Ross Greener

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. We conducted in-depth interviews (9 counselors, 15 nurses, 5 doctors) and focus group discussions (6 counselors, 7 professional nurses) in eThekwini District, South Africa. Data were translated, transcribed, and analyzed using content analysis with NVivo10 software. Results:Among 42 participants, median age was 41 (range, 28–60) years, 93% (39) were women, and median years worked in the clinic was 7 (range, 1–27). Some providers assessed womens, not mens, plans for having children at antiretroviral therapy initiation, to avoid fetal exposure to efavirenz. When conducted, reproductive counseling included CD4 cell count and HIV viral load assessment, advising mutual HIV status disclosure, and referral to another provider. Barriers to safer conception counseling included provider assumptions of HIV seroconcordance, low knowledge of safer conception strategies, personal feelings toward PLWH having children, and challenges to tailoring safer sex messages. Conclusions:Providers need information about HIV serodiscordance and safer conception strategies to move beyond discussing only perinatal transmission and maternal health for PLWH who choose to conceive. Safer conception counseling may be more feasible if the message is distilled to delaying conception attempts until the infected partner is on antiretroviral therapy. Designated and motivated nurse providers may be required to provide comprehensive safer conception counseling.

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 Womans Condom, the VA worn-of-women (wow) Condom Feminine, and the Cupid female condom-against the existing second-generation female condom (FC2). METHODS We did a randomised controlled, non-inferiority, four-period crossover trial at three sites in Shanghai, China, and one site in Durban, South Africa, between May 1, 2011, and Jan 31, 2012. Participants aged 18-45 years who were sexually active, monogamous, not pregnant, and not sex workers, were eligible for inclusion if they were literate, had no known allergies to the study products; used a reliable, non-barrier method of contraception, and had no visible or reported sexually transmitted infections. We used a computer-generated randomisation sequence with a Williams square design of size four to assign patients (1:1:1:1) to the FC2 control device, or the Womans, VA wow, or Cupid condoms, with 12 potential allocations. Randomisation was stratified by site. Participants were not masked to condom type, but allocation was concealed from study investigators. The primary non-inferiority endpoints were total clinical failure and total female condom failure, with a non-inferiority margin of 3%. Women were asked to use five of each condom type and were interviewed after use of each type. We also assessed safety data for each type. We did both per-protocol and intention-to-treat analyses. We calculated frequencies and percentages for each failure event and estimated differences in performance with a generalised estimating equation model. This study is registered, number DOH-27-0113-4271. FINDINGS 616 women were assessed for eligibility, of whom 600 were randomly assigned to condom-type order (30, 120, and 150 women in the three sites in China, and 300 women in the site in South Africa). 572 women completed follow-up, with at least one condom of each type. Total female condom failure was 3·43% for FC2, 3·85% for the Womans Condom (difference 0·42%, 90% CI -1·42 to 2·26), 3·02% for VA wow (-0·42%, -1·86 to 1·32), and 4·52% for Cupid (1·09%, -0·60 to 2·78); total clinical failure was 2·88%, 3·05% (0·17%, -1·48 to 1·81), 2·49% (-0·25%, -1·75 to 1·26), and 3·87% (0·99%, -0·55 to 2·52), respectively. Only two (<1%) participants, in South Africa, reported serious adverse events, unrelated to use of the study products. INTERPRETATION Non-inferiority was shown for all condom failure events for the three new devices versus the FC2, within the predefined margin. FUNDING Universal Access to Female Condoms (UAFC).

“If I don’t use a condom … I would be stressed in my heart that I’ve done something wrong”: Routine Prevention Messages Preclude Safer Conception Counseling for HIV-Infected Men and Women in South Africa

Intended conception likely contributes to a significant proportion of new HIV infections in South Africa. Safer conception strategies require healthcare provider–client communication about fertility intentions, periconception risks, and options to modify those risks. We conducted in-depth interviews with 35 HIV-infected men and women accessing care in South Africa to explore barriers and promoters to patient–provider communication around fertility desires and intentions. Few participants had discussed personal fertility goals with providers. Discussions about pregnancy focused on maternal and child health, not sexual HIV transmission; no participants had received tailored safer conception advice. Although participants welcomed safer conception counseling, barriers to client-initiated discussions included narrowly focused prevention messages and perceptions that periconception transmission risk is not modifiable. Supporting providers to assess clients’ fertility intentions and offer appropriate advice, and public health campaigns that address sexual HIV transmission in the context of conception may improve awareness of and access to safer conception strategies.

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.

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

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.

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.

BackgroundFemale 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.MethodsA 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–Šidák correction.ResultsCurrent 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.ConclusionThe 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.

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, Womans Condom, Cupid and VA w.o.w) among 300 women in Durban, South Africa. FC functional failure (breakage, slippage, invagination and misdirection) by condom type and use period was investigated in women using five FCs of each type (20 FC uses in total). RESULTS Of the 5364 condoms used during intercourse by 272 women, 200 clinical failures occurred in 195 condoms (190 condoms had one failure, and 5 had two failures). Total clinical failure was comparable across FC types. Of the 195 condoms in which failures occurred, the number of failures in the first condom use period was 103 (7.7%), decreasing to 43 events (3.2%) in the second, 33 (2.5%) in the third and 16 (1.2%) in the fourth. Only 2 failures were reported in the 20th use of an FC compared to 29 in the first use, irrespective of condom type. CONCLUSIONS FC failure rates decreased markedly after use of the first five condoms regardless of FC type and continued to fall across the next three use periods. IMPLICATIONS FC failure rates decrease over 20 uses, regardless of FC condom type used. The decrease is higher at the beginning of use, indicating that improvement is greatest after the first five uses.

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.