Impact of vaginal douching products on vaginal Lactobacillus, Escherichia coli and epithelial immune responses.

We compared the effect of commercial vaginal douching products on Lactobacillus crispatus, L. jensenii, L. gasseri, L. iners, E. coli, and immortalized vaginal epithelial cells (VK2). All studied douching products (vinegar, iodine and baking soda based) induced epithelial cell death, and all inhibited growth of E. coli. Co-culture of vaginal epithelial cells with any of the lactobacilli immediately following exposure to douching products resulted in a trend to less human cell death. However, co-culture of epithelial cells with L. iners was associated with higher production of IL6 and IL8, and lower IL1RA regardless of presence or type of douching solution. Co-culture with L. crispatus or L. jensenii decreased IL6 production in the absence of douches, but increased IL6 production after exposure to vinegar. Douching products may be associated with epithelial disruption and inflammation, and may reduce the anti-inflammatory effects of beneficial lactobacilli.

The association between douching, genital talc use, and the risk of prevalent and incident cervical cancer.

While human papillomavirus is the primary cause of cervical cancer, other factors may influence susceptibility and response to the virus. Candidates include douching and talcum powder applied in the genital area. We used Cox proportional hazards models to estimate confounder-adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) in the Sister Study (2003-2009), a US cohort of women aged 35-74. We considered pre-baseline (n = 523) and incident (n = 31) cervical cancers. Douching at ages 10-13 was positively associated with pre-baseline cervical cancer (HR 1.32, 95% CI 0.86-2.03), though the association was not statistically significant. We did not observe an association between adolescent talc use and pre-baseline cervical cancer (HR 0.95, 95% CI 0.76-1.19). Douching in the year before enrollment was positively associated with incident cervical cancer (HR 2.56, 95% CI 1.10-5.99). The association between recent genital talc use and incident cervical cancer was positive, but not statistically significant (HR 1.79, 95% CI 0.78-4.11). The observed positive association between douching and incident cervical cancer is consistent with previous retrospective case-control studies. In the first study to examine genital talc use and cervical cancer, we did not see evidence of an association.

Understanding Women's Vaginal Douching Behaviors and Practices for Consideration in the Development of a Potential Future Vaginal Microbicide Douche for HIV Prevention: A Systematic Review of the Literature.

Despite clinicians consistently advising against vaginal douching, 29-92% of women worldwide report douching. This review documents women's douching practices, motivations for douching, and specific associations (or absence of associations) between vaginal douche use and vaginal outcomes thought to be associated with douching. Understanding women's existing douching behaviors and vaginal health outcomes is critical for developing a safe vaginal microbicide douche that can be used as HIV pre-exposure prophylaxis (PrEP). A vaginal douche as PrEP could help prevent new HIV infections, since emerging evidence shows some women discontinue oral PrEP. We performed a systematic review of the literature using the guidelines for Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA). Articles included in the analysis (N = 48) were published 2009-2019 in English and focused on women's experiences with douching. Two trained independent reviewers assessed these articles for content on vaginal douching, including racial/ethnic focus of studies, study design, sampling, women's reasons for douching, contents of douche solutions, and associations between vaginal douching and vaginal health outcomes. Several studies focused on Black women (N = 12 studies) or had no racial/ethnic focus (N = 12). Just over half of all studies (N = 24) were cross-sectional and involved a self-reported questionnaire and lab samples. Studies sampled women from health clinics where they were (N = 13) or were not (N = 14) presenting for vaginal health complaints. Women's primary motivation for douching was for "general cleanliness" (N = 13), and most douche solutions contained water (N = 12). There was little empirical agreement between vaginal douche use and most vaginal health outcomes. Future studies of PrEP vaginal douches should be well controlled and prioritize safety to ensure positive vaginal health outcomes.

Intravaginal Practices Among Women Attending a Sexually Transmitted Disease Clinic-Philadelphia, 2017.

ABSTRACT: We conducted a survey among women attending an urban public sexually transmitted disease clinic to determine the type and frequency of intravaginal cleansing practices. Both intravaginal washing and douching were frequent, performed mostly for routine hygiene, and associated with self-report of sexually transmitted infection and bacterial vaginosis (douching and intravaginal washing).

