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Research Article

Individual and Population Level Bear on of Key HIV Risk Factors on HIV Incidence Rates in Durban, Due south Africa

• Gita Ramjee,
• Suri Moonsamy,
• Nathlee Samantha Abbai,
• Handan Wand

x

• Published: April 22, 2016
• https://doi.org/10.1371/journal.pone.0153969

Figures

Abstract

We aimed to approximate the private and joint bear upon of age, marital condition and diagnosis with sexually transmitted infections (STIs) on HIV conquering among immature women at a population level in Durban, KwaZulu-Natal, Due south Africa. A full of 3,978 HIV seronegative women were recruited for 4 biomedical intervention trials from 2002–2009. Point and interval estimates of partial population attributable take a chance (PAR) were used to quantify the proportion of HIV seroconversions which can exist prevented if a combination of run a risk factors is eliminated from a target population. More than 70% of the observed HIV acquisitions were collectively attributed to the 3 risk factors: younger age (<25 years old), single 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 loftier HIV incidence rates amid young women and the population every bit a whole.

Commendation: Ramjee Chiliad, Moonsamy S, Abbai NS, Wand H (2016) Private and Population Level Touch on of Central HIV Hazard Factors on HIV Incidence Rates in Durban, Southward Africa. PLoS Ane 11(iv): e0153969. https://doi.org/10.1371/journal.pone.0153969

Editor: Weijing He, Academy of Texas Health Scientific discipline Centre San Antonio Texas, UNITED STATES

Received: October viii, 2015; Accepted: Apr 6, 2016; Published: April 22, 2016

Copyright: © 2016 Ramjee et al. This is an open access article distributed under the terms of the Creative Eatables Attribution License, which permits unrestricted use, distribution, and reproduction in whatever medium, provided the original author and source are credited.

Data Availability: Data are restricted from public sharing due to participant-specific information in the underlying data. Please email Prof Gita Ramjee at Gita.Ramjee@mrc.air-conditioning.za for coordination of approval of various datasets.

Funding: The authors have no support or funding to report.

Competing interests: The authors have declared that no competing interests exist.

Introduction

Southern Africa is at the epicenter of the global HIV epidemic, with an estimated xl% of the global HIV brunt occurring amongst individuals in this region [1,2]. Ane of the key population groups with high reported HIV incidence rates are adolescent girls and young women of between15-24 years of historic period, who contribute to almost one 3rd of all new reported HIV incident infections [3]. In South Africa (SA) alone, it is reported that greater than 100,000 infections occur in young women each year, which is more than four times the number of new reported HIV infections estimated to occur in adolescent and young men [1,2].

The province of KwaZulu-Natal (KZN) in SA, is the region nigh affected by HIV and AIDS and women business relationship for greater than 60% of infections [4,5]. The near dominant mode of transmission in this hyper-endemic (occurrence of concentrated epidemics in generalized epidemic settings) setting is mainly through unprotected heterosexual contacts.

Combined with behavioral risks such as multiple and concurrent partnerships, lack of condom apply and age disparate relationships, contained associations have been reported between HIV and sexually transmitted infections (STIs) including Chlamydia trachomatis, Neisseria gonorrhoeae, Syphilis and Trichomonas vaginalis [6–nine]. While biological, behavioral, cultural, socio-economical and structural hazard factors have been associated with HIV seroconversion in Southward African women, the relative contributions of these risk factors vary widely between studies and across dissimilar sub-populations [10,11].

In social club to inform and constitute more constructive prevention strategies targeted at immature women, there is a need to better empathise HIV transmission dynamics and the risks associated with HIV seroconversion.

Estimating an individuals' hazard is the most mutual way to assess causality, but they do not provide necessary information about their potential affect on HIV incidence rates at a population level. The population attributable hazard (PAR) is an epidemiologic measure out that serves to provide such information as a quantitative cess of the potential reduction in affliction occurrence if the risk gene were to exist entirely removed from the population [12]. PAR provides information well-nigh the public health significance of specific and potentially modifiable risk factor(s) on a disease by bookkeeping for both the strength of the association on the outcome of interest, likewise as the prevalence of the risk factor in the population. Therefore, identification of measures of attributable gamble is imperative non only in guiding policy and prioritizing prevention strategies, simply also allows for modifying common adventure factors in populations with relative high hazard ratios to assist in minimizing the burden of diseases associated with HIV infection.

