Exploring user and stakeholder perspectives from South Africa and Uganda to refine microarray patch development for HIV PrEP delivery and as a multipurpose prevention technology.

BACKGROUND: Oral HIV pre-exposure prophylaxis (PrEP) is highly effective, but alternative delivery options are needed to reach more users. Microarray patches (MAPs), a novel drug-delivery system containing micron-scale projections or "microneedles" that deliver drugs via skin, are being developed to deliver long-acting HIV PrEP and as a multipurpose prevention technology to protect from HIV and unintended pregnancy. We explored whether MAP technology could meet user and health system needs in two African countries. METHODS: Researchers in South Africa and Uganda conducted 27 focus group discussions, 76 mock-use exercises, and 31 key informant interviews to explore perceptions about MAPs and specific features such as MAP size, duration of protection, delivery indicator, and health system fit. Participants included young women and men from key populations and vulnerable groups at high risk of HIV and/or unintended pregnancy, including adolescent girls and young women; female sex workers and men who have sex with these women; and men who have sex with men. In Uganda, researchers also recruited young women and men from universities and the community as vulnerable groups. Key stakeholders included health care providers, sexual and reproductive health experts, policymakers, and youth activists. Qualitative data were transcribed, translated, coded, and analyzed to explore perspectives and preferences about MAPs. Survey responses after mock-use in Uganda were tabulated to assess satisfaction with MAP features and highlight areas for additional refinement. RESULTS: All groups expressed interest in MAP technology, reporting perceived advantages over other methods. Most participants preferred the smallest MAP size for ease of use and discreetness. Some would accept a larger MAP if it provided longer protection. Most preferred a protection duration of 1 to 3 months or longer; others preferred 1-week protection. Upper arm and thigh were the most preferred application sites. Up to 30 minutes of wear time was considered acceptable; some wanted longer to ensure the drug was fully delivered. Self-administration was valued by all groups; most preferred initial training by a provider. CONCLUSIONS: Potential users and stakeholders showed strong interest in/acceptance of MAP technology, and their feedback identified key improvements for MAP design. If a MAP containing a high-potency antiretroviral or a MAP containing both an antiretroviral and hormonal contraceptive is developed, these products could improve acceptability/uptake of protection options in sub-Saharan Africa.

Microarray patch for HIV prevention and as a multipurpose prevention technology to prevent HIV and unplanned pregnancy: an assessment of potential acceptability, usability, and programmatic fit in Kenya.

Background: Microarray patches (MAPs), a novel drug delivery system, are being developed for HIV pre-exposure prophylaxis (PrEP) delivery and as a multipurpose prevention technology (MPT) to protect from both HIV and unintended pregnancy. Prevention technologies must meet the needs of target audiences, be acceptable, easy to use, and fit health system requirements. Methodology: We explored perceptions about MAP technology and assessed usability, hypothetical acceptability, and potential programmatic fit of MAP prototypes using focus group discussions (FGD), usability exercises, and key informant interviews (KII) among key populations in Kiambu County, Kenya. Adolescent girls and young women (AGYW), female sex workers (FSW), and men who have sex with men (MSM) assessed the usability and acceptability of a MAP prototype. Male partners of AGYW/FSW assessed MAP acceptability as partners of likely users. We analyzed data using NVivo, applying an inductive approach. Health service providers and policymakers assessed programmatic fit. Usability exercise participants applied a no-drug, no-microneedle MAP prototype and assessed MAP features. Results: We implemented 10 FGD (4 AGYW; 2 FSW; 2 MSM; 2 male partners); 47 mock use exercises (19 AGYW; 9 FSW; 8 MSM; 11 HSP); and 6 policymaker KII. Participants reported high interest in MAPs due to discreet and easy use, long-term protection, and potential for self-administration. MAP size and duration of protection were key characteristics influencing acceptability. Most AGYW preferred the MPT MAP over an HIV PrEP-only MAP. FSW saw value in both MAP indications and voiced need for MPTs that protect from other infections. Preferred duration of protection was 1-3 months. Some participants would accept a larger MAP if it provided longer protection. Participants suggested revisions to the feedback indicator to improve confidence. Policymakers described the MPT MAP as "killing two birds with one stone," in addressing AGYW needs for both HIV protection and contraception. An MPT MAP is aligned with Kenya's policy of integrating health care programs. Conclusions: MAPs for HIV PrEP and as an MPT both were acceptable across participant groups. Some groups valued an MPT MAP over an HIV PrEP MAP. Prototype refinements will improve usability and confidence.