Consideration of Cultural Practices When Characterizing the Vaginal Microbiota Among African and African American Women.

This manuscript considers intravaginal practices prevalent among African and African-American women, with the aim of providing a framework for how these practices may affect vaginal health and the vaginal microbiota, and consequently, impact pregnancy outcomes. Intravaginal practices are influenced by traditional socio-cultural beliefs and gender norms, with prominent practices including intravaginal insertion of substances (herbs and traditional medicines), intravaginal cleansing (douching), and anatomical modification of the female organs (labia elongation and female genital mutilation). Common motivations for such practices included hygiene, prevention of infection, enhancement of sexual pleasure, and compliance with societal or cultural norms. The use of soaps and other chemicals for vaginal douching has been reported to reduce diversity of the vaginal microbiota and lower pH, thus increasing the chances of bacterial vaginosis, but the evidence is minimal. The practice of vaginal insertion of natural or other substances is associated with physical abrasions, disruption of the vaginal flora, bacterial vaginosis, and HIV and other infections, but effects on pregnancy outcomes and the vaginal microbiota are unclear. Finally, female genital mutation has been reported to have immediate and prolonged physiological and psychological effects, including frequent infections and chronic inflammation, but similar to most other practices, consequences for preterm birth remain understudied and for the vaginal microbiota, unknown. Overall, findings identify the need for additional research, focusing on how these common practices influence both birth outcomes and the vaginal microbiota, so that nurses, midwives, physicians, and other providers worldwide are better equipped to assess and care for pregnant women.

Exposure to Volatile Organic Compounds and Use of Feminine Hygiene Products Among Reproductive-Aged Women in the United States.

Background: Feminine hygiene products (FHPs) are personal care products widely used by women. A few studies have detected some volatile organic compounds (VOCs) in FHPs, but no previous epidemiological studies have linked use of these products to human exposure to VOCs using biomarkers. Therefore, we evaluated whether the use of FHPs was associated with VOC exposures among reproductive-aged women in the United States. Materials and Methods: Data on 2432 women aged 20-49 years from National Health and Nutrition Examination Survey 2001-2004 were utilized. Self-reported use of feminine products (tampons, sanitary napkins, vaginal douches, sprays, powders, wipes/towelettes, and other products) was obtained from questionnaires. Survey-weighted linear regression models were used to estimate percent changes in VOC whole blood concentrations and 95% confidence intervals (CIs). Results: Black women had significantly more use of vaginal douching and significantly higher whole blood concentrations of 1,4-dichlorobenzene (DCB) (p < 0.0001). After adjusting for confounders, we observed a dose-response relationship between the frequency of vaginal douching in the past 6 months and 1,4-DCB concentrations. Compared with never users, women with occasional use (≤1 time/month) of vaginal douching had 18% (95% CI: -12% to 59%) higher concentrations, and those with frequent use (≥2 time/month) had 81% (95% CI: 2% to 221%) higher concentrations of 1,4-DCB (p for trend = 0.04). Use of feminine powder in the past month was significantly associated with 36% (95% CI: 0.4% to 83%) higher concentrations of ethylbenzene. Conclusions: Our findings suggest that differences in whole blood VOC concentrations might be explained by feminine hygiene practices. The presence of environmental chemicals in FHPs warrants further examination.

Vaginal douching in Zambia: a risk or benefit to women in the fight against cervical cancer: a retrospective cohort study.

