Tags

Type your tag names separated by a space and hit enter

Acceptability and performance of a nonwoven device for vaginal drug delivery among women and their male partners in KwaZulu-Natal, South Africa.
Eur J Contracept Reprod Health Care. 2019 Oct; 24(5):390-398.EJ

Abstract

Background:

Multipurpose prevention technologies are needed to provide protection against HIV and sexually transmitted infections. Gel-based vaginal microbicides inserted via an applicator are prone to leakage. A novel device for vaginal drug delivery was developed to contain gel-based formulations, aiming to improve gel retention and reduce leakage. The objectives of this study were to assess acceptability and performance of a nonwoven vaginal delivery device.

Methods:

A nonwoven vaginal delivery device was prepared, pre-saturated with a commercially available water-based lubricant, with a finger pocket for insertion and string for removal. Quantitative and qualitative methods were used to collect data from interviews with 40 women and 10 male partners recruited from a sexual and reproductive health clinic in Durban, KwaZulu-Natal, South Africa. Women wore one device in the clinic and one device overnight or with their partner during intercourse. The primary endpoint was acceptability including comfort, ease of insertion and removal, and opinions on device attributes.

Results:

Most women said the device was 'easy' to insert and remove. Six women reported leakage after insertion and 34 reported having sexual intercourse while wearing the device. One woman was lost-to-follow-up and five women only wore the device overnight because their partners did not agree to intercourse with the inserted device. The best-liked attribute was the device's lubrication (22 women, 7 men); the least-liked was the removal string (9 women, 8 men).

Conclusions:

Data are promising for further development of this nonwoven device for vaginal drug delivery. Plain English summary Multipurpose prevention technologies (MPTs) that protect against HIV and sexually transmitted infections (STIs) are urgently needed. A variety of vaginal gel-based products are actively being researched; however, these products can often have challenges with vaginal leakage and retention. This research investigates the acceptability and performance of a nonwoven device to deliver vaginal gel formulations. The gel used in this study was a currently available marketed personal lubricant. In South Africa, 40 women (and 10 male partners) were recruited and given the opportunity to comment on various device attributes after insertion, overnight wear and sexual intercourse with their male partners. Generally, participants found the device easy to use and acceptable, where many factors possibly contributed to the device's acceptability (i.e., similarity to tampons, saturation with lubricant, minimal leakage, ease of insertion, comfort during intercourse and the male partners' willingness to have vaginal intercourse with the device in place). Further studies of the vaginal delivery device for acceptability, safety and efficacy using a gel-based formulation with an active ingredient are warranted.

Authors+Show Affiliations

Clinical Sciences and Product Quality and Compliance Department, FHI 360 , Durham , NC , USA.Joanis Consulting , Kennesaw , GA , USA.Women's Global Health Imperative, RTI International , San Francisco , CA , USA.Maternal, Adolescent and Child Health Research Unit (MRU), Department of Obstetics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand , Durban , South Africa.Maternal, Adolescent and Child Health Research Unit (MRU), Department of Obstetics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand , Durban , South Africa.Maternal, Adolescent and Child Health Research Unit (MRU), Department of Obstetics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand , Durban , South Africa.Maternal, Adolescent and Child Health Research Unit (MRU), Department of Obstetics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand , Durban , South Africa.Maternal, Adolescent and Child Health Research Unit (MRU), Department of Obstetics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand , Durban , South Africa.Maternal, Adolescent and Child Health Research Unit (MRU), Department of Obstetics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand , Durban , South Africa.Independent Consultant , Chapel Hill , NC , USA.Clinical Sciences and Product Quality and Compliance Department, FHI 360 , Durham , NC , USA.Clinical Sciences and Product Quality and Compliance Department, FHI 360 , Durham , NC , USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31517545

