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Curable sexually transmitted infections (STIs) affect millions of people across the world. Besides unacceptably high HIV rates, South Africa also has the highest burden of STIs in the world. The aim of the study was to investigate temporal changes in STI incidence rates using the data from ~ 10,000 women who enrolled in several HIV prevention trials, KwaZulu-Natal, South Africa (2002–2016). We particularly focused on the changes in distribution of the most influential factors and their population-level impacts on STI incidence rates over time. Characteristics of the women were compared across the study periods: 2002–2004, 2005–2008, 2009–2011, and 2012–2016. Besides multivariable Cox regression models, population attributable risks were calculated for the significant factors. Despite the significant progress in prevention, testing, and treatment programs, infection rates increased substantially from 13.6 to 20.0 per 100 person-year over the study period. Our findings provided a compelling evidence for single/non-cohabiting South African women to be the most vulnerable population who consistently and substantially contributed to increasing STI rates during the 15 years of study duration (PAR%: 44%–47%). We also highlighted the impact of women's lack of knowledge related to their partner, using injectable contraceptives, less parity, and baseline STI positivity which were increased substantially over time. Our findings suggest that a significant proportion of STIs could be prevented by targeting single/non-cohabiting. These results may provide guidance in developing more effective STI prevention programs by targeting women at highest risk of infections and delivering more realistic messages. [ABSTRACT FROM AUTHOR]

Background: Women enrolled in human immunodeficiency virus (HIV) prevention efficacy trials receive counseling on prevention of HIV, sexually transmitted infections (STIs), and pregnancy during every visit. Incident pregnancy has an impact on efficacy outcomes. Incidence rates of pregnancy and HIV/STIs among women who became pregnant and associated risk factors were assessed.Methods: Data from 9165 women participating in HIV prevention trials in KwaZulu-Natal, South Africa from 2002-2012 were combined. Demographic and behavioral predictors of incidence pregnancy and incidence HIV and STIs were determined using Cox regression models.Results: Overall pregnancy incidence was 9.6 per 100 person-year (py) (95% confidence interval [Cl], 9.1-10.3). Human immunodeficiency virus incidence among pregnant women was 5.93 per 100 py (95% Cl, 4.73-7.44). Incidence of STIs among pregnant women for Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae, and Treponema pallidum (syphilis) were 10.87, 7.42, 3.92, and 1.43 per 100 py, respectively. In the adjusted analyses, we observed overlapping risk factors for HIV acquisition during pregnancy, ie, young age, not married/not cohabitating, and low parity. The risk of pregnancy and HIV acquisition is more than 3 times higher among young women (<20 years of age).Conclusions: We identified overlapping risk factors for pregnancy and HIV incidence, suggesting an urgent need for appropriate, targeted, individual-centred counseling for women participating in HIV prevention trials. [ABSTRACT FROM AUTHOR]

We aimed to estimate the individual and joint impact of age, marital status and diagnosis with sexually transmitted infections (STIs) on HIV acquisition among young women at a population level in Durban, KwaZulu-Natal, South Africa. A total of 3,978 HIV seronegative women were recruited for four biomedical intervention trials from 2002–2009. Point and interval estimates of partial population attributable risk (PAR) were used to quantify the proportion of HIV seroconversions which can be prevented if a combination of risk factors is eliminated from a target population. More than 70% of the observed HIV acquisitions were collectively attributed to the three risk factors: younger age (<25 years old), unmarried and not cohabiting with a stable/regular partner and diagnosis with STIs. Addressing these risks requires targeted structural, behavioural, biomedical and cultural interventions in order to impact on unacceptably high HIV incidence rates among young women and the population as a whole. [ABSTRACT FROM AUTHOR]

The article discusses research which examined preexposure prophylaxis against HIV-1 infection in women in Africa. Topics covered include the use of oral tenofovir disoproxil fumarate, oral tenofovir-emtricitabine or tenofovir vaginal gel in patients, the incidence of HIV-1 infection among study participants and the elevations of serum creatinine levels among participants.

Introduction: Understanding the impact of curable sexually transmitted infections (STIs) on HIV transmissibility is essential for effective HIV prevention programs. Investigating the impact of longitudinally measured recurrent STIs on HIV seroconversion is the interest of the current paper. Methods: In this prospective study, data from a total of 1456 HIV-negative women who enrolled in a HIV biomedical trial were used. It was hypothesized that women who had recurrent STI diagnoses during the study share a common biological heterogeneity which cannot be quantified. To incorporate this "unobserved" correlation in the analysis, times to HIV seroconversion were jointly modelled with repeated STI diagnoses using Cox regression with random effects. Results and discussion: A total of 110 HIV seroconversions were observed (incidence rate of 6.00 per 100 person-years). In a multivariable model, women who were diagnosed at least once were more likely to seroconvert compared to those who had no STI diagnosis [hazard ratio (HR): 1.63, 95% confidence interval (CI): 1.04, 2.57]; women who had recurrent STI diagnoses during the study were 2.5 times more likely to be at increased risk of HIV infection (95% CI: 1.35, 4.01) with an estimated frailty variance of 1.52, with p<0.001, indicating strong evidence that there is a significant correlation (heterogeneity) among women who had recurrent STIs. In addition to this, factors associated with incidence of STIs, namely not being married and having a new sexual partner during the study follow-up, were all significantly associated with increased risk for HIV seroconversion (HR: 2.92, 95% CI: 1.76, 5.01 and HR: 2.25, 95% CI: 1.63, 3.83 respectively). Conclusions: The results indicated that women who were at risk for STIs were also at risk of HIV infection. In fact, they share the similar risk factors. In addition to this, repeated STI diagnoses also increased women's susceptibility for HIV infection significantly. Decreasing STIs by increasing uptake of testing and treatment and reducing partner change plays a significant role in the trajectory of the epidemic. [ABSTRACT FROM AUTHOR]

Background: In South Africa, poverty and the dual epidemics of HIV and tuberculosis underscore the need for prevention efforts for obesity. The aim of this study was to describe the prevalence of obesity in a cohort of South African women and discuss the implications for public health practices. Methods: A total of 5,495 HIV-negative women from KwaZulu-Natal, South Africa enrolled in three microbicide trials during the period of 2002-2008 were categorised as normal weight (body mass index (BMI: 18.6-<25), overweight (BMI: 25-<30) or obese (BMI: 30+). Incidence of HIV and other sexually transmitted infections such as Chlamydia and gonorrhoea were also estimated and compared by BMI groups. Combined data was analysed using STATA 10.0. Results: Approximately 70% of the sample population was classified as being overweight or obese. Older age and lack of education were determined to be significant predictors of obesity. Women who were 35 years or older were more than three times as likely to be overweight and more than 12 times as likely to be obese compared to the youngest group. The highest HIV and STI incidence rates were observed among those with BMI <25 kg/m² (normal weight) compared to women with BMI more than 25 kg/m² (8.1 and 19.8 per 100 person-year respectively, P<0.001, both). Conclusion: Effective obesity prevention strategies are needed to re-formulate HIV prevention programmes by incorporating healthy diet and life style messages to target those who are at highest risk not just for HIV infection but also for non-communicable diseases. [ABSTRACT FROM AUTHOR]

