Volume 19, Number 1 : May 2022
PRODUCT UPDATE
Dapivirine Vaginal Ring
We join sexual and reproductive health advocates in celebrating the South African Health Products Regulatory Authority’s (SAHPRA) approval of the dapivirine vaginal ring. The silicone ring is intended for monthly use and is the first long-acting and user-controlled option for HIV prevention available to women* in South Africa who cannot use a regimen such as PrEP that requires a daily pill. The International Partnership for Microbicides (IPM), a nonprofit that develops new HIV prevention and sexual and reproductive health tools, announced approval for this application in March. The dapivirine ring has also received regulatory approval for use in Zimbabwe, and regulatory applications are pending in additional countries in eastern and southern Africa.
Despite a 2021 conditional recommendation from the World Health Organization that the dapivirine ring be made available to women at high risk of HIV transmission, feedback from the US Food and Drug Administration (USFDA) led IPM to withdraw their new drug application in December, removing the dapivirine ring from consideration for regulatory approval in the United States. USFDA feedback on the application indicated a lower likelihood of approval given the focus on oral PrEP regimens in the United States. Offering a full range of HIV prevention options, inclusive of the dapivirine ring, would ensure every person could protect themselves from HIV transmission using a method that is acceptable, appropriate, and aligns with their sexual and reproductive health needs.
If you are interested in learning more about the dapivirine ring as news emerges, we encourage you to follow the work of IPM as more updates are released.
*Although we use the term “women” as was used in regulatory applications and approval language, it is important to acknowledge that a range of people, including transgender men and nonbinary people may not identify as women, but have vaginas and may want a long-acting and user-controlled HIV prevention method like the dapivirine vaginal ring.
RESEARCH HIGHLIGHTS
In February, Jackson et al. published results of an evaluation of the pilot introduction of the Caya diaphragm in Niger. The study team fielded a telephone survey of 150 participants after six months of using the single-size diaphragm. Qualitative study components included conducted in-depth interviews with 25 survey participants regardless of continued Caya use, 15 men who attended a single family planning education session inclusive of information about Caya, and 15 family planning providers who had received training and Caya supplies six months prior to the interview. The full abstract follows below and will be included in our annual bibliography update including published diaphragm and cervical cap-related literature in 2022.
Jackson A, Angel A, Bagourmé AM, Boubacar M, Maazou A, Issoufa H, Bouanchaud P. A New Contraceptive Diaphragm in Niamey, Niger: A Mixed Methods Study on Acceptability, Use, and Programmatic Considerations. Glob Health Sci Pract. 2022 Feb 28;10(1):e2100532. doi: 10.9745/GHSP-D-21-00532.
Introduction: Diaphragms have never been widely available in West Africa, a region with very low contraceptive use due in part to health system constraints and low demand for other modern methods of contraception. Research has demonstrated the single-size Caya contoured diaphragm to be a safe and effective barrier method of nonhormonal, self-care contraception, offering features that improve upon the design of traditional diaphragms. No studies have measured continuation of Caya. In Niamey, Niger, this pilot introduction study explored Caya acceptability, use, and programmatic considerations.
Methods: Women in Niger participated in surveys (n=150) and in-depth interviews (n=25) 6 months after adopting Caya. In-depth interviews were also conducted with men in the community (n=15) and family planning providers (n=15). We conducted descriptive analysis of the percentage of adopters who continued to use the method at 6 months and women’s reasons for discontinuation among women who completed the 6-month follow-up survey. We used deductive thematic analysis of in-depth interview data from women, men, and providers to understand program elements and other factors associated with acceptability.
Results: Six months after initiation, 76.7% (95% confidence interval=0.70, 0.83) of 150 survey respondents reported continued use of Caya. Top reasons for use included: Caya causes no side effects for most users, works on demand, and is reusable for up to 2 years. Roughly one-quarter of women interviewed reported inconsistent use. Some men supported their partner’s use; in other cases, women used Caya without informing or involving their partners. Providers described Caya as compatible with the needs of many women and credited pelvic models with enabling effective counseling.
Discussion: The Caya diaphragm has the potential to be a valuable addition to the range of contraceptive options, especially in settings with high levels of opposition to other modern methods.