Food insecurity associated with educational disruptions during the COVID-19 pandemic for college students and the role of anxiety and depression.

Objective: To test the association between food insecurity and educational disruptions from the COVID-19 pandemic and the role of anxiety or depression in mediating this association. Participants: Representative sample of 2,282 City University of New York students. Methods: Using an April 2020 online survey, we estimated adjusted prevalence ratios (aPR) for educational outcomes based on food insecurity status, adjusting for age, sex, race/ethnicity, and degree level with weighted Poisson regressions with robust standard errors. Results: Prevalence of decreased ability to do schoolwork was greater in those with moderate (aPR = 1.12, 95% CIs 1.02, 1.23) and high (aPR = 1.18, 95% CIs 1.08, 1.2) levels of food insecurity compared to food-secure students. Results were similar for dropping/withdrawing from classes and expecting delays or uncertainty around graduation. Anxiety and depression mediated the relationship between food insecurity and educational outcomes. Conclusion: Findings emphasize the urgency of expanded food assistance and mental health services for college students.

The relationship between hormonal contraception and cervical dysplasia/cancer controlling for human papillomavirus infection: A systematic review.

OBJECTIVE: Studies on the effect of long-term use of combined oral contraceptives (COCs) on cervical dysplasia and/or cancer risk have been inconsistent. Less is known about the effects of other forms of hormonal contraception (HC). We examine whether HC use increases the risk of incident cervical intraepithelial neoplasia (CIN) 2, 3 and/or cancer after accounting for preexisting human papillomavirus (HPV) infection. STUDY DESIGN: Systematic review of prospective studies on HC use as risk factor for cervical dysplasia with HPV infection documented prior to outcome assessment including PubMed and EMBASE records between January 2000 and February 2020 (Prospero #CRD42019130725). RESULTS: Among nine eligible studies, seven described recency and type of HC use and therefore comprise the primary analysis; two studies limit comparisons to ever versus never use and are summarized separately. All seven studies explored the relationship between oral contraceptive (OC) use and cervical dysplasia/cancer incidence: two found increased risk (adjusted odds ratio, aOR = 1.5-2.7), one found no association but decreased risk when restricted to women with persistent HPV (adjusted hazard ratio = 0.5), and four found no association. None of the seven studies differentiated between COC and progestin-only pills (POPs) by use recency or duration. The only study that included injectable progestin-only contraception (DMPA) found increased CIN3 incidence among current versus never users (aOR = 1.6). The one study that included Norplant found no association. Two studies included intrauterine device (IUD) use, but did not differentiate between hormonal and copper IUDs, and found no association. CONCLUSION: We found no consistent evidence that OC use is associated with increased risk for cervical dysplasia/cancer after controlling for HPV infection. There were too few studies of progestin-only injectables, implants or IUDs to assess their effect on cervical dysplasia/cancer risk. IMPLICATIONS: Use of single self-reported HC measures and insufficient distinction by hormonal constituent cloud our understanding of whether some HCs increase risk for cervical cancer. Methodologically rigorous studies with distinct HCs measured as time-varying exposures are needed to inform cervical cancer prevention efforts and improve our understanding of cervical cancer etiology.

Risk-based screening to identify reproductive tract infection among HIV-infected women desiring use of intrauterine contraceptives.

BACKGROUND: Reproductive tract infections (RTIs) are a major cause of morbidity and mortality, yet RTI testing remains limited in resource-constrained settings. We assessed performance of an existing RTI risk assessment screening tool among women living with HIV (WLHIV) considering intrauterine contraceptive (IUC) use. METHODS: We conducted a cross-sectional analysis among WLHIV screened for participation in an IUC trial in Cape Town, South Africa (NCT01721798). RTI testing included Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis and bacterial vaginosis. Tool scoring was based on five separately scored criteria: (1) age under 25 years, (2) cohabitation with a partner, (3) secondary education, (4) self-reported intermenstrual bleeding and (5) number of current sexual partners and condom use frequency (score 0-5). We assessed tool performance in detecting RTI at 0 vs 1-5, 0-1 vs 2-5 and 0-2 vs 3-5 score thresholds. RESULTS: Of 303 women, 52% (n=157) reported antiretroviral therapy use and median age was 31 years. The prevalence of any RTI was 38% (gonorrhoea=7%, chlamydia=11%, trichomoniasis=12% and bacterial vaginosis=18%) and 8% of women had multiple RTIs. Overall, 4%, 27% and 69% of women had screening tool scores of 0, 1 or 2+, respectively. At a threshold of at least one scored criterion, the tool demonstrated high sensitivities (95%-97%) but low specificities (3%-4%) for detecting any RTI. Increasing the score threshold and/or inclusion of abnormal vaginal discharge marginally improved specificity. CONCLUSION: The prevalence of RTIs observed in this population was high, and the screening tool had no discriminatory power to detect prevalent RTIs.

