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.author Nel, Annalene en_ZA
dc.contributor.author Bekker, Linda-Gail en_ZA
dc.contributor.author Bukusi, Elizabeth en_ZA
dc.contributor.author Hellstrӧm, Elizabeth en_ZA
dc.contributor.author Kotze, Philip en_ZA
dc.contributor.author Louw, Cheryl en_ZA
dc.contributor.author Martinson, Francis en_ZA
dc.contributor.author Masenga, Gileard en_ZA
dc.contributor.author Montgomery, Elizabeth en_ZA
dc.contributor.author Ndaba, Nelisiwe en_ZA
dc.contributor.author Van der Straten, Ariane en_ZA
dc.contributor.author Van Niekerk, Neliëtte en_ZA
dc.contributor.author Woodsong, Cynthia en_ZA
dc.date.accessioned 2016-04-13T12:34:34Z
dc.date.available 2016-04-13T12:34:34Z
dc.date.issued 2016 en_ZA
dc.identifier.citation Nel, 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.0147743 en_ZA
dc.identifier.uri http://dx.doi.org/10.1371/journal.pone.0147743 en_ZA
dc.identifier.uri http://hdl.handle.net/11427/18850
dc.description.abstract 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 en_ZA
dc.language.iso eng en_ZA
dc.publisher Public Library of Science en_ZA
dc.rights This 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.uri http://creativecommons.org/licenses/by/4.0 en_ZA
dc.source PLoS One en_ZA
dc.source.uri http://journals.plos.org/plosone en_ZA
dc.subject.other Blood plasma en_ZA
dc.subject.other South Africa en_ZA
dc.subject.other Chlamydia infection en_ZA
dc.subject.other Microbicides en_ZA
dc.subject.other Adverse events en_ZA
dc.subject.other Candidiasis en_ZA
dc.subject.other HIV prevention en_ZA
dc.subject.other Phase III clinical investigation en_ZA
dc.title Safety, acceptability and adherence of dapivirine vaginal ring in a microbicide clinical trial conducted in multiple countries in sub-Saharan Africa en_ZA
dc.type Journal Article en_ZA
dc.rights.holder © 2016 Nel et al en_ZA
uct.type.publication Research en_ZA
uct.type.resource Article en_ZA
dc.publisher.institution University of Cape Town
dc.publisher.faculty Faculty of Health Sciences en_ZA
dc.publisher.department Desmond Tutu HIV Centre en_ZA
uct.type.filetype Text
uct.type.filetype Image
dc.identifier.apacitation Nel, 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/11427/18850 en_ZA
dc.identifier.chicagocitation Nel, 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/11427/18850 en_ZA
dc.identifier.vancouvercitation Nel 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.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


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This 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. Except where otherwise noted, this item's license is described as This 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.