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OBJECTIVE: To assess the effect of oral and injectable contraceptive use compared to nonhormonal contraceptive use on HIV acquisition among Southern African women enrolled in a microbicide trial. STUDY DESIGN: This is a prospective cohort study using data from women enrolled in HIV Prevention Trials Network protocol 035. At each quarterly visit, participants were interviewed about self-reported contraceptive use and sexual behaviors and underwent HIV testing. Cox proportional hazards regression was used to assess the effect of injectable and oral hormonal contraceptive use on HIV acquisition. RESULTS: The analysis included 2830 participants, of whom 106 became HIV infected (4.07 per 100 person-years). At baseline, 1546 (51%) participants reported using injectable contraceptives and 595 (21%) reported using oral contraceptives. HIV incidence among injectable, oral and nonhormonal contraceptive method users was 4.72, 2.68 and 3.83 per 100 person-years, respectively. Injectable contraceptive use was associated with a nonstatistically significant increased risk of HIV acquisition [adjusted hazard ratio (aHR)=1.17; 95% confidence interval (CI) 0.70, 1.96], while oral contraceptive use was associated with a nonstatistically significant decreased risk of HIV acquisition (aHR=0.76; 95% CI 0.37,1.55). CONCLUSION: In this secondary analysis of randomized trial data, a marginal, but nonstatistically significant, increase in HIV risk among women using injectable hormonal contraceptives was observed. No increased HIV risk was observed among women using oral contraceptives. Our findings support the World Health Organizations recommendation that women at high risk for acquiring HIV, including those using progestogen-only injectable contraception, should be strongly advised to always use condoms and other HIV prevention measures. IMPLICATIONS: Among Southern African women participating in an HIV prevention trial, women using injectable hormonal contraceptives had a modest increased risk of HIV acquisition; however, this association was not statistically significant. Continued research on the relationship between widely used hormonal contraceptive methods and HIV acquisition is essential.

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]

Introduction: Some observational data suggest that the progestogen injectable contraceptive depot medroxyprogesterone acetate (DMPA) may increase a woman's risk of HIV acquisition but a randomized clinical trial did not find a statistically significant increase in HIV risk for women using DMPA compared to two other methods. However, it could not rule out up to 30% increased HIV risk for DMPA users. We evaluate changes to contraceptive method mix in South Africa under different assumptions about the existence and strength of a possible undetected relationship between DMPA use and HIV risk. Methods: A mathematical model was developed to simulate the ongoing HIV epidemic and contraceptive method mix in South Africa to estimate how changes in method mix could impact HIV‐ and reproductive health‐related outcomes. We made different assumptions about the relationship between DMPA use and HIV risk, from no relationship to a 30% increase in HIV risk for women using DMPA. Scenario analyses were used to investigate the impact of switching away from DMPA predominance to new patterns of contraceptive use. Results: In South Africa, the HIV‐related benefits of reduced DMPA use could be as great as the harms of increased adverse reproductive health outcomes over 20 years, if DMPA did increase the risk of HIV acquisition by a relative hazard of infection of 1.1 or greater. A reduction in DMPA use among HIV‐positive women would have no benefit in terms of HIV infections, but would incur additional negative reproductive health outcomes. The most important driver of adverse reproductive health outcomes is the proportion of women who switch away from DMPA to no contraceptive method. Conclusions: If there is any real increased HIV risk for DMPA users that has not been detected by the recent randomized trial, a reduction in DMPA use could reduce the ongoing number of new HIV infections. However, such a change would place more women at risk of adverse reproductive health effects. It is imperative that these effects are minimized by focusing on expanding access to safe, effective and acceptable alternative contraceptive methods for all women. [ABSTRACT FROM AUTHOR]

In addition to being the epicentre of the HIV epidemic, South Africa also has the highest burden of sexually transmitted infections (STIs) in the world. Therefore, understanding the most influential risk factors of STIs is a research priority. Using the data from 9948 women who resided in KwaZulu Natal, South Africa, we estimated the population attributable risk to quantify the combined impacts of the most influential factors on STI diagnosis. Overall STI prevalence was 20%, and STI incidence was 15 per 100 person-years. Four factors: age at sexual debut, single/not cohabiting, two or more sex partners and parity <3 were identified as the most influential risk factors for STI prevalence and incidence rates. However, these factors collectively associated with only 51% and 53% of the excess STI prevalence and incidence rates, respectively. These relatively modest impacts provide empirical evidence for the significant impacts of unmeasured factors on STIs. Culturally and socially appropriate prevention programs may be more effective to target those at highest risk of STIs. [ABSTRACT FROM AUTHOR]

South Africa has the highest burden of human immunodeficiency virus (HIV) infections in the world with significant geographical variations. We identified the predictors of HIV infections and their sub-geographical-level contributions to the epidemic using a decade long data (2002-2012) from 6484 South African women. Generalized additive models were used to uncover the most significant features of these estimates across the region. In the overall analysis, younger age, not married or cohabiting with a partner, partner has another partner(s) and null/prim parity, using injectable contraceptives and presence of other sexually transmitted infections (STIs) were identified as independent predictors of HIV seroconversions. Overall, the top three highest contributors to infections were women's marital status (PAR% = 73%, 95% CI: 68%, 77%), parity (PAR% = 47%, 95% CI: 42%, 53%) and partnership factors (PAR% = 37%, 95% CI: 30%, 44%). However, their contributions varied remarkably at sub-geographical level. This was mainly due to the substantial localized variations in their prevalence and hazard ratios across the region. Our results will guide policy makers to develop tailored prevention strategies in order to allocate scarce resources by targeting the most significant contributors of HIV infection at sub-geographical level. [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 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]

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]

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]

The objective of this study was to estimate the joint impact of demographic and sexual risk behaviors on HIV acquisition. A total of 2,523 HIV seronegative women were recruited through three community based studies in Durban, South Africa. 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 80% of the observed HIV acquisitions were attributed to five risk factors: lack of cohabitation, frequency of sex, sexually transmitted infections (STIs), incidence of pregnancy and not being employed/no income. Structural factors such as minimizing migratory patterns by ensuring cohabitation of partners, access to treatment of STIs, income generation and safe sex negotiation skills are likely to play an important role in future prevention strategies. [ABSTRACT FROM AUTHOR]

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.