Sociodemographic variation in the oral microbiome.

PURPOSE: Variations in the oral microbiome are potentially implicated in social inequalities in oral disease, cancers, and metabolic disease. We describe sociodemographic variation of oral microbiomes in a diverse sample. METHODS: We performed 16S rRNA sequencing on mouthwash specimens in a subsample (n = 282) of the 2013-2014 population-based New York City Health and Nutrition Examination Study. We examined differential abundance of 216 operational taxonomic units, and alpha and beta diversity by age, sex, income, education, nativity, and race/ethnicity. For comparison, we examined differential abundance by diet, smoking status, and oral health behaviors. RESULTS: Sixty-nine operational taxonomic units were differentially abundant by any sociodemographic variable (false discovery rate < 0.01), including 27 by race/ethnicity, 21 by family income, 19 by education, 3 by sex. We found 49 differentially abundant by smoking status, 23 by diet, 12 by oral health behaviors. Genera differing for multiple sociodemographic characteristics included Lactobacillus, Prevotella, Porphyromonas, Fusobacterium. CONCLUSIONS: We identified oral microbiome variation consistent with health inequalities, more taxa differing by race/ethnicity than diet, and more by SES variables than oral health behaviors. Investigation is warranted into possible mediating effects of the oral microbiome in social disparities in oral and metabolic diseases and cancers.

Tobacco exposure associated with oral microbiota oxygen utilization in the New York City Health and Nutrition Examination Study.

PURPOSE: The effect of tobacco exposure on the oral microbiome has not been established. METHODS: We performed amplicon sequencing of the 16S ribosomal RNA gene V4 variable region to estimate bacterial community characteristics in 259 oral rinse samples, selected based on self-reported smoking and serum cotinine levels, from the 2013-2014 New York City Health and Nutrition Examination Study. We identified differentially abundant operational taxonomic units (OTUs) by primary and secondhand tobacco exposure, and used "microbe set enrichment analysis" to assess shifts in microbial oxygen utilization. RESULTS: Cigarette smoking was associated with depletion of aerobic OTUs (Enrichment Score test statistic ES = -0.75, P = .002) with a minority (29%) of aerobic OTUs enriched in current smokers compared with never smokers. Consistent shifts in the microbiota were observed for current cigarette smokers as for nonsmokers with secondhand exposure as measured by serum cotinine levels. Differential abundance findings were similar in crude and adjusted analyses. CONCLUSIONS: Results support a plausible link between tobacco exposure and shifts in the oral microbiome at the population level through three lines of evidence: (1) a shift in microbiota oxygen utilization associated with primary tobacco smoke exposure; (2) consistency of abundance fold changes associated with current smoking and shifts along the gradient of secondhand smoke exposure among nonsmokers; and (3) consistency after adjusting for a priori hypothesized confounders.

Healthcare facility characteristics associated with achievement and maintenance of HIV viral suppression among persons newly diagnosed with HIV in New York City.

Health care facility characteristics have been shown to influence intermediary health outcomes among persons with HIV, but few longitudinal studies of suppression have included these characteristics. We studied the association of these characteristics with the achievement and maintenance of HIV viral suppression among New York City (NYC) residents aged 13 years and older newly diagnosed with HIV between 2006 and 2012. The NYC HIV surveillance registry provided individual and facility data (N = 12,547 persons). Multivariable proportional hazards models estimated the likelihood of individual achievement and maintenance of suppression by type of facility, patient volume, and distance from residence, accounting for facility clustering and for individual-level confounders. Viral suppression was achieved within 12 months by 44% and at a later point by another 29%. Viral suppression occurred at a lower rate in facilities with low HIV patient volume (e.g., 10-24 diagnoses per year vs. ≥75, adjusted hazard ratio [AHR] = 0.87, 95% confidence interval [CI] 0.79-0.95) and in screening/diagnosis sites (vs. hospitals, AHR = 0.86, 95% CI 0.80-0.92). Among persons achieving viral suppression, 18% experienced virologic failure within 12 months and 24% later. Those receiving care at large outpatient facilities or large private practices had a lower rate of virologic failure (e.g., large outpatient facilities vs. large hospitals, AHR = 0.63, 95% CI 0.53-0.75). Achievement and maintenance of viral suppression were associated with facilities with higher HIV-positive caseloads. Some facilities with small caseloads and screening/diagnosis sites may need stronger care or referral systems to help persons with HIV achieve and maintain viral suppression.

