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Introducing the female condom through the public health sector: experiences from South Africa.

The successful implementation of new public health policy is influenced by provider preparedness and user acceptability of the new intervention. This paper describes the development and implementation of a participatory Training of Trainers (TOT) programme as a precursor to launch the South African government's female-initiated HIV prevention strategies in public health clinics. Three hundred peer-trainees from throughout South Africa were trained through a comprehensive, modular and interactive three-day workshop. The workshop content included: HIV/AIDS knowledge, beliefs and attitudes; values clarification regarding HIV infection and sexuality; sexual desensitization; 'hands-on' training in the use of and introduction of the female condom; and counselling, communication and programme planning skills. The TOT generated a cadre of knowledgeable health care workers for training others and provided a support structure at the service delivery level for ensuring potential users' access to the female condom within each province. Qualitative assessments of the training and trainer debriefing sessions suggest that the training was successful in increasing knowledge and promoting positive attitudes about female condoms. In addition, the expanded repertoire of problem-solving approaches left providers feeling confident about recommending this method to clients.

Attitude to Health↗

Efficacy of the female condom as a barrier to semen during intercourse.

In 1996-1998, the authors measured prostate-specific antigen (PSA) in vaginal fluid to assess the frequency of female condom failure and to evaluate the association of self-reported failure with semen exposure. Women at low risk of sexually transmitted diseases (n = 210) were recruited in Birmingham, Alabama. They were trained to use the female condom, sample vaginal fluid before and after condom use, and complete forms to report problems during each use. Semen exposure was assessed by comparing pre- and postcoital PSA levels in vaginal fluid. A total of 175 women used 2,232 condoms. The rate of semen exposure ranged from 7% to 21% of condom uses, depending on the exposure criterion. Exposure was more likely (21-34%) and more intense (mean postcoital PSA, 24.7 ng/ml) if participants reported a mechanical problem versus other problems or no problems (exposure rate, 5-20% in both instances; mean postcoital PSA, 9.6 and 7.8 ng/ml, respectively). In logistic regression analyses for repeated measurements, user-reported problems accounted for less than 59% of the instances of semen exposure. The female condom prevented semen exposure in 79-93% of condom uses. Exposure was associated with user-reported problems but also occurred in their absence. Reported problems and semen exposure decreased with user experience.

Adult↗

Use of reality "female condoms" for anal sex by US men who have sex with men. HIVNET Vaccine Preparedness Study Protocol Team.

OBJECTIVES: This study assessed use of Reality "female condoms" for anal sex by HIV-seronegative men who have sex with men and are at high risk for HIV infection. METHODS: Self-administered questionnaires were completed by 2277 participants in a 6-city prospective cohort study. RESULTS: Of the 1084 (48%) men who had heard of using the female condom for anal sex, 145 (13%) reported using it in the prior 6 months. Users were at greater risk than nonusers: 47 receptive and 35 insertive users reported problems, including bleeding by the receptive partner (4). CONCLUSIONS: Redesign of the female condom could increase acceptability and use by men who have sex with men and could address possible safety concerns.

Adult↗

Making the female condom a "reality" for adolescents.

Alarming rates of pregnancy, sexually transmitted diseases, and human immunodeficiency virus infection among adolescents point to the need for expanding contraceptive options for adolescents. The female condom-a female-controlled barrier method that protects both partners from sexually transmitted diseases-marks an important breakthrough in contraceptive technology. This report reviews current research on the efficacy and acceptability of the female condom and considers the feasibility of its use in the adolescent population. Specifically, the authors first consider the factors that affect teenage condom (and other contraceptive) use (efficacy, cost and availability, and acceptability) and then apply the mechanics of the female condom to these issues. Based on this analysis, recommendations for future steps to be taken by researchers, adolescent health practitioners, and the manufacturer of the female condom are presented.

Adolescent↗

Introductory study on female condom use among sex workers in China.

There is lack of barrier method use among sex workers (SWs) in China. Our objective was to find new ways to introduce female condoms (FCs) among SWs, and to increase knowledge of, support for, and use of this method in this population. We used the intervention study method and provided the SWs of experimental groups with information, education, and communication on FCs and provided them with FCs. We recruited 330 SWs as the participants of the study in Enping City, China. The selected 330 SWs were randomly divided into the experimental group (165 SWs to use female condom) and the others into the reference group (165 SWs to use male condom). Questionnaires were used to evaluate the intervention study. At the end of our study, 15 SWs were lost of follow-up, so only 315 were included in the analysis. After intervention, about 97% of SWs in the intervention group expressed that they would use FC in the future. The rate of SWs who reported liking FC increased from 60% at pre-intervention to 94% at post-intervention. The rate of SWs who considered their clients could accept FC increased from 27% to 92%, and the rate of SWs who were willing to recommend FC to others increased from 19% to 70%. In comparison with the first several uses, during last several uses about 80% of SWs expressed that it became easier to use FC. Our intervention increased knowledge of, positive attitudes towards, and correct use of FC in this population of SWs.