Microarray patches: Breaking down the barriers to contraceptive care and HIV prevention for women across the globe.

Despite the existence of a variety of contraceptive products for women, as well as decades of research into the prevention and treatment of human immunodeficiency virus (HIV), there is still a globally unmet need for easily accessible, acceptable, and affordable products to protect women's sexual and reproductive health. Microarray patches (MAPs) are a novel platform being developed for the delivery of hormonal contraception and antiretroviral drugs. MAPs provide enhanced drug delivery to the systemic circulation via the transdermal route when compared to transdermal patches, oral and injectable formulations. These minimally invasive patches can be self-administered by the user, reducing the burden on health care personnel. Since MAPs represent needle-free drug delivery, no sharps waste is generated after application, thereby eliminating possible MAP reuse and risk of needle-stick injuries. This review discusses the administration of contraceptive and antiretroviral drugs using MAPs, their acceptability by end-users, and the future perspective of the field.

HIV prevention is not all about HIV - using a discrete choice experiment among women to model how the uptake and effectiveness of HIV prevention products may also rely on pregnancy and STI protection.

INTRODUCTION: In sub-Saharan Africa, considerable HIV-burden exists among women. Anti-retroviral (ARV) based prevention products could decrease this burden, and their uptake could be increased if they also protect against pregnancy and sexually transmitted infections (STI). METHODS: A discrete choice experiment (DCE) was undertaken in South Africa (2015) through a household survey of adult females (n = 158) and adolescent girls (n = 204) who self-reported HIV-negative status. The DCE was used to project the uptake (percentage using product) of oral pre-exposure prophylaxis (PrEP), vaginal rings, and injectable long-lasting ARV agents among these women, and how uptake could depend on whether these products protect against pregnancy or STI acquisition. Uptake estimates were used to model how each product could decrease a women's HIV acquisition risk. RESULTS: In adolescent women, there will be limited uptake (< 6% for any product) and impact (< 4% decrease in HIV acquisition risk) of new products unless they provide pregnancy protection, which could quadruple use and impact. Adult women have weaker preference for pregnancy protection, with moderate use (< 17% for each) and impact (< 14 percentage point decrease) if they only provide HIV protection. All women had highest preference for injectable ARVs, with oral PrEP having high preference if injectable ARVs are not available. Adult women will use the ring, but adolescent women will not. Importantly, even with three additional prevention products, all providing pregnancy and STI protection, > 14% of women will remain unprotected and > 31% of the baseline acquisition risk will remain. CONCLUSIONS: Incorporating multiple prevention components into new ARV-based prevention products may increase their uptake and impact among women.

Functional performance study of an adapted design of the woman's condom: a crossover, noninferiority, randomized clinical trial.

Objectives: We aimed to assess the functional performance and safety of a modified Woman's Condom (WC2) against the existing FC2 female condom. Study design: This randomized clinical trial enrolled 287 women in one South African site. The primary outcome of the study was the rate of female condom failure. Participants were asked to use five of each female condom type and to collect information on use in a condom log at home and were interviewed after use of each FC type. Results: Noninferiority was demonstrated for the WC2 with respect to the reference condom FC2 for all condom functions. The WC2 was found to be superior to the FC2 reference condom for clinical failure (p = .000), total female condom failure (p = .001), misdirection (p = .000) and slippage (p = .004). Conclusion: The WC2 female condom performs as well as the FC2 female condom and offers good stability during use. Implications: Results from this study will inform further refinement of this female condom design, resulting in a new and potentially less expensive Woman's Condom.

