Publications by authors named "Margaret P Kasaro"

12 Publications

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Weekly 17 alpha-hydroxyprogesterone caproate to prevent preterm birth among women living with HIV: a randomised, double-blind, placebo-controlled trial.

Lancet HIV 2021 Sep 9. Epub 2021 Sep 9.

Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, NC, USA.

Background: Women with HIV face an increased risk of preterm birth. 17 alpha-hydroxyprogesterone caproate (17P) has been shown in some trials to reduce early delivery among women with a history of spontaneous preterm birth. We investigated whether 17P would reduce this risk among women with HIV.

Methods: We did a randomised, double-blind, placebo-controlled trial in pregnant women with HIV at the University Teaching Hospital and Kamwala District Health Centre in Lusaka, Zambia. Eligible patients were women aged 18 years or older with confirmed HIV-1 infection, viable intrauterine singleton pregnancy at less than 24 weeks of gestation, and were receiving or intending to commence antiretroviral therapy during pregnancy. Exclusion criteria were major uterine or fetal anomaly; planned or in situ cervical cerclage; evidence of threatened miscarriage, preterm labour, or ruptured membranes at screening; medical contraindication to 17P; previous participation in the trial; or history of spontaneous preterm birth. Eligible participants provided written informed consent and were randomly assigned (1:1) to receive 250 mg intramuscular 17P or placebo once per week, starting between 16 and 24 weeks of gestation until delivery, stillbirth, or reaching term (37 weeks). Participants and study staff were masked to assignment, except for pharmacy staff who did random assignment and prepared injections but did not interact with participants. The primary outcome was a composite of delivery before 37 weeks or stillbirth at any gestational age. Patients attended weekly visits for study drug injections and antenatal care. We estimated the absolute and relative difference in risk of the primary outcome and safety events between treatment groups by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03297216, and is complete.

Findings: Between Feb 7, 2018 and Jan 13, 2020, we assessed 1042 women for inclusion into the study. 242 women were excluded after additional assessments, and 800 eligible patients were enrolled and randomly assigned to receive intramuscular 17P (n=399) or placebo (n=401). Baseline characteristics were similar between groups. Adherence to study drug injections was 98% in both groups, no patients were lost to follow-up, and the final post-partum visit was on Aug 6, 2020. 36 (9%) of 399 participants assigned to 17P had preterm birth or stillbirth, compared with 36 (9%) of 401 patients assigned to placebo (risk difference 0·1, 95% CI -3·9 to 4·0; relative risk 1·0, 95% CI 0·6 to 1·6; p=0·98). Intervention-related adverse events were reported by 140 (18%) of 800 participants and occurred in similar proportions in both randomisation groups. No serious adverse events were reported.

Interpretation: Although 17P seems to be safe and acceptable to participants, available data do not support the use of the drug to prevent preterm birth among women whose risk derives solely from HIV infection. The low risk of preterm birth in both randomisation groups warrants further investigation.

Funding: US National Institutes of Health and the Bill and Melinda Gates Foundation.
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http://dx.doi.org/10.1016/S2352-3018(21)00150-8DOI Listing
September 2021

Circulating angiogenic factors and HIV among pregnant women in Zambia: a nested case-control study.

BMC Pregnancy Childbirth 2021 Jul 28;21(1):534. Epub 2021 Jul 28.

Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Background: Maternal HIV increases the risk of adverse birth outcomes including preterm birth, fetal growth restriction, and stillbirth, but the biological mechanism(s) underlying this increased risk are not well understood. We hypothesized that maternal HIV may lead to adverse birth outcomes through an imbalance in angiogenic factors involved in the vascular endothelial growth factor (VEGF) signaling pathway.

Methods: In a case-control study nested within an ongoing cohort in Zambia, our primary outcomes were serum concentrations of VEGF-A, soluble endoglin (sEng), placental growth factor (PlGF), and soluble fms-like tyrosine kinase-1 (sFLT-1). These were measured in 57 women with HIV (cases) and 57 women without HIV (controls) before 16 gestational weeks. We used the Wilcoxon rank-sum and linear regression controlling for maternal body mass index (BMI) and parity to assess the difference in biomarker concentrations between cases and controls. We also used logistic regression to test for associations between biomarker concentration and adverse pregnancy outcomes (preeclampsia, preterm birth, small for gestational age, stillbirth, and a composite of preterm birth or stillbirth).