Adolescent↗

Reducing HIV/AIDS transmission among African-American females: is the female condom a solution?

Rates of HIV/AIDS have increased at an alarming rate among minority women, especially African-American women. Suggestions that have been presented to decrease HIV/AIDS transmission among African-American women include promoting abstinence and the use of the male condom. Little recognition and support have been given for promoting the female condom as a viable solution to combating the HIV/AIDS epidemic.

Black or African American↗

Short-term acceptability of the Reality polyurethane female condom and a synthetic latex prototype: a randomized crossover trial among South African women.

PURPOSE: This multisite, randomized, crossover trial comparing the acceptability of the Reality(R) female condom (FC1), with a new synthetic latex prototype (FC2) of similar design and appearance to FC1, was conducted in Durban, South Africa. METHODS: In total, 276 women were enrolled and 1910 FC1 condoms and 1881 FC2 condoms were used by 218 and 216 women, respectively. RESULTS: Overall experience of use was reported as good for over half the participants with both condom types (FC1=50.9%, FC2=55.1%). Similar acceptability issues were reported in like proportions for FC1 and FC2, with features such as the lubricant (FC1=36.7%, FC2=37.0%) and the material (FC1=36.2%, FC2=29.2%) most commonly viewed positively for both condom types. Negative aspects commonly reported for both female condoms were the lubricant (FC1=30.3%, FC2=31.5%) and the appearance (FC1=29.8%, FC2=34.0%). Preference for FC1 was 29.5% and was slightly higher for FC2 (36.6%). Some women felt that there was no real difference between the two devices (33.8%). CONCLUSION: The acceptability of FC1 and FC2 was comparable, and women who find FC1 acceptable to use should also find FC2 acceptable.

Adult↗

Country-wide distribution of the nitrile female condom (FC2) in Brazil and South Africa: a cost-effectiveness analysis.

OBJECTIVE: To evaluate the cost-effectiveness and potential impact of expanded female condom distribution. DESIGN: Cost-effectiveness analysis assessing HIV infections averted annually and incremental cost per HIV infection averted for country-wide distribution of the nitrile female condom (FC2) among sexually active individuals, 15-49 years, with access to publicly distributed condoms in Brazil and South Africa. RESULTS: In Brazil, expansion of FC2 distribution to 10% of current male condom use would avert an estimated 604 (5-95th percentiles, 412-831) HIV infections at 20,683 US dollars (5-95th percentiles, 13,497-29,521) per infection averted. In South Africa, 9577 (5-95th percentiles, 6539-13,270) infections could be averted, at 985 US dollars (5-95th percentiles, 633-1412) per infection averted. The estimated cost of treating one HIV-infected individual is 21,970 US dollars (5-95th percentiles, 18,369-25,719) in Brazil and 1503 US dollars (5-95th percentiles, 1245-1769) in South Africa, indicating potential cost savings. The incremental cost of expanded distribution would be reduced to 8930 US dollars (5-95th percentiles, 5864-13,163) per infection averted in Brazil and 374 US dollars (5-95th percentiles, 237-553) in South Africa by acquiring FC2s through a global purchasing mechanism and increasing distribution threefold. Sensitivity analyses show model estimates to be most sensitive to the estimated prevalence of sexually transmitted infections, total sexual activity, and fraction of FC2s properly used. CONCLUSIONS: Expanded distribution of FC2 in Brazil and South Africa could avert substantial numbers of HIV infections at little or no net cost to donor or government agencies. FC2 may be a useful and cost-effective supplement to the male condom for preventing HIV.

Adolescent↗

An intervention to promote the female condom to sexually transmitted disease clinic patients.

This article describes a 1-hour behavioral intervention designed to promote female condoms and safer sex to women at a high risk for sexually transmitted diseases (STDs). The intervention includes a promotional videotape; a skills-oriented counseling session with a nurse clinician; assorted take-home items, including a videotape for men; and free supplies of female and male condoms. Designed for women ages 18 to 34 attending public STD clinics, the intervention is developed using a systematic process of formative evaluation influenced by principles of social marketing and drawing on the social cognitive theory. The effect of the intervention on female and male condom use is evaluated using a pretest-posttest design with 1,159 women. Most elements of the intervention could be replicated in settings other than STD clinics and delivered by persons other than nurse clinicians.

Acquired Immunodeficiency Syndrome↗

[Female condom: a possibility for autonomy in HIV-positive women].

