA
dc.subject.otherBlood plasmaen_ZA
dc.subject.otherSouth Africaen_ZA
dc.subject.otherChlamydia infectionen_ZA
dc.subject.otherMicrobicidesen_ZA
dc.subject.otherAdverse eventsen_ZA
dc.subject.otherCandidiasisen_ZA
dc.subject.otherHIV preventionen_ZA
dc.subject.otherPhase III clinical investigationen_ZA
dc.titleSafety, acceptability and adherence of dapivirine vaginal ring in a microbicide clinical trial conducted in multiple countries in sub-Saharan Africaen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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