Study protocol: A randomised trial of the effectiveness of the Common Elements Treatment Approach (CETA) for improving HIV treatment outcomes among women experiencing intimate partner violence in South Africa.

INTRODUCTION: Intimate partner violence (IPV) is a barrier to consistent HIV treatment in South Africa. Previous trials have established that the Common Elements Treatment Approach (CETA), a cognitive-behavioural-based intervention, is effective in reducing mental and behavioural health problems but has not been trialled for effectiveness in improving HIV outcomes. This paper describes the protocol for a randomised trial that is testing the effectiveness of CETA in improving HIV treatment outcomes among women experiencing IPV in South Africa. METHODS AND ANALYSIS: We are conducting a randomised trial among HIV-infected women on antiretroviral therapy, who have experienced sexual and/or physical IPV, to test the effect of CETA on increasing retention and viral suppression and reducing IPV. Women living with HIV who have an unsuppressed viral load or are at high risk for poor adherence and report experiencing recent IPV, defined as at least once within in the last 12 months, will be recruited from HIV clinics and randomised 1:1 to receive CETA or an active attention control (text message reminders). All participants will be followed for 24 months. Follow-up HIV data will be collected passively using routinely collected medical records. HIV outcomes will be assessed at 12 and 24 months post-baseline. Questionnaires on violence, substance use and mental health will be administered at baseline, post-CETA completion and at 12 months post-baseline. Our primary outcome is retention and viral suppression (<50 copies/mL) by 12 months post-baseline. We will include 400 women which will give us 80% power to detect an absolute 21% difference between arms. Our primary analysis will be an intention-to-treat comparison of intervention and control by risk differences with 95% CIs. ETHICS AND DISSEMINATION: Ethics approval provided by University of the Witwatersrand Human Research Ethics Committee (Medical), Boston University Institutional Review Board and Johns Hopkins School Institutional Review Board. Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04242992.

Similar costs and outcomes for differentiated service delivery models for HIV treatment in Uganda.

This cost-outcome study estimated, from the perspective of the service provider, the total annual cost per client on antiretroviral therapy (ART) and total annual cost per client virally suppressed (defined as < 1000 copies/ml at the time of the study) in Uganda in five ART differentiated service delivery models (DSDMs). These included both facility- and community-based models and the standard of care (SOC), known as the facility-based individual management (FBIM) model. The Ministry of Health (MOH) adopted guidelines for DSDMs in 2017 and sought to measure their costs and outcomes, in order to effectively plan for their resourcing, implementation, and scale-up. In Uganda, the standard of care (FBIM) is considered as a DSDM option for clients requiring specialized treatment and support, or for those who select not to join an alternative DSDM. Note that clients on second-line regimes and considered as "established on treatment" can join a suitable DSDM.Using retrospective client record review of a cohort of clients over a two-year period, with bottom-up collection of clients' resource utilization data, top-down collection of above-delivery level and delivery-level providers' fixed operational costs, and local unit costs. Forty-seven DSDMs located at facilities or community-based points in the four regions of Uganda were included in the study, with 653 adults on ART (> 18 years old) enrolled in a DSDM. The study found that retention in care was 98% for the sample as a whole [96-100%], and viral suppression, 91% [86-93%]. The mean cost to the provider (MOH or NGO implementers) was $152 per annum per client treated, ranging from $141 to $166. Differences among the models' costs were largely due to clients' ARV regimens and the proportions of clients on second line regimens. Service delivery costs, excluding ARVs, other medicines and laboratory tests, were modest, ranging from $9.66-16.43 per client per year. We conclude that differentiated ART service delivery in Uganda achieved excellent treatment outcomes at a cost similar to the standard of care. While large budgetary savings might not be immediately realized, the reallocation of "saved" staff time could improve health system efficiency and with their equivalent or better outcomes and large benefits to clients, client-centred differentiated models would nevertheless add great societal value.

Fertility desires of people living with HIV: does the implementation of a sexual and reproductive health and HIV integration model change healthcare providers' attitudes and clients' desires?