The cost-effectiveness of multi-purpose HIV and pregnancy prevention technologies in South Africa.

INTRODUCTION: A number of antiretroviral HIV prevention products are efficacious in preventing HIV infection. However, the sexual and reproductive health needs of many women extend beyond HIV prevention, and research is ongoing to develop multi-purpose prevention technologies (MPTs) that offer dual HIV and pregnancy protection. We do not yet know if these products will be an efficient use of constrained health resources. In this paper, we estimate the cost-effectiveness of combinations of candidate multi-purpose prevention technologies (MPTs), in South Africa among general population women and female sex workers (FSWs). METHODS: We combined a cost model with a static model of product impact based on incidence data in South Africa to estimate the cost-effectiveness of five candidate co-formulated or co-provided MPTs: oral PrEP, intravaginal ring, injectable ARV, microbicide gel and SILCS diaphragm used in concert with gel. We accounted for the preferences of end-users by predicting uptake using a discrete choice experiment (DCE). Product availability and protection were systematically varied in five potential rollout scenarios. The impact model estimated the number of infections averted through decreased incidence due to product use over one year. The comparator for each scenario was current levels of male condom use, while a health system perspective was used to estimate discounted lifetime treatment costs averted per HIV infection. Product benefit was estimated in disability-adjusted life years (DALYs) averted. Benefits from contraception were incorporated through adjusting the uptake of these products based on the DCE and through estimating the costs averted from avoiding unwanted pregnancies. We explore the additional impact of STI protection through increased uptake in a sensitivity analysis. RESULTS: At central incidence rates, all single- and multi-purpose scenarios modelled were cost-effective among FSWs and women aged 16-24, at a governmental willingness-to-pay threshold of $1175/DALY averted (range: $214-$810/DALY averted among non-dominant scenarios), however, none were cost-effective among women aged 25-49 (minimum $1706/DALY averted). The cost-effectiveness of products improved with additional protection from pregnancy. Estimates were sensitive to variation in incidence assumptions, but robust to other parameters. CONCLUSIONS: To the best of our knowledge, this is the first study to estimate the cost-effectiveness of a range of potential MPTs; suggesting that MPTs will be cost-effective among higher incidence FSWs or young women, but not among lower incidence older women. More work is needed to make attractive MPTs available to potential users who could use them effectively.

A Randomized Crossover Study Evaluating the Use and Acceptability of the SILCS Diaphragm Compared to Vaginal Applicators for Vaginal Gel Delivery.

INTRODUCTION: This study aimed to assess acceptability and preferences for the SILCS diaphragm for vaginal gel delivery compared to a prefilled applicator. METHODS: A randomized crossover study among 115 women in South Africa, using both methods during five sex acts. RESULTS: We found no significant differences in acceptability between the two products. Experience of gel leakage after sex was greater when inserted via applicator. More women were interested in SILCS/gel for multipurpose protection (68%) than in either SILCS alone (17%) or microbicide gel alone (14%). CONCLUSIONS: A SILCS gel delivery system for multipurpose prevention seems feasible and acceptable.

Divergent Preferences for HIV Prevention: A Discrete Choice Experiment for Multipurpose HIV Prevention Products in South Africa.

BACKGROUND: The development of antiretroviral (ARV)-based prevention products has the potential to substantially change the HIV prevention landscape; yet, little is known about how appealing these products will be outside of clinical trials, as compared with the existing options. METHODS: We conducted a discrete choice experiment (DCE) to measure preferences for 5 new products among 4 important populations in the HIV response: adult men and women in the general population (aged 18 to 49 y), adolescent girls (aged 16 to 17 y), and self-identifying female sex workers (aged 18 to 49 y). We interviewed 661 self-reported HIV-negative participants in peri-urban South Africa, who were asked to choose between 3 unique, hypothetical products over 10 choice sets. Data were analyzed using multinomial, latent class and mixed multinomial logit models. RESULTS: HIV protection was the most important attribute to respondents; however, results indicate significant demand among all groups for multipurpose prevention products that offer protection from HIV infection, other STIs, and unwanted pregnancy. All groups demonstrated a strong preference for long-lasting injectable products. There was substantial heterogeneity in preferences within and across population groups. LIMITATIONS: Hypothetical DCE data may not mirror real-world choices, and products will have more attributes in reality than represented in choice tasks. Background data on participants, including sensitive areas of HIV status and condom use, was self-reported. CONCLUSIONS: These results suggest that stimulating demand for new HIV prevention products may require a more a nuanced approach than simply developing highly effective products. No single product is likely to be equally attractive or acceptable across different groups. This study strengthens the call for effective and attractive multipurpose prevention products to be deployed as part of a comprehensive combination prevention strategy.