Objective: To describe and quantify the differences in risk behaviours, HIV prevalence and incidence rates by birth cohorts among a group of women in Durban, South Africa. Methods: Cross-sectional and prospective cohort analyses were conducted for women who consented to be screened and enrolled in an HIV prevention trial. Demographic and sexual behaviours were described by five-year birth cohorts. Semiparametric regression models were used to investigate the bivariate associations between these factors and the birth cohorts. HIV seroconversion rates were also estimated by birth cohorts. Results: The prevalence of HIV-1 infection at the screening visit was lowest (20.0%) among the oldest (born before 1960) cohorts, while the highest prevalence was observed among those born between 1975 and 79. Level of education increased across the birth cohorts while the median age at first sexual experience declined among those born after 1975 compared to those born before 1975. Only 33.03% of the oldest group reported ever using a condom while engaging in vaginal sex compared to 73.68% in the youngest group; however, HIV and other sexually transmitted infection (STI) incidence rates were significantly higher among younger women compared to older women. Conclusions: These findings clearly suggest that demographic and sexual risk behaviours are differentially related to the birth cohorts. Significantly high HIV and STI incidence rates were observed among the younger group. Although the level of education increased, early age at sexual debut was more common among the younger group. The continuing increase in HIV and STI incidence rates among the later cohorts suggests that the future trajectory of the epidemic will be dependent on the infection patterns in younger birth cohorts. [ABSTRACT FROM AUTHOR]

Objective To estimate the potential impact of using hormonal contraceptives on rates of infection with human immunodeficiency virus type 1 (HIV-1) and pregnancy by theoretically removing the use of hormonal contraceptives from a study population.Methods A prospective cohort study included 3704 HIV-negative women who were enrolled in two biomedical trials that tested two vaginal microbicides (PRO 2000 and Carraguard®) for the prevention of HIV-1 in Durban, South Africa, in 2004-2009. Cox proportional hazards regression models along with partial population attributable risks (PARs) and their 95% confidence intervals (CIs) were calculated to assess the relative population-level impact of the use of hormonal contraceptives on HIV-1 seroconversion rates and on pregnancy rates.Findings Women who reported using hormonal contraceptives at enrolment in the trial had a higher risk of HIV-1 seroconversion (adjusted hazards ratio: 1.24; 95% CI: 0.97-1.58) than women who reported using other types of contraceptives at enrolment. At the population level, the use of hormonal contraceptives (pills or injectables) at baseline and during study follow-up accounted for approximately 20% (95% CI: 16-22) of HIV-1 seroconversions. However, the partial PAR indicated a relative impact of 12% (95% CI: 9.0-15.7). On the other hand, 72% (95% CI: 66-77) of the pregnancies could have been avoided if all women had used hormonal contraceptives.Conclusion Women using hormonal contraceptives need comprehensive counselling on simultaneous prevention of HIV-1 infection. [ABSTRACT FROM AUTHOR]

In this prospective study, we aimed to investigate and evaluate the impact of combinations of behavioural and biological risk factors on HIV acquisition in a cohort of women. Demographic, sexual and biologic risk factors including HIV seroconversion results from 1485 HIV negative women who were enrolled in a HIV prevention trial were used. First, Cox regression models were used to create a prediction model and weighted scoring system. Second, internal validation data-set was used to evaluate the performance characteristics of the model prospectively. In the prediction model, an increasing number of lifetime sexual partners, women who were classified as in a “high risk behavior” group, and those who were not cohabitating with their partners were consistently associated with increased risk of HIV acquisition. Among the baseline biological factors, genital epithelial disruption, genital signs and symptoms, genital discharge and detecting edema, erythma or warts in vulva were all associated with HIV seroconversion. High scores were associated with increased risk of HIV seroconversion. A cut-point score of 15 (out of 44) or higher distinguished an “increased risk” group with a sensitivity of 88%. This study presents reasonable robust analyses for investigating and evaluating epidemiological measures on HIV infection. Results from this study may be included as part of a health promotion to prompt those who are at increased risk of HIV infection which may potentially lead to increased uptake and frequency of testing. [ABSTRACT FROM PUBLISHER]

Although the HIV incidence rate has slowed in some countries, HIV remains a serious health challenge, particularly in the developing world. The epidemic is increasingly feminised, with young women at high risk of acquiring the virus. There is thus a clear requirement for acceptable woman-initiated methods of HIV prevention. Foremost among these are vaginally-applied substances known as microbicides; early research into potential microbicides focussed on non-HIV-specific compounds such as surfactants and polyanionic entry inhibitors. However, proof of the microbicide concept as a viable prevention strategy was not provided until the CAPR|SA 004 trial of a microbicide containing the HIV-specific antiretroviral tenofovir was completed in mid-2010. Confirmation of the proof of concept provided by CAPRISA 004 by at least two major trials will hopefully lead to licensure of the product by 2018. Parallel studies are planned to ascertain the feasibility of implementation of these products in the public sector with subsequent research focussed on appropriate and acceptable methods of delivery of the active ingredient, and to increase adherence through other delivery systems such as vaginal rings. [ABSTRACT FROM AUTHOR]

Background: In South Africa, the severity of the HIV/AIDS epidemic varies according to geographical location; hence, localized monitoring of the epidemic would enable more effective prevention strategies. Our objectives were to assess the core areas of HIV infection in KwaZulu-Natal, South Africa, using epidemiological data among sexually active women from localized communities. Methods: A total of 5753 women from urban, peri-rural and rural communities in KwaZulu-Natal were screened from 2002 to 2005. Each participant was geocoded using a global information system, based on residence at time of screening. The Spatial Scan Statistics programme was used to identify areas with disproportionate excesses in HIV prevalence and incidence. Results: This study identified three hotspots with excessively high HIV prevalence rates of 56%, 51% and 39%. A total of 458 sexually active women (19% of all cases) were included in these hotspots, and had been exclusively recruited by the Botha's Hill (west of Durban) and Umkomaas (south of Durban) clinic sites. Most of these women were Christian and Zulu-speaking. They were also less likely to be married than women outside these areas (12% vs. 16%, p = 0.001) and more likely to have sex more than three times a week (27% vs. 20%, p < 0.001) and to have had more than three sexual partners (55% vs. 45%, p < 0.001). Diagnosis of genital herpes simplex virus type 2 was also more common in the hotspots. This study also identified areas of high HIV incidence, which were broadly consistent with those with high prevalence rates. Conclusions: Geographic excesses of HIV infections at rates among the highest in the world were detected in certain rural communities of Durban, South Africa. The results reinforce the inference that risk of HIV infection is associated with definable geographical areas. Localized monitoring of the epidemic is therefore essential for more effective prevention strategies - and particularly urgent in a region such as KwaZulu-Natal, where the epidemic is particularly rampant. [ABSTRACT FROM AUTHOR]