Citation

Hart, Catherine W., et al. "Acceptability and Performance of a Nonwoven Device for Vaginal Drug Delivery Among Women and Their Male Partners in KwaZulu-Natal, South Africa." The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception, vol. 24, no. 5, 2019, pp. 390-398.
Hart CW, Joanis C, Hartmann M, et al. Acceptability and performance of a nonwoven device for vaginal drug delivery among women and their male partners in KwaZulu-Natal, South Africa. Eur J Contracept Reprod Health Care. 2019;24(5):390-398.
Hart, C. W., Joanis, C., Hartmann, M., Milford, C., Smit, J., Beksinska, M., Rambally-Greener, L., Pienaar, J., Mabude, Z., Butterworth, G. A. M., Sokal, D., & Jenkins, D. (2019). Acceptability and performance of a nonwoven device for vaginal drug delivery among women and their male partners in KwaZulu-Natal, South Africa. The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception, 24(5), 390-398. https://doi.org/10.1080/13625187.2019.1656188
Hart CW, et al. Acceptability and Performance of a Nonwoven Device for Vaginal Drug Delivery Among Women and Their Male Partners in KwaZulu-Natal, South Africa. Eur J Contracept Reprod Health Care. 2019;24(5):390-398. PubMed PMID: 31517545.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Acceptability and performance of a nonwoven device for vaginal drug delivery among women and their male partners in KwaZulu-Natal, South Africa. AU - Hart,Catherine W, AU - Joanis,Carol, AU - Hartmann,Miriam, AU - Milford,Cecilia, AU - Smit,Jennifer, AU - Beksinska,Mags, AU - Rambally-Greener,Letitia, AU - Pienaar,Jacqui, AU - Mabude,Zonke, AU - Butterworth,George A M, AU - Sokal,David, AU - Jenkins,David, Y1 - 2019/09/13/ PY - 2019/9/14/pubmed PY - 2020/3/4/medline PY - 2019/9/14/entrez KW - HIV KW - South Africa KW - Vaginal drug delivery KW - acceptability KW - microbicides KW - nonwoven SP - 390 EP - 398 JF - The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception JO - Eur J Contracept Reprod Health Care VL - 24 IS - 5 N2 - Background: Multipurpose prevention technologies are needed to provide protection against HIV and sexually transmitted infections. Gel-based vaginal microbicides inserted via an applicator are prone to leakage. A novel device for vaginal drug delivery was developed to contain gel-based formulations, aiming to improve gel retention and reduce leakage. The objectives of this study were to assess acceptability and performance of a nonwoven vaginal delivery device. Methods: A nonwoven vaginal delivery device was prepared, pre-saturated with a commercially available water-based lubricant, with a finger pocket for insertion and string for removal. Quantitative and qualitative methods were used to collect data from interviews with 40 women and 10 male partners recruited from a sexual and reproductive health clinic in Durban, KwaZulu-Natal, South Africa. Women wore one device in the clinic and one device overnight or with their partner during intercourse. The primary endpoint was acceptability including comfort, ease of insertion and removal, and opinions on device attributes. Results: Most women said the device was 'easy' to insert and remove. Six women reported leakage after insertion and 34 reported having sexual intercourse while wearing the device. One woman was lost-to-follow-up and five women only wore the device overnight because their partners did not agree to intercourse with the inserted device. The best-liked attribute was the device's lubrication (22 women, 7 men); the least-liked was the removal string (9 women, 8 men). Conclusions: Data are promising for further development of this nonwoven device for vaginal drug delivery. Plain English summary Multipurpose prevention technologies (MPTs) that protect against HIV and sexually transmitted infections (STIs) are urgently needed. A variety of vaginal gel-based products are actively being researched; however, these products can often have challenges with vaginal leakage and retention. This research investigates the acceptability and performance of a nonwoven device to deliver vaginal gel formulations. The gel used in this study was a currently available marketed personal lubricant. In South Africa, 40 women (and 10 male partners) were recruited and given the opportunity to comment on various device attributes after insertion, overnight wear and sexual intercourse with their male partners. Generally, participants found the device easy to use and acceptable, where many factors possibly contributed to the device's acceptability (i.e., similarity to tampons, saturation with lubricant, minimal leakage, ease of insertion, comfort during intercourse and the male partners' willingness to have vaginal intercourse with the device in place). Further studies of the vaginal delivery device for acceptability, safety and efficacy using a gel-based formulation with an active ingredient are warranted. SN - 1473-0782 UR - https://www.unboundmedicine.com/medline/citation/31517545/Acceptability_and_performance_of_a_nonwoven_device_for_vaginal_drug_delivery_among_women_and_their_male_partners_in_KwaZulu_Natal_South_Africa_ L2 - https://www.tandfonline.com/doi/full/10.1080/13625187.2019.1656188 DB - PRIME DP - Unbound Medicine ER -