BACKGROUND: There is a need for information and healthcare support for the fertility desires and contraceptive needs of people living with HIV (PLHIV) in order to provide safer conception support for sero-discordant couples wanting to safely conceive. A model to integrate sexual and reproductive health and HIV services was developed and implemented in a district hospital and six clinics in the eThekwini District, South Africa. METHODS: To evaluate the model's success, a cross-sectional survey was conducted before and after implementation of the model. As part of this evaluation, fertility desires of PLHIV (both male and female), and providers' perspectives thereof were explored. Changes in desires and attitudes after integration of services were investigated. RESULTS: Forty-six healthcare providers and 269 clients (48 male, 221 female) were surveyed at baseline, and 44 providers and 300 clients (70 male, 230 female) at endline. Various factors including relationship status, parity and antiretroviral treatment (ART) access influenced PLHIVs' desires for children. Concerns for their own and their child's health negatively impacted on PLHIV's fertility desires. These concerns declined after integration of services. Similarly, providers' concerns about PLHIV having children decreased after the implementation of the model. CONCLUSIONS: Integrated services are important to facilitate provision of information on contraceptive options as well as safer conception information for PLHIV who want to have children.

Performance of Male Condoms When Used With and Without a Silicone Placebo Vaginal Ring-A Randomized, Crossover Trial.

BACKGROUND: The dapivirine vaginal ring reduced the risk of HIV infection by approximately 30% in Phase III trials. To ensure higher levels of protection against HIV and sexually transmitted infections, women should be counseled to use condoms when using the vaginal ring. This article evaluates the compatibility of male condoms with a placebo vaginal ring. METHODS: This was a 2-period crossover, randomized, noninferiority trial. Couples in 2 sites in the United States were randomized to male condom use, with and without a placebo silicone vaginal ring, and asked to use 4 male condoms in each period. The primary noninferiority end points were total clinical failure and their component failure events (clinical breakage or slippage). Frequencies and percentages were calculated for each failure mode and differences in performance of the 2 periods using the male condom without the ring as reference. Noninferiority was defined using a 3% margin at the 5% significance level. Safety and acceptability were also assessed. RESULTS: Seventy couples were enrolled, and 68 completed the trial with a total of 275 male condoms used in each period. Total condom clinical failure rates were 2.2% and 4.0% in the presence and absence of the vaginal ring, respectively, with a difference of -1.9% (95% confidence interval: -5.3% to 1.5%), thereby demonstrating noninferiority when used with the ring. There was no difference in safety between the 2 periods. DISCUSSION: Concurrent use of the placebo silicone vaginal ring had no significant effect on male condom functionality or safety outcomes.

Performance and Acceptability of the FC2 Female Condom When Used With and Without a Silicone Placebo Vaginal Ring-A Randomized, Crossover Trial.

BACKGROUND: The silicone Dapivirine Vaginal Ring 25 mg, has been developed to provide an additional HIV prevention option for women. If approved for use, women will always be counselled to use condoms when using the vaginal ring for maximum protection. This paper evaluates the compatibility of female condoms with the ring. METHODS: This was a 2-period crossover, randomized noninferiority trial. Couples in 2 sites in the United States of America were randomized to FC2 Female Condom (FC2) with and without a placebo silicone ring and asked to use 4 female condoms in each period. The primary noninferiority endpoint was the clinical failure rate during intercourse or withdrawal (self-reported clinical breakage, slippage, misdirection, and invagination). Frequencies and percentages were calculated for each failure mode and differences in performance of the 2 periods, using the female condom without the ring as reference. Noninferiority was defined using an 8% margin at the 5% significance level. Safety and tolerability were also assessed. RESULTS: Eighty-one couples were enrolled and 79 completed the trial using a total of 596 female condoms (297 and 299 with/without a ring inserted, respectively). Total female condom clinical failure was 14.1% and 15.7% in the presence and absence of a ring, respectively, with a difference of -2.1% (95% confidence interval: -7.8% to 3.6%), thereby demonstrating noninferiority when used with the ring. There were no differences in safety and tolerability between the 2 periods. DISCUSSION: Concurrent use of the placebo silicone vaginal ring had no significant effect on female condom functionality or safety outcomes.

Sexual Relationship Power and Periconception HIV-Risk Behavior Among HIV-Infected Men in Serodifferent Relationships.

