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.

Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women.

BACKGROUND: The incidence of human immunodeficiency virus (HIV) infection remains high among women in sub-Saharan Africa. We evaluated the safety and efficacy of extended use of a vaginal ring containing dapivirine for the prevention of HIV infection in 1959 healthy, sexually active women, 18 to 45 years of age, from seven communities in South Africa and Uganda. METHODS: In this randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned participants in a 2:1 ratio to receive vaginal rings containing either 25 mg of dapivirine or placebo. Participants inserted the rings themselves every 4 weeks for up to 24 months. The primary efficacy end point was the rate of HIV type 1 (HIV-1) seroconversion. RESULTS: A total of 77 participants in the dapivirine group underwent HIV-1 seroconversion during 1888 person-years of follow-up (4.1 seroconversions per 100 person-years), as compared with 56 in the placebo group who underwent HIV-1 seroconversion during 917 person-years of follow-up (6.1 seroconversions per 100 person-years). The incidence of HIV-1 infection was 31% lower in the dapivirine group than in the placebo group (hazard ratio, 0.69; 95% confidence interval [CI], 0.49 to 0.99; P=0.04). There was no significant difference in efficacy of the dapivirine ring among women older than 21 years of age (hazard ratio for infection, 0.63; 95% CI, 0.41 to 0.97) and those 21 years of age or younger (hazard ratio, 0.85; 95% CI, 0.45 to 1.60; P=0.43 for treatment-by-age interaction). Among participants with HIV-1 infection, nonnucleoside reverse-transcriptase inhibitor resistance mutations were detected in 14 of 77 participants in the dapivirine group (18.2%) and in 9 of 56 (16.1%) in the placebo group. Serious adverse events occurred more often in the dapivirine group (in 38 participants [2.9%]) than in the placebo group (in 6 [0.9%]). However, no clear pattern was identified. CONCLUSIONS: Among women in sub-Saharan Africa, the dapivirine ring was not associated with any safety concerns and was associated with a rate of acquisition of HIV-1 infection that was lower than the rate with placebo. (Funded by the International Partnership for Microbicides; ClinicalTrials.gov number, NCT01539226 .).

Acceptability and performance of a nonwoven device for vaginal drug delivery among women and their male partners in KwaZulu-Natal, South Africa.

Background: Multipurpose prevention technologies are needed to provide protection against HIV and sexually transmitted infections. Gel-based vaginal microbicides inserted via an applicator are prone to leakage. A novel device for vaginal drug delivery was developed to contain gel-based formulations, aiming to improve gel retention and reduce leakage. The objectives of this study were to assess acceptability and performance of a nonwoven vaginal delivery device. Methods: A nonwoven vaginal delivery device was prepared, pre-saturated with a commercially available water-based lubricant, with a finger pocket for insertion and string for removal. Quantitative and qualitative methods were used to collect data from interviews with 40 women and 10 male partners recruited from a sexual and reproductive health clinic in Durban, KwaZulu-Natal, South Africa. Women wore one device in the clinic and one device overnight or with their partner during intercourse. The primary endpoint was acceptability including comfort, ease of insertion and removal, and opinions on device attributes. Results: Most women said the device was 'easy' to insert and remove. Six women reported leakage after insertion and 34 reported having sexual intercourse while wearing the device. One woman was lost-to-follow-up and five women only wore the device overnight because their partners did not agree to intercourse with the inserted device. The best-liked attribute was the device's lubrication (22 women, 7 men); the least-liked was the removal string (9 women, 8 men). Conclusions: Data are promising for further development of this nonwoven device for vaginal drug delivery. Plain English summary Multipurpose prevention technologies (MPTs) that protect against HIV and sexually transmitted infections (STIs) are urgently needed. A variety of vaginal gel-based products are actively being researched; however, these products can often have challenges with vaginal leakage and retention. This research investigates the acceptability and performance of a nonwoven device to deliver vaginal gel formulations. The gel used in this study was a currently available marketed personal lubricant. In South Africa, 40 women (and 10 male partners) were recruited and given the opportunity to comment on various device attributes after insertion, overnight wear and sexual intercourse with their male partners. Generally, participants found the device easy to use and acceptable, where many factors possibly contributed to the device's acceptability (i.e., similarity to tampons, saturation with lubricant, minimal leakage, ease of insertion, comfort during intercourse and the male partners' willingness to have vaginal intercourse with the device in place). Further studies of the vaginal delivery device for acceptability, safety and efficacy using a gel-based formulation with an active ingredient are warranted.