In gild to advance our understanding of the high incidence rates in young women, we undertook a sub-analysis by combining data from large randomized controlled trials (RCTs) or studies conducted past the states to gauge the relative and attributable risks associated with HIV seroconversion. We peculiarly focused on i unmodifiable run a risk factor (age) and two modifiable risk factors (not beingness married and/or cohabiting with a stable/regular partner), and being diagnosed with at least 1 sexually transmitted disease. Furthermore, this sub-assay study is one of the starting time to narrow downwards individual and combination of multiple chance factors into iii specific modifiable factors to accost population level touch on of such risks on HIV incidence rates amidst young women.

Methods

Study Population

Nosotros combined information of 3,978 sexually active women who consented to screening for 4 studies in the Province of KZN: Methods for Improving Reproductive Wellness in Africa (MIRA) RCT using the vaginal diaphragm for HIV prevention (September2002-September 2005; undertaken in Umkomaas and Botha's Loma, Due south and N Due east of Durban, respectively) [13]; The Microbicides Development Programme (MDP) Feasibility Study in Preparation for Phase Iii Microbicide Trials (August 2002-December 2004; undertaken in semi-rural Tongaat and Verulam, northern Durban) [14], the HIV Prevention Trials Network (HPTN) Site Preparedness study (HPTN 055) for Time to come Implementation of Phase2/IIb/III clinical trials (June 2003—October 2005; undertaken in rural district of Hlabisa, and urban Durban) [6] and the Carraguard® RCT which tested the potential microbicide, Carraguard^® [15] at a urban middle, Isipingo between (March 2004 –March 2007).

All study populations have previously been described elsewhere [6,13–fifteen]. For the MIRA and HPTN 055 studies, HIV diagnostic testing was adamant by using 2 rapid tests on whole blood sourced from either finger-prick or venipuncture: Make up one's mind HIV-ane/2 (Abbot Laboratories, Tokyo, Nippon) and Oraquick (Orasure Technologies, Bethlehem, PA, USA). The Abbot IMX ELISA test (Abbot Diagnostics, Africa Sectionalisation) was used for HIV diagnosis during the MDP Feasibility report. For the Carraguard^® RCT, HIV serostatus was confirmed with parallel HIV-ane rapid tests and positive/discordant tests were confirmed by third-generation enzyme immunoassay or polymerase chain reaction (PCR) for the detection of HIV-1 ribonucleic acid (RNA).

Briefly, the primary eligibility criteria were similar for all studies and included: being sexually active; HIV negative status at screening; willingness to provide written consent and follow study process; not meaning with intention to maintain non-pregnant status; and residence in and around the study area for a minimum of 1 twelvemonth. At all visits, participants received risk reduction counseling and access to condoms. Counselors emphasized that condoms are the only known method to prevent HIV and STIs, and that condoms should exist used for every sexual practice act. Women who were HIV-positive at screening were referred to local health care facilities for care and back up. Women who seroconverted during the trials remained in the study and were provided with ongoing counseling and referral to local health intendance facilities for farther care upon completion of the studies. All protocols and informed consent forms were canonical by the Biomedical Research Ethics Commission (BREC) at the University of KwaZulu-Natal. All participants provided written informed consent to participate in the studies.

Statistical Analysis

Nosotros conducted prospective observational assay by combining the data from the 4 studies as described above. Cox proportional regression models of HIV seroconversion on the detached time scale of monthly and quarterly visits. With this approach, the behavior variables were assessed at the same fourth dimension that the blood was drawn for seroconversion testing, and refer to the previous ane-month (for monthly visits) or 3-month time period (for quarterly visits).

Given that none of the study interventions showed efficacy in preventing HIV transmission, nosotros combined the data as one accomplice irrespective of treatment arm allocations.

The chief consequence was incident HIV infection every bit divers time from enrollment to seroconversion, on the basis of a discrete time scale determined by an private's monthly /quarterly visit. For women who seroconverted, the time of seroconversion was divers equally the fourth dimension of first positive HIV test consequence. For cases in which 1 or more visits were missed in the intervals between the final negative and first positive tests, the time of seroconversion was causeless to be the visit containing the midpoint betwixt these two fourth dimension points.