Hormonal Contraceptives and the Acquisition of Sexually Transmitted Infections: An Updated Systematic Review.

BACKGROUND: Evidence suggests that some forms of hormonal contraception (HC) increase women's risk of non-human immunodeficiency virus sexually transmitted infections (STIs), yet evidence has not been reviewed since 2008. We conducted an updated systematic review to incorporate studies published between January 2009 and June 2017 to examine the relationship between HCs and incident or recurrent STIs. METHODS: We searched PubMed and EMBASE to identify prospective studies comparing risk of Chlamydia trachomatis, Neisseria gonorrhoeae, human papillomavirus (HPV), herpes simplex virus type 2 (HSV-2), Treponema pallidum, or Trichomonas vaginalis, between women using HC versus nonhormonal methods or no methods. We summarize results by type of STI and HC and study quality using an adapted Newcastle-Ottawa Quality Assessment Scale. RESULTS: Thirty articles met the inclusion criteria. Depo-medroxyprogesterone acetate (DMPA) reduces the risk of trichomoniasis (consistent evidence) and may increase the risk of HSV-2 (strong effect, few studies); inconclusive evidence exists for HPV, chlamydia, gonorrhea, and syphilis. Data on oral contraceptive pills (OCPs; generally not differentiated whether combined or progestin-only pills) suggest that use is associated with a reduced risk of trichomoniasis with inconclusive findings for HSV-2, HPV, chlamydia, gonorrhea, and syphilis. Very few studies included norethisterone enanthate (Net-En) injectable, implants or the levonorgestrel intrauterine device. CONCLUSIONS: Depo-medroxyprogesterone acetate and OCPs reduce the risk of trichomoniasis and DMPA may increase the risk of HSV-2. However, the potential for confounding cannot be ruled out. Future studies should specify the type of injectable or OCP used to increase understanding of biological pathways; more research is needed on implants and hormonal intrauterine devices.

Vaginal and Rectal Clostridium sordellii and Clostridium perfringens Presence Among Women in the United States.

OBJECTIVE: To characterize the presence of Clostridium sordellii and Clostridium perfringens in the vagina and rectum, identify correlates of presence, and describe strain diversity and presence of key toxins. METHODS: We conducted an observational cohort study in which we screened a diverse cohort of reproductive-aged women in the United States up to three times using vaginal and rectal swabs analyzed by molecular and culture methods. We used multivariate regression models to explore predictors of presence. Strains were characterized by pulsed-field gel electrophoresis and tested for known virulence factors by polymerase chain reaction assays. RESULTS: Of 4,152 participants enrolled between 2010 and 2013, 3.4% (95% confidence interval [CI] 2.9-4.0) were positive for C sordellii and 10.4% (95% CI 9.5-11.3) were positive for C perfringens at baseline. Among the 66% with follow-up data, 94.7% (95% CI 88.0-98.3) of those positive for C sordellii and 74.4% (95% CI 69.0-79.3) of those positive for C perfringens at baseline were negative at follow-up. At baseline, recent gynecologic surgery was associated with C sordellii presence, whereas a high body mass index was associated with C perfringens presence in adjusted models. Two of 238 C sordellii isolates contained the lethal toxin gene, and none contained the hemorrhagic toxin gene. Substantial strain diversity was observed in both species with few clusters and no dominant clones identified. CONCLUSION: The relatively rare and transient nature of C sordellii and C perfringens presence in the vagina and rectum makes it inadvisable to use any screening or prophylactic approach to try to prevent clostridial infection. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01283828.

Validity and reliability of using a self-lavaging device for cytology and HPV testing for cervical cancer screening: findings from a pilot study.