BACKGROUND: Cervical cancer was the most commonly diagnosed cancer and the leading cause of cancer related deaths in 2013 among women in Zambia. We determined factors associated with vaginal douching with any solution other than water and examined its role as a risk factor for abnormal cervical lesions among Zambian women. METHODS: We conducted a retrospective cohort study using data from the Cervical Cancer Prevention Program in Zambia among 11,853 women (15 years or older) who had screened for cervical cancer from 6 provinces of Zambia. Stata version 15 was used to analyze the data. Investigator led stepwise logistic regression was used to estimate adjusted odds ratios and 95% confidence intervals for various characteristics, with vaginal douching with any solution as primary outcome and abnormal cervical lesions as secondary outcome. RESULTS: Douching with any solution other than water was practiced by 8.1% (n = 960) of the study participants. Older women (35-44 and 45 years or older) vs young women (15-24 years old) were less likely to douche with a solution (AOR 0.74; 95% CI: 0.57-0.97, p = 0.027 and AOR 0.65; 95% CI: 0.49-0.87, P = 0.004), respectively, and so were women in informal employment compared to housewives (AOR 0.72; 95% CI: 0.58-0.89, p = 0.002). Odds of douching were higher among women with secondary vs. no formal education (AOR 1.64; 95% CI: 1.15-2.35, P = 0.007), and among women who used condoms sometimes compared to those who never with their regular sexual partners (AOR 1.19; 95% CI: 1.01-1.40, PP = 0.037). About 12.2% of study participants had abnormal cervical lesions. The use of either vinegar, ginger, lemon, salt or sugar solution was associated with increased risk of abnormal cervical lesions (AOR 7.37; 95% CI: 1.43-38.00, p = 0.017) compared to using water. CONCLUSION: We find an association between douching with a solution and a woman's age, educational attainment, occupation and condom use. Vaginal douching with either vinegar, ginger, lemon, salt or sugar solution was associated with increased risk for abnormal cervical lesions. We recommend further research on ever vs never douching and the risk for abnormal cervical lesions.

Vaginal herb use and Chlamydia trachomatis infection: cross-sectional study among women of various ethnic groups in Suriname.

OBJECTIVE: Vaginal steam baths with herb leaves (herb use) is practised by some Surinamese women. We assessed herb use among women from the five most prevalent ethnic groups, and if herb use is associated with Chlamydia trachomatis infection. SETTING: Participants were recruited at a sexually transmitted infection (STI) clinic and a family planning clinic (FP) in Paramaribo, Suriname. PARTICIPANTS: 1040 women were included subsequently, comprising the following ethnic groups: Creole (26.7%), Hindustani (24.6%), Javanese (15.7%), Maroon (13.3%) and mixed descent (19.7%). METHODS: Nurses collected a questionnaire and vaginal swabs for nucleic acid amplification C. trachomatis testing. PRIMARY OUTCOMES: Determinants of vaginal herb use and C. trachomatis infection via univariable and multivariable logistic regression. RESULTS: Herb use was most common among Maroon (68.8%) and Creole women (25.2%). In multivariable analysis including only Maroon and Creole women, determinants significantly associated with vaginal herb use were (OR; 95% CI): Maroon ethnic descent (5.33; 3.26 to 8.71 vs Creole), recruitment at the STI clinic (2.04; 1.24 to 3.36 vs FP), lower education levels (3.80; 1.68 to 8.57 lower vs higher, and 2.02; 0.90 to 4.51 middle vs higher). Lower age and recruitment at the STI clinic were associated with C. trachomatis infection, but not vaginal herb use. CONCLUSION: In Suriname, vaginal herb use is common among Maroon and Creole women. Education, ethnic group and recruitment site were determinants for herb use. Vaginal herb use was not a determinant of C. trachomatis infection. Future research should focus on the effect of herb use on the vaginal microbiome and mucosal barrier.

Association between vaginal washing and vaginal bacterial concentrations.