In this article, the authors report an experience developed in the Specialized Care Sevice on STD/AIDS from Porto Alegre, where one of them works. It approaches adult women, emphasizing sexuality, reproduction and vulnerability concerning STDs, mainly HIV infection. The methodology used is a data survey starting from the return to the service in order to receive female condoms within one year. Subjects are HIV-positive women linked to the service. Results show that the use of this method is incipient and that its adoption demands a change in behaviour from women already in an early stage of their development, prior to adult age, and that there is a huge importance of raising awareness among professionals, either in Education or Health fields.

Adult↗

Female condom and male condom failure among women at high risk of sexually transmitted diseases.

OBJECTIVE: The objective of this study was to study the frequency and determinants of breakage and slippage during female and male condom use. GOAL: The goal of this study was to determine condom breakage and slippage rate. STUDY: We conducted a 6-month prospective follow-up study of women attending 2 sexually transmitted disease clinics. Breakage and slippage rates were computed. Logistic regression was used to evaluate baseline characteristics and time-dependent behaviors. RESULTS: A total of 869 women used condoms in 20,148 acts of intercourse. Breakage was less common for female condoms (0.1%; 95% confidence interval [CI], 0.05-0.21) than for male condoms (3.1%; 95% CI, 2.80-3.42). Slippage was more common for female condoms (5.6%; 95% CI, 5.10-6.13) than for male condoms (1.1%; 95% CI, 0.90-1.28). Rates significantly decreased with use and increased with number of previous failures. From first use to >15 uses, combined failure rate fell from 20% to 1.2% for female condoms (P < 0.0001) and 9% to 2.3% for male condoms (P < 0.01). CONCLUSIONS: Both condoms may provide good protection against sexually transmitted diseases. Experience determines success with either condom.

Adolescent↗

[Female condom or male condom: offer a choice!].

OBJECTIVES: As in the entire Ile-de-France, the Val-de-Marne is facing an increase in female contamination by HIV, a clear increase in STI and furthermore the number of legal abortions is still high. Various recent studies have emphasized the decrease in condom use since 1998. Can the possibility of proposing another condom, more specifically controlled by women, boost condom use? PATIENTS AND METHODS: The conseil général (local government authority) thus initiated a study in the general population, from January 1st 2001 to December 31st 2001, in order to study the criteria of acceptability of the female condom (FC). RESULTS: Although the women coming to consultation had no specific requests a quarter finally tested the female condom during sexual intercourse. Among them 4 out of 10 are ready to use it again. Curiosity was the primary motivation of those who accepted to test the female condom (77 %). Women who were more at ease with their sexuality were twice more likely to test the female condom. Three main advantages were put forward by the women who tested the FC: the strength of the FC, the fact that insertion was possible prior to the sexual act and the possibility of postponing removal, the latter being considered a supplementary advantage. The disadvantages most frequently cited before use were its appearance and difficult insertion process. The frequency of utilisation of the FC was multiplied by three when women practised putting the condom in place in a non-sexual context. However, even when they recognized one or several disadvantages women accepted to test it. In addition, whenever a woman finds at least one advantage before use she is twice more likely to test it. This is where counselling by professionals in charge of presenting the FC becomes a deciding factor. DISCUSSION AND CONCLUSIONS: The chance of using at least one sort of condom is increased when a choice of condoms is available. When both male and female condoms are available, the responsibility for prevention is better balanced within the couple: each partner can then be in charge of his or her own health. However the adoption of a barrier method such as the condom, means that the individual is conscious of such a need and finds that there are benefits mainly staying in good health. However the insufficient number of prevention and health promotion campaigns in France does not favour such an awareness. The availability of inexpensive female condoms in pharmacies, supermarkets as well as free distribution by certain institutions remains an unresolved question.

Acquired Immunodeficiency Syndrome↗

Cost-effectiveness of the female condom in preventing HIV and STDs in commercial sex workers in rural South Africa.

We assessed the cost-effectiveness of the female condom (FC) in preventing HIV infection and other STDs among commercial sex workers (CSWs) and their clients in the Mpumulanga Province of South Africa. The health and economic outcomes of current levels of male condom (MC) use in 1000 CSWs who average 25 partners per year and have an HIV prevalence of 50.3% was compared with the expected outcomes resulting from the additional provision of FCs to these CSWs. A simulation model calculated health and public sector cost outcomes assuming 5 years of HIV infectivity, 1 month of syphilis and gonorrhea infectivity, and FC use in 12% of episodes of vaginal intercourse. Delayed infections and interactions between STDs and HIV were modeled. The simulation was extended to non-CSWs with as few as one casual partner per year. We conducted multiple sensitivity analyses. The program would distribute 6000 FCs annually at a cost of $4002 and would avert 5.9 HIV, 38 syphilis, and 33 gonorrhea cases. This would save the public sector health payer $12,090 in averted HIV/AIDS treatment costs, and $1,074 in averted syphilis and gonorrhea treatment costs for a net saving of $9163. Sensitivity analyses indicate that the economic findings are robust across a wide range of values for key inputs. The program generates net savings of $5421 if HIV prevalence in CSWs is 25% rather than 50.3% and savings of S3591 if each CSW has an average of 10 clients per year rather than 25. A program focusing on non-CSWs with only one casual partner would save $199. We conclude that a well-designed FC program oriented to CSWs and other women with casual partners is likely to be highly cost-effective and can save public sector health funds in rural South Africa.