"It Was Not My Aim to Sleep There": The Impact of Timing and Location of Sex on Adherence to Coitally-Dependent HIV Pre-exposure Prophylaxis.

The FACTS 001 trial found that vaginal pre- and post-coital application of 1% tenofovir gel did not prevent HIV-1 infection amongst young South African women. The trial included a multi-faceted approach to adherence support and collected objective and self-reported adherence measures. Using qualitative data collected from a random sub-set of FACTS 001 participants (135 in-depth interviews at product discontinuation and 13 focus group discussions at dissemination of trial results), we explore the importance of 'place' and 'timing' in shaping acts of sexual intimacy and product adherence. Demographically, this qualitative sub-sample is similar to the trial cohort of predominantly young, unemployed women living with parents or other family members. Sexual intimacy was largely unpredictable and happened across multiple locations in which women had limited privacy, autonomy, or control over the timing of sex. This made adherence to the dosing strategy challenging. Findings may inform the development of future event-driven pre-exposure prophylaxis regimens or products.

Developing a model for integrating sexual and reproductive health services with HIV prevention and care in KwaZulu-Natal, South Africa.

BACKGROUND: There are few rigorous studies evaluating the benefits of vertical versus integrated delivery of healthcare services, and limited published studies describing conceptual models of integration at service-delivery level in public healthcare facilities. This article seeks to fill this gap, by describing the development of a district-based model for integrating sexual and reproductive health (SRH) and HIV services in KwaZulu-Natal, South Africa. METHODS: Baseline data were collected from seven urban public healthcare facilities through client and provider interviews, and a facility inventory was completed to assess current service integration practices. Feedback sessions were held with health providers from participating facilities to share data collected and explore appropriate integration scenarios. A conceptual model of potential service integration was then designed, and subsequently implemented and evaluated in the research sites. RESULTS: Key principles of the model included a focus on health system strengthening and strong community input and involvement. The model was designed primarily to support the integration of family planning into HIV services, and included measures to improve client and commodity monitoring; capacity building through training and mentorship; and a 'health navigation' strategy to strengthen referrals within and between public healthcare facilities. Endline evaluation data were collected in the same facilities following implementation of the model. CONCLUSIONS: This manuscript demonstrates the utility of the conceptual model. It shows that service integration can be accomplished in a phased manner with support of community and healthcare providers. In addition, local context must be taken into account and the components of the model should be flexible to suit the needs of the health system.

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.

Sexual and reproductive health risk behaviours among South African university students: results from a representative campus-wide survey.

Among South African university students, HIV prevalence is lower than in age-peers, but at 3.8% it is not negligible. We examined prevalence of factors potentially associated with HIV risk, focusing on partnership characteristics and consistent condom use. We hypothesised that contraceptive-related factors, for example, desire to prevent pregnancy and not using hormonal contraceptives, would be positively associated with consistent condom use. Data were drawn from a representative interviewer-administered survey of 2nd to 4th year students conducted during registration at a university campus in KwaZulu-Natal. Of 576 students, 218 (83 women, 135 men) reported vaginal intercourse in the past 2 months. Of these, 7% of women and 43% of men reported past-year concurrent partnerships, and 24% knew/ suspected partner non-monogamy. Although reported condom use at last intercourse was 90%, 2-month consistent use was 53% (women) and 73% (men). Reported hormonal contraception use was low (women: 36.8%; men: 16.7%), and 68% used condoms for dual protection. In gender-stratified multivariable analyses, consistent condom use was higher for men who reported their partner did not use (vs. used) hormonal contraception (aOR = 5.84; 95%CI = 2.71, 12.57; p < 0.001) and who reported using condoms for dual protection (vs. single protection) (aOR = 2.46; 95%CI = 1.43, 4.25; p = 0.001). No contraception-related factors were associated with consistent condom use among women. Sexual partnership characteristics potentially place sexually active university students at high HIV risk and should be investigated further. Among men, but not women, contraceptive concerns were associated with consistent condom use. Promoting condoms for dual protection may resonate with students and should be continued.