Vaginal washing is a common practice associated with adverse outcomes including bacterial vaginosis (BV) and HIV infection. Prior studies have not examined the associations between vaginal washing and individual vaginal bacteria, or whether these associations are independent of the effect of vaginal washing on BV. The purpose of this study was to characterize the association between vaginal washing and the presence and concentrations of vaginal bacteria associated with optimal and sub-optimal vaginal states. The analysis utilized data from participants in the placebo arm of the Preventing Vaginal Infections trial, which enrolled HIV-uninfected women from the United States and Kenya. Detection of bacterial taxa associated with BV was compared between visits with versus without reported vaginal washing. The effect of vaginal washing on a number of vaginal bacteria differed substantially (p<0.05) between the US and Kenya, so results were stratified by country. In US women, vaginal washing was associated with a significantly higher likelihood of detection of BV associated bacterium 1 (BVAB1) (relative risk [RR] 1.55, 95% confidence interval [CI] 1.15-2.09, p = 0.004), BVAB2 (RR 1.99, 95%CI 1.46-2.71, p<0.001), Mageeibacillus indolicus (RR 2.08, 95%CI 1.46-2.96, p<0.001), Atopobium vaginae (RR 1.34, 95%CI 1.13-1.59, p = 0.001), Leptotrichia/Sneathia species (RR 1.66, 95% CI 1.33-2.09, p<0.001), Megasphaera species (RR 1.78, 95%CI 1.34-2.37, p<0.001) and Gardnerella vaginalis (RR 1.08, 95%CI 1.01-1.16, p = 0.02). No significant association between vaginal washing and bacterial detection was found in Kenyan women. Adjustment for bacterial vaginosis diagnosed by Gram stain did not alter these results. This study provides evidence that the association between vaginal washing and detection of individual bacterial taxa can vary regionally. For some vaginal bacteria, the association with vaginal washing may be independent of the effect on Gram stain detection of BV. Larger prospective studies in diverse geographic settings should explore whether eliminating vaginal washing impacts the presence and concentrations of key vaginal bacteria.

'You'll always stay right': understanding vaginal products and the motivations for use among adolescent and young women in rural KZN.

The use of vaginal products may increase the risk of HIV infection by affecting the vaginal biome. Understanding what vaginal products young women are using, and why, is key to assessing the complexity of sexual health and risk. This study reports on findings from research with adolescent and young women in rural KwaZulu-Natal about the vaginal products they use and motivations for using them. The study identified over 26 products that young women used to enhance their sexual experience and found some young women spent time preparing and sourcing vaginal products in order to pleasure and retain partners. Opinions differed about vaginal product use. While some women perceived that vaginal products could provide a means of out-performing other women, retaining a partner and providing sexual autonomy, there was a stigma attached to using them. Study findings highlight the social value of using vaginal products, especially in settings where partner retention is linked to economic survival. Expanding our understanding of what products are used and the reasons young women use them warrants continued investigation.

Vaginal health and hygiene practices and product use in Canada: a national cross-sectional survey.

BACKGROUND: The vaginal microbiome influences quality of life and health. The composition of vaginal microbiota can be affected by various health behaviors, such as vaginal douching. The purpose of this study was to examine the types and prevalence of diverse vaginal/genital health and hygiene behaviors among participants living in Canada and to examine associations between behavioral practices and adverse gynecological health conditions. METHOD: An anonymous online survey, available in English and French, was distributed across Canada. The sample consisted of 1435 respondents, 18 years or older, living in Canada. RESULTS: Respondents reported engaging in diverse vaginal/genital health and hygiene behavioral practices, including the use of commercially manufactured products and homemade and naturopathic products and practices. Over 95% of respondents reported using at least one product in or around the vaginal area. Common products and practices included vaginal/genital moisturizers, anti-itch creams, feminine wipes, washes, suppositories, sprays, powders, and waxing and shaving pubic hair. The majority of the sample (80%) reported experiencing one or more adverse vaginal/genital symptom in their lifetime. Participants who had used any vaginal/genital product(s) had approximately three times higher odds of reporting an adverse health condition. Several notable associations between specific vaginal/genital health and hygiene products and adverse health conditions were identified. CONCLUSIONS: This study is the first of its kind to identify the range and prevalence of vaginal/genital health and hygiene behaviors in Canada. Despite a lack of credible information about the impact of these behaviors on women's health, the use of commercially manufactured and homemade products for vaginal/genital health and hygiene is common. Future research can extend the current exploratory study by identifying causal relationships between vaginal/genital health and hygiene behaviors and changes to the vaginal microbiome.

Higher Levels of a Cytotoxic Protein, Vaginolysin, in Lactobacillus-Deficient Community State Types at the Vaginal Mucosa.

Vaginolysin (VLY), a cytotoxic protein produced by Gardnerella vaginalis, may contribute to bacterial vaginosis. We observed that women with G. vaginalis, low levels of lactobacilli, history of vaginal douching, higher Nugent scores, and higher vaginal pH had increased VLY. Inflammatory markers were not highly expressed with increasing VLY. Vaginolysin's role in bacterial vaginosis warrants further evaluation.

