Cupid female condom receives UNFPA prequalification  

 In July 2012, the Cupid female condom received WHO/UNFPA prequalification. A fully prequalified product means that the manufacturing site has been inspected and independent testing of the factory's product has been successfully completed. UNFPA, the largest public sector procurer of contraceptives and related commodities, only procures female condoms from prequalified suppliers, and prequalification therefore has major implications for women's access worldwide.

With this announcement, the Cupid female condom became the second female condom design to successfully complete the prequalification process (alongside the FC2, the second generation female condom by the Female Health Company). Additionally, there are several new designs of female condom products in various stages of development, which WHO/UNFPA expects to review in the future.

We extend our congratulations to Cupid Ltd!

For more information on WHO/UNFPA prequalification for female condoms, including a new manual from WHO/UNFPA on the topic, please see the Resources section below.

Review of new female condoms in development

A special edition of the journal Reproductive Health Matters, to be published later this month, will have a feature on female condom products that are available now and those in development that are expected to be available within the next two to five years.    

We preview the abstract below. 

New female condoms in the pipeline
Beksinska M, Smit J, Joanis C, Potter W. Reproductive Health Matters 2012;20(40).

Abstract

Male and female condoms are currently the only effective dual protection methods against unintended pregnancy and transmission of STIs and HIV. In recent years, advocacy and support to female condom (FC) programmes and increased distribution have played a significant role in highlighting to donors, policy-makers and programme managers the importance of FCs as essential tools for dual prevention. Further, the emergence of new FC products, differing in design and materials, has the potential to lower cost and improve acceptability. There are hurdles in developing new FC products, by far the greatest being the clinical studies required for regulatory purposes. However, several new designs are now available in selected countries and some are progressing through the final stages of regulatory approval, after which they will be more widely available. The new FC designs, which may also be more affordable, will increase options and choice for couples who want to use FCs as their prevention method. Here, we review the FC products that are available now and those still in development which are expected to be available within the next two to five years. © 2012 Reproductive Health Matters

ANNOUNCING THE FEMALE CONDOMS ARE_______ FILM CONTEST 

Submit your female condom film; enter to win prize money!

Female condoms may be one of the most promising health technologies that people don't know or hear much about. But together we can change this.

That's why PATH, Universal Access to Female Condoms (UAFC) Joint Programme, Center for Health and Gender Equity (CHANGE), and the National Female Condom Coalition (NFCC) are thrilled to kick off:

FEMALE CONDOMS ARE_______
an international film contest seeking creative and compelling stories from around the globe

SHARE YOUR STORY: Why does the world need female condoms? How can female condoms enhance your life? They are calling for short films that tell a story about what Female Condoms Are to you and your community. Filmmakers of all levels of experience are encouraged to enter.

WIN CASH PRIZES: The top three film entries as determined by contest judges will receive cash prizes. First place: US$5,000; Second place: US$2,000; Third place: US$500.

GET RECOGNITION: Winning entries will be screened at the Women Deliver 2013 Conference in Kuala Lumpur, Malaysia--the largest global meeting of the decade to focus on the health and well-being of girls and women.

HOW TO ENTER: Visit their contest website for complete contest details, including eligibility requirements, Official Contest Rules, submission instructions, and more. This contest runs from November 28, 2012-March 1, 2013.

HELP SPREAD THE WORD! We invite you to participate and to share this opportunity with your colleagues, friends, and family. Circulate the contest flyer to your networks and visit the contest promotion web page for resources on getting the word out. 

Questions? Contact femalecondomfilm@path.org.

www.femalecondomfilm.org 

RESOURCES

Updated cervical barriers and female condoms bibliographies

We are excited to share these updated resources with the CBAS community. Our bibliographies of the literature on the diaphragm and cervical cap and on the female condom now include the latest peer-reviewed, published articles (updated through November 2012). Both bibliographies can be downloaded on our website or by following the links below.

Female condom bibliography
Diaphragm and cervical cap bibliography   

WHO/UNFPA Female Condom: Generic Specification, Prequalification and Guidelines for Procurement, 2012

UNFPA is committed to only purchasing female condoms from factories that have been pre-qualified according to the WHO/UNFPA Prequalification Scheme. In order to be granted prequalification, manufacturers must satisfy the requirements in the WHO/UNFPA Technical Review Process to show that the safety and efficacy of the product have been demonstrated and have a product that complies with the WHO/UNFPA Female Condom Generic Specification. This document provides detailed information about the technical review process and prequalification scheme. 

UNFPA and WHO/RHR have worked in collaboration with many partners from the private and public sectors to generate the evidence and gain the consensus needed to recommend the procedures detailed in this manual. This document addresses issues related to:

• Ensuring the procurement of a quality product;
• Improving levels of competence in procurement;
• Improving levels of confidence in the performance of the product;
• Ensuring the health and safety of the end user.

Click here to read the full report.

FEATURED RESEARCH

In this section we highlight new research in the pipeline on cervical caps, diaphragms, and female condoms. 