Assessment of modifiable and non-modifiable risk factors

Take a chance factors were classified as (at least theoretically) modifiable (by public wellness intervention) and non-modifiable (even theoretically) and/or background risk factors (all persons similarly exposed or potential confounders for HIV manual). Amid the established take a chance factors, cohabitation status (unmarried and not cohabiting with a stable/regular partner), and incidence of STIs (Chlamydia trachomatis, Neisseria gonorrhoeae, Syphilis or Trichomonas vaginalis) during the follow upwardly were both considered to be potentially modifiable gamble factors. Age at infection was considered to be a non-modifiable and/or background chance factor and causeless to remain unchanged.

Estimation of relative and population attributable risks

Hazard ratios and 95% confidence intervals (95% CIs) for HIV incidence rates were calculated using Cox regression models.

PAR was calculated past combining the hazard ratios and the observed prevalence of the risk factors of interest [xvi]. Briefly, PAR is used to measure the reduction expected in the number of HIV infected women if all the known risk factors were eliminated from the target population. We refer to this equally the full PAR (PAR _F ). In evaluating preventive interventions in a multi-factorial disease settings such equally HIV, the primary interest is in the percentage of cases associated with the modifiable risk factors while other non-modifiable gamble factors, such equally age is kept unchanged. Therefore, we focus hither on the partial PAR (PAR _p ) which estimates the percent of cases associated with modifiable risk factors only. Briefly, PAR and their 95% CIs were calculated for private risk factors besides as their combinations using Cox regression models for the incidence rate of HIV seroconversion and observed prevalence rates of the adventure factors of interest.

We also created a "highest risk" category for the women who were "younger than 25 years of historic period", "unmarried and not cohabiting with a stable/regular partner" and "diagnosed with other STIs". Population owing risks, which were estimates of the proportion of HIV seroconversions during follow-up that would not accept occurred if all women had been in "low risk" category, bold that the observed associations represent causal effects. For simplicity and increased statistical efficiency, we used a unmarried binary categorical variable to calculate the PAR% pertaining to the impact of depression-hazard gene.

Since age was a strong determinant adventure cistron of seroconversion, we also stratified our analysis by age groups.

Analyses were performed using SAS statistical software, version 10 (SAS Inc., Cary, NC).

Results

Study population

Approximately 41% of women in the study population (northward = 3978) were younger than 25 years of historic period. More than 70% of women were single and not cohabiting with a stable/regular partner and approximately one-quarter of the women (26%) were diagnosed with at least one STI [i.e. (Chlamydia trachomatis, Neisseria gonorrhoeae, Syphilis or Trichomonas vaginalis)] during study follow-upwards visits. Furthermore, 33% of women reported having lower than secondary education status and 63% reported using at least one type of contraceptive.

Approximately half (50%) of the report population reported no condom use in last sexual acts, whilst slightly just over 50% of them reported more than than iii sexual acts per calendar week. In the overall report population, pregnancy incidence of 18% (data not shown) was observed, whereas a total of 318 women seroconverted for HIV (ten% in MIRA trial, 8% in Carraguard trial and six% in feasibility and HPTN055 studies, respectively).

Risk factors and their articulation impacts of on HIV seroconversion

A total of 318 HIV seroconversions (incidence cases) were observed during study follow-upwards visits with an overall incidence rate of 6.3 per 100 women-years [95% Confidence interval (CI): 5.half dozen,7.04]. Table 1 provides the frequency distributions and the crude HIV incidence rates for each of the three risk factors in this sub-assay: younger than 25 years of historic period, unmarried and not cohabiting with a stable/regular partner and being diagnosed with an STI. HIV seroconversions were significantly higher among younger women equally compared to older women (9.63 per 100 person year, 95% CI: 8.35, 11.11 and 4.16 per 100 person yr, 95% CI: 3.50, iv.95, p-value<0.001). Women who were unmarried and non cohabiting with a stable/regular partner likewise had the highest HIV incidence rates with vii.80 per 100 person twelvemonth (95%CI: 7.00, 8.76) compared to those married or cohabiting with their sexual partners (2.00 per 100 person year, 95% CI: one.36, 2.94, p-value <0.001). Women who reported existence diagnosed with at least one or more STIs (i.due east. Chlamydia trachomatis, Neisseria gonorrhoeae, Syphilis or Trichomonas vaginalis) during the study were also significantly associated with HIV seroconversion compared to those diagnosed with no STIs (ten.xix per 100 person year, 95% CI: 8.62,12.06 vs. four.90 per 100 person-year, 95% CI: 4.22,5.66, p-value<0.001).