Gender norms affect HIV risk within serodifferent partnerships. We assessed how the sexual relationship power described by men living with HIV (MLWH) associates with periconception HIV-transmission risk behavior. Quantitative surveys were conducted with 82 MLWH reporting a recent pregnancy with an HIV-negative or unknown-serostatus partner in KwaZulu-Natal, South Africa. Surveys assessed decision-making dominance (DMD) using the Pulerwitz et al. sexual relationship power scale; partnership characteristics; and HIV-risk behaviors. Multivariable logistic regression models evaluated associations between DMD score and HIV-risk behaviors. Higher male decision-making dominance was associated with non-disclosure of HIV-serostatus to pregnancy partner (aRR 2.00, 95% CI 1.52, 2.64), not knowing partner's HIV-serostatus (aRR 1.64, 95% CI 1.27, 2.13), condomless sex since pregnancy (aRR 1.92, 95% CI 1.08, 3.43), and concurrent relationships (aRR 1.50, 95% CI 1.20, 1.88). Efforts to minimize periconception HIV-risk behavior must address gender norms and power inequities.

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.

Provider understandings of and attitudes towards integration: Implementing an HIV and sexual and reproductive health service integration model, South Africa.

In South Africa, a lack of integration between sexual and reproductive health (SRH) and HIV services has led to lost opportunities in the treatment cascade. In a context of high HIV, tuberculosis (TB) and unplanned pregnancies, a model for integrating SRH and HIV services was implemented in a hospital and six feeder clinics in KwaZulu-Natal, South Africa. Changes in healthcare provider knowledge, attitudes and understandings were explored following model implementation. Baseline data were collected via focus group discussions (FGDs) and a cross-sectional survey, and were used to inform the development of a model for integrating SRH and HIV services. Following the implementation of the model, an endline survey was conducted to explore any changes. Four FGDs were conducted with healthcare providers at study facilities. A total of 46 providers participated in the baseline survey, and 44 in the endline survey. Qualitative data were thematically analysed using NVivo 11, and quantitative data were descriptively analysed using SPSS 24. The understanding of integration improved by endline. Integration of services was considered important for reducing stigma and increasing access to and improving quality of care. Concerns raised were that integration would increase workload and time per client. Physical structure of facilities was not always conducive to referral or integration. Perceived benefits of integration and actual integration of services improved between baseline and endline. Enhanced understanding of integration and increased levels of reported integration over time imply that providers are more aware, suggesting that the model was effective. Provider perspectives and understandings are important for the successful integration of services. This integration model is relevant and useful to inform training and mentoring of providers, as well as to provide recommendations for policy implementation.

Healthcare providers' understanding of HIV serodiscordance in South Africa and Uganda: implications for HIV prevention in sub-Saharan Africa.

HIV transmission within stable heterosexual HIV serodiscordant couples accounts for almost half the new incident infections in South Africa and Uganda. Advances in HIV prevention provide opportunities to reduce transmission risk within serodiscordant partnerships (e.g., antiretroviral treatment (ART), pre-exposure prophylaxis (PrEP), medical male circumcision, and couples-based HIV counselling and testing). These interventions require a clinical encounter with a provider who recognises prevention opportunities within these partnerships. We explored healthcare provider understanding of HIV serodiscordance in a reproductive counselling study with providers in eThekwini district, South Africa, and Mbarara district, Uganda. In eThekwini, in-depth interviews (29) and focus group discussions (2) were conducted with 42 providers (counsellors, nurses and doctors) from public sector clinics. In Mbarara, in-depth interviews were conducted with 38 providers (medical officers, clinical officers, nurses, peer counsellors and village health workers). Thematic analysis was conducted using NVivo software. In eThekwini, many providers assumed HIV seroconcordance among client partners and had difficulty articulating how serodiscordance occurs. Mbarara providers had a better understanding of HIV serodiscordance. In the two countries, providers who understood HIV serodiscordance were better able to describe useful HIV-prevention strategies. Healthcare providers require training and support to better understand the prevalence and mechanisms of HIV serodiscordance to implement HIV-prevention strategies for HIV serodiscordant couples.

Effect of a 'diagonal' intervention on uptake of HIV and reproductive health services by female sex workers in three sub-Saharan African cities.