UNLABELLED: Self-sampling could increase cervical cancer screening uptake. While methods have been identified for human papillomavirus (HPV) testing, to date, self-sampling has not provided adequate specimens for cytology. We piloted the validity and reliability of using a self-lavaging device for cervical cytology and HPV testing. We enrolled 198 women in New York City in 2008-2009 from three ambulatory clinics where they received cervical cancer screening. All were asked to use the Delphi Screener™ to self-lavage 1-3 months after clinician-collected index cytological smear (100 normal; 98 abnormal). Women with abnormal cytology results from either specimen underwent colposcopy; 10 women with normal results from both specimens also underwent colposcopy. We calculated sensitivity of self-collected cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results. One hundred and ninety-seven (99.5%) women self-collected a lavage. Seventy-five percent had moderate to excellent cellularity, two specimens were unsatisfactory for cytology. Seven of 167 (4%) women with definitive results had CIN2+; one had normal and six abnormal cytology results with the self-lavage (sensitivity = 86%, 95% Confidence Interval, CI: 42, 100). The kappa for paired cytology was low (0.36; 95% CI: 0.25, 0.47) primarily due to clinician specimens with atypical squamous cells of undetermined significance (ASC-US) and low grade squamous intraepithelial lesion (LSIL) coded as normal using Screener specimens. However, three cases of HSIL were coded as ASC-US and one as normal using Screener specimens. Seventy-three women had paired high-risk HPV tests with a kappa of 0.66 (95% CI: 0.49, 0.84). Based on these preliminary findings, a larger study to estimate the performance of the Screener for co-testing cytology and HPV or for HPV testing with cytology triage is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT00702208.

Alanine transaminase has opposite associations with death from diabetes and ischemic heart disease in NHANES III.

PURPOSE: Diabetes increases the risk of ischemic heart disease (IHD). Stringent control of diabetes does not reliably reduce cardiovascular events. Some global regions, such as East Asia, have low mortality rates from IHD and high rates of diabetes. We hypothesized that some aspects of liver function might underlie this paradox. METHODS: We used multivariable proportional hazards regression in 16,865 adults from the National Health and Nutrition Examination Survey (NHANES) III (1988-1994) followed until December 31, 2006, to assess the adjusted associations of gender-specific tertiles of alanine transaminase (ALT), as a marker of hepatocellular damage, and bilirubin (BIL), as a marker of other aspects of liver function, with death from diabetes (n = 132), IHD related to diabetes (n = 153), and IHD unrelated to diabetes (n = 921). RESULTS: ALT was positively associated with death from diabetes (hazard ratio [HR], 2.17; 95% confidence interval [CI], 1.19-3.98 for high compared with low ALT tertile) and IHD related to diabetes (HR, 2.14; 95% CI, 1.07-4.31), but negatively associated with IHD unrelated to diabetes (HR, 0.76; 95% CI, 0.58-0.98) adjusted for age, gender, education, race/ethnicity, smoking, and alcohol use. BIL had no such associations. CONCLUSIONS: ALT may be a marker of an underlying etiology relating to the paradoxical associations of diabetes and IHD at a population level.

The acceptability of a self-lavaging device compared to pelvic examination for cervical cancer screening among low-income women.

BACKGROUND: A simpler approach to cervical cancer screening could increase coverage, thus reducing cervical cancer mortality in the United States. Self-collection of specimens for screening tests may be one such approach. The aim of this study was to assess the acceptability of a self-lavaging device (Delphi Screener(™), Scherpenzeel, The Netherlands) for cervical cancer screening. Self-lavage specimens have been shown to have equivalent sensitivity for detection of high-grade cervical intraepithelial neoplasia (CIN) when coupled with high-risk human papillomavirus (HPV) tests as clinician-collected specimens with cytologic review. METHODS: Low-income women (n=198) who had recently received cervical cytologic testing in one of three participating clinics in New York City enrolled; 197 self-lavaged. Women answered open-ended and closed-ended questions on ease of use, level of comfort with the self-lavage and the pelvic examination, and future screening preference. RESULTS: Ninety-six percent of women reported they were very/somewhat comfortable self-lavaging compared to 47% very/somewhat comfortable with the clinician collecting a specimen during a pelvic examination (p<0.001). The majority (79%) would prefer self-lavage the next time they need to be screened; only 8% would prefer pelvic examination by a doctor, and 14% had no preference. The main reasons for preferring self-lavage centered on convenience and comfort. CONCLUSIONS: Self-lavaging was highly acceptable to women in this study. Self-collection of specimens has the potential to simplify screening and reduce logistical barriers for many women, which could increase overall coverage of cervical cancer screening.