Table 2 provides adjusted (for level of education, average number of sexual acts for final two weeks, and contraceptive use) hazard ratios (HRs) for these reported risk factors. We presented estimates of the proportion of HIV incidence cases owing to the three main non-modifiable/modifiable risk factors and possible intervention scenarios for HIV manual. In the overall study population, three factors, namely, younger age, unmarried and not cohabiting with a stable/regular partner and diagnosis with STIs were associated with 71% of all reported HIV seroconversions (95% CI: 68, 73). Their partial contributions to the HIV seroconversions were 23% (95% CI: 18,27) for those younger than 25 years of historic period, 59% for those who were unmarried and not cohabiting with a stable/regular partner and xviii% for being diagnosed with an STI. In the stratified analysis by historic period, approximately 50% of immature women in the study population (95% CI: 27, 68) and lx% of older women (95% CI: 51, 66) (older) of the reported cases were attributed for those who were unmarried. The high hazard ratios of marital status were responsible for this reported bear upon among women.

Discussion

This is one of the first studies to evidence that in a combined accomplice of women, 71% of observed cases of incident HIV infections among women in Durban, Southward Africa are associated with one non-modifiable (younger historic period) and two established modifiable risk factors (unmarried and not cohabiting with a stable/regular partner), and being diagnosed with at least one STI (Chlamydia trachomatis, Neisseria gonorrhoeae, Syphilis or Trichomonas vaginalis) by utilizing PAR as an approximate of the proportion of infections which may have been averted, after taking into account the relationships with other variables. We found that being unmarried and not cohabiting with a stable/regular partner was associated with an nigh 3-fold higher risk of HIV seroconversion than being married. As a event, 59% of the population risk was attributable to this behavior. Hence, if this behavior was not present in the population, the number of infections would have been reduced by approximately 60%.

Further, we showed that 26% of women with a diagnosis of an STI was one of the contributing risk factors, the risk ratio was 1.75 (95% CI: ane.40–two.xix) and the PAR was eighteen%. Although the contribution of an STI is meaning, by comparison of the estimated PAR it is clear that being unmarried or not cohabiting with a stable partner, is the stronger driver of population HIV risk than diagnosis with an STI. The state of affairs is particularly grim for women and young girls in sub-Saharan Africa and the burden of disease peculiarly continues to increase amid immature women. Therefore, an effective intervention is needed, which encourages HIV testing, condom sexual practice counseling, reduction in risky sexual behavior, promoting STI testing and treatment and cohabiting with partners is needed. Should this exist accomplished, we can await a reduction in HIV incidence.

In Due south Africa, significantly loftier HIV infection rates have been observed among single individuals compared to married individuals [17] and our results are concordant with the reported report. In our setting, women who were unmarried and not cohabiting with a stable/regular partner faced more than a double hazard of HIV acquisition when compared to women that were married or without whatever sexual partners. The reason why so many women in particular remain unmarried is owing to cultural practices such every bit the requirement of high price of "lobola"–where the potential male person partner has to provide to the female person partner's family may contribute to lack of formal marriages in this society [xviii]. In improver, these unmarried women are exposed to structural factors such as migration, transactional sex for economic survival, gender norms and urbanization, which in turn are contributory factors that farther augments their vulnerability to HIV [19].

Despite the introduction of HIV prevention and treatment programs, the overall HIV incidence rate of six.3 per 100 women'due south year amongst women younger than 25 years of age remains unacceptably high as reported in this written report. This tendency has been observed in the final decade [20–22]. Thus, our findings are consistent with previous reports [20–22]. Our written report shows that younger age (<25 years of historic period) carries a ii-fold greater gamble of HIV acqusition.

The importance of measuring HIV incidence is key to understanding the dynamics of HIV transmission and conquering to shape and modify constructive responses. The persistence of high HIV incidence rates and the vulnerability of young women in our setting remains a major health concern. It has been suggested that the gamble for HIV increases every bit soon equally immature women initiates sexual intercourse–biological vulnerability [23]. For instance, in older women, the endocervix is made upward of simple columnar epithelium, while the ectocervix and vagina are lined with a stratified squamous epithelium. As women age, the columnar epithelium of the ectocervix transforms into squamous epithelium. All the same, in immature women, cervical ectopy and the presence of a simple columnar epithelium is part of the normal physiology, and this leads to increased susceptibility to HIV and other STIs [23]. In addition, young women have relatively higher levels of genital inflammation, which further increases the run a risk of acquiring HIV [23].