Background: South Africa, with its scientific capacity, good infrastructure and high HIV incidence rates, is ideally positioned to conduct large-scale HIV prevention trials. The HIV Prevention Research Unit of the South African Medical Research Council conducted four phase III and one phase IIb trials of women-initiated HIV prevention options in KwaZulu-Natal between 2003 and 2009. A total of 7046 women participated, with HIV prevalence between 25% and 45% and HIV incidence ranging from 4.5-9.1% per year. Unfortunately none of the interventions tested had any impact on reducing the risk of HIV acquisition; however, extremely valuable experience was gained, lessons learned and capacity built, while the communities gained associated benefits. Experience: Our experience in conducting these trials ranged from setting up community partnerships to developing clinical research sites and dissemination of trial results. Community engagement included setting up communitybased research sites with approval from both political and traditional leaders, and developing community advisory groups to assist with the research process. Community-wide education on HIV/sexually transmitted infection prevention, treatment and care was provided to over 90 000 individuals. Myths and misconceptions were addressed through methods such as anonymous suggestion boxes in clinic waiting areas and intensive education and counselling. Attempts were made to involve male partners to foster support and facilitate recruitment of women. Peer educator programmes were initiated to provide ongoing education and also to facilitate recruitment of women to the trials. Recruitment strategies such as door-to-door recruitment and community group meetings were initiated. Over 90% of women enrolled were retained. Community benefits from the trial included education on HIV prevention, treatment and care and provision of ancillary care (such as Pap smears, reproductive health care and referral for chronic illnesses). Social benefits included training of home-based caregivers and sustainable ongoing HIV prevention education through peer educator programmes. Challenges: Several challenges were encountered, including manipulation by participants of their eligibility criteria in order to enroll in the trial. Women attempted to co-enroll in multiple trials to benefit from financial reimbursements and individualised care. The trials became ethically challenging when participants refused to take up referrals for care due to stigma, denial of their HIV status and inadequate health infrastructure. Lack of disclosure of HIV status to partners and family members was particularly challenging. Some of the ethical dilemmas put to the test our responsibility as researchers and our obligation to provide health care to research participants. Conclusion: Conducting these five trials in a period of six years provided us with invaluable insights into trial implementation, community participation, recruitment and retention, provision of care and dissemination of trial results. The critical mass of scientists trained as clinical trialists will continue to address the relentless HIV epidemic in our setting and ensure our commitment to finding a biomedical HIV prevention option for women in the future. [ABSTRACT FROM AUTHOR]

The article reports on the results of research which was conducted in an effort to determine the efficacy and safety issues of the microbicide Carraguard in preventing the transmission of HIV in women in South Africa. Researchers used a randomised, double blind, placebo controlled study to evaluate 3,103 sexually active, HIV-negative women. They found that Carraguard was not effective in preventing the vaginal transmission of HIV and did not find any safety concerns related to the use of Carraguard.

Background: We evaluated the effectiveness of the Ortho All-Flex Diaphragm, lubricant gel (Replens®) and condoms compared to condoms alone on the incidence of chlamydial and gonococcal infections in an open-label randomized controlled trial among women at risk of HIV/STI infections. Methods: We randomized 5045 sexually-active women at three sites in Southern Africa. Participants who tested positive for curable STIs were treated prior to enrollment as per local guidelines. Women were followed quarterly and tested for Chlamydia trachomatis (CT) or Neisseria gonorrhoeae (GC) infection by nucleic-acid amplification testing (Roche Amplicor®) using first-catch urine specimens. STIs detected at follow-up visits were treated. We compared the incidence of first infection after randomization between study arms in both intent-to-treat (ITT) and per-protocol populations. Findings: Baseline demographic, behavioral and clinical characteristics were balanced across study arms. Nearly 80% of participants were under 35 years of age. Median follow-up time was 21 months and the retention rate was over 93%. There were 471 first chlamydia infections, 247 in the intervention arm and 224 in the control arm with an overall incidence of 6.2/100 woman-years (wy) (relative hazard (RH) 1.11, 95% Confidence Interval (CI): 0.93-1.33; p = 0.25) and 192 first gonococcal infections, 95 in the intervention arm and 97 in the control arm with an overall incidence of 2.4/100wy (RH 0.98, 95%CI: 0.74-1.30; p = 0.90). Per protocol results indicated that when diaphragm adherence was defined as ''always use'' since the last visit, there was a significant reduction in the incidence of GC infection among women randomized to the intervention arm (RH 0.61, 95%CI: 0.41-0.91, P = 0.02). Interpretation: There was no difference by study arm in the rate of acquisition of CT or GC. However, our per-protocol results suggest that consistent use of the diaphragm may reduce acquisition of GC. [ABSTRACT FROM AUTHOR]

Recently revised statistics show the number of individuals living with HIV at over 33 million worldwide, with 68% being in sub-Saharan Africa. Current HIV prevention methods, such as condom use, monogamy and abstinence, are not always feasible. The need for improved HIV preventative technologies remains urgent. Of these, microbicides represent a promising female-initiated preventative method. Microbicides are designed to be applied vaginally to prevent HIV and STI acquisition. Research is also being undertaken to assess the safety of the product during rectal application. The biannual Microbicides conference took place in New Delhi, India from 24–27 February 2008. The conference was open to delegates from the scientific and medical fields, as well as communities and advocates. In addition to microbicide research and development, the conference afforded the opportunity for the discussion of key issues such as ethics, acceptability, access, and community involvement. In this conference report we provide brief summaries of recent advancements made and challenges experienced in microbicide research and development, including updates on basic and clinical science, social and behavioural science, and community mobilisation and advocacy activities pertaining to clinical trials. [ABSTRACT FROM AUTHOR]

The article discusses a study which examines site preparedness for phase 2/IIb/III HIV prevention trials. The sites studied are Durban and Hlabisa in South Africa, Lusaka in Zambia and Moshi in Tanzania. Preparatory studies provide accurate local estimates of HIV incidence, recruitment and retention rates, and behavioral characteristics of targeted populations.

Background: The promise of microbicides as an HIV prevention method will not be realized if not supported by health care providers. They are the primary source of sexual health information for potential users, in both the public and private health sectors. Therefore, the aim of this study was to determine perceptions of vaginal microbicides as a potential HIV prevention method among health care providers in Durban and Hlabisa, South Africa, using a combination of quantitative and qualitative methods. Results: During 2004, semi structured interviews with 149 health care providers were conducted. Fifty seven percent of hospital managers, 40% of pharmacists and 35% of nurses possessed some basic knowledge of microbicides, such as the product being used intra-vaginally before sex to prevent HIV infection. The majority of them were positive about microbicides and were willing to counsel users regarding potential use. Providers from both public and private sectors felt that an effective microbicide should be available to all people, regardless of HIV status. Providers felt that the product should be accessed over-the-counter in pharmacies and in retail stores. They also felt a need for potential microbicides to be available free of charge, and packaged with clear instructions. The media was seen by health care providers as being an effective strategy for promoting microbicides. Conclusion: Overall, health care providers were very positive about the possible introduction of an effective microbicide for HIV prevention. The findings generated by this study illustrated the need for training health care providers prior to making the product accessible, as well as the importance of addressing the potential barriers to use of the product by women. These are important concerns in the health care community, and this study also served to educate them for the day when research becomes reality. [ABSTRACT FROM AUTHOR]