Lifecourse infectious origins of sexual inequalities in central adiposity.

BACKGROUND: Social disparities in obesity are often more marked among women than men, possibly due to social factors. Taking a life-history perspective, we hypothesized that childhood infections could be relevant via sex-specific effects of immune system activation on sexual development and, hence, body shape. METHODS: We used multivariable linear regression to assess the sex-specific, adjusted associations of 'childhood' pathogens [0 (n = 1002), 1 (n = 2199), 2 (n = 3442) or 3 (n = 4833) of HSV1, CMV and hepatitis A antibodies] and 'adult' pathogens [0 (n = 5836), 1 (n = 3018) or ≥ 2 (n = 720) of HSV2, HHV8 and hepatitis B or C) with waist-hip ratio (WHR) and body mass index (BMI) standard deviations (SDs) using NHANES III (1988-94). As validation, we assessed associations with height. RESULTS: 'Childhood' pathogens were positively associated with WHR among women [0.18 SD, 95% confidence interval (95% CI) 0.04-0.32 for 3, compared with 0], but not men (-0.04 SD, 95% CI -0.15 to 0.08), adjusted for age, education, race/ethnicity, smoking and alcohol. Further adjustments for leg length barely changed the estimates. There were no such sex-specific associations for BMI or for adult pathogens. 'Childhood', but not 'adult', pathogens were negatively associated with height, adjusted for age, sex, education and race/ethnicity. CONCLUSIONS: These observations are consistent with the lifecourse hypothesis that early exposure to infections makes women vulnerable to central obesity. This hypothesis potentially sheds new light on the developmental origins of obesity, and is consistent with the generally higher levels of central obesity among women than men in developing populations.

Do new guidelines and technology make the routine pelvic examination obsolete?

Routine pelvic examinations are the core of the periodic gynecological examination and widely tolerated as a necessary part of health maintenance. Is this examination beneficial for asymptomatic women? Justifications for the pelvic examination include screening for Chlamydia (or gonorrhea) infection, evaluation before initiation of hormonal contraception, screening for cervical cancer, and early detection of ovarian cancer. Current nucleic acid amplification tests for Chlamydia and gonorrhea permit the use of urine and self-administered vaginal swabs, which most women prefer over a pelvic examination. Pelvic examination findings do not affect the decision to prescribe or withhold systemic hormonal contraception; a pelvic examination is not needed to initiate these contraceptives. Recent American College of Obstetricians and Gynecologists (ACOG) guidelines recommend less frequent cervical screening, thus decreasing the frequency of a speculum examination for cervical screening. Bimanual examinations for palpation of the uterus and ovaries are also routinely performed in the United States. Clinical trial data, however, show these examinations do not lead to earlier detection of ovarian cancer. No evidence identifies benefits of a pelvic examination in the early diagnosis of other conditions in the asymptomatic woman. Speculum and bimanual examinations are uncomfortable, disliked by many women, and use scarce time during a well woman visit. Eliminating the speculum examination from most visits and the bimanual examination from all visits of asymptomatic women will free resources to provide services of proven benefit. Overuse of the pelvic examination contributes to high healthcare costs without any compensatory health benefit.

Differentiating normal from abnormal rates of genital epithelial findings in vaginal microbicide trials.

BACKGROUND: Candidate vaginal microbicides could cause genital irritation, which in turn could facilitate HIV transmission instead of preventing it. While genital epithelial findings are documented in a standardized manner in most microbicide trials, little is known about background rates and predictors for many types of genital findings. STUDY DESIGN: A secondary analysis was conducted using data from a Phase II expanded safety study of the candidate microbicide Carraguard gel (Population Council, NY, USA) in Thailand. Genital findings were identified by visual inspection of the cervix, vaginal walls and external genitalia during pelvic exams prior to gel use (screening and enrollment) and during gel use (at 2 weeks and Months 1-12). Women were interviewed about potential risk factors for genital findings at every visit and tested routinely for sexually transmitted and vaginal infections. RESULTS: A total of 258 genital findings were identified in 152 woman-years of follow-up. Genital findings were positively associated with older age, increased parity, self-report of genital symptoms, positive HSV-2 serology, bacterial vaginosis by Nugent scoring and the presence of a genital finding at baseline. Furthermore, vaginal findings were positively associated with vaginal practices and yeast infections. Genital findings were negatively associated with use of hormonal contraception, inconsistently associated with frequency of sex and applicator use, and not associated with condom use. CONCLUSIONS: Several factors that are common in women of reproductive age account for the background rate of genital epithelial findings in this population.