To 'douche' or not to 'douche': hygiene habits may have detrimental effects on vaginal microbiota.

The importance of a healthy vaginal micro-flora is indisputable. Therefore, intravaginal practices, such as vaginal douching (VD), may inhibit or lower the colonisation of beneficial Lactobacilli strains. Although the results of disrupted vaginal microbiota have been widely reported in the literature, direct microbicidal effects of products used for VD have been rarely studied. Moreover, there are certain studies advocating the beneficial effects of VD. This in vitro study was designed to provide more evidence to help health care givers in disseminating the knowledge that VD might have detrimental effects on vaginal microbiota. Three commercially available VD products (A, B and C) were examined for their minimal inhibiting concentrations (MICs) against Lactobacilli strains. Although the MICs of product A (ranging from 0.19% to 0.09%, p < .05) were proven to be lower than the other two, all the products were potentially able to inhibit the growth of Lactobacilli strains effectively, and hence should be used with caution. Impact statement What is already known on this subject? The importance of vaginal microbiota has long been reported for the maintenance of health. The lack of a healthy vaginal ecosystem may lead to various diseases including pelvic inflammatory disease, bacterial vaginosis, sexually transmitted diseases, etc. Moreover, studies also stress that lack of beneficial bacteria may lead to miscarriages, premature delivery, ectopic pregnancy and cervical cancer. Despite a huge amount of data regarding the importance of vaginal microbiota, studies confirm that women still utilise VD for various reasons. Whilst the detrimental effect of VD have been widely reported in the literature; there are a few publications advocating the potential benefits of VD. Educational efforts are reported to lessen this practice. What do the results of this study add? In this in vitro study we aimed to substantiate the bactericidal potential of three commercially available products. There are studies about the clinical outcomes of VD, but a limited number of in vitro studies exist. Our results represent a direct measure of how potentially destructive VD is. What are the implications of these findings for clinical practice and/or further research? This information can be used for educational purposes, enhancing the efforts provided by health care givers used to lessen VD practice.

[Hydrating cleansing: efficacy and tolerability of new formulations with hyaluronic acid 0.2% for intimate hygiene in the woman in fertile age and menopause].

Dehydration of genital areas, known as vaginal dryness, frequently affects woman's life, from fertile to postmenopausal period, and must be treated with specific products, including proper intimate cleansing. Based on that, two new cleanser formulations, characterized by Hyaluronic Acid 0.2% as main ingredient, have been developed (Hyalo Gyn® Intimo Active and Hyalo Gyn® Intimo Advance), with the aim to provide an effective hydration of the vaginal, vulvar, perianal and anal areas beyond guaranteeing daily intimate hygiene. The two intimate cleansing mousses have been formulated in mousse and differentiated, in terms of ingredients, accordingly to the different physiological conditions and female needs of fertile age and menopause respectively. Clinical trials conducted on women of childbearing age and menopause showed that daily cleansing with these intimate washes promotes hydration of vaginal tissues thanks to the presence of hyaluronic acid. In particular, the cleansing mousse for fertile women gives also a soothing effect, offers antimicrobial protection and a long lasting feeling of freshness. The cleansing mousse for menopausal women provides a freshness sensation, improves elasticity and tonicity and exerts an anti-smell and anti-oxidative effect.

Influencing the importance of health, partners, and hygiene among Zambian women.