Background and Methods: When on the market, microbicides are likely to be used by individuals who do not know their HIV status. Hence, assessment of safety and acceptability among HIV positive men and women is important. Acceptability of Carraguard, the Population Council's lead microbicide candidate was assessed in a Phase I safety study among healthy HIV-positive sexually abstinent women and men, and sexually active women (20 per group), in Durban, South Africa. Participants were randomized to use Carraguard gel, placebo gel, or no product. All women in the gel arms applied 4 ml gel vaginally every evening for 14 intermenstrual days (women in the sexually active group inserted gel within 1 hour prior to sex on days when sex occurred), and sexually abstinent men applied gel directly to the penis every evening for 7 days. Acceptability was assessed by face-to-face structured questionnaires and semi-structured in-depth interviews with all participants. Gel use questions were applicable to participants in the gel arms only (13 sexually abstinent women, 14 sexually active women, and 13 abstinent men). Results: Overall, 93% of the women liked the study gel (Carraguard or placebo) very much, 4% disliked it somewhat, and 4% were neutral. 15% of men and women disliked the gel's color, smell, or packaging. Most women and men reported never experiencing pain or irritation during or after gel application. Although over two thirds of the women preferred some lubrication during sex, some of the women felt that the gel was frequently too wet. Twenty-one percent of women and 42% of men said they felt covert use of a microbicide would be acceptable. Over 60% of women and men would prefer to use a microbicide alone instead of using it with a condom. Conclusion: Acceptability of Carraguard among HIV-positive women and men in Durban was good. The wetness experienced by the women may be attributed to the delivery of gel volume. The applicator was designed to deliver 4 mls whereas in fact between 4 ml to 5 mls were actually dispensed. Condom migration in the event of a partially effective product is of concern. [ABSTRACT FROM AUTHOR]

Current HIV/AIDS statistics show that women account for almost 60% of HIV infections in Sub-Saharan Africa. HIV prevention tools such as male and female condoms, abstinence and monogamy are not always feasible options for women due to various socio-economic and cultural factors. Microbicides are products designed to be inserted in the vagina or rectum prior to sex to prevent HIV acquisition. The biannual Microbicides conference took place in Cape Town, South Africa from 23-26 April 2006. The conference was held for the first time on the African continent, the region worst affected by the HIV/AIDS pandemic. The conference brought together a record number of 1,300 scientists, researchers, policy makers, healthcare workers, communities and advocates. The conference provided an opportunity for an update on microbicide research and development as well as discussions around key issues such as ethics, acceptability, access and community involvement. This report discusses the current status of microbicide research and development, encompassing basic and clinical science, social and behavioural science, and community mobilisation and advocacy activities. [ABSTRACT FROM AUTHOR]

Presents a study that investigated the impact of incident and prevalent Herpes Simplex Virus-2 (HSV) infection on the incidence of HIV-1 infection among female sex workers in KwaZulu-Natal, South Africa. Follow-up at monthly intervals when blood was drawn; HIV-1 seropositive and HSV-2 seropositive.

Background: Improved treatment of sexually transmitted infections (STIs) is associated with decreased HIV incidence. However, the success of such programs among HIV-positive sex workers has not been shown. GOAL The goal of the study was to determine the incidence of STIs ( and infections) among HIV-positive sex workers.Study Design: A cohort of HIV-positive sex workers was treated for all STIs at baseline and observed monthly to detect and treat new infections.Results: Seventy-seven HIV-positive sex workers were followed up for a total of 58.1 women-years. The incidence rate per 100 women-years was 150 (CI: 120-180) infections; 66 (CI: 45-87) infections; 30 (CI: 14-42) infections; and 244 (CI: 200-280) STIs of any type.Conclusion: In this cohort of HIV-positive sex workers the incidence of STIs was high, despite their participation in a prevention program comprising monthly STI treatment, counseling, and condom promotion. [ABSTRACT FROM AUTHOR]

Summary: Background: Nonoxynol-9 (rINN, nonoxinol-9) is an over-the-counter spermicide that has in-vitro anti-HIV-1 activity. Results of studies of its effectiveness in prevention of HIV-1 infection in women have been inconclusive. We aimed to assess effectiveness of this vaginal gel. Methods: We did a randomised, placebo-controlled, triple-blinded, phase 2/3 trial with COL-1492, a nonoxynol-9 vaginal gel, in 892 female sex workers in four countries: Benin, Côte d'Ivoire, South Africa, and Thailand. 449 women were randomly allocated nonoxynol-9 and 443 placebo. Primary endpoint was incident HIV-1 infection. Secondary endpoints included Neisseria gonorrhoeae and Chlamydia trachomatis infections. Analysis was by intention to treat. Findings: 765 women were included in the primary analysis. HIV-1 frequency in nonoxynol-9 users was 59 (16%) of 376 compared with 104 (27%) of 389 in placebo users (402.5 vs 435.0 woman-years; hazard ratio adjusted for centre 1.5; 95% CI 1.0-2.2; p=0.047). 239 (32%) women reported use of a mean of more than 3.5 applicators per working day, and in these women, risk of HIV-1 infection in nonoxynol-9 users was almost twice that in placebo users (hazard ratio 1.8; 95% CI 1.0-3.2). 516 (68%) women used the gel less frequently than 3.5 times a day, and in these, risk did not differ between the two treatments. No significant effect of nonoxynol-9 on N gonorrhoeae (1.2; 0.9-1.6) or C trachomatis (1.2; 0.8-1.6) infections was reported. Interpretation: This study did not show a protective effect of COL-1492 on HIV-1 transmission in high-risk women. Multiple use of nonoxynol-9 could cause toxic effects enhancing HIV-1 infection. This drug can no longer be deemed a potential HIV-1-prevention method. Assessment of other microbicides should continue. [ABSTRACT FROM AUTHOR]

Background: Although the role of mobile populations in the spread of HIV has been documented in several countries, there are few data on HIV among truck drivers in South Africa and the sex workers with whom they interact.Goal: To determine HIV prevalence and risk behavior in a sample of truck drivers visiting commercial sex workers at truck stops.Study Design: Two sex workers from each of five truck stops were trained to obtain informed consent, administer questionnaires to obtain data on demographic and migration patterns, and collect saliva samples for HIV testing from their clients. Data on HIV prevalence and demographic characteristics of sex workers operating at the truck stops were obtained from an ongoing vaginal microbicide trial.Results: The mean age of the truck drivers (all men) was 37 years (range, 18-71 years), and that of the sex workers (all females) was 25 years (range, 15-49 years). Sixty-six percent of the men reported having a sexually transmitted infection in the previous six months, and 37% always stopped for sex along the route. Twenty-nine percent reported never using condoms with sex workers, whereas 13% had used condoms with their wives. All men traveled to more than one province in South Africa, and 65% traveled to neighboring countries. Anal sex was practiced by 42% of the men. The overall HIV prevalence (in the two groups combined) was 56%.Conclusion: Truck drivers may have facilitated the spread of HIV infection throughout southern Africa. [ABSTRACT FROM AUTHOR]

Determines the perceptions of South African men on their preferences for a potential vaginal microbicide. Importance of HIV prevention methods controlled by women in the prevalence of AIDS epidemic; Significance lubrication provided by the product and noninterference with sexual pleasure with sexual pleasure to the acceptability of the microbicide; Analysis on the preference for an effective noncontraceptive microbicide.