There are various other socio-behavioural factors that increases a immature women's risk for acquiring HIV such as early on historic period of sexual debut, age-disparate relationships, inconsistent condom utilise, transactional sex activity and concurrent sexual partners [24]. Studies accept reported that residing in urban informal settlements, being unmarried and/or unemployed was associated with higher HIV incidence underscoring some of the underlying structural and social factors that drive the epidemic [24].

Age disparate relationships were reported to be one of the chief reasons for loftier HIV incidence rates among young women. The aggregating incidence rates of HIV infections with increasing age implies that a young woman engaging in a sexual human relationship with an older human is at a college risk of acquiring HIV compared to a young woman engaging with a male peer. Dellar and her colleagues (2015) reported that young women less than 25 years of age establish nearly 30% of all new infections and are more likely to seroconvert v–7 years earlier compared to their male counterparts [25]. In add-on, these very young women are eight times more likely to learn HIV infections compared to their male counterparts [25]. Furthermore, a young woman engaging in a relationship with an older human may exist less likely to negotiate prophylactic use given the gender-power dynamics, which further increases her take a chance of HIV conquering.

Conversely, recent data suggests that the epidemic in South Africa may be shifting [26,27]. A more recent study conducted by Street and her colleagues among 1355 women aged sixteen years and older in the South African setting reported that no significant correlation exists between sexual partner age disparity and HIV acquisition [26]. Women in this report were divided into three singled-out categories: non-historic period disparate, intra-generational age disparate relationships and inter-generational historic period disparate relationships. Findings suggest that age, marital condition and concurrency of sexual partners were the primary contributing factors for inter-generational age disparate relationships between younger women and older men [26]. Similarly, Balkus and her colleagues analyzed data from women that participated in the Vaginal and Oral Interventions to Control the Epidemic (Vocalisation) clinical trial and reported that no association exists between male person partner age and gamble of HIV acquisition of women who were involved in age-disparate relationships [27]. Women who reported to be in an age disparate relationship with a male person partner older than five or ten years did not appear to be at a high risk of HIV-1 acquisition.

When considering the manifestly uniquely loftier per-act HIV acquisition take chances in immature women, information technology is also necessary to consider other relevant contextual factors that may mediate the infection environment such as other STIs and contraceptive utilize. Many bacterial and viral STIs are associated with increased risk of HIV infection. Nosotros show that women who were diagnosed with STIs were at increased risk for HIV infections. Our findings are supported by previous studies in Southward Africa [28,29][30]. The mechanism by which STIs increase susceptibility to HIV has been described by Kleppa et al [31,32], Reddy et al [33] and Sperling et al [34]. Sexually transmitted infections have been shown to increment susceptibility to HIV, by causing disruption of the genital epithelium, by increasing the number of HIV target cells and by immune activation in the genital mucosa [31]. Furthermore, STIs are the major causes of inflammatory cytokine up-regulation and immune jail cell recruitment to the genital mucosa [33,34].

Beyond STIs, other biological risk factors may also exist amplified in young women. A recent study past Finchorova et al suggests that young women of reproductive age, who utilise hormonal contraceptives accept altered cervical amnesty in presence of genital tract infections such as STIs, which contributes to the increased take a chance to HIV acquisition [35]. Similarly, in ane of our earlier reports, nosotros assessed the population-level impact of hormonal contraceptive employ (i.e. injectables and pills) in relation to HIV-i seroconversion and the incidence of pregnancy during follow-upwardly from two combined cohorts of HIV-1 negative, non-pregnant women who participated in two biomedical trials (MDP 301 and Carraguard) conducted in Durban, south Africa [36]. In this prospective accomplice report, hormonal contraceptive use was considered a modifiable risk gene of interest, whilst adjusting for all other confounding factors. Approximately 78% of women reported hormonal contraceptive use in the study [36]. A higher proportion of hormonal contraception was reported among young and unmarried women [36]. Women who reported using hormonal contraceptives at enrolment in the trial had a higher hazard of HIV-1 seroconversion (adapted hazards ratio: 1.24; 95% CI: 0.97–one.58) than women who reported using other types of contraceptives at enrolment [36]. At the population level, the use of hormonal contraceptives (pills or injectables) at baseline and during study follow-upwardly deemed for approximately xx% (95% CI: 16–22) of HIV-1 seroconversions. Notwithstanding, the partial PAR indicated a relative bear on of 12% (95% CI: 9.0–xv.7). On the other hand, 72% (95% CI: 66–77) of the pregnancies could take been avoided if all women had used hormonal contraceptives [36].