Short-Term Acceptability of the Woman's Condom among Married Couples in Shanghai.

Background. The Woman's Condom, a second-generation female condom designed for acceptability, is poised for introduction in China. Method. This single-arm study was conducted among 60 couples in China in 2010 to assess acceptability of the Woman's Condom. Results. Male participants reported that ease of handling, inserting, and removing the device improved significantly from first to fourth use. Female and male participants reported that comfort during insertion, feel of lubricant during insertion, comfort/fit of outer ring during use, and overall comfort improved significantly from first to fourth use. Further, at fourth use, female participants reported significant improvement in the comfort of the feel of the condom material and lubricant. Female and male participants reported that satisfaction with stability and sensation during sex and ability to achieve orgasm improved significantly from first to fourth use. At fourth use, female participants reported statistically significant improvement in sensation compared to using nothing. A majority of participants (78%) stated that they would use the Woman's Condom in the future, primarily due to its dual protection profile. Conclusion. This study has shown that, in China, the Woman's Condom appears to be acceptable to married couples. User experience contributes to improvement in many aspects of device acceptability.

Exploring vaginal ring acceptability for contraception and sexually transmissible infection protection in India: a qualitative research study.

UNLABELLED: Background New vaginal rings are being developed as single and multipurpose prevention technologies to protect women from pregnancy and/or sexually transmissible infections, such as HIV. Data on ring acceptability in low-resource settings is critical for new technologies to meet user needs. METHODS: Women from slum and lower-income areas around Delhi, India, participated in focus group discussions on vaginal ring product perceptions and preferences. Participants were recruited based on following eligibility categories: age, marital status, contraceptive use, and number of children. The translated transcriptions of the qualitative data were analysed using a coding scheme generated from the areas of inquiry and relevant literature. RESULTS: A total of 103 women from lower-middle-class or slum areas in Delhi participated in 13 focus group discussions between December 2012 and January 2013. Participants shared perceptions of vaginal ring product attributes, including size, colour, intended use (single indication or dual purpose), duration of use, side effects, biodegradability, and various preferences regarding product use, including access, use during sex, wear patterns, cleaning, and disposal. Participants also reflected on willingness to pay and male partner acceptability. CONCLUSIONS: The results of this hypothetical acceptability study indicate that these low-income women in Delhi are: willing to try vaginal rings; unconcerned about wearing them during sex; very interested in protection from infections and unintended pregnancy; indifferent about colour of new rings; emphatic about being told that rings may change colour from menstrual blood staining; comfortable with thinner rings; willing to try thicker rings once familiar with thinner rings; in favour of starting with 1-month rings and then transitioning to longer-term rings; and in favour of first accessing rings at a facility and then managing resupply independently.

Cost-Effectiveness of Introducing the SILCS Diaphragm in South Africa.

