Original research articleComparative acceptability study of the Reality® female condom and the version 4 of modified Reddy female condom in India
Introduction
Sexual transmission is the main mode of human immunodeficiency virus (HIV) infection worldwide. Females are more vulnerable to HIV infection and sexually transmitted diseases (STDs) than males because of various biological and sociodemographic factors [1]. Consistent and correct use of male condoms can protect females against STDs including HIV infection. However, females have no control over the use of male condoms and are not adequately empowered to negotiate condom use in many cultures or settings. Therefore, development of effective methods and devices that could be used by females [2], [3], such as vaginal microbicides and female condoms, is of prime importance. These methods are expected to help women protect themselves from STDs and HIV infections.
According to the Joint United Nations Program on HIV/AIDS (UNAIDS), heterosexual contact accounted for most of the estimated 4.2 million new adult HIV infections acquired during 2003 [4]. Young women of reproductive age are more vulnerable to HIV infection in developing countries where more than 90% of new infections occur. India is facing one of the largest burdens of HIV infection of any single country, and heterosexual intercourse is the most common route of transmission [5]. Initially, the Indian HIV epidemic in women was concentrated among commercial sex workers [6]. However, recent studies have also reported higher rates of HIV infection among married, monogamous women who do not have traditional HIV risk behavior. Our research group has reported a high HIV prevalence (14%) among married, monogamous women attending sexually transmitted infection (STI) clinics between 1993 and 1996 [7]. Similarly, in Chennai, in India, among 134 HIV-positive women who sought care for their HIV, 82% were married, monogamous women whose risk factor for HIV infection was sexual intercourse with their HIV-infected spouse [8]. In a study from Manipur, 45% of wives of HIV-infected injection drug users were detected to be HIV-positive despite not being injection drug users themselves [9]. In spite of effective mass awareness programs for population control and HIV prevention, male condom use was as low as 3% in India as per the National Family Health Survey-2, conducted in 1998–1999 [10].
In 1993, the U.S. Food and Drug Administration (USFDA) approved the Reality female condom against pregnancy and STIs. Reality female condom is made of polyurethane. It is a 17-cm-long cylindrical sheath with an inner movable ring and an outer fixed ring. It has been designed to offer better protection against STDs than the male condom, because it provides greater coverage of the external female genitalia [11]. The female condom prevents passage of virus particles as small as the hepatitis B virus that are smaller than HIV particles. The retail cost of Reality female condom is US$2.50 per device, which is 20 times more expensive than that of a male condom, and it is not likely to be affordable to the majority of women in developing countries.
The Reddy female condom, manufactured by Medtech Products, Chennai, India, is an investigational product. It is not approved by the Indian Regulatory Agency or the USFDA and is not commercially available. It is made of latex rubber. The cost of the product is likely to be significantly less than the Reality condoms. The Reddy condom has an inner polyurethane sponge that is meant to anchor the device during intercourse and absorb semen. The outer triangular ring is designed to prevent inward displacement of the condom. It is lubricated with silicone and packaged with the sheath rolled up similar to a male condom. It is inserted by holding the side of the triangular ring and by pushing the sponge up in the vagina. Reality female condom is being introduced in India, and the Reddy condom has not undergone any clinical trial in the Indian population.
We conducted a randomized crossover study at two sites in India: Chennai and Pune. The primary objective of the study was to compare the functional performance of the Reality and the version 4 of Reddy female condoms with comparative acceptability as the secondary endpoint. Because version 4 of the Reddy condom was a prototype device, and as a result of this study, it has undergone design changes, we are reporting only the comparative acceptability of the Reality and the version 4 of the Reddy female condoms among a selected population of Indian women.
Section snippets
Methods and materials
The study received technical assistance from CONRAD, Family Health International (FHI) and the U.S. Agency for International Development. Packaging, randomization and distribution of the condoms were done by FHI. The protocol and informed consent received approval from the ethics committees of both the participating institutes in Chennai and Pune.
Demographic profile
A total of 60 couples were enrolled, 30 at NARI and 30 at YRG CARE from June 2002 until December 2002. The mean age of the female participants was 30.3 years (SD=6.03) and that of their male partners was 36.1 years (SD=6.98). All of them were Indians. Thirty percent of the participants had studied above the 10th standard of schooling.
Contraceptive methods
Of the 60 participants enrolled, 44 females (73.3%) had undergone tubal ligation, 8 (13.3%) were using an intrauterine contraceptive device (IUCD), 6 (10.0%) were
Discussion
This is the first report on the evaluation of two types of female condoms among Indian women. None of the participants had ever heard of or seen a female condom, and only 50% of the participating individuals had past experience with a male condom. The randomized crossover design of this study minimized any possible bias in acceptability assessment based on reporting influenced by the use order effect. All questionnaires completed by the participating couples were returned after completing use
Acknowledgments
The Department of Biotechnology, Government of India, funded this study. We thank the Family Health International (USA) for the technical support provided for randomization, packaging and labeling of the study packets. We thank Patrick Murphy, Director, Data Management, FHI, for help in setting up the data management system at NARI and Mr. Hanumant Shedge from NARI for actually setting up the system. We also thank Dr. Oza and other staff of Family Planning Association of India, Pune branch, and
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