An acceptability and safety study of the Duet® cervical barrier and gel delivery system in Zimbabwe
Background Adherence problems with coitally dependent, female‐initiated HIV prevention methods have contributed to several trials' failure to establish efficacy. Continuous use of a cervical barrier with once‐daily cleaning and immediate reinsertion may simplify use for women and improve adhere...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2010-01-01
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| Series: | Journal of the International AIDS Society |
| Online Access: | https://doi.org/10.1186/1758-2652-13-30 |
| _version_ | 1797894793243656192 |
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| author | Elizabeth T Montgomery Cynthia Woodsong Petina Musara Helen Cheng Tsungai Chipato Thomas R Moench Freya Spielberg Ariane van derStraten |
| author_facet | Elizabeth T Montgomery Cynthia Woodsong Petina Musara Helen Cheng Tsungai Chipato Thomas R Moench Freya Spielberg Ariane van derStraten |
| author_sort | Elizabeth T Montgomery |
| collection | DOAJ |
| description | Background Adherence problems with coitally dependent, female‐initiated HIV prevention methods have contributed to several trials' failure to establish efficacy. Continuous use of a cervical barrier with once‐daily cleaning and immediate reinsertion may simplify use for women and improve adherence. We assessed the acceptability and safety of precoital and continuous use of the Duet®, a cervical barrier and gel delivery system, in Zimbabwean women. Methods Using a two‐arm crossover design with a parallel observation group, we randomized 103 women in a 2:2:1 ratio: (1) to use the Duet continuously for 14 days, followed by a minimum of seven days of washout and then 14 days of precoital use; (2) to use the same Duet regimens in reverse order; or (3) for observation only. Women were aged 18 to 40 years; half were recruited from a pool of previous diaphragm study participants and the other half from the general community. Acceptability and adherence were assessed through an interviewer‐administered questionnaire at each of two follow‐up visits. Safety was monitored through pelvic speculum exams and report of adverse events. Results The proportion of women who reported consistent Duet use during sex was virtually identical during continuous and precoital regimens (88.6% vs. 88.9%). Partner refusal was the most common reason cited for non‐use during sex in both use regimens. Not having the device handy was the most common reason cited for non‐daily use (in the continuous regimen). Most women were “very comfortable” using it continuously (86.3%) and inserting it precoitally (92.8%). The most favoured Duet attribute was that it did not interfere with “natural” sex (55%). The least favoured Duet attribute was the concern that it might come out during sex (71.3%). No serious adverse events were reported during the study; 57 participants reported 90 adverse events classified as mild or moderate. There were no statistically significant differences in: (1) the proportion of women reporting adverse events; (2) the severity of events among those using the Duet and observational controls; or (3) event severity reported during each regimen use period. Conclusions In this study, the Duet was found to be acceptable and safe when inserted precoitally or used continuously for 14 days. Assignment to use of the Duet continuously did not increase adherence to the Duet during sex. Future HIV prevention trials should evaluate use of the Duet (precoitally and continuously) with promising microbicide candidates. |
| first_indexed | 2024-04-10T07:15:03Z |
| format | Article |
| id | doaj.art-4f061492f69847d393274b670bf7180a |
| institution | Directory Open Access Journal |
| issn | 1758-2652 |
| language | English |
| last_indexed | 2024-04-10T07:15:03Z |
| publishDate | 2010-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the International AIDS Society |