Compares sexual behavior data from weekly, daily questionnaires and a coital diary. Challenges in sexual behavior research; Data collection instruments; Advantages of the methods.

Presents a study which was conducted to investigate the prevalence of sexually transmitted infections among female sex workers operating at truckstops in KwaZulu-Natal, South Africa. Details on the gynecologic examination done on the women recruited for the study; Percentages of the women examined who were HIV positive; Other diseases present in these women.

South Africa has the highest number of HIV infected individuals in the world. The primary objective of the current study was to describe temporal changes in HIV incidence rates using the data from 9,948 women who enrolled in one of the six HIV prevention trials conducted in KwaZulu-Natal, South Africa. Characteristics of the study population were presented and compared across the four study periods: 2002–2004, 2005–2008, 2009–2011 and 2012–2016. HIV infection rates increased from 6.2 to 9.3 per 100 person-year over the 15 years. These rates were as high as 14 per 100 person-year among women younger than 20 years age. Being single/not cohabiting, using injectable contraceptives, having less than two children, and diagnosed with STI(s) were associated with increased risk of HIV infection. These four factors were associated with 71%, 75%, 80% and 88% of the HIV seroconversions in four study periods. As the research continues to find ways of controlling the spread of the infections, quantifying the temporal trends in risk factors and their population-level impacts on HIV infection may have significant implications. This information may assist in developing effective counselling and education programs by targeting the sexually active single women and delivering more realistic messages. [ABSTRACT FROM AUTHOR]

Background: Fine scale geospatial analysis of HIV infection patterns can be used to facilitate geographically targeted interventions. Our objective was to use the geospatial technology to map age and time standardized HIV incidence rates over a period of 10 years to identify communities at high risk of HIV in the greater Durban area.Methods: HIV incidence rates from 7557 South African women enrolled in five community-based HIV prevention trials (2002-2012) were mapped using participant household global positioning system (GPS) coordinates. Age and period standardized HIV incidence rates were calculated for 43 recruitment clusters across greater Durban. Bayesian conditional autoregressive areal spatial regression (CAR) was used to identify significant patterns and clustering of new HIV infections in recruitment communities.Results: The total person-time in the cohort was 9093.93 years and 613 seroconversions were observed. The overall crude HIV incidence rate across all communities was 6·74 per 100PY (95% CI: 6·22-7·30). 95% of the clusters had HIV incidence rates greater than 3 per 100PY. The CAR analysis identified six communities with significantly high HIV incidence. Estimated relative risks for these clusters ranged from 1.34 to 1.70. Consistent with these results, age standardized HIV incidence rates were also highest in these clusters and estimated to be 10 or more per 100 PY. Compared to women 35+ years old younger women were more likely to reside in the highest incidence areas (aOR: 1·51, 95% CI: 1·06-2·15; aOR: 1.59, 95% CI: 1·19-2·14 and aOR: 1·62, 95% CI: 1·2-2·18 for < 20, 20-24, 25-29 years old respectively). Partnership factors (2+ sex partners and being unmarried/not cohabiting) were also more common in the highest incidence clusters (aOR 1.48, 95% CI: 1.25-1.75 and aOR 1.54, 95% CI: 1.28-1.84 respectively).Conclusion: Fine geospatial analysis showed a continuous, unrelenting, hyper HIV epidemic in most of the greater Durban region with six communities characterised by particularly high levels of HIV incidence. The results motivate for comprehensive community-based HIV prevention approaches including expanded access to PrEP. In addition, a higher concentration of HIV related services is required in the highest risk communities to effectively reach the most vulnerable populations. [ABSTRACT FROM AUTHOR]

Despite expanded antiretroviral therapy (ART) eligibility in South Africa, many people diagnosed with HIV do not initiate ART promptly, yet understanding of the reasons is limited. Using data from an 8-month prospective cohort interview study of women and men newly-diagnosed with HIV in three public-sector primary care clinics in the eThekwini (Durban) region, South Africa, 2010–2014, we examined if theoretically-relevant social-structural, social-cognitive, psychosocial, and health status indicators were associated with time to ART initiation. Of 459 diagnosed, 350 returned to the clinic for their CD4+ test results (linkage); 153 (33.3%) were ART-eligible according to treatment criteria at the time; 115 (75.2% of those eligible) initiated ART (median = 12.86 weeks [95% CI: 9.75, 15.97] after linkage). In adjusted Cox proportional hazard models, internalized stigma was associated with a 65% decrease in the rate of ART initiation (Adjusted hazard ratio [AHR] 0.35, 95% CI: 0.19–0.80) during the period less than four weeks after linkage to care, but not four or more weeks after linkage to care, suggesting that stigma-reduction interventions implemented shortly after diagnosis may accelerate ART uptake. As reported by others, older age was associated with more rapid ART initiation (AHR for 1-year age increase: 1.04, 95% CI: 1.01–1.07) and higher CD4+ cell count (≥300μL vs. <150μL) was associated with a lower rate of initiation (AHR 0.38, 95% CI: 0.19–0.80). Several other factors that were assessed prior to diagnosis, including stronger belief in traditional medicine, higher endorsement of stigma toward people living with HIV, food insecurity, and higher psychological distress, were found to be in the expected direction of association with ART initiation, but confidence intervals were wide and could not exclude a null finding. [ABSTRACT FROM AUTHOR]

South Africa is faced with a high HIV and STI prevalence and incidence, respectively, with pockets of high burden areas driving these diseases. Localised monitoring of the HIV epidemic and STI endemic would enable more effective targeted prevention strategies. We assessed spatial variations in curable STI incidence among a cohort of women enrolled in HIV prevention clinical trials between 2002 and 2012. STI incidence rates from 7557 South African women enrolled in five HIV prevention trials were geo-mapped using participant household GPS coordinates. Age and period standardised incidence rates were calculated for 43 recruitment areas and Bayesian conditional autoregressive areal spatial regression (CAR) was used to identify significant patterns and spatial patterns of STI infections in recruitment communities. Overall age and period standardised STI incidence rate were estimated as 15 per 100 PY and ranged from 6 to 24 per 100 PY. We identified five significant STI high risk areas with higher-than-expected incidence of STIs located centrally (three-locations) and southern neighbouring areas of Durban (two-locations). Younger age (<25), not married/cohabitating, parity <3 and poor education were all significant correlates of high STI communities. Findings demonstrate sustained STI incidence rates across the greater Durban area. The role of STI incidence in HIV acquisition in high HIV endemic areas need to be revisited as current highly effective PrEP interventions do not protect from STI acquisition. In these settings there is an urgent need for integrative HIV and STI prevention and treatment services. [ABSTRACT FROM AUTHOR]