Health systems and market opportunities for SILCS as a barrier contraceptive in India

Market introduction study

Location: Delhi, Mysore, and Rajasthan, India

This assessment will explore opportunities and challenges for future introduction of the SILCS diaphragm in India. This study will begin with national stakeholder interviews in Delhi, and then move to interviews with state-level stakeholders, such as FP/SRH providers and NGOs, and focus group discussions with potential consumers in two states in India. Using a systems perspective, researchers will characterize issues/attitudes that will need to be addressed when planning for future introduction of this non-hormonal barrier contraceptive in this context. This assessment will outline the regulatory pathway, potential service delivery scenarios, target audiences, and communications and training materials needed in support future introduction. This study will take place from October 2012-July 2013.

The study is being conducted by Ashodaya Samithi of Mysore, in Karnataka state, India, and Katharine Shapiro, a reproductive health consultant, in collaboration with PATH. This assessment is funded by USAID.

Market assessment of SILCS as a reusable delivery system for microbicide gel in South Africa

Market introduction study

Location: KwaZulu Natal and Western Cape, South Africa

This activity is designed to understand the opportunities and challenges for future introduction of SILCS diaphragm in South Africa both as a non-hormonal barrier contraceptive and as a reusable delivery system for microbicide, such as Tenofovir gel. Through desk research, key informant and in-depth interviews, and service delivery facility assessments, researchers will identify policies, regulatory guidance, service delivery scenarios, as well as training requirements to plan for future introduction of the SILCS diaphragm. Focus group discussions with potential user groups will help identify which market segments are most likely to be interested in this non-hormonal barrier method. This study will take place from October 2012-July 2013.

The study is being conducted by researchers at MatCH located in Durban, South Africa, in conjunction with PATH. This assessment is funded by USAID.

A Randomized Controlled Trial of the Functional Performance of HLL FC, FC2 and Cupid2 Female Condoms

Location: South Africa

The objective of this study is to compare the functional performance and overall acceptability and safety of new female condoms (FCs), including the HLL FC, FC2, and Cupid2 models. The FC2 will serve as the control. The design will be a randomized comparative cross-over trial to evaluate device function, safety, and acceptability. Primary endpoints will be total clinical failure and total device failure for each condom type. Secondary endpoints will include rates of invagination, complete slippage, misdirection, and breakage. The target population will be urban, sexually-active women who are either novice or experienced users of FCs.  Recruitment will be from a large family planning clinic associated with MatCH (at the University of the Witwatersrand, Durban, South Africa). The study will enroll 300 women and will last 18 months. Approximately 280 women are expected to complete the study. Results will be used to complete manufacturer dossiers for WHO pre-qualification. This study will also conduct a pilot functionality evaluation of the Annova panty condom.

This study is expected to begin in 2013.

The study is being conducted by MatCH and is funded by the Universal Access to Female Condoms (UAFC) Joint Programme.

RECENT CONFERENCES AND EVENTS

International Female Condom Day of Action - summary of highlights  

by Jessica Terlikowski     

September 12, 2012 marked the first Global Female Condom Day. Created by the National Female Condom Coalition, Global Female Condom Day aims to increase the number of women, men, transgender people, and youth who know about, use, and advocate for female condoms. Individuals and organizations around the world employed diverse tactics to increase awareness, access, and use of female condoms in their communities.

The following is a list of accomplishments and outcomes that resulted from Global Female Condom Day. Additionally, the National Female Condom Coalition also developed and disseminated a survey among Global Female Condom Day participants to learn more about activities that were conducted.  

• People from 40 countries and  26 states participated
• Recruitment of 194 organizations, health departments, companies, and universities from 26 countries and 19 states to sign female condom support letter
• Grew National Female Condom Coalition contact list from 60 people to 320 people representing 40 countries and 28 states during July to September
• Coverage by 56 media outlets in 14 countries covered Global Female Condom Day
• March for female condoms in the Democratic Republic of the Congo

Female condoms at the AIDS conference 

Summary and photos by Mags Beksinska, MatCH (CBAS steering committee member)

Female condoms featured in a number of activities, workshops, and posters at the AIDS 2012 conference in Washington, DC. The Global Village, a presentation, exhibition, and gathering space at the conference, hosted many of these activities. Read about some of the events below.

Is the scientific and programming community ignoring condoms?

This lively debate examined the visibility and role of male and female condoms in the prevention arena. The panelists included international researchers, advocates, donors, and international NGOs. While many panelists argued that condoms are the bedrock of HIV prevention, they noted that more must be done to increase availability, access, and uptake.

Demonstrating the female condom at the Condomize Zone in the Global Village

The Condomize Zone, both within the main conference venue and the Global Village, was a real crowd puller. The Zone gave round the clock demonstrations on an exciting range of condoms and lubricants, held topical condom discussions, distributed condoms and T-shirts, and got participants involved in making condom art pins, among other activities. One of the afternoon topics was female condoms, during which Mags Beksinska of MatCH and Tian Johnson of the Female Health Company led a female condom demonstration and information session in the Zone.

The female condom fashion show

The female condom fashion show was held one evening and featured several beautiful dresses and outfits made entirely from female condoms. Used in imaginative and creative styles, female condom dresses may really catch on!

Other sessions

Other sessions included a community engagement in female condom programming workshop, where best practices and lessons learned in community involvement were shared. Additionally, the Pleasure Project hosted a dialogue session on sexual pleasure and the female condom, which emphasized the positive aspects of female condom use in not only safe sex but also in how using the female condom can make sex more pleasurable for both partners.