Intravaginal practices (IVPs) are common in Zambia and are usually practiced for hygiene, partner pleasure, and health. IVPs are associated with HIV acquisition, changes in the vaginal flora, and bacterial vaginosis (BV), making it important to understand the decision-making process behind IVP engagement. The Women's and Sexual Health (WASH) intervention decreased IVP engagement among HIV-infected Zambian women, though change in reasons for engagement has not been assessed. We used conjoint analysis (CA) to quantify the decision-making process of IVP engagement and evaluated how the WASH intervention impacted these factors. Participants were N = 84 women (37 ± 8 years old) randomized to WASH (n = 46) or standard of care plus (SOC+; n = 38) who completed demographic measures and a CA questionnaire at baseline, six months, and 12 months to quantify the importance placed on hygiene, partner pleasure, and health. The importance placed on health increased from baseline to six months (15.5 versus 25.1; p < 0.001) and from baseline to 12 months (15.5 versus 50.5; p < 0.001), and was higher in SOC+ at six months (19.9 versus 30.3; p = 0.003). Hygiene importance decreased from baseline (63.6) to six months (50.3), and from baseline to 12 months (26.1), and was higher in the experimental arm at six months (56.1) compared to SOC+ (44.6; p = 0.029). Importance placed on partner pleasure did not change over time in either group. Findings suggest that both groups exhibited an increase in the importance placed on health and a decrease on hygiene importance for IVP engagement, suggesting that SOC+ may be sufficient to promote attitude changes that may facilitate IVP discontinuation and may prove to be more cost effective by using fewer monetary resources. Findings highlight the potential of interventions to influence attitudes toward IVPs and provide novel avenues for research to improve the design and conduct of interventions aimed at reducing IVPs among Zambian women and contribute to HIV prevention efforts.

Intravaginal practices among young HIV-infected women in Lusaka, Zambia.

Intravaginal practices (IVP) are linked to bacterial vaginosis (BV), obstetric/gynecological complications, and HIV. Late adolescent and young adult (LAYA) women in Zambia have high rates of HIV. Adult and mature (AM) HIV-infected women in Zambia engage in IVP for hygiene, health, and sexuality reasons; however, to our knowledge, IVP use among LAYA women has not been examined. This study compares IVP use between LAYA and AM women to identify age-specific factors to target when developing IVP reduction interventions for LAYA women. LAYA (≤25 years; n = 24) and AM (>25 years; n=124) HIV-infected women completed self-administered demographic, HIV history, sexual risk factor, and IVP measures. LAYA and AM women were then compared. Number of sexual partners, sexual activity, or condom use did not differ between groups. Rates of IVP in the prior month with different products were similar, though LAYA women used soap more frequently (96% versus 74.2%, p = 0.034). LAYA women were more likely to use products for hygiene reasons (soap 83% versus 43%; cloth, paper, or wipes 50% versus 17%, p < 0.05); and AM women to use products to please sexual partners (cloth 20% versus 56%, p = 0.074). Interventions tailored to LAYA women may be needed to reduce IVP and subsequent BV as LAYA women may have different reasons for engaging in IVP, in comparison with AM women. Reduced IVP among LAYA women may decrease the risk for HIV transmission to sexual partners and newborns and is urgently needed in settings with high prevalence of IVP, BV, and HIV infections, such as Zambia.

[Sulphurous vaginal douching and vulvovaginal atrophy].

OBJECTIVE: During climacteric the reduction or interruption of estrogenic stimulus determines a gradual atrophy of the tissues of the urogenital tract.Vulvovaginal atrophy can be cause of dryness, itch, burning, and dyspareunia. Vulvovaginal atrophy is associated also with depression. Hence the importance of an appropriate treatment of the vulvovaginal atrophy. Between therapeutic options we can add, particularly for women who suffer only from vaginal symptoms, the spa therapy that uses mineral waters with benefic effects on vaginal tissue wellness and health. On the basis of considerations described above and on the insufficient literature data, the objective of our single-arm pilot study has been to evaluate, in women suffering from vulvovaginal atrophy, the effects and safety of a vaginal douching cycle with sulphurous mineral water and impact on depression disorder frequently observed. PATIENTS AND METHODS: The study was conducted on 24 women affected by vulvovaginal atrophy; mean age:57±11 years; age range:42-81 years. The subjects were treated, for 2 weeks, with sulphurous vaginal douching from Terme of Telese S.p.A. (Benevento-Italy). At the beginning and at the end of the SPA treatment the following symptoms were evaluated: dryness, burning, itch, dyspareunia and leucorrhoea (using VAS scale); the impact on psychological distress (using S.D.S. Zung-test). RESULT: At the end of the spa treatment, the mean values±SD, compared to baseline, have showed a significant (p<0.05) reduction in leucorrhoea (-88%), in vulvar itch (-79%), in vaginal burning (-71%), in vaginal dryness (-65%) with an improvement of psichological distress as demonstrated by S.D.S. Zung-test. CONCLUSION: The data of this single-arm pilot clinical trial show that the sulphurous vaginal douching cycle can be considered very useful in women suffering from vulvovaginal atrophy with improving of the quality of life and social relationship.