Few studies have examined HIV-testing decision-making since the South African national HIV counseling and testing campaign in 2010–2011 and subsequent expansion in antiretroviral therapy (ART) eligibility in 2012. We describe HIV-testing decision-making and pathways to testing among participants inPathways to Care, a cohort study of newly-diagnosed HIV-positive adults in KwaZulu-Natal. Our analysis is embedded within a theoretical framework informed by Arthur Kleinman’s work on pluralistic healthcare systems, and the concept ofdiagnostic itineraries(i.e., the route taken to HIV testing). We conducted 26 semi-structured interviews in 2012, within one month of participants’ diagnosis. Most (n = 22) deferred testing until they had developed symptoms, and then often sought recourse in non-biomedical settings. Of the eleven symptomatic participants who accessed professional medical services prior to testing, only three reported that a healthcare professional had offered or recommended an HIV test. Although ART emerged as an important motivator, offering hope of health and normalcy, fear of death and HIV-related stigma remained key barriers. Despite national policy changes in testing and treatment, health system and individual factors contributed to ongoing high levels of late diagnosis of HIV in this study population. Encouraging local health systems to direct clients toward HIV testing, and continuing to raise awareness of the benefits of routine testing remain important strategies to reduce delayed diagnoses. [ABSTRACT FROM PUBLISHER]

The article presents information on a study which examined anal sex and HIV transmission in women in South Africa. Receptive anal sex is associated with an increased risk of HIV infection among gay men. However, the risk of HIV transmission associated with anal sex in women is lesser known. The study investigated whether anal sex was a risk factor for HIV infection in a group of sex workers recruited between August 1996 and March 1997 from truck stops along the main national road in South Africa. Women who were included in the study have an average age of 24 and had been involved in sex work for an average of 3 years.

Background: In South Africa, poverty and the dual epidemics of HIV and tuberculosis underscore the need for prevention efforts for obesity. The aim of this study was to describe the prevalence of obesity in a cohort of South African women and discuss the implications for public health practices.Methods: A total of 5,495 HIV-negative women from KwaZulu-Natal, South Africa enrolled in three microbicide trials during the period of 2002-2008 were categorised as normal weight (body mass index (BMI: 18.6-<25), overweight (BMI: 25-<30) or obese (BMI: 30+). Incidence of HIV and other sexually transmitted infections such as Chlamydia and gonorrhoea were also estimated and compared by BMI groups. Combined data was analysed using STATA 10.0.Results: Approximately 70% of the sample population was classified as being overweight or obese. Older age and lack of education were determined to be significant predictors of obesity. Women who were 35 years or older were more than three times as likely to be overweight and more than 12 times as likely to be obese compared to the youngest group. The highest HIV and STI incidence rates were observed among those with BMI <25 kg/m(2) (normal weight) compared to women with BMI more than 25 kg/m2 (8.1 and 19.8 per 100 person-year respectively, P<0.001, both).Conclusion: Effective obesity prevention strategies are needed to re-formulate HIV prevention programmes by incorporating healthy diet and life style messages to target those who are at highest risk not just for HIV infection but also for non-communicable diseases. [ABSTRACT FROM AUTHOR]

Background: Little is known regarding HIV disease outcomes among individuals who become infected with HIV while receiving antiretroviral medications for prevention. We compared HIV disease parameters among women who seroconverted while receiving tenofovir-containing oral or vaginal pre-exposure prophylaxis (PrEP) to placebo. Methods: Participants with HIV seroconversion in a randomized placebo-controlled trial of oral tenofovir, oral tenofovir/emtricitabine, and vaginal tenofovir gel (MTN-003) were followed in a longitudinal cohort study (MTN-015). The effect of oral and vaginal tenofovir-containing PrEP on HIV disease progression was compared to placebo using linear mixed effects and Cox proportional hazard models, as appropriate. Additional analyses were performed to compare the outcomes among participants with detectable tenofovir or emtricitabine in plasma at the first quarterly visit in MTN-003. Results: A total of 224 participants were included in the analysis; 93% from South Africa and 94% clade C virus. No differences in HIV RNA at steady state or the trajectory over 12 months were observed for each active arm compared to placebo; tenofovir gel recipients had higher CD4+ T cell counts (722 vs 596 cells/mm3; p = 0.02) at 90 days after estimated HIV seroconversion and higher average rates of change over 12 months compared to placebo (-181 vs -92 cells/mm3 per year; p = 0.08). With a median follow-up of 31 months, no significant differences were observed for time to CD4+ T cell count ≤350 cells/mm3, or the composite endpoint of CD4+ T cells ≤350 cells/mm3, initiation of antiretroviral therapy or death for each active arm compared to placebo. Additionally, there were no significant differences in the HIV RNA or CD4+ T cell counts at baseline, the change to month 12, or any disease progression outcomes among participants with oral drug detected and no oral drug detected compared to placebo. Conclusions: No clinically significant differences in HIV seroconversion outcomes were observed among women randomized to tenofovir-containing oral or vaginal PrEP regimens, however low overall adherence limits the generalizability of these findings. [ABSTRACT FROM AUTHOR]

Background: Herpes Simplex Virus 2 (HSV-2) is one of the most common sexually transmitted infections (STIs) worldwide and is a risk factor for the acquisition and transmission of other STIs, including HIV. We determined the prevalence and predictors of HSV-2 infection among women screened for a HIV prevention trial in Durban, South Africa. Univariate and multivariate logistic and Cox regression models were used to determine the correlates and predictors of HSV-2 infection at enrolment and seroconversion during the study respectively. Results: Prevalence of HSV-2 at screening was 65% and crude incidence was 22.3 per 100 person-years (PY) (95% CI 20.4-24.3). The HIV seroconversion was significantly higher among those testing positive for HSV-2 at baseline compared to women who were negative [8.7 per 100 person years (PY) versus 5.2 per 100 PY; (p < 0.001)]. In univariate analysis, age was determined to be the most significant predictor for HSV-2 diagnosis, while co-infection with syphilis was also a significant predictor, while age and co-infection with syphilis remained the two most significant predictors of having HSV-2 in multivariate analysis at baseline. Consistent with these results, along with HIV seroconversion, age was also identified as a significant predictor for incidence of HSV-2. Conclusion: Given the unacceptably high prevalence and incidence rates of HSV-2 infection reported here, HSV-2 and general STI education needs to be reinforced in these communities, with a focus on condom education for prevention. HSV-2 has emerged as the most prevalent STI which is most often asymptomatic and unrecognized, and which increases women’s risk of acquiring other STIs, including HIV. [ABSTRACT FROM AUTHOR]

The researchers who conducted the cellulose sulphate microbicide trial share the lessons they learned from the trial's early closure. [ABSTRACT FROM AUTHOR]