Agreement between self- and clinician-collected specimen results for detection and typing of high-risk human papillomavirus in specimens from women in Gugulethu, South Africa.

We assessed the agreement in detection of high-risk human papillomavirus (HPV), as well as specific HPV types, between self- and clinician-obtained specimens for 450 women over 18 years of age attending a community health center in Gugulethu, South Africa. Both self-collected swabs and tampons had high agreement with clinician-obtained brushes when the Roche Reverse Line Blot Assay (RLBA) was used (for swabs, 86% concordance, with a kappa statistic [kappa] of 0.71; for tampons, 89% concordance, with kappa of 0.75). Agreement was lower, although still fair, with the Digene Hybrid Capture 2 test (HC2), with kappa higher for swabs than for tampons (for swabs, 81% concordance, with kappa of 0.61; for tampons, 82% concordance, with kappa of 0.55). Low-risk HPV types were nearly two times more common in self-collected specimens than in clinician-collected specimens tested by RLBA. All 15 women diagnosed with high-grade lesions by cytology tested positive for high-risk HPV with clinician-collected specimens tested by RLBA and HC2, while 11 out of 15 tested positive with self-collected specimens by HC2 and 5 out of 6 tested positive by RLBA. Self-collected specimens can provide valid specimens for HPV testing using nucleic acid amplification tests, although a few cytological abnormalities may be missed.

Home-based self-sampling and self-testing for sexually transmitted infections: acceptable and feasible alternatives to provider-based screening in low-income women in São Paulo, Brazil.

OBJECTIVE: The objective of this study was to determine whether home-based screening for sexually transmitted infections (STIs) is acceptable, feasible, and increases the proportion of women screened among low-income women in São Paulo, Brazil. STUDY DESIGN: Eight hundred eighteen women were randomized to receive a clinic appointment or a kit for home-based STI self-collection and testing. All participants collected 2 vaginal swabs, one for polymerase chain reaction detection of chlamydia, gonorrhea, and trichomoniasis and another for a self-conducted rapid test for trichomoniasis. RESULTS: Slightly more women responded to the initiative within 2 weeks in the home group (80%) than in the clinic group (76%) with younger women showing improved response to home-based screening. Ninety-four percent of home group participants successfully completed self-collection and self-testing on their first attempt. CONCLUSIONS: Home-based self-collection and self-testing was acceptable, feasible, and resulted in a slightly higher response rate. Home sampling and testing provide promising alternatives to clinic-based STI screening across diverse contexts.

Safety and acceptability of the candidate microbicide Carraguard in Thai Women: findings from a Phase II Clinical Trial.

OBJECTIVE: To determine the safety and acceptability of vaginal application of Carraguard, a carrageenan-derived candidate microbicide gel. DESIGN: A randomized, placebo-controlled, triple-blinded clinical trial was conducted in Chiang Rai, northern Thailand. METHODS: Women were asked to insert one applicator of study gel vaginally at least three times per week (with or without sex) and to use gel with condoms every time they had sex. Safety was assessed by visual inspection of the vagina and cervix, changes in vaginal flora and self-reported symptoms at day 14, month 1 and then monthly for up to 1 year. Acceptability was assessed through reported use of the gel, return of used and unused applicators, and quarterly interviews. RESULTS: One hundred sixty-five women were randomized: 83 to Carraguard and 82 to the placebo (methylcellulose gel) group. Study gel use was similarly high in both groups throughout the trial with an average of four applicators per week. Carraguard use was not associated with abnormal genital clinical findings, abnormal vaginal flora, Pap smear abnormalities or other abnormal clinical signs or symptoms. Adverse events were mostly mild, not attributed to gel use, and similarly distributed between groups. Participants in both groups reported high acceptability. CONCLUSIONS: Carraguard can safely be used an average of four times per week with or without sex and is acceptable to Thai women. A Phase III efficacy trial of Carraguard is warranted and is currently ongoing in South Africa.