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Contraceptive knowledge assessment: Validity and reliability of a novel contraceptive research tool [Meeting Abstract]

Campol, Haynes M; Saleh, M; Ryan, N; Winkel, A; Ades, V
Objectives: In order to develop effective teaching methods for contraceptive education, researchers require a validated, reliable tool to measure subjects' contraceptive knowledge. However, most widely used indices are outdated and no longer useful. The objective of this study was to create and assess the validity and reliability of a novel assessment tool for measuring contraceptive knowledge. Method: The study tool was validated using both qualitative and quantitative methods. The tool was developed by the research team and then reviewed by a selected group of experts. Participants for testing the tool included English-speaking men and women ages 15- 45 at a single institution. Structured interviews were conducted with a randomly selected group of patients for qualitative feedback regarding the readability and ease of administration and the study tool was adapted accordingly. Quantitative tests included (1) comparison with a gold standard; (2) test-retest reliability; (3) comparison between a group with low contraceptive knowledge and a group with high contraceptive knowledge. Results: Qualitative feedback was obtained on the 25-question knowledge assessment tool from 6 experts and 7 patients. The study tool was administered to a total of 102 patients, with a mean score of 9.0. In comparison with the gold standard, the mean score was significantly higher (new tool 9.1 vs. gold standard 5.8, p<0.001). Test-retest reliability was demonstrated via repeat testing within 2- 4 weeks, demonstrating no difference between test and retest in the same subjects (p=0.667). When compared to medical students, patients' mean scores were significantly lower as expected (patients 9.1 vs. medical students 19.4, p<0.005). Conclusions: We have designed a valid and reliable study tool to measure a person's level of knowledge regarding contraception. This tool will allow the assessment of baseline knowledge, educational gaps, and post-educational knowledge achievements after an intervention
EMBASE:72069736
ISSN: 0020-7292
CID: 1874862

Reproductive health needs of survivors of sex trafficking, sexual violence and female genital cutting [Meeting Abstract]

Sample, N; Ryan, N; Ades, V
Objectives: Primary objective: to determine the prevalence of prior physical, sexual and emotional abuse among survivors of sex trafficking and sexual violence. Secondary objectives: to determine the prevalence of (1) unplanned pregnancy, (2) sexually transmitted infections (STI), (3) prior obstetrical complications, and (4) uptake of family planning among survivors of sex trafficking and sexual violence. Method: This is a retrospective cohort study with chart review of electronic medical records from the EMPOWER clinic at Gouverneur Health. The EMPOWER clinic for Survivors of Sex Trafficking and Sexual Violence provides integrated psychiatric and gynecologic care to survivors of sex trafficking and sexual violence. Data was collected in a REDCap database and analyzed using Stata v13. Outcomes were evaluated using descriptive statistics. Results: Of 51 women, 76.0% had been trafficked, and 91.9% of those were trafficked for sex work. Most of the women spoke Spanish (68.6%) and nearly half are from Mexico (47.1%). The prevalence of prior physical, sexual or emotional abuse was 38.8%, 32.7%, and 26.5%, respectively. On initial intake, a large majority desired a routine exam (82.3%) and/or reported specific symptoms (74.5%), while 9.8% with unplanned pregnancy at the time of intake. Of the women with prior pregnancies, 28.2% reported prior pregnancy complications and 27.5% of all patients reported a prior STI. Only 19.6% were using effective contraception. Conclusions: Most of the women presenting to EMPOWER are from Mexico or other Latin American countries, but there is a wide geographical range represented in the cohort. Prior history of physical, sexual, or emotional abuse is common. There appears to be a high prevalence of unplanned pregnancy, as well as a high prevalence of reported prior pregnancy complications. While most requested a routine exam, the vast majority also had a specific symptom requiring evaluation. There is a high unmet need for contraception among this population, and although all undergo contraceptive counseling, uptake of effective contraception is still inadequate
EMBASE:72069755
ISSN: 0020-7292
CID: 1904912

Audio computer-assisted self-interviewing (ACASI) method to determine prevalence of intimate partner violence among Latina women in a low income clinic in New York City [Meeting Abstract]

Ades, V; Mendez, K; Duenas-Bianchi, L; Ryan, N
Objectives: Intimate partner violence (IPV) is a known public health concern and growing problem. Prevalence may be higher within Latino communities than the general population, which has a number of barriers to reporting IPV. The objective of this study is to determine the prevalence of intimate partner violence among Latina women at Gouverneur Health using ACASI, and to elicit reasons why women do not report domestic violence. Method: Subjects were approached in the waiting room of a women's health clinic of Gouverneur Health, a Medicaid and low-income clinic in New York City. A research assistant demonstrated use of the ACASI on an iPad, which included simple yes/no questions and read the questions aloud as well as displayed them on a screen. Subjects were anonymous and filled out the questionnaire independently. Data was collected automatically from the iPad questionnaire using Google analytics into a csv database, and analyzed using Stata v.13. Results: Physical violence by a current partner has occurred for 16.7%, while 55.5% reporting physical violence by a part partner, though only 37.5% characterized this as physical abuse. Past sexual abuse was reported by 37.5%. Most common reasons for not reporting to a doctor included concerns about being judged and hope that the situation would improve, though 57.1% said that they would have reported if asked. Common reasons for not reporting to police include concerns about being judged, fears about deportation, and financial concerns for the family. Forty percent reported knowing a friend or family member who suffers from domestic violence. Conclusions: Prevalence of intimate partner violence is high, though women may not recognize certain acts by their partners as physical, emotional or sexual abuse. Women would like to report to an authority figure like a doctor, but concerns about being judged by others, as well as practical concerns of deportation and financial concerns, prevent them from reporting the abuse. The ACASI method is a feasible and acceptable method of screening for domestic violence
EMBASE:72069053
ISSN: 0020-7292
CID: 1904922