Results: Compared to controls, women with HIV had significantly lower median concentrations of PlGF (7.6 vs 10.2 pg/mL, p = 0.02) and sFLT-1 (1647.9 vs 2055.6 pg/mL, p = 0.04), but these findings were not confirmed in adjusted analysis. PlGF concentration was lower among women who delivered preterm compared to those who delivered at term (6.7 vs 9.6 pg/mL, p = 0.03) and among those who experienced the composite adverse birth outcome (6.2 vs 9.8 pg/mL, p = 0.02). Median sFLT-1 concentration was lower among participants with the composite outcome (1621.0 vs 1945.9 pg/mL, p = 0.04), but the association was not significant in adjusted analysis. sEng was not associated with either adverse birth outcomes or HIV. VEGF-A was undetectable by Luminex in all specimens.

Conclusions: We present preliminary findings that HIV is associated with a shift in the VEGF signaling pathway in early pregnancy, although adjusted analyses were inconclusive. We confirm an association between angiogenic biomarkers and adverse birth outcomes in our population. Larger studies are needed to further elucidate the role of HIV on placental angiogenesis and adverse birth outcomes.
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http://dx.doi.org/10.1186/s12884-021-03965-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8317322PMC
July 2021

ART initiation among women newly diagnosed with HIV in a contraceptive trial in sub-Saharan Africa.

AIDS Care 2021 Jun 27:1-8. Epub 2021 Jun 27.

MatCH Research Unit (MRU), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.

Current guidelines recommend starting antiretroviral therapy (ART) as soon as possible after HIV diagnosis to reduce morbidity, mortality and onward HIV transmission. We examined factors influencing ART initiation by women who seroconverted during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial. ECHO, conducted between 2015 and 2018, enrolled HIV-negative, sexually active women, aged 16-35 years, from four African countries. Follow-up was 12-18 months, with quarterly HIV testing. Women with incident HIV infection received extensive counselling by trial staff and referral to local facilities for HIV care. Of 304 women with ≥90 days follow-up time since HIV diagnosis, 186(61.2%) initiated ART within 90 days, 69(22.7%) initiated after 90 days, and 49(16.1%) had not initiated by the end of the study. There were no statistically significant differences in characteristics among women who initiated ART ≤90 days versus those who did not. Frequent reasons for delayed or non-initiation of ART included not feeling ready to start ART and being newly diagnosed. In a large clinical trial, ART initiation was modest within 90 days of HIV diagnosis and grew to 84% with longer observation. Despite extensive counselling on the importance of early ART initiation, personal barriers delayed some women from starting ART.
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http://dx.doi.org/10.1080/09540121.2021.1944601DOI Listing
June 2021

Maternal HIV Infection and Spontaneous Versus Provider-Initiated Preterm Birth in an Urban Zambian Cohort.

J Acquir Immune Defic Syndr 2021 06;87(2):860-868

University of North Carolina Global Projects Zambia, Lusaka, Zambia; and.

Objective: We investigated the effect of maternal HIV and its treatment on spontaneous and provider-initiated preterm birth (PTB) in an urban African cohort.

Methods: The Zambian Preterm Birth Prevention Study enrolled pregnant women at their first antenatal visit in Lusaka. Participants underwent ultrasound, laboratory testing, and clinical phenotyping of delivery outcomes. Key exposures were maternal HIV serostatus and timing of antiretroviral therapy initiation. We defined the primary outcome, PTB, as delivery between 16 and 37 weeks' gestational age, and differentiated spontaneous from provider-initiated parturition.

Results: Of 1450 pregnant women enrolled, 350 (24%) had HIV. About 1216 (84%) were retained at delivery, 3 of whom delivered <16 weeks. Of 181 (15%) preterm deliveries, 120 (66%) were spontaneous, 56 (31%) were provider-initiated, and 5 (3%) were unclassified. In standardized analyses using inverse probability weighting, maternal HIV increased the risk of spontaneous PTB [RR 1.68; 95% confidence interval (CI): 1.12 to 2.52], but this effect was mitigated on overall PTB [risk ratio (RR) 1.31; 95% CI: 0.92 to 1.86] owing to a protective effect against provider-initiated PTB. HIV reduced the risk of preeclampsia (RR 0.32; 95% CI: 0.11 to 0.91), which strongly predicted provider-initiated PTB (RR 17.92; 95% CI: 8.13 to 39.53). The timing of antiretroviral therapy start did not affect the relationship between HIV and PTB.