Background: It is well documented that the mucosal linings of the female genital tract (FGT) usually provides a robust barrier that protects against sexually acquired infections. However, to the best of our knowledge there are limited South African studies that have investigated the association between damage to the mucosal linings and the acquisition of HIV infections. We hypothesize that in this cohort of women, a higher rate of HIV seroconversions will be observed for women who present with evidence of mucosal damage.Methods: We undertook a secondary analysis of the Methods for Improving Reproductive Health in Africa (MIRA) trial that assessed the effectiveness of the latex diaphragm and lubricant gel on HIV prevention among women. Participants underwent a physical examination which included a pelvic examination to detect the presence of mucosal abnormalities. During the physical examinations, the study clinicians examined the genitalia, cervix and vagina for signs of epithelial disruptions and abnormal vaginal discharge. The association between the various genital factors and HIV seroconversion was modeled using Cox proportional hazards regression analysis.Results: In this cohort of 1485 women that had enrolled to participate in the study, women that had presented with genital epithelial disruptions and abnormal vaginal discharge were shown to be at highest risk for HIV acquisition (Hazard Ratio (HR): 4.30, 95% CI: 2.25, 8.22, p <0001, HR: 2.37, 95% CI: 1.69, 3.33, p <0.001) respectively. In addition, the Kaplan Meier analysis showed that the highest number of seroconversions was observed in women that had disrupted genital epithelia (27 per 100/py, 95% CI: 15.0, 50.7) and abnormal vaginal discharge (12 per 100/py, 95% CI: 9.70, 16.7). Other significant factors included: genital signs and symptoms (HR: 1.67, 95% CI: 1.07, 2.61, p = 0.02) and genital ulcers/sores (HR: 1.79, 95% CI: 1.05, 3.06, p = 0.03).Conclusion: We have shown that damage to the mucosal epithelial lining increases a women's risk of HIV seroconversion. Future studies that provide an in depth understanding of the mechanisms associated with the FGT and mucosal immunity will be most valuable. An understanding of all of these mechanisms will be key in directing the advancement of products most suitable for combating HIV infection in women.Trial Registration: This study was registered with ClinicalTrials.gov,number NCT00121459 on the 28th February 2007. [ABSTRACT FROM AUTHOR]

Background: The World Health Organization estimates that 536 million people aged 15--49 are infected with Herpes simplex virus type 2 (HSV-2), the causative agent of genital herpes. The aim of this study was to investigate the role of behavioral and demographic factors that contribute to the high HSV-2 sero-prevalence among women participating in a HIV prevention trial. The Methods for Improving Reproductive Health in Africa (MIRA) study assessed the effectiveness the latex diaphragm and lubricant gel on HIV prevention among women in South Africa and Zimbabwe. At screening an interviewer administered questionnaire on demographics and sexual behaviour was obtained. HSV-2 serum antibodies were detected using HerpeSelect™ ELISA IgG. Statistical analysis was performed using STATA release 12.0. This study was registered with ClinicalTrials.gov,number NCT00121459 on the 28th February 2007. Findings: Of the 3 472 women screened at the Durban research sites 2 218 (73%) had a prevalent HSV-2 infection and 1431 (41%) of the women were also co-infected with HIV. In the multivariate analyses, older women (adjusted odds ratio) [aOR]: 3.49, 95% CI: (2.71,4.49) for >35 years and aOR: 1.82, 95% CI: 1.49, 2.22 for 25--34 years compared with <25 years, p < 0.001 for both comparisons were more likely to be HSV-2 sero-positive. Low level of education (OR: 1.26 95% CI: 1.03, 1.53), having >1 life-time sexual partners (OR: 2.48, 95% CI: 1.92, 3.20), parity >1 (OR: 1.95 95% CI: 1.92, 3.20) and being HIV positive (OR: 6.31, 95% CI: 5.06, 7.88) were significantly associated with HSV-2 infection. Conclusion: The high sero-prevalence of HSV-2 in the studied population is of great public health importance since this high risk population could act as a reservoir for future infections particularly HIV transmission. [ABSTRACT FROM AUTHOR]

Objectives: To assess clinician provision of hormonal contraception for HIV-positive and at-risk women in Southern Africa.Study Design: We conducted a nationally representative survey of clinicians (n=1444) in HIV-prevalent settings in South Africa and Zimbabwe to evaluate evidence-based contraceptive care and clinician views of hormonal contraceptives for HIV-positive and at-risk women. Multivariable logistic regression was used to analyze differences in contraceptive provision by professional training and practice setting.Results: Most providers offered oral contraceptives (85%), but only a small minority considered them appropriate for women at risk of HIV (27%) or HIV-positive women (25%). A higher proportion of clinicians considered injections appropriate for women at risk of HIV (42%) or HIV-positive women (46%). Very few considered emergency contraceptives appropriate (13%). Multivariable results showed that family planning training and clinic as compared to hospital practices were associated with evidence-based attitudes about contraception for HIV-positive or at-risk women and greater provision. There were no differences, however, between physicians and nurses or by HIV training.Conclusions: These findings emphasize the need to improve clinicians' awareness of evidence-based guidelines for hormonal contraception for women at high risk of HIV and HIV-positive women. Evidence-based information that oral contraception and injections are appropriate is essential. Contraceptive education should be integrated into HIV training to reach at-risk populations. [ABSTRACT FROM AUTHOR]

Objectives To assess clinician provision of hormonal contraception for HIV-positive and at-risk women in Southern Africa. Study Design We conducted a nationally representative survey of clinicians ( n = 1444) in HIV-prevalent settings in South Africa and Zimbabwe to evaluate evidence-based contraceptive care and clinician views of hormonal contraceptives for HIV-positive and at-risk women. Multivariable logistic regression was used to analyze differences in contraceptive provision by professional training and practice setting. Results Most providers offered oral contraceptives (85%), but only a small minority considered them appropriate for women at risk of HIV (27%) or HIV-positive women (25%). A higher proportion of clinicians considered injections appropriate for women at risk of HIV (42%) or HIV-positive women (46%). Very few considered emergency contraceptives appropriate (13%). Multivariable results showed that family planning training and clinic as compared to hospital practices were associated with evidence-based attitudes about contraception for HIV-positive or at-risk women and greater provision. There were no differences, however, between physicians and nurses or by HIV training. Conclusions These findings emphasize the need to improve clinicians' awareness of evidence-based guidelines for hormonal contraception for women at high risk of HIV and HIV-positive women. Evidence-based information that oral contraception and injections are appropriate is essential. Contraceptive education should be integrated into HIV training to reach at-risk populations. [ABSTRACT FROM AUTHOR]

Participant recruitment, retention and product adherence are necessary to measure the efficacy or effectiveness of an intervention in a clinical trial. As part of a Phase III HIV prevention trial in a rural area in Kwazulu-Natal, South Africa, a peer educator programme was initiated to aid in recruitment and retention of trial participants from the community. Enrolled trial participants who had completed at least 6 months of trial participation and who had honoured all of their scheduled trial visits within that period were approached to be peer educators. Following additional selection criteria, 24 participants were eligible to be trained as peer educators. Training topics included HIV/AIDS, sexually transmitted infections, nutrition, antiretrovirals, clinical trials, and methods of disseminating this information to the community. The role of peer educators was to bring interested women from their community to the trial site for comprehensive education and information about the trial and possibly trial participation. A total of 1879 women were educated by peer educators between July 2004 and December 2006. Of these, 553 women visited the trial site for further education and screening for participation in the trial. Peer educators provided continuous education and support to women enrolled in the trial which also promoted retention, ultimately contributing to the site's 94% retention rate. Recruitment and retention efforts of trial participants are likely to be enhanced by involving trial participants as peer educators. Such trial participants are in a better position to understand cultural dynamics and hence capable of engaging the community with appropriate HIV prevention and trial-related messaging. [ABSTRACT FROM AUTHOR]