The question remains every bit to how nosotros address the multiple risks that women confront in acquiring HIV in KwaZulu-Natal and their contribution to the overall population take chances? Biomedical interventions for HIV prevention such every bit vaginal microbicides did not yield a positive outcome in all but one trial [37,38] and PreExposure prophylaxis (PrEP) for HIV prevention showed conflicting outcomes among women in Southward Africa [39]. The poor outcomes were associated mainly with depression adherence to product use. This may be in role due to women in SA who exercise not perceive themselves to exist at risk of HIV acquisition [40,41]. For instance, the FEM-PrEP HIV Prevention trial was unable to demonstrate the effectiveness antiretroviral (ARV) agent Truvada, amid women at high risk for HIV exposure [41]. A sub-analysis of the FEM-PrEP trial data was conducted to appraise whether low perceived HIV risk could be a cistron for poor adherence. Women were assessed for perceived HIV adventure at enrolment and follow-up visits for a menses of four weeks. Women who perceived themselves to be at HIV adventure were better adherers to the study product compared to those women who did not perceive themselves at risk [41]. An array of factors such every bit concurrency of partners, sexual contacts without condom employ and cognition of partner HIV status were associated with college risk perception [41]. These results indicated a significant correlation between the caste of risk perception and level of adherence. Another study (unpublished Ramjee et al) suggests that women, who had perceived themselves at risk of pregnancy and were using condoms for pregnancy prevention, were more than likely to adhere to boosted prevention options such equally a vaginal microbicide. These findings suggest that adventure perceptions may exist a key chemical element in addressing adherence to study products for not just PreExposure prophylaxis (PrEP), but other HIV prevention options. Given the high incidence rates, it is counter intuitive that women in our setting practice not perceive themselves at take a chance of HIV.

Structural interventions such as greenbacks transfer initiatives that targeted immature women in Due south Africa did not have an bear on on HIV incidence [42,43]. Health systems at primary health intendance centres are able to treat STIs. However, we need to understand if women do seek these treatments and whether if these healthcare systems are integrated in the main holistic care to women [43].

Information technology is evident from our study that a woman's perceived hazard and her actual run a risk may differ. Hence, nosotros show that at that place are other run a risk factors to HIV conquering and non just sexual behaviour. Assessment of her social status, sexual behaviour patterns, role of the male partner and his HIV and migratory condition, type of relationship between sexual partners (to rule out gender based violence) and her health seeking behaviour regarding regular HIV/STI testing and reproductive care is critical. Current data shows that we are unlikely to have a "1-size fits all" prevention package, but based from commonage insights through numerous research studies in our setting; we know that addressing the epidemic among young women in KwaZulu-Natal will require an integrated effort at all levels.

Determination

To our noesis, this is the showtime study to investigate the PAR of HIV hazard factors in Durban, South Africa. Our results imply that over 70% of the observed HIV seroconversions which were collectively attributed to three risk factors: younger historic period (<25 years old), unmarried and diagnosis with STIs could exist avoided past implementing targeted combinations of behavioural, structural, biomedical and cultural interventions. The most efficient employ of scarce resources in reducing HIV infections will require complex balancing betwixt the PAR for a given take chances factor(s), the efficacy of interventions to change the gamble cistron, and the cost of these interventions. In KZN, we need to address a combination of factors including biological, behavioral, structural and cultural bug in society to reduce HIV infection rates among women and the South African population equally a whole. It requires a commonage effort from all levels of lodge including policy makers, traditional and customs leaders, community organizations, health systems, researchers, and organizations specifically targeting women's wellness in the country.

Acknowledgments

We thank the contribution of all trial participants in these studies, the communities, and the MIRA, HPTN 055, Carraguard and MDP Feasibility study/protocol teams and study teams of the HIV Prevention Research Unit (Durban) of Due south African Medical Research Quango.

Author Contributions

Conceived and designed the experiments: GR SM NSA HW. Performed the experiments: HW. Analyzed the data: GR SM NSA HW. Contributed reagents/materials/analysis tools: HW. Wrote the newspaper: GR SM NSA HW.

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