Conclusion: The risk of HIV on spontaneous PTB seems to be opposed by a protective effect of HIV on provider-initiated PTB. These findings support an inflammatory mechanism underlying HIV-related PTB and suggest that published estimates of PTB risk overall underestimate the risk of spontaneous PTB.
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http://dx.doi.org/10.1097/QAI.0000000000002654DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8131221PMC
June 2021

Adverse birth outcomes and their clinical phenotypes in an urban Zambian cohort.

Gates Open Res 2019 24;3:1533. Epub 2020 Jan 24.

Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina, School of Medicine, Chapel Hill, NC, USA.

: Few cohort studies of pregnancy in sub-Saharan Africa use rigorous gestational age dating and clinical phenotyping. As a result, incidence and risk factors of adverse birth outcomes are inadequately characterized. : The Zambian Preterm Birth Prevention Study (ZAPPS) is a prospective observational cohort established to investigate adverse birth outcomes at a referral hospital in urban Lusaka. This report describes ZAPPS phase I, enrolled August 2015 to September 2017. Women were followed through pregnancy and 42 days postpartum. At delivery, study staff assessed neonatal vital status, birthweight, and sex, and assigned a delivery phenotype. Primary outcomes were: (1) preterm birth (PTB; delivery <37 weeks), (2) small-for-gestational-age (SGA; <10 percentile weight-for-age at birth), and (3) stillbirth (SB; delivery of an infant without signs of life). : ZAPPS phase I enrolled 1450 women with median age 27 years (IQR 23-32). Most participants (68%) were multiparous, of whom 41% reported a prior PTB and 14% reported a prior stillbirth. Twins were present in 3% of pregnancies, 3% of women had short cervix (<25mm), 24% of women were HIV seropositive, and 5% were syphilis seropositive. Of 1216 (84%) retained at delivery, 15% were preterm, 18% small-for-gestational-age, and 4% stillborn. PTB risk was higher with prior PTB (aRR 1.88; 95%CI 1.32-2.68), short cervix (aRR 2.62; 95%CI 1.68-4.09), twins (aRR 5.22; 95%CI 3.67-7.43), and antenatal hypertension (aRR 2.04; 95%CI 1.43-2.91). SGA risk was higher with twins (aRR 2.75; 95%CI 1.81-4.18) and antenatal hypertension (aRR 1.62; 95%CI 1.16-2.26). SB risk was higher with short cervix (aRR 6.42; 95%CI 2.56-16.1). : This study confirms high rates of PTB, SGA, and SB among pregnant women in Lusaka, Zambia. Accurate gestational age dating and careful ascertainment of delivery data are critical to understanding the scope of adverse birth outcomes in low-resource settings.
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http://dx.doi.org/10.12688/gatesopenres.13046.2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7047437PMC
January 2020

Highly diverse anaerobe-predominant vaginal microbiota among HIV-infected pregnant women in Zambia.

PLoS One 2019 2;14(10):e0223128. Epub 2019 Oct 2.

Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, United States of America.

Vaginal dysbiosis has been shown to increase the risk of some adverse birth outcomes. HIV infection may be associated with shifts in the vaginal microbiome. We characterized microbial communities in vaginal swabs collected between 16-20 gestational weeks in the Zambian Preterm Birth Prevention Study to investigate whether HIV and its treatment alter the microbiome in pregnancy. We quantified relative abundance and diversity of bacterial taxa by whole-genome shotgun sequencing and identified community state types (CST) by hierarchical clustering. Associations between exposures-HIV serostatus (HIV+ vs HIV-) and preconceptional ART (ART+ vs ART-)-and microbiome characteristics were tested with rank-sum, and by linear and logistic regression, accounting for sampling by inverse-probability weighting. Of 261 vaginal swabs, 256 (98%) had evaluable sequences; 98 (38%) were from HIV+ participants, 55 (56%) of whom had preconceptional ART exposure. Major CSTs were dominated by: L. crispatus (CST 1; 17%), L.] iners (CST 3; 32%), Gardnerella vaginalis (CST 4-I; 37%), G. vaginalis & Atopobium vaginae (CST 4-II; 5%), and other mixed anaerobes (CST 4-III; 9%). G. vaginalis was present in 95%; mean relative abundance was higher in HIV+ (0.46±0.29) compared to HIV- participants (0.35±0.33; rank-sum p = .01). Shannon diversity was higher in HIV+/ART+ (coeff 0.17; 95%CI (0.01,0.33), p = .04) and HIV+/ART- (coeff 0.37; 95%CI (0.19,0.55), p < .001) participants compared to HIV-. Anaerobe-dominant CSTs were more prevalent in HIV+/ART+ (63%, AOR 3.11; 95%CI: 1.48,6.55, p = .003) and HIV+/ART- (85%, AOR 7.59; 95%CI (2.80,20.6), p < .001) compared to HIV- (45%). Restricting the comparison to 111 women in either CST 3 (L. iners dominance) or CST 1 (L. crispatus dominance), CST 3 frequency was similar in HIV- (63%) and HIV+/ART- participants (67%, AOR 1.31; 95%CI: (0.25,6.90), p = .7), but higher in HIV+/ART+ (89%, AOR 6.44; 95%CI: (1.12,37.0), p = .04). Pregnant women in Zambia, particularly those with HIV, had diverse anaerobe-dominant vaginal microbiota.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0223128PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6774526PMC
March 2020