To compare the 2 control arms of HPTN 035 [a hydroxyethylcellulose (HEC) gel control arm and a no-gel control arm] to assess the behavioral effects associated with gel use and direct causal effects of the HEC gel on sexually transmitted infections (STIs), pregnancy, and genital safety.Randomized trial with 1 blinded (HEC gel) and 1 open-label (no-gel) control arms.HIV-uninfected, sexually active women were randomized into the HEC gel arm (n = 771) and into the no-gel arm (n = 772) in 5 countries. Participants in the HEC gel arm were instructed to insert the study gel intravaginally <1 hour before each vaginal sex act. Data on sexual behavior, adherence, safety, pregnancy, and STIs were collected quarterly for 12-30 months of follow-up.During follow-up, mean reported condom use in the past week was significantly higher in the no-gel arm (81% versus 70%, P < 0.001). There were no significant differences, after adjusting for this differential condom use, between the 2 arms in the rates of genital safety events, pregnancy outcomes, or STIs, including HIV-1.In this large randomized trial, we found no significant differences between the no-gel and HEC gel arms in the rates of genital safety events, pregnancy outcomes, or STIs. These results aid interpretation of the results of previous vaginal microbicide trials that used the HEC gel as a control. The HEC gel is suitable as a control for ongoing and future vaginal microbicide studies. [ABSTRACT FROM AUTHOR]

Background: The severity of the HIV/AIDS epidemic in South Africa varies between and within provinces, with differences noted even at the suburban scale. We investigated the geographical variability of HIV infection in rural areas of the eThekwini Metropolitan Municipality in KwaZulu-Natal province, South Africa. Method: We used geoadditive models to assess nonlinear geographical variation in HIV prevalence while simultaneously controlling for important demographic and sexual risk factors. A total of 3,469 women who were screened for a Phase-III randomized trial were included in the current analysis. Results: We found significant spatial patterns that could not be explained by demographic and sexual risk behaviors. In particular, the epidemic was determined to be much worse 44 km south of Durban after controlling for all demographic and sexual risk behaviors. Conclusion: The study revealed significant geographic variability in HIV infection in the eThekwini Metropolitan Municipality in KwaZulu-Natal, South Africa. [ABSTRACT FROM AUTHOR]

The article presents data on studies that explore the acceptability on the use of microbicides. In South Africa, frontline health providers are enthusiastic about any method that would prevent or slow the HIV/AIDS epidemic. U.S. providers balanced their enthusiasm with more concerns. Across all studies, participants raised issues about safety, cost and side effects of such contraceptive, as well as its significance as HIV prevention method. Researchers states that microbicide advocates need to effectively communicate to providers the necessary approaches of using the said contraceptive.

From 2003 to 2006, the number of human immunodeficiency virus-infected people in sub-Saharan Africa able to access antiretroviral therapy (ART) has increased from 100,000 to >1 million. The World Health Organization estimates that >3.5 million patients are still in need. The challenges to more expeditious provision of ART in Africa are many. This article is an analysis of the barriers to ART scale-up that are unique to South Africa. With 5.3 million people infected and 1 million needing ART, this country carries nearly one-quarter of the treatment burden of the continent. Although South Africa is undeniably a middle-income nation, inequities born of apartheid, lack of political commitment, poverty, and cultural barriers have significantly slowed efforts to provide universal access to ART to South African citizens. [ABSTRACT FROM AUTHOR]

This article presents the results of a clinical trial on the use of a diaphragm and lubricant gel for the prevention of HIV acquisition in southern African women. Female controlled methods of HIV prevention are urgently needed. The goal of the trial was to assess the use of a latex diaphragm, lubricant gel and condoms compared with condoms alone on HIV seroincidence in women in South Africa and Zimbabwe. The study found that there was no added protective benefit against HIV infection from the added use of a diaphragm and lubricant gel but the study does suggest that women with diaphragms and without condoms did not see an increased infection rate.

Objectives. We examined perceptions of the effectiveness and acceptability of a candidate microbicide among 94 South African female sex workers who had participated in a phase 3 microbicide trial for HIV prevention. Methods. Sixteen focus groups were conducted in 2001,12 to 15 months after participants were informed that the candidate microbicide had been determined to be ineffective in preventing HIV and other sexually transmitted infections (STIs). Results. Participants clearly indicated that they understood the experimental nature of the candidate microbicide, and they recognized that they had been informed after the trial that the product was ineffective. Nevertheless, most continued to believe that the candidate microbicide helped prevent HIV and other STIs, alleviated reproductive tract pain and STI symptoms, and helped to clean the vagina. Conclusions. These findings underscore the importance of understanding women's perceptions of the efficacy of candidate microbicides and the rationale for these beliefs. These issues need to be addressed in counseling throughout microbicide trials for HIV prevention. These results also demonstrate how desperate many women at high risk of HIV infection may be for new HIV prevention technologies. (Am J Public Health. 2006;96:1073-1077. doi:10.2105/AJPH.2004.047514) [ABSTRACT FROM AUTHOR]

We aimed to determine the effectiveness of the vaginally administered spermicide nonoxynol-9 (N-9) among women for the prevention of HIV and other sexually transmitted infections (STIs). We did a systematic review of randomised controlled trials. Nine such trials including 5096 women, predominantly sex workers, comparing N-9 with placebo or no treatment, were included. Primary outcomes were new HIV infection, new episodes of various STIs, and genital lesions. Five trials included HIV and nine included STI outcomes, and all but one (2% of the data) contributed to the meta-analysis. Overall, relative risks of HIV infection (1·12, 95% confidence interval 0·88–1·42), gonorrhoea (0·91, 0·67–1·24), chlamydia (0·88, 0·77–1·01), cervical infection (1·01, 0·84–1·22), trichomoniasis (0·84, 0·69–1·02), bacterial vaginosis (0·88, 0·74–1·04) and candidiasis (0·97, 0·84–1·12) were not significantly different in the N-9 and placebo or no treatment groups. Genital lesions were more common in the N-9 group (1·18, 1·02–1·36). Our review has found no statistically significant reduction in risk of HIV and STIs, and the confidence intervals indicate that any protection that may exist is likely to be very small. There is some evidence of harm through genital lesions. N-9 cannot be recommended for HIV and STI prevention. [ABSTRACT FROM AUTHOR]

Examines the presence of cervical human papillomavirus (HPV) DNA in HIV type 1-infected and -uninfected sex workers. Significantly higher prevalence of HPV DNA displayed by HIV-positive that HIV-negative women; High seroprevalence rate for anti-VLP-16 immunoglobulin G antibodies by both HIV-positive and HIV-negative women.