BACKGROUND: Though South Africa has high contraceptive use, unintended pregnancies are still widespread. The SILCS diaphragm could reduce the number of women with unmet need by introducing a discreet, woman-initiated, non-hormonal barrier method to the contraceptive method mix. METHODS: A decision model was built to estimate the impact and cost-effectiveness of the introduction of the SILCS diaphragm in Gauteng among women with unmet need for contraception in terms of unintended and mistimed pregnancies averted, assuming that the available contraceptives on the market were not a satisfying option for those women. Full costs were estimated both from a provider's and user's perspective, which also accounts for women's travel and opportunity cost of time, assuming a 5% uptake among women with unmet contraceptive need. The incremental cost-effectiveness ratio is computed at five and 10 years after introduction to allow for a distribution of fixed costs over time. A probabilistic sensitivity analysis was conducted to incorporate decision uncertainty. RESULTS: The introduction of the SILCS diaphragm in Gauteng could prevent an estimated 8,365 unintended pregnancies and 2,117 abortions over five years, at an annual estimated cost of US$55 per woman. This comes to a cost per pregnancy averted of US$153 and US$171 from a user's and provider's perspectives, respectively, with slightly lower unit costs at 10 years. Major cost drivers will be the price of the SILCS diaphragm and the contraceptive gel, given their large contribution to total costs (around 60%). CONCLUSIONS: The introduction of the SILCS diaphragm in the public sector is likely to provide protection for some women for whom current contraceptive technologies are not an option. However to realize its potential, targeting will be needed to reach women with unmet need and those with likely high adherence. Further analyses are needed among potential users to optimize the introduction strategy.

Estimating the hypothetical dual health impact and cost-effectiveness of the Woman's Condom in selected sub-Saharan African countries.

BACKGROUND: Female condoms are the only currently available woman-initiated option that offers dual protection from pregnancy and sexually transmitted infections, including HIV. The Woman's Condom is a new female condom designed to provide dual protection and to be highly pleasurable and acceptable. OBJECTIVE: We sought to estimate the potential dual health impact and cost-effectiveness of a Woman's Condom distribution program in 13 sub-Saharan African countries with HIV prevalence rates >4% among adults aged 15-49 years. We used two separate, publicly available models for this analysis, the Impact 2 model developed by Marie Stopes International and the Population Services International disability-adjusted life years (DALY) calculator program. We estimated the potential numbers of pregnancies and DALYs averted when the Woman's Condom is used as a family planning method and the HIV infections and DALYs averted when it is used as an HIV prevention method. RESULTS: Programming 100,000 Woman's Condoms in each of 13 countries in sub-Saharan Africa during a 1-year period could potentially prevent 194 pregnancies and an average of 21 HIV infections in each country. When using the World Health Organization CHOosing Interventions that are Cost-Effective (WHO-CHOICE) criteria as a threshold to infer the potential cost-effectiveness of the Woman's Condom, we found that the Woman's Condom would be considered cost-effective. CONCLUSION: This was a first and successful attempt to estimate the impact of dual protection of female condoms. The health impact is greater for the use of the Woman's Condom as an HIV prevention method than for contraception. Dual use of the Woman's Condom increases the overall health impact. The Woman's Condom was found to be very cost-effective in all 13 countries in our sample.

Contraceptive efficacy, safety, fit, and acceptability of a single-size diaphragm developed with end-user input.

OBJECTIVE: To estimate contraceptive efficacy, safety, acceptability, and fit of a single-size diaphragm used with contraceptive gel. METHODS: We conducted a multicenter trial in which 450 couples used the single-size diaphragm, 300 randomized to acid-buffering gel and 150 to nonoxynol-9, for at least 190 days and six menstrual cycles. Visits were at enrollment and after menstrual cycles 1, 3, and 6. Study outcomes included pregnancy probability, safety, acceptability, and fit. Pregnancy and safety were compared with an historical control group who used a standard diaphragm with these gels. RESULTS: Most (439/450 [98%]) women could be fitted with the single-size diaphragm. A total of 421 of 450 (94%) provided follow-up. The 35 study pregnancies yielded 6-month Kaplan-Meier cumulative typical use pregnancy probabilities per 100 women with 95% confidence intervals (CIs) of 10.4 (6.9-14.0) for all users and 9.6 (5.5-13.6) and 12.5 (5.4-19.5) with acid-buffering gel and nonoxynol-9, respectively. Historical control analysis yielded a propensity score-adjusted estimate of this pregnancy probability for the single-size diaphragm of 11.3 compared with 10.7 per 100 women for the standard diaphragm ([rounded] difference 0.7, 95% CI -3.6 to 4.9). Approximately half (51%) reported at least one urogenital event but compared favorably to the standard diaphragm in historical control analysis. Most (282/342 [82%]) liked the diaphragm. Results suggest that if provided by a clinician, 94% (95% CI 92-96%) could insert, correctly position, and remove the diaphragm. CONCLUSION: The single-size diaphragm was safe, as effective as a standard diaphragm, and acceptable when used with contraceptive gel. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00578877.