The Zambian Preterm Birth Prevention Study (ZAPPS): Cohort characteristics at enrollment.

Gates Open Res 2018 15;2:25. Epub 2019 Jul 15.

University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Sub-Saharan Africa bears a disproportionate burden of preterm birth and other adverse outcomes. A better understanding of the demographic, clinical, and biologic underpinnings of these adverse outcomes is urgently needed to plan interventions and inform new discovery.  The Zambian Preterm Birth Prevention Study (ZAPPS) is a prospective observational cohort established at the Women and Newborn Hospital (WNH) in Lusaka, Zambia. We recruit pregnant women from district health centers and the WNH and offer ultrasound examination to determine eligibility. Participants receive routine obstetrical care, lab testing, midtrimester cervical length measurement, and serial fetal growth monitoring. At delivery, we assess gestational age, birthweight, vital status, and sex and assign a delivery phenotype. We collect blood, urine, and vaginal swab specimens at scheduled visits and store them in an on-site biorepository. In September 2017, enrollment of the ZAPPS Phase 1-the subject of this report-was completed. Phase 2, which is limited to HIV-uninfected women, reopened in January 2018.  Between August 2015 and September 2017, we screened 1784 women, of whom 1450 (81.2%) met inclusion criteria and were enrolled. The median age at enrollment was 27 years (IQR 23-32) and median gestational age was 16 weeks (IQR 13-18). Among women with a previous pregnancy (n=1042), 19% (n=194) reported a prior miscarriage.  Among parous women (n=992), 41% (n=411) reported a prior preterm birth and 14% (n=126) reported a prior stillbirth. The HIV seroprevalence was 24%. We have established a large cohort of pregnant women and newborns at the WNH to characterize the determinants of adverse birth outcomes in Lusaka, Zambia. Our overarching goal is to elucidate biological mechanisms in an effort to identify new strategies for early detection and prevention of adverse outcomes. We hope that findings from this cohort will help guide future studies, clinical care, and policy.
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http://dx.doi.org/10.12688/gatesopenres.12820.3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6350406PMC
July 2019

HIV serostatus, viral load, and midtrimester cervical length in a Zambian prenatal cohort.

Int J Gynaecol Obstet 2019 Aug 29;146(2):206-211. Epub 2019 Apr 29.

Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Objective: To evaluate whether maternal HIV serostatus and plasma viral load (VL) are associated with midtrimester cervical length (CL).

Methods: The Zambian Preterm Birth Prevention Study (ZAPPS) is an ongoing prospective cohort that began enrolling in Lusaka in August 2015. Pregnant women undergo ultrasound to determine gestational age and return for CL measurement at 16-28 weeks. We evaluated crude and adjusted associations between dichotomous indicators and short cervix (≤2.5 cm) via logistic regression, and between VL and CL as a continuous variable via linear regression.

Results: This analysis includes 1171 women enrolled between August 2015 and September 2017. Of 294 (25.1%) HIV-positive women, 275 (93.5%) had viral load performed close to CL measurement; of these, 148 (53.8%) had undetectable virus. Median CL was 3.6 cm (IQR 3.5-4.0) and was similar in HIV-infected (3.7 cm, IQR 3.5-4.0) versus uninfected (3.6 cm, IQR 3.5-4.0) participants (P=0.273). The odds of short CL were similar by HIV serostatus (OR 0.64; P=0.298) and detectable VL among those infected (OR 2.37, P=0.323). We observed no association between log VL and CL via linear regression (-0.12 cm; P=0.732).