Condoms↗

The acceptability of the female condom among low-income African-American women.

Among women, African Americans are at the highest risk for contracting the human immunodeficiency virus (HIV). Unfortunately, the majority of African-American women do not perceive themselves to be at risk nor perceive the need to engage in safe-sex practices. Given the alarming rate of increase of HIV disease among African-American women, more in-depth information about the sociocultural factors influencing these nonhealth-promoting beliefs and behaviors is needed immediately in order to design effective Information, Education, Communication campaigns. As part of such an effort, a premarketing study of the recently developed female condom, Reality (Wisconsin Pharmacal, Jackson, Wisconsin), was used as an opportunity to assess not only acceptance and relevance of the product, but also knowledge, attitudes, and practices among a group of African-American women in New Orleans. The methodology chosen was focus group discussions. The main finding from these discussions is that the previously reported low-risk perception of HIV disease among African-American females is also true among this group. The discussions suggest that cultural norm of female submission and passivity in sexual negotiation is a major barrier to preventive actions among these African-American women, ie, insistence on condom use during sexual intercourse [corrected]. The second important finding from these focus group discussions is that the women enthusiastically endorsed the female condom because they felt this condom allowed them control over safe-sex practices without having to challenge the power of their male partners. This study also demonstrates that the dynamics of universality and interpersonal learning inherent to insight-oriented or support groups can also be present.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Performance of the Reality polyurethane female condom and a synthetic latex prototype: a randomized crossover trial among South African women.

OBJECTIVE: This multisite, randomized, crossover trial comparing the performance of the Reality female condom (FC1) with a new synthetic latex prototype (FC2) was conducted in Durban, South Africa. METHOD: In total, 276 women were enrolled and 201 women completed the study. Altogether, 1910 FC1 condoms and 1,881 FC2 condoms were used. RESULTS: Total breakage was 0.73% in FC1 and 0.85% in FC2 (95% confidence interval, -0.64 to 0.87). The number of clinical breakages (those that could result in a pregnancy or sexually transmitted infection) was similar for each condom type (FC1, n=9; FC2, n=8). Incorrect penetration (penis between condom and vaginal wall) was 1.26% and 0.64% for FC1 and FC2, respectively. Outer ring displacements (outer ring pushed into the vagina partially or fully) were comparable for both condoms (FC1, 3.14%; FC2, 2.98%). Slippage (condom came out of the vagina) was rare and reported in 0.37% or less of devices used. Total clinical failure was 5.24% in FC1 and 4.3% in FC2. CONCLUSION: The FC1 and FC2 performed comparably within this trial.

Adult↗

Participation and retention in a study of female condom use among women at high STD risk.

PURPOSE: Differential participation and retention can bias the findings of a follow-up study. This problem was evaluated in a study of barrier contraception among women at high STD risk. The goal of this study was to identify predictors of participation and retention and determine whether they could influence study results. METHODS: Six-month follow-up study of women attending STD clinics. Determinants of participation and retention were evaluated using logistic and proportional hazards models. RESULTS: Agreement to participate was associated with young age, black race, low education and income, older age at first intercourse, the number of lifetime partners, and STD history. Early attrition was associated with young age, non-black race, higher income, lack of interest/commitment to using the female condom, high coital frequency, no STD history, not using a birth control method at baseline, and with inconsistent condom use, high coital frequency, and pregnancy during follow up. CONCLUSIONS: There was little evidence that differential participation influenced the validity of the study. Differential attrition may have biased behavioral measures of intervention effectiveness, but not necessarily measures of condom use effectiveness.

Adult↗

The female condom. A pilot study of the acceptability of a new female barrier method.

The best available prevention against sexually transmitted diseases is limited to a consistent and correct use of a condom by the male. A new barrier method has been developed for the female. As it can be inserted into the vagina before sexual intercourse starts, and as it covers the entrance of the vagina, the opening of the urethra and the root of the penis, it is presumed to give a high degree of protection against sexually transmitted diseases and unwanted pregnancy. The preliminary results concerning acceptability are promising, and further investigations concerning acceptability and efficacy are in progress or completed in several countries. The method should be regarded as one aspect in the pattern of protection, particularly suitable for females with sexual risk behavior.

Adult↗