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]

We explored factors associated with differential HIV incidence among women participating in a HIV prevention trial in Harare, Durban, and Johannesburg. The trial had shown no effect of the intervention (diaphragm and lubricant gel) on HIV incidence.A prospective cohort analysis was conducted of trial participants followed for 12-24 months. Sociodemographic, biological, and behavioral data were collected at baseline and at quarterly visits. Factors associated with HIV incidence were estimated using multivariable Cox regression models, stratified by study location. Attributable risk was calculated from the adjusted hazard ratios (AHR).There were 309 incident HIV infections among the 4948 women in the analysis. HIV incidence was highest in Durban [6.75/100 person-years; 95% confidence interval (CI): 5.74 to 7.93], lower in Johannesburg (3.33/100 person-years; 95% CI: 2.51 to 4.44), and lowest in Harare (2.72/100 person-years; 95% CI: 2.26 to 3.26). Sexually transmitted infections were important risk factors in Harare [prevalent herpes simplex virus type 2 (HSV2) AHR = 2.56, 95% CI: 1.61 to 4.06; incident HSV2 AHR = 12.60, 95% CI: 2.13 to 21.87; Neisseria gonorrhoeae AHR = 6.82, 95% CI: 2.13 to 21.87] and in Durban (prevalent HSV2 AHR = 1.64, 95% CI: 1.07 to 2.51; N. gonorrhoeae AHR = 4.40, 95% CI: 2.07 to 9.39). In Durban, having multiple partners (adjusted odds ratio (AOR) = 1.78 95% CI: 1.11 to 2.85) and sex although a partner was under the influence of alcohol/drugs (AOR = 1.51 95% CI: 1.05 to 2.16) significantly increased risk, whereas in Johannesburg, sexual debut <16 years (AOR = 2.60 95% CI: 1.30 to 5.17) was a strong predictor of HIV acquisition.Important differences were seen in drivers of HIV incidence at the 3 study locations. Results from this analysis imply that targeted HIV programing could have a large impact on incident HIV infection in women, and that the most effective approach will likely vary based on knowledge of the local situation/epidemiology. [ABSTRACT FROM AUTHOR]

We examine changes in sexual risk behaviors before and after HIV seroconversion in southern African women enrolled in the Methods for Improving Reproductive Health in Africa trial.HIV testing and counseling, and assessment of sexual behaviors by audio computer-assisted self-interviewing were performed approximately every 3 months. We compared the following sexual behaviors: being sexually active, coital frequency, consistent male condom use, use of any female condoms, anal sex, and >1 sex partner, at study visits before and after HIV seroconversion.During the trial, 327 women seroconverted to HIV, contributing 718 pre-HIV and 1110 post-HIV study visits. Women were significantly more likely to report consistent condom use at visits after HIV seroconversion compared with visits before HIV infection [adjusted odds ratio, (AOR): 1.36 (95% confidence interval (CI): 1.11 to 1.67)] and were less likely to have >1 male sex partner after serconversion [AOR: 0.66 (95% CI: 0.48 to 0.91)]. Women reported less frequently being sexually active [AOR: 0.63 (95% CI: 0.39 to 1.02)], fewer episodes of sex [>4 sex acts over the past week AOR: 0.74 (95% CI: 0.60 to 0.91)], and a reduction in anal sex [AOR: 0.58 (95% CI: 0.36 to 0.95)] at visits after HIV seroconversion. The observed reductions in sexual risk behaviors persisted over time.Women significantly decreased their sexual risk behaviors after HIV seroconversion, but these changes were relatively modest, suggesting the need for further secondary prevention. Timely notification of HIV status coupled with prevention messages can contribute to reductions in sexual risk behaviors. [ABSTRACT FROM AUTHOR]

Abstract: Background: The identification of new HIV prevention methods that women can initiate themselves are urgently needed, particularly in high prevalence settings. HIV prevention trials must be designed with large sample sizes and/or substantial follow-up periods to ensure enough statistical power to measure product effectiveness. This paper describes the attendance rates of the Methods for Improving Reproductive Health in Africa (MIRA) trial, reasons for missed visits, and strategies used to retain participants; and examines demographic and behavioural predictors of retaining women. Methods: HIV negative, sexually active females were enrolled into the MIRA trial in Zimbabwe and South Africa. Once enrolled, women were expected to visit the clinic at 2 weeks and quarterly thereafter for 12 to 24 months. Tabulations of visit-specific retention rates are presented, along with a descriptive summary of retention strategies established prior to and in response to challenges incurred during implementation. Both univariate and multivariate logistic regression models were created in STATA to examine predictors of being retained vs. lost-to-follow-up. Results: At the three sites, the final retention rates were 94%, 93% and 89% for Zimbabwe, Durban and Johannesburg, respectively. This was achievable through intensive outreach efforts toward the latter part of the trial and a commitment from all staff. Each site implemented several retention strategies. Conclusion: The high retention rates were achievable in this trial through added staff efforts and resources. Community involvement was also crucial to achieve these rates. Retention of trial participants should be considered during trial design and implemented from the onset. [Copyright &y& Elsevier]