OBJECTIVES: To enhance uptake of sexual and reproductive health (SRH) services by female sex workers (FSWs), we conducted an implementation study in which we piloted and tested context-specific 'diagonal' interventions, combining vertical, targeted interventions with horizontally improved access to the general health services, in three cities in sub-Saharan Africa. METHODS: We collected indicators of SRH service uptake through face-to-face interviews with approximately 400 FSWs, pre- and post-intervention, in Durban, South Africa; Tete, Mozambique; and Mombasa, Kenya, recruited by respondent-driven sampling. Changes in uptake were tested for their statistical significance using multivariate logistic regression models. RESULTS: In all cities, overall uptake of services increased. Having used all services for contraception, STI care, HIV testing, HIV care, cervical cancer screening and sexual violence, if needed, increased from 12.5% to 41.5% in Durban, 25.0% to 40.1% in Tete and 44.9% to 69.1% in Mombasa. Across cities, the effect was greatest in having been tested for HIV in the past six months which increased from 40.9% to 83.2% in Durban, 56.0% to 76.6% in Tete and 70.9% to 87.6% in Mombasa. In Tete and Mombasa, rise in SRH service use was almost entirely due to a greater uptake of targeted services. Only in Durban was there additionally an increase in the utilisation of general health services. CONCLUSION: SRH service utilisation improved in the short-term in three different sub-Saharan African contexts, primarily through vertical, targeted components. The long-term effectiveness of diagonal approaches, in particular on the use of general, horizontal health services, needs further investigation.

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.

Sexual and reproductive health services utilization by female sex workers is context-specific: results from a cross-sectional survey in India, Kenya, Mozambique and South Africa.

BACKGROUND: Female sex workers (FSWs) are extremely vulnerable to adverse sexual and reproductive health (SRH) outcomes. To mitigate these risks, they require access to services covering not only HIV prevention but also contraception, cervical cancer screening and sexual violence. To develop context-specific intervention packages to improve uptake, we identified gaps in service utilization in four different cities. METHODS: A cross-sectional survey was conducted, as part of the baseline assessment of an implementation research project. FWSs were recruited in Durban, South Africa (n = 400), Mombasa, Kenya (n = 400), Mysore, India (n = 458) and Tete, Mozambique (n = 308), using respondent-driven sampling (RDS) and starting with 8-16 'seeds' identified by the peer educators. FSWs responded to a standardised interviewer-administered questionnaire about the use of contraceptive methods and services for cervical cancer screening, sexual violence and unwanted pregnancies. RDS-adjusted proportions and surrounding 95% confidence intervals were estimated by non-parametric bootstrapping, and compared across cities using post-hoc pairwise comparison tests with Dunn-Sidák correction. RESULTS: Current use of any modern contraception ranged from 86.2% in Tete to 98.4% in Mombasa (p = 0.001), while non-barrier contraception (hormonal, IUD or sterilisation) varied from 33.4% in Durban to 85.1% in Mysore (p < 0.001). Ever having used emergency contraception ranged from 2.4% in Mysore to 38.1% in Mombasa (p < 0.001), ever having been screened for cervical cancer from 0.0% in Tete to 29.0% in Durban (p < 0.001), and having gone to a health facility for a termination of an unwanted pregnancy from 15.0% in Durban to 93.7% in Mysore (p < 0.001). Having sought medical care after forced sex varied from 34.4% in Mombasa to 51.9% in Mysore (p = 0.860). Many of the differences between cities remained statistically significant after adjusting for variations in FSWs' sociodemographic characteristics. CONCLUSION: The use of SRH commodities and services by FSWs is often low and is highly context-specific. Reasons for variation across cities need to be further explored. The differences are unlikely caused by differences in socio-demographic characteristics and more probably stem from differences in the availability and accessibility of SRH services. Intervention packages to improve use of contraceptives and SRH services should be tailored to the particular gaps in each city.

Client and provider knowledge and views on safer conception for people living with HIV (PLHIV).

OBJECTIVE(S): The childbearing needs of people living with HIV (PLHIV) and the experiences of healthcare providers serving them are explored. We examine provider and client knowledge and views on safer conception methods. METHODS: The study uses exploratory qualitative research to understand provider and client perspectives on childbearing and safer conception. Interviews were conducted at 3 sites (1 rural, 2 urban) in eThekwini District, KwaZulu-Natal, South Africa between May 2011 and August 2012, including in-depth interviews with 43 PLHIV, 2 focus group discussions and 12 in-depth interviews with providers. RESULTS: Clients had little knowledge and providers had limited knowledge of safer conception methods. While clients were eager to receive counseling on safer conception, providers had some hesitations but were eager to receive training in delivering safer conception services. Clients and providers noted that biological parentage is a major concern of PLHIV. Clients were willing to use any of the described methods to have biological children but some expressed concerns about potential risks associated with timed unprotected intercourse. Male clients required access to reproductive health information. CONCLUSIONS: Providers need to routinely initiate discussions with clients about childbearing intentions. Providers need to be enabled with approved guidelines and training to support client access to safer conception methods.

