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.

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.

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.

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.

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.

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.

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

We aimed to assess the functional performance and safety of a modified Woman's Condom (WC2) against the existing FC2 female condom. 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Acceptability and performance of the menstrual cup in South Africa: a randomized crossover trial comparing the menstrual cup to tampons or sanitary pads.

Background: In low-income settings, many women and girls face activity restrictions during menses, owing to lack of affordable menstrual products. The menstrual cup (MC) is a nonabsorbent reusable cup that collects menstrual blood. We assessed the acceptability and performance of the MPower® MC compared to pads or tampons among women in a low-resource setting.

The female condom learning curve: patterns of female condom failure over 20 uses.

Background: Male and female condom (FC) functional performance failure declines with user experience. With the recent availability of a wider range of FCs, it is important to know if women with experience in using one type of FC are more proficient in using another type, even if the FC design is quite different.

Study Design: A randomized, noninferiority crossover clinical trial assessed the function of four FCs (FC2, Woman's Condom, Cupid and VA w.

Lost opportunities to reduce periconception HIV transmission: safer conception counseling by South African providers addresses perinatal but not sexual HIV transmission.

Introduction: Safer conception strategies create opportunities for HIV-serodiscordant couples to realize fertility goals and minimize periconception HIV transmission. Patient-provider communication about fertility goals is the first step in safer conception counseling.

Methods: We explored provider practices of assessing fertility intentions among HIV-infected men and women, attitudes toward people living with HIV (PLWH) having children, and knowledge and provision of safer conception advice.

South Africans with recent pregnancy rarely know partner's HIV serostatus: implications for serodiscordant couples interventions.

Background: Implementation of safer conception strategies requires knowledge of partner HIV-serostatus. We recruited women and men in a high HIV-prevalence setting for a study to assess periconception risk behavior among individuals reporting HIV-serodiscordant partnerships. We report screening data from that study with the objective of estimating the proportion of individuals who are aware that they are in an HIV-serodiscordant relationship at the time of conception.

Performance and safety of the second-generation female condom (FC2) versus the Woman's, the VA worn-of-women, and the Cupid female condoms: a randomised controlled non-inferiority crossover trial.

Background: New designs of female condom have been developed to reduce costs and improve acceptability. To secure regulatory approvals, clinical studies are needed to verify performance. We aimed to assess the functional performance and safety of three new condom types-the Woman's Condom, the VA worn-of-women (wow) Condom Feminine, and the Cupid female condom-against the existing second-generation female condom (FC2).