Promoting Female Condom Use Among Female University Students in KwaZulu-Natal, South Africa: Results of a Randomized Behavioral Trial.

Relatively few interventions have tested the efficacy of female condom promotion either alone or in combination with other barrier methods. We evaluated the efficacy of a two-session (enhanced) cognitive-behavioral intervention (EI) (n = 147) against a one-session control (minimal) educational intervention (MI) (n = 149) to promote female condom (FC) use among female students aged 18-28 at a South African university. We assessed change from baseline to 2.5 and 5 months in number of vaginal intercourse occasions unprotected by male or female condoms in EI versus MI using generalized linear models with a log link function and GEE. Both groups reported significant reductions in number of unprotected vaginal intercourse occasions from baseline to each follow-up, with no significant difference between the two-session and single-session intervention. Introduction of a brief group-based MI FC promotion intervention with FC access holds promise for delivery in clinics and other community venues.

Inkwari: an emerging high-risk place potentiating hiv spread among young adults in a hyper-endemic South African setting.

Young adults in South Africa are at the epicenter of the HIV epidemic. The prevalence of HIV among young people in the province of KwaZulu-Natal (KZN) is particularly high. This study characterizes inkwari (Zulu word for raves or weekend-long parties) in eThekwini District, KZN and explored how these place-based dynamics shape the risk environment for the young adult attendees. In 2011, 13 qualitative interviews were conducted with men and women between 18 and 30 years-old who reported unprotected sex with at least one casual partner in the prior 3 months and attended an inkwari in the same time period. Interviews were analyzed using qualitative content analysis. Nine key informant interviews helped to triangulate these data. Five women and eight men were interviewed and the mean age was 25 years (SD 3.24). Ten reported meeting a sexual partner at an inkwari. Inkwari were characterized as sexualized settings with limited adult supervision. Participants attended inkwari to socialize with peers, use drugs and alcohol, and meet sexual partners. Sexual and physical violence also occurred at inkwari. Given the convergence of social, sexual, and substance-using networks at inkwari, further inquiry is needed to determine how this place may potentiate HIV transmission risk in an endemic setting.

Whoonga: potential recreational use of HIV antiretroviral medication in South Africa.

Whoonga is a drug cocktail in South Africa rumored to contain illicit drugs and HIV antiretroviral (ARV) medication. Although its use may adversely impact adherence to HIV treatment and may have the potential to generate ARV resistance, there is a paucity of research characterizing whoonga. We learned of whoonga during semi-structured interviews about substance abuse and HIV risk at "club-events" known as inkwaris in an urban township of Durban, South Africa. Whoonga was an emerging theme spontaneously identified as a problem for the community by 17 out of 22 informants. Perceptions of whoonga suggest that it is highly addictive, contains ARVs (notably efavirenz), is used by individuals as young as 14, and poses a threat to the health and safety of those who use it, including increasing the risk of HIV infection. Our informants provide preliminary evidence of the dangers of whoonga and reinforce the need for further study.

Everywhere you go, everyone is saying condom, condom. But are they being used consistently? Reflections of South African male students about male and female condom use.