HIV prevention and care-seeking behaviour among female sex workers in four cities in India, Kenya, Mozambique and South Africa.

OBJECTIVE: To identify gaps in the use of HIV prevention and care services and commodities for female sex workers, we conducted a baseline cross-sectional survey in four cities, in the context of an implementation research project aiming to improve use of sexual and reproductive health services. METHODS: Using respondent-driven sampling, 400 sex workers were recruited in Durban, 308 in Tete, 400 in Mombasa and 458 in Mysore and interviewed face-to-face. RDS-adjusted proportions were estimated by nonparametric bootstrapping and compared across cities using post hoc pairwise comparison. RESULTS: Condom use with last client ranged from 88.3% to 96.8%, ever female condom use from 1.6% to 37.9%, HIV testing within the past 6 months from 40.5% to 70.9%, receiving HIV treatment and care from 35.5% to 92.7%, care seeking for last STI from 74.4% to 87.6% and having had at least 10 contacts with a peer educator in the past year from 5.7% to 98.1%. Many of the differences between cities remained statistically significant (P < 0.05) after adjusting for differences in FSWs' socio-demographic characteristics. CONCLUSION: The use of HIV prevention and care by FSWs is often insufficient and differed greatly between cities. Differences could not be explained by variations in socio-demographic sex worker characteristics. Models to improve use of condoms and HIV prevention and care services should be tailored to the specific context of each site. Programmes at each site must focus on improving availability and uptake of those services that are currently least used.

Where Do Female Sex Workers Seek HIV and Reproductive Health Care and What Motivates These Choices? A Survey in 4 Cities in India, Kenya, Mozambique and South Africa.

BACKGROUND: A baseline cross-sectional survey among female sex workers (FSWs) was conducted in four cities within the context of an implementation research project aiming to improve FSWs' access to HIV, and sexual and reproductive health (SRH) services. The survey measured where FSWs seek HIV/SRH care and what motivates their choice. METHODS: Using respondent-driven sampling (RDS), FWSs were recruited in Durban, South Africa (n = 400), Tete, Mozambique (n = 308), Mombasa, Kenya (n = 400) and Mysore, India (n = 458) and interviewed. RDS-adjusted proportions were estimated by non-parametric bootstrapping, and compared across cities using post-hoc pairwise comparison tests. RESULTS: Across cities, FSWs most commonly sought care for the majority of HIV/SRH services at public health facilities, most especially in Durban (ranging from 65% for condoms to 97% for HIV care). Services specifically targeting FSWs only had a high coverage in Mysore for STI care (89%) and HIV testing (79%). Private-for-profit clinics were important providers in Mombasa (ranging from 17% for STI care and HIV testing to 43% for HIV care), but not in the other cities. The most important reason for the choice of care provider in Durban and Mombasa was proximity, in Tete 'where they always go', and in Mysore cost of care. Where available, clinics specifically targeting FSWs were more often chosen because of shorter waiting times, perceived higher quality of care, more privacy and friendlier personnel. CONCLUSION: The place where care is sought for HIV/SRH services differs substantially between cities. Targeted services have limited coverage in the African cities compared to Mysore. Convenience appears more important for choosing the place of care than aspects of quality of care. The best model to improve access, linking targeted interventions with general health services, will need to be tailored to the specific context of each city.

Choice in HIV testing: the acceptability and anticipated use of a self-administered at-home oral HIV test among South Africans.

Combination HIV prevention is being widely promoted by funders. This strategy aims to offer HIV prevention choices that can be selected and combined to decrease HIV risk in ways that fit with each individual's situation. Treatment as prevention and pre-exposure prophylaxis are two new evidence-based strategies to decrease HIV incidence, both of which require high HIV testing rates to be effective, and the Joint United Nations Programme on HIV/AIDS (UNAIDS) has set a goal of 90% of HIV-positive individuals knowing their status by 2030. However, HIV testing rates in many countries remain suboptimal. Just as no single HIV prevention method is ideal for all people in all situations, no single HIV testing modality is likely to be acceptable to everyone. By offering HIV testing choices, we may be able to increase testing rates. However, many low-resourced countries have been slow to take up new HIV testing options such as the self-administered at-home oral HIV test that is currently available in the United States. In this paper, we present findings from 20 in-depth interviews, conducted in 2010, documenting opinions about self-administered at-home oral HIV testing, a testing modality still largely unavailable in Africa. Participants were clients of three primary healthcare clinics in South Africa. Self-testing was seen as enabling confidentiality/privacy, saving time, and facilitating testing together with partners. However, concerns were raised about psychological distress when testing at home without a counsellor. Some suggested this concern could be minimised by having experienced clinic-based HIV testing and counselling before getting self-testing kits for home use. Thus, self-administered HIV testing could be an option added to the current testing modalities to address some important barriers to testing.