Potential for revitalisation of the diaphragm for family planning in Uganda: a rapid assessment of the feasibility of introducing the SILCS Diaphragm.

This health systems assessment evaluated the feasibility of introducing a new contraceptive device, the SILCS single-size diaphragm, into the existing family planning method mix in Uganda. A total of 26 focus group discussions with 201 female and 77 male potential users and 98 key informant interviews with policymakers and providers were conducted between June and August 2010. Potential users, providers, and policymakers recognised that the SILCS Diaphragm could fill a gap in the method mix and expressed eagerness to make the SILCS Diaphragm available, particularly because it is nonhormonal and woman initiated. The diaphragm was viewed by all stakeholders as a method that would increase choice and could improve women's reproductive health in Uganda. Like many countries, Uganda's family planning programme is financially stretched, and clear support for the SILCS Diaphragm by end-users will need to be demonstrated before the product will be considered for public-sector introduction.

Potential for revitalisation of the diaphragm for family planning in Uganda: a rapid assessment of the feasibility of introducing the SILCS Diaphragm

This health systems assessment evaluated the feasibility of introducing a new contraceptive device, the SILCS single-size diaphragm, into the existing family planning method mix in Uganda. A total of 26 focus group discussions with 201 female and 77 male potential users and 98 key informant interviews with policymakers and providers were conducted between June and August 2010. Potential users, providers, and policymakers recognised that the SILCS Diaphragm could fill a gap in the method mix and expressed eagerness to make the SILCS Diaphragm available, particularly because it is nonhormonal and woman initiated. The diaphragm was viewed by all stakeholders as a method that would increase choice and could improve women's reproductive health in Uganda. Like many countries, Uganda's family planning programme is financially stretched, and clear support for the SILCS Diaphragm by end-users will need to be demonstrated before the product will be considered for public-sector introduction. Afr J Reprod Health 2014; 18[2]: 77-86)

Initial reactions to the Woman's Condom by potential user groups in Shanghai, China.

BACKGROUND: The Woman's Condom, a second-generation female condom, is currently being manufactured in China by the Shanghai Dahua Medical Apparatus Company. The manufacturer plans to launch the product in China. METHODS: A survey and focus group discussions were conducted with 73 women and 57 men from nine potential user groups in the Shanghai area to explore, on the basis of visual inspection of the Woman's Condom and product information, their perceptions and attitudes toward the Woman's Condom and lubricant. The potential user groups were male and female university students, male and female college-educated young people, married women and men, migrant women and men, and women working in the entertainment industry. RESULTS: Female condoms were a new concept for almost all study participants. Women (49%) and men (51%) reported that the Woman's Condom would make "some" or a "great" difference in their lives. Participants reported interest in using the Woman's Condom for sexually transmitted infection (STI) (50%) or dual protection (43%) rather than for pregnancy prevention alone (33%). Findings highlighted comfort, partner approval and lubricant as possible concerns. CONCLUSIONS: Product introduction activities should be oriented toward the most likely early adopter groups (i.e. university students, college-educated young people, migrant women and women working in the entertainment industry). Lack of interest in using the new device by married women/men and migrant men may indicate that they do not perceive a need for a dual protection product since they are already using a contraceptive method and/or do not perceive themselves at risk of STIs.

A modified SILCS contraceptive diaphragm for long-term controlled release of the HIV microbicide dapivirine.