Young men in South Africa can play a critical role in preventing new human immunodeficiency virus (HIV) infections, yet are seldom targeted for HIV prevention. While reported condom use at last sex has increased considerably among young people, consistent condom use remains a challenge. In this study, 74 male higher education students gave their perspectives on male and female condoms in 10 focus group discussions. All believed that condoms should be used when wanting to prevent conception and protect against HIV, although many indicated that consistent condom use was seldom attained, if at all. Three possible situations for not using condoms were noted: (i) when sex happens in the heat of the moment and condoms are unavailable, (ii) when sexual partnerships have matured and (iii) when female partners implicitly accept unprotected sex. Men viewed it as their responsibility to have male condoms available, but attitudes about whose decision it was to initiate condom use were mixed. Almost all sexually active men had male condom experience; however, very few had used female condoms. Prevention initiatives should challenge traditional gendered norms that underpin poor condom uptake and continued use and build on the apparent shifts in these norms that are allowing women greater sexual agency.

Safety, adherence, and HIV-1 seroconversion among women using the dapivirine vaginal ring (DREAM): an open-label, extension study.

BACKGROUND: The Ring Study, a phase 3 trial in 1959 sexually active women (randomised 2:1), showed a favourable safety profile and a 31% HIV-1 infection risk reduction for a vaginal ring containing 25 mg of dapivirine, compared with a placebo ring. We report here the DREAM study, which aimed to evaluate safety, adherence, and HIV-1 incidence in those using the dapivirine vaginal ring (DVR) in open-label use. METHODS: The DREAM study is an open-label extension of The Ring Study, done at five research centres in South Africa and one research centre in Uganda. Former participants from The Ring Study, who remained HIV-negative and who did not discontinue the study due to an adverse event or safety concern that was considered to be related to the investigational product, were eligible. Women who were pregnant, planning to become pregnant, or breastfeeding at screening for DREAM were excluded. All participants received the DVR for insertion at the enrolment visit. Participants attended a 1-month follow-up visit and could either proceed with visits once every 3 months or attend monthly visits up to month 3 and then continue with visits once every 3 months. At each visit, HIV testing and safety evaluations were done, and residual dapivirine measured in used rings (approximately 4 mg is released from the DVR over 28 days of consistent use). HIV-1 incidence was compared descriptively with the simulated incidence rate obtained from bootstrap sampling of participants in the placebo group of The Ring Study, matched for research centre, age, and presence of sexually transmitted infections at enrolment. This study is registered with ClinicalTrials.gov, NCT02862171. FINDINGS: Between July 12, 2016, and Jan 11, 2019, 1034 former participants from The Ring Study were screened, 941 were enrolled and 848 completed the trial. 616 (65·5%) of 941 participants reported treatment-emergent adverse events. Of these, six (0·6%) had events considered to be treatment-related. No treatment-related serious adverse events were reported. Measurements of monthly ring residual amounts in participants enrolled in both trials showed consistently lower mean values in DREAM than in The Ring Study. Arithmetic mean ring residual amounts of participants in The Ring Study DVR group who enrolled in DREAM were 0·25 mg lower (95% CI 0·03-0·47; p=0·027) than the mean ring residual amounts of these participants in The Ring Study. 18 (1·9%) HIV-1 infections were confirmed during DVR use, resulting in an incidence of 1·8 (95% CI 1·1-2·6) per 100 person-years, 62% lower than the simulated placebo rate. INTERPRETATION: Although efficacy estimation is limited by the absence of a placebo group, the observed low HIV-1 incidence and improved adherence observed in DREAM support the hypothesis that increased efficacy due to improved adherence occurs when women know the demonstrated safety and efficacy of the DVR. The feasibility of a visit schedule of once every 3 months was shown, indicating that the DVR can be used in a real-world situation in usual clinical practice. FUNDING: The Ministry of Foreign Affairs (MFA) Denmark, Flanders MFA, Irish Aid, Dutch MFA, UK Aid from the UK Government's Foreign, Commonwealth and Development Office, and the US President's Emergency Plan for AIDS Relief through the US Agency for International Development.

HIV Incidence Among Pregnant and Nonpregnant Women in the FACTS-001 Trial: Implications for HIV Prevention, Especially PrEP Use.