Barriers to HIV and sexual and reproductive health care for female sex workers in Tete, Mozambique: results from a cross-sectional survey and focus group discussions.

BACKGROUND: In the context of an operational research project in Tete, Mozambique, use of, and barriers to, HIV and sexual and reproductive health (HIV/SRH) commodities and services for female sex workers (FSWs) were assessed as part of a baseline situational analysis. METHODS: In a cross-sectional survey 311 FSWs were recruited using respondent driven sampling and interviewed face-to-face, and three focus group discussions were held with respectively 6 full-time Mozambican, 7 occasional Mozambican and 9 full-time Zimbabwean FSWs, to investigate use of, and barriers to, HIV/SRH care. RESULTS: The cross-sectional survey showed that 71 % of FSWs used non-barrier contraception, 78 % sought care for their last sexually transmitted infection episode, 51 % of HIV-negative FSWs was tested for HIV in the last 6 months, 83 % of HIV-positive FSWs were in HIV care, 55 % sought help at a health facility for their last unwanted pregnancy and 48 % after sexual assault, and none was ever screened for cervical cancer. Local public health facilities were by far the most common place where care was sought, followed by an NGO-operated clinic targeting FSWs, and places outside the Tete area. In the focus group discussions, FSWs expressed dissatisfaction with the public health services, as a result of being asked for bribes, being badly attended by some care providers, stigmatisation and breaches of confidentiality. The service most lacking was said to be termination of unwanted pregnancies. CONCLUSIONS: The use of most HIV and SRH services is insufficient in this FSW population. The public health sector is the main provider, but access is hampered by several barriers. The reach of a FSW-specific NGO clinic is limited. Access to, and use of, HIV and SRH services should be improved by reducing barriers at public health facilities, broadening the range of services and expanding the reach of the targeted NGO clinic.

A randomized noninferiority crossover controlled trial of the functional performance and safety of new female condoms: an evaluation of the Velvet, Cupid2, and FC2.

OBJECTIVES: New designs of female condoms have been developed to lower cost and/or improve acceptability. To secure regulatory approvals, clinical studies are required to verify performance. We aimed to assess the functional performance and safety of two new female condom types - Velvet and Cupid2 female condom - against the existing FC2 female condom. STUDY DESIGN: This was a three-period crossover, randomized noninferiority clinical trial with 300 women randomized to condom-type order in one South African site. Primary end points were total clinical failure and total female condom failure. Noninferiority of component modes, clinical breakage, nonclinical breakage, slippage, misdirection and invagination were also determined. Safety data were also assessed for each female condom. Participants were asked to use five of each female condom type and to collect information on use in a condom diary at home and were interviewed after use of each type. Frequencies and percentages were calculated by condom type for each failure mode, and differences in performance of the three female condoms using FC2 as reference, with 95% confidence intervals, were estimated using generalized estimating equation models. RESULTS: A total of 282 (94%) participants completed follow-up, using at least one condom of each type. Total clinical failure (clinical breakage, invagination, misdirection, slippage) was <5% for all female condoms: FC2 (4.50%), Cupid2 (4.79%) and Velvet (3.93%). Noninferiority was demonstrated for all condom failure modes for the two new female condoms with respect to FC2, within the margin of 3% difference in mean failure, at the 5% significance level. CONCLUSION: Noninferiority for the two new female condoms was demonstrated with respect to the marketed FC2. These data are used to support manufacturer dossiers for World Health Organization (WHO)/United Nations Population Fund (UNFPA) prequalification. IMPLICATIONS: Data from this study have been submitted to WHO/UNFPA and will contribute to the prequalification submission requirements for the Cupid2 and Velvet female condoms.