| spelling | doaj.art-4f061492f69847d393274b670bf7180a2023-02-25T12:30:34ZengWileyJournal of the International AIDS Society1758-26522010-01-01131303010.1186/1758-2652-13-30An acceptability and safety study of the Duet® cervical barrier and gel delivery system in ZimbabweElizabeth T Montgomery0Cynthia Woodsong1Petina Musara2Helen Cheng3Tsungai Chipato4Thomas R Moench5Freya Spielberg6Ariane van derStraten7Women's Global Health Imperative, RTI International, San Francisco Project Office, San Francisco, CA, USAInternational Partnership for Microbicides, Paarl, South AfricaUniversity of Zimbabwe‐University of California San Francisco Research Collaborative Programme in Women's Health, Harare, ZimbabweWomen's Global Health Imperative, RTI International, San Francisco Project Office, San Francisco, CA, USAUniversity of Zimbabwe‐University of California San Francisco Research Collaborative Programme in Women's Health, Harare, ZimbabweReProtect, Inc., Baltimore, MD, USAWomen's Global Health Imperative, RTI International, San Francisco Project Office, San Francisco, CA, USAWomen's Global Health Imperative, RTI International, San Francisco Project Office, San Francisco, CA, USABackground Adherence problems with coitally dependent, female‐initiated HIV prevention methods have contributed to several trials' failure to establish efficacy. Continuous use of a cervical barrier with once‐daily cleaning and immediate reinsertion may simplify use for women and improve adherence. We assessed the acceptability and safety of precoital and continuous use of the Duet®, a cervical barrier and gel delivery system, in Zimbabwean women. Methods Using a two‐arm crossover design with a parallel observation group, we randomized 103 women in a 2:2:1 ratio: (1) to use the Duet continuously for 14 days, followed by a minimum of seven days of washout and then 14 days of precoital use; (2) to use the same Duet regimens in reverse order; or (3) for observation only. Women were aged 18 to 40 years; half were recruited from a pool of previous diaphragm study participants and the other half from the general community. Acceptability and adherence were assessed through an interviewer‐administered questionnaire at each of two follow‐up visits. Safety was monitored through pelvic speculum exams and report of adverse events. Results The proportion of women who reported consistent Duet use during sex was virtually identical during continuous and precoital regimens (88.6% vs. 88.9%). Partner refusal was the most common reason cited for non‐use during sex in both use regimens. Not having the device handy was the most common reason cited for non‐daily use (in the continuous regimen). Most women were “very comfortable” using it continuously (86.3%) and inserting it precoitally (92.8%). The most favoured Duet attribute was that it did not interfere with “natural” sex (55%). The least favoured Duet attribute was the concern that it might come out during sex (71.3%). No serious adverse events were reported during the study; 57 participants reported 90 adverse events classified as mild or moderate. There were no statistically significant differences in: (1) the proportion of women reporting adverse events; (2) the severity of events among those using the Duet and observational controls; or (3) event severity reported during each regimen use period. Conclusions In this study, the Duet was found to be acceptable and safe when inserted precoitally or used continuously for 14 days. Assignment to use of the Duet continuously did not increase adherence to the Duet during sex. Future HIV prevention trials should evaluate use of the Duet (precoitally and continuously) with promising microbicide candidates.https://doi.org/10.1186/1758-2652-13-30 |
| spellingShingle | Elizabeth T Montgomery Cynthia Woodsong Petina Musara Helen Cheng Tsungai Chipato Thomas R Moench Freya Spielberg Ariane van derStraten An acceptability and safety study of the Duet® cervical barrier and gel delivery system in Zimbabwe Journal of the International AIDS Society |
| title | An acceptability and safety study of the Duet® cervical barrier and gel delivery system in Zimbabwe |
| title_full | An acceptability and safety study of the Duet® cervical barrier and gel delivery system in Zimbabwe |
| title_fullStr | An acceptability and safety study of the Duet® cervical barrier and gel delivery system in Zimbabwe |
| title_full_unstemmed | An acceptability and safety study of the Duet® cervical barrier and gel delivery system in Zimbabwe |
| title_short | An acceptability and safety study of the Duet® cervical barrier and gel delivery system in Zimbabwe |
| title_sort | acceptability and safety study of the duet r cervical barrier and gel delivery system in zimbabwe |
| url | https://doi.org/10.1186/1758-2652-13-30 |
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