BACKGROUND: During pregnancy and postpartum period, the sexual behaviors of women and their partners change in ways that may either increase or reduce HIV risks. Pregnant women are a priority population for reducing both horizontal and vertical HIV transmission. SETTING: Nine sites in 4 South African provinces. METHODS: Women aged 18-30 years were randomized to receive pericoital tenofovir 1% gel or placebo gel and required to use reliable modern contraception. We compared HIV incidence in women before, during, and after pregnancy and used multivariate Cox Proportional hazards models to compare HIV incidence by pregnancy status. RESULTS: Rates of pregnancy were 7.1 per 100 woman-years (95% confidence interval [CI]: 6.3 to 8.1) and highest in those who reported oral contraceptive use (25.1 per 100 woman-years; adjusted hazard ratio 22.97 higher than other women; 95% CI: 5.0 to 105.4) or had 2 children. Birth outcomes were similar between trial arms, with 59.8% having full-term live births. No difference was detected in incident HIV during pregnancy compared with nonpregnant women (2.1 versus 4.3%; hazard ratio = 0.56, 95% CI: 0.14 to 2.26). Sexual activity was low in pregnancy and the early postpartum period, as was consistent condom use. CONCLUSIONS: Pregnancy incidence was high despite trial participation being contingent on contraceptive use. We found no evidence that rates of HIV acquisition were elevated in pregnancy when compared with those in nonpregnant women. Risks from reductions in condom use may be offset by reduced sexual activity. Nevertheless, high HIV incidence in both pregnant and nonpregnant women supports consideration of introducing antiretroviral-containing pre-exposure prophylaxis for pregnant and nonpregnant women in high HIV prevalence settings.

Lessons from the evaluation of the South African National Female Condom Programme.

BACKGROUND: Understanding of the facilitators and challenges to female condom (FC) uptake has been limited due to lack of evaluation of national FC programmes. SETTING: The FC has been an integral component of South Africa's (SA) HIV prevention programme for 20 years and is the largest government-funded FC programme worldwide. METHODS: The national FC evaluation used a mixed-methods approach and consisted of key informant interviews and a telephone survey in a national sample of public and non-public sites. A sub-sample of sites participated in client and provider interviews, and a self-administered client survey. A review of distribution statistics from South Africa's District Health Information System was also conducted. RESULTS: All 256 public-sector and 28 non-public-sector facilities reported having ever distributed FCs. Less than 5% of these facilities reported stock-outs and less than 3% reported they had a supply of expired female condoms. Systems for male condom (MC) and FC distribution were complementary, with similar ordering, delivery and reporting processes. FC promotion by providers (n = 278) varied with regard to FC training, whether attitudes about FCs influenced providers offer of FCs, and how they counselled clients about FCs. Of the 4442 self-administered client surveys in 133 facilities, similar proportions of women (15.4%) and men (15.2%) had ever used FCs. Although FCs were available at almost all sites surveyed, only two-thirds of clients were aware of their availability. CONCLUSION: Data highlight the role of providers as gatekeepers to FC access in public and non-public sectors and provide support for further FC programme expansion in SA and globally.

Perceived male partner attitudes toward the female condom predict female university students' use of the female condom.

Female and male condoms are the only methods that prevent both sexually transmitted infections (STIs), including HIV, and unintended pregnancy. Despite continuing high STI rates, few studies investigate factors predicting whether women initiating female condom (FC) use sustain use. Using data from a randomized trial, we examined predictors of sustained FC use at five-month follow-up (FU2) among female university students in South Africa who participated in either a one-session, information-only, group-delivered Minimal Intervention or a two-session, group-delivered Enhanced Intervention. In the final multiple logistic regression model, believing one's partner holds positive attitudes toward the FC (aOR = 1.40; p = 0.028), and greater FC use for vaginal sex at previous assessment (aOR) = 1.19; p = 0.008) were associated with greater odds of FC use at FU2. Excluding number of FC-protected occasions at FU1 from the analysis, discussing FC use with partner (aOR = 2.89; p = 0.071) and believing one's partner holds positive attitudes toward the FC (aOR = 1.63; p < 0.001) were associated with greater odds of use at FU2. The FC empowers women to protect themselves from both STIs and unintended pregnancy, but targeted interventions are needed to address men's negative attitudes toward the device. Engaging men as FC champions to support and promote FC use, along with marketing campaigns targeted to men, may expand FC coverage and enhance uptake.

