AEGiS-15IAC: Removing regulatory barriers to widespread use of the diaphragm as a potential HIV prevention method.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Removing regulatory barriers to widespread use of the diaphragm as a potential HIV prevention method.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. ThOrE1377)

Lince N, Montgomery E, Naidoo S, Backes K, Harrison T, Ramjee G, Dinat N, Chipato T, Padian N
Ibis Reproductive Health, Cambridge, United States

ISSUES: The number of female-controlled methods for prevention of HIV/AIDS is limited. Currently available methods, like diaphragms, are being evaluated to see if they can prevent HIV. The Methods for Reproductive Health in Africa (MIRA) study is an ongoing randomized controlled trial of 4500 women in Zimbabwe and South Africa to examine the effectiveness of the diaphragm and Replens gel in preventing HIV acquisition. But, even if the diaphragm proves to be effective, regulatory issues in different countries could hamper broad access. An in-depth look at potential regulatory barriers is necessary to make sure these methods will be available once current research produces results.

DESCRIPTION: We discuss the regulatory status of the diaphragm and the changes that would be required to ensure widespread access, should the MIRA trial produce positive results. The diaphragm is indicated for use with a spermicide, which could be problematic in settings where the prevalence of HIV is high. Therefore, current labeling and other regulatory issues related to the diaphragm may inhibit widespread distribution of the method and hinder efforts to promote the diaphragm as a viable HIV prevention method. Product labeling and service delivery requirements in the United States, at the World Health Organization, and in countries most deeply affected by the epidemic will influence access and availability throughout the world. The elements of this analysis include an assessment of legal or regulatory obstacles to widespread access to the diaphragm.

LESSONS LEARNED: If the diaphragm is found to reduce HIV/STI transmission, women may have the opportunity to use a prevention method that they can control, but this cannot happen without appropriate, effective regulatory policies. Recommendation: In order to operationalize the results of the MIRA trial, policy changes and research are needed now to ensure that women have access to a potentially life-saving technology.

Keywords: AEGIS, Contraceptive Devices, Female, Acquired Immunodeficiency Syndrome, HIV Infections, Spermatocidal Agents, HIV Seropositivity, Research, Prevalence, United States, Africa, Zimbabwe, South Africa, Humans, Female, prevention & control, utilization, legislation & jurisprudence, methods

040711
ThOrE1377