Conclusion: We found no evidence of association between HIV infection and short CL.
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http://dx.doi.org/10.1002/ijgo.12823DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6610732PMC
August 2019

Field performance evaluation of dual rapid HIV and syphilis tests in three antenatal care clinics in Zambia.

Int J STD AIDS 2019 03 25;30(4):323-328. Epub 2018 Nov 25.

1 Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.

This cross-sectional study of 3212 pregnant women assessed the field performance, acceptability, and feasibility of two dual HIV/syphilis rapid diagnostic tests, the Chembio DPP HIV-syphilis Assay and the SD Bioline HIV/syphilis Duo in antenatal clinics. Sensitivity and specificity for HIV and syphilis were calculated compared to the rapid Determine HIV-1/2 with Uni-Gold to confirm positive results for HIV and the Treponema pallidum particle agglutination assay for syphilis. RPR titers ≥1:4 were used to define active syphilis detection. Acceptability and feasibility were assessed using self-reported questionnaires. For Chembio, the HIV sensitivity was 90.6% (95%CI = 87.4, 93.0) and specificity was 97.2% (95%CI = 96.2, 97.8); syphilis sensitivity was 68.6% (95%CI = 61.9, 74.6) and specificity was 98.5% (95%CI = 97.8, 98.9). For SD Bioline, HIV sensitivity was 89.4% (95%CI = 86.1, 92.0) and specificity was 96.3% (95%CI = 95.3, 97.1); syphilis sensitivity was 66.2% (95%CI = 59.4, 72.4) and specificity was 97.2% (95%CI = 96.4, 97.9). Using the reference for active syphilis, syphilis sensitivity was 84.7% (95%CI = 76.1, 90.6) for Chembio and 81.6% (95%CI = 72.7, 88.1) for SD Bioline. Both rapid diagnostic tests were assessed as highly acceptable and feasible. In a field setting, the performance of both rapid diagnostic tests was comparable to other published field evaluations and each was rated highly acceptable and feasible. These findings can be used to guide further research and proposed scale up in antenatal clinic settings.
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http://dx.doi.org/10.1177/0956462418800872DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6751556PMC
March 2019

Preconception ART and preterm birth: real effect or selection bias?

Lancet HIV 2017 04;4(4):e150

University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC, USA.

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http://dx.doi.org/10.1016/S2352-3018(17)30046-2DOI Listing
April 2017

Patient engagement in HIV care and treatment in Zambia, 2004-2014.

Trop Med Int Health 2017 03 19;22(3):332-339. Epub 2017 Jan 19.

University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Objective: To describe engagement along the HIV continuum of care using a large network of clinics in Zambia.

Methods: We employed a practical framework to describe retention along the HIV treatment cascade, using routinely collected clinical data available in resource-constrained settings. We included health facilities in four Zambian provinces with more than 300 enrolled patients over the age of 5 years. We described attrition at each step, from HIV enrolment to 720 days after ART initiation. The population was further stratified by year of enrolment to describe temporal trends in patient engagement.

Results: From January 2004 to December 2014, 444 439 individuals over the age of 5 years sought HIV care at 75 eligible health facilities. Among those enrolled into HIV care, 82.1% (95% confidence interval [CI]: 79.4-84.5%) were fully assessed for ART eligibility within 180 days of enrolment and 63.6% (95% CI: 61.7-65.3) were found to be eligible for ART based on the HIV treatment guidelines at the time. Of those patients eligible for ART, 81.1% (95% CI: 79.5-82.7%) initiated ART within 180 days. Patient retention in ART programme was 81.2% (95% CI: 80.4-81.9%) at 90 days, 70.0% (95% CI: 68.7-71.2%) at 360 days and 61.6% (95% CI: 60.0-63.2%) at 720 days. We noted a steady decline in proportions assessed for ART eligibility and deemed eligible for ART in the time frame. Proportions that started ART and remained in care remained relatively consistent.

Conclusion: We describe a simple approach for assessing patient engagement after enrolment into HIV care. Using limited types of data routinely available, we demonstrate an important and replicable approach to monitoring programmes in resource-constrained settings.
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http://dx.doi.org/10.1111/tmi.12832DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6506213PMC
March 2017

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

Int J STD AIDS 2017 04 10;28(5):467-475. Epub 2016 Jul 10.

2 Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.

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.
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http://dx.doi.org/10.1177/0956462416653001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5145791PMC
April 2017
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