Trajectories of initiation for the heroin-based drug whoonga - qualitative evidence from South Africa.

BACKGROUND: Whoonga is a smoked heroin-based street drug that first emerged in South Africa a decade ago. While previous scientific reports suggest that use is growing and youth are particularly vulnerable, trajectories of initiation are not well characterized. METHODS: In 2015, 30 men undergoing residential addiction treatment for this smoked heroin drug in KwaZulu-Natal, South Africa participated in semi-structured interviews about their experiences using the drug. Interview data were coded using qualitative content analysis. RESULTS: Participant trajectories to initiating smoked heroin were "vertical" in the context of marijuana use or "horizontal" in the context of other hard drug use. Participants reporting vertical trajectories began smoking heroin as youth at school or in other settings where people were smoking marijuana. Several participants with horizontal trajectories started smoking heroin to address symptoms of other drug or alcohol addiction. Social influences on initiation emerged as an overarching theme. Members of participants' social networks who were smoking or distributing heroin figured prominently in initiation narratives. Surprisingly, references to injection drug use were absent from initiation narratives. Participants reported people who smoke heroin differ from those who inject heroin by race. CONCLUSION: Consistent with theories implicating social and structural influences on substance use initiation, people who started smoking heroin had social contacts who smoked heroin and frequented places where substance use was common. Smoked heroin initiation for several participants with horizontal trajectories may have been averted if they accessed evidence-based treatments for stimulant or alcohol use disorders. With increasing reports of heroin use across Africa, a coordinated approach to address this growing epidemic is needed. However, because smoked heroin and injection heroin use occur in distinct risk environments, interventions tailored to people who use smoked heroin will be needed to prevent smoked heroin use, prevent transition to injection use, and mitigate other social harms.

Gender norms in South Africa: implications for HIV and pregnancy prevention among African and Indian women students at a South African tertiary institution.

In post-Apartheid South Africa, women are constitutionally guaranteed protections and freedoms that were previously unknown to them. These freedoms may have positive implications for women's ability to negotiate sexual protection with partners and hence prevent unintended pregnancy and decrease their risk of HIV. Among tertiary institution students, who are a relatively 'privileged' group, there is little information on gender norms that might shape responses to HIV-prevention programmes. To elicit gender norms regarding women's and men's roles, condom and contraceptive use, sexual communication and sexual pleasure, we conducted 10 semi-structured focus group discussions with African and Indian female tertiary institution students in order to understand how norms might be used to buttress HIV- and pregnancy-prevention. Participants reported dramatic changes in the structure of gender norms and relations with the formal recognition of women's rights in the post-Apartheid context. These generational shifts in norms are supported by other research in South Africa. At the same time, women recognized the co-existence of traditional constructions of gender that operate to constrain women's freedom. The perceived changes that have taken place provide an entry point for intervention, particularly for reinforcing emerging gender norms that promote women's protection against unintended pregnancy and HIV/STIs.

Male partner involvement and assistance in female condom use.

OBJECTIVE: To investigate how males assist their partners in using the female condom. METHODS: A multi-site, randomized, cross-over trial was conducted to test the performance and acceptability of the Reality female condom compared to a prototype similar in design and appearance but made of synthetic latex (FC2). In this study women were asked about male partner assistance in FC use. RESULTS: Partner assistance in FC use was similar across FC type. Of the women who returned for the first follow-up visit (n = 233), just over a third (35.2%) reported that the male partner assisted in the insertion compared to 26.4% of the 201 women who returned for the second visit. In most cases where the partner assisted, the device was inserted using the inner ring, as recommended in the instructions for use. A small number (6%) mentioned that partners assisted in removal. CONCLUSION: Men have a role to play in the use of the female condom and are willing to assist their partners in using it.

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

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