BACKGROUND: There is considerable interest in developing new multipurpose prevention technologies to address women's reproductive health needs. This study describes an innovative barrier contraceptive device--based on the SILCS diaphragm--that also provides long-term controlled release of the lead candidate anti-HIV microbicide dapivirine. STUDY DESIGN: Diaphragm devices comprising various dapivirine-loaded polymer spring cores overmolded with a nonmedicated silicone elastomer sheath were fabricated by injection molding processes. In vitro release testing, thermal analysis and mechanical characterization were performed on the devices. RESULTS: A diaphragm device containing a polyoxymethylene spring core loaded with 10% w/w dapivirine provided continuous and controlled release of dapivirine over a 6-month period, with a mean in vitro daily release rate of 174 mcg/day. The mechanical properties of the new diaphragm were closely matched to the SILCS diaphragm. CONCLUSIONS: The study demonstrates proof of concept for a dapivirine-releasing diaphragm with daily release quantities potentially capable of preventing HIV transmission. In discontinuous clinical use, release of dapivirine may be readily extended over 1 or more years.

Performance of the woman's condom among couples in Shanghai, China.

BACKGROUND: The Woman's Condom, a second-generation female condom, is poised for introduction in China. STUDY DESIGN: This single-arm couples' use study was conducted in China in 2010 to assess performance and safety of the Woman's Condom and feasibility of mobile phone technology to record adherence data. RESULTS: Sixty couples were enrolled in this study, and 59 couples completed all four of the condom uses, resulting in 234 condom uses. Two condoms were opened but not used. Total breakage was 0.85% (two non-clinical breakages). Misdirection (2%), invagination (0.85%) and slippage (1%) were consistent with data on condom failure from other studies. Total clinical failure was 4%. Fifteen mild and no serious adverse events were reported during the study. CONCLUSIONS: This study has shown that in China, the Woman's Condom performs well. Mobile phones cannot yet replace the use of a coital log and questionnaire. Further work on effectiveness is required.

A review of the effectiveness and acceptability of the female condom for dual protection.

The female condom remains the sole female-initiated method of dual protection against unintended pregnancy and sexually transmissible infections (STIs), including HIV. We reviewed published data on the effectiveness and acceptability of the female condom for protection against pregnancy and infection. Overall, use of the female condom is low and several barriers hinder the wider adoption of the use of the method. Research on effectiveness has focussed on pregnancy, STIs and biological markers of semen exposure. Although the data available suggest that female condoms (or a mixture of female and male condoms) may provide similar degrees of protection against pregnancy and STIs as do latex male condoms alone, this conclusion has not been demonstrated and thus comparative research is urgently needed.

Couples' acceptability of the SILCS diaphragm for microbicide delivery.

BACKGROUND: Disposable plastic applicators used in microbicide gel studies are expensive and have a negative environmental impact. The SILCS diaphragm is a barrier contraceptive that could offer a reusable delivery system. STUDY DESIGN: Thirty-six couples in this randomized, cross-over study evaluated single- and double-sided gel delivery from a SILCS diaphragm compared with gel from an applicator. Couples used each gel scenario during two acts of intercourse and completed acceptability questionnaires after each. RESULTS: All three scenarios received favorable ratings for ease of application, acceptability and perceived effectiveness. Both female and male participants tended to rate the gel applicator significantly more favorably than either SILCS gel delivery scenarios for all attributes except messiness/leakage and effectiveness. Additionally, about 60% of female participants and about half of male participants preferred the gel applicator to either of the gel delivery systems using SILCS. The preference for the SILCS scenario for pregnancy protection was statistically significant for both sexes. Male participants were also significantly more likely to prefer the SILCS single-sided delivery system to the gel applicator for protection from sexually transmitted infection. CONCLUSIONS: In this study population, participants found the gel applicator to be more acceptable than either single- or double-sided gel delivery from a SILCS diaphragm. Further research of the SILCS as a microbicide delivery system should be implemented to assess its acceptability among study populations that reflect diverse potential user groups such as women and men from both low and high HIV prevalence settings including HIV-positive populations and with and without experience using female barrier methods.