A bio-behavioral intervention to decrease intravaginal practices and bacterial vaginosis among HIV infected Zambian women, a randomized pilot study.

BACKGROUND: Intravaginal practices (IVP) (cleansing or introducing products inside the vagina for hygiene, health or to please sexual partners) are common among women with HIV. IVP increase the risk of developing bacterial Vaginosis (BV), the most common genital infection associated with transmission of sexually transmitted infections and HIV. This study tested a pilot intervention to reduce IVP and BV in HIV infected women in Zambia. METHODS: One hundred twenty-eight HIV infected women engaging in IVP were randomized to two conditions: enhanced standard of care (n = 70) and experimental (n = 58) from May 1, 2013 to February 28, 2014. All participants received a brief educational counseling session on discontinuation of IVP, and those with BV, were provided with medical treatment for BV. Women in the experimental condition received an additional group-based, culturally tailored intervention. Participants completed questionnaires assessing sexual risk factors and IVP and were assessed for BV using Nugent criteria at baseline, 6 months and 12 months. RESULTS: At 12-month, the proportion of self-reported use of IVPs decreased in the experimental condition: soap (28% vs. 47%); cloth or a rag (19% vs. 38%); and traditional medicines (22% vs. 42%) (all p < 0.05)) compared with the enhanced standard of care condition. The prevalence of BV at 6 and 12 months did not differ by study condition but averaging over study condition, prevalence of BV decreased from 64.2% at baseline to 15.6% at 6 months (p < 0.01) and to 23.6% at 12 months (p = 0.15). Using an enhanced standard of care approach and an enhanced standard of care + a group intervention, IVP and BV decreased over time, but the experimental condition had greater reduction in self-reported use of IVP. CONCLUSIONS: Future studies should address interventions in communities with high burden of IVP, BV and HIV. Interventions that could be administered during routine medical care and decrease IVP and BV are needed, and should be considered part of women's health programs. TRIAL REGISTRATION NUMBER: NCT03134924 (retrospectively registered 21st April 2017).

Impact of targeted counseling on reported vaginal hygiene practices and bacterial vaginosis: the HIV Prevention Trials Network 035 study.

The objective of this study was to describe the impact of intense counseling to reduce vaginal hygiene practices and its effect on bacterial vaginosis. A secondary data analysis of the HIV Prevention Trials Network 035 study was undertaken, focusing on HIV-negative, nonpregnant women who were at least 18 years old, in seven African sites and one US site. At enrollment and during follow-up quarterly visits, vaginal hygiene practices were determined by face-to-face administration of a behavioral assessment questionnaire. Vaginal hygiene practices were categorized as insertion into the vagina of (1) nothing, (2) water only, and (3) other substances with or without water. Each practice was quantified by frequency and type/combination of inserted substances. At quarterly visits, diagnosis of bacterial vaginosis was made using the Nugent score. Trends for vaginal hygiene practices and bacterial vaginosis were evaluated using generalized estimating equation models. A total of 3087 participants from the HIV Prevention Trials Network 035 study were eligible for this analysis. At enrollment, 1859 (60%) reported recent vaginal hygiene practices. By one year, this figure had decreased to 1019 (33%) with counseling. However, bacterial vaginosis prevalence remained consistent across the study observation period, with 36%-38% of women testing positive for the condition ( p for trend = 0.27). Overall, those who reported douching with water only (AOR = 1.03, 95%CI: 0.94-1.13) and those who reported inserting other substances (AOR= 0.98, 95%CI: 0.88-1.09) in the past quarter were not more likely to have bacterial vaginosis compared to those who reported no insertions. However, in South Africa, an increase in bacterial vaginosis was seen among those who reported inserting other substances (AOR: 1.48, 95%CI: 1.17, 1.88). In conclusion, targeted counseling against vaginal hygiene practices resulted in change in self-reported behavior but did not have an impact on bacterial vaginosis diagnosis in all but one site.