Efficacy and safety of lopinavir/ritonavir versus efavirenz-based antiretroviral therapy in HIV-infected pregnant Ugandan women

Cohan, Deborah; Natureeba, Paul; Koss, Catherine A; Plenty, Albert; Luwedde, Flavia; Mwesigwa, Julia; Ades, Veronica; Charlebois, Edwin D; Gandhi, Monica; Clark, Tamara D; Nzarubara, Bridget; Achan, Jane; Ruel, Theodore; Kamya, Moses R; Havlir, Diane V
OBJECTIVE:: Combination antiretroviral therapy (ART) is now the global standard for HIV-infected pregnant and breastfeeding women at all CD4 cell counts. We compared the efficacy and safety of an efavirenz versus lopinavir/ritonavir regimen for HIV-infected pregnant women initiating ART in rural Uganda. DESIGN:: Randomized clinical trial. METHODS:: We performed a planned secondary analysis comparing viral load suppression (HIV-1 RNA
PMCID:4428759
PMID: 25426808
ISSN: 0269-9370
CID: 1359862

Lopinavir/ritonavir versus Efavirenz-based Antiretroviral Treatment for the Prevention of Malaria among HIV-infected Pregnant Women

Natureeba, Paul; Ades, Veronica; Luwedde, Flavia; Mwesigwa, Julia; Plenty, Albert; Okong, Pius; Charlebois, Edwin D; Clark, Tamara D; Nzarubara, Bridget; Havlir, Diane V; Achan, Jane; Kamya, Moses R; Cohan, Deborah; Dorsey, Grant
BACKGROUND: HIV-infected pregnant women are at increased risk of malaria and its complications. In vitro and in vivo data suggest that the HIV protease inhibitor lopinavir/ritonavir may have potent anti-malarial activity. We sought to evaluate whether lopinavir/ritonavir-based antiretroviral therapy (ART) reduced the risk of placental malaria. METHODS: HIV-infected, ART-naive pregnant women were enrolled between 12-28 weeks gestation and randomized to lopinavir/ritonavir or efavirenz-based ART. Women received daily trimethoprim-sulfamethoxazole prophylaxis and insecticide-treated bednets at enrollment and were followed up to 1 year postpartum. Primary outcome was placental malaria defined by the detection of malaria parasites using microscopy or PCR from placental blood. Secondary outcomes included placental malaria defined by histopathology, adverse birth outcomes, incidence of malaria, and prevalence of asymptomatic parasitemia. Analyses were done using an intention-to-treat approach. RESULTS: Of 389 subjects randomized, 377 were followed through to delivery. There was no significant difference in the risk of placental malaria defined by thick smear or PCR between the lopinavir/ritonavir and efavirenz-based ART arms (7.4% vs. 9.8%, p=0.45). Similarly, there were no differences in secondary outcomes between the two treatment arms. CONCLUSIONS: Lopinavir/ritonavir-based ART did not reduce the risk of placental or maternal malaria or improve birth outcomes compared to efavirenz-based ART. Trial registration. ClinicalTrials.gov (NCT00993031).
PMCID:4296178
PMID: 24958908
ISSN: 0022-1899
CID: 1050992

Household Food Insecurity, Maternal Nutritional Status, and Infant Feeding Practices Among HIV-infected Ugandan Women Receiving Combination Antiretroviral Therapy

Young, Sera L; Plenty, Albert H J; Luwedde, Flavia A; Natamba, Barnabas K; Natureeba, Paul; Achan, Jane; Mwesigwa, Julia; Ruel, Theodore D; Ades, Veronica; Osterbauer, Beth; Clark, Tamara D; Dorsey, Grant; Charlebois, Edwin D; Kamya, Moses; Havlir, Diane V; Cohan, Deborah L
Household food insecurity (HHFI) may be a barrier to both optimal maternal nutritional status and infant feeding practices, but few studies have tested this relationship quantitatively, and never among HIV-infected individuals. We therefore described the prevalence of HHFI and explored if it was associated with poorer maternal nutritional status, shorter duration of exclusive breastfeeding (EBF) and fewer animal-source complementary foods. We assessed these outcomes using bivariate and multivariate analyses among 178 HIV-infected pregnant and breastfeeding (BF) women receiving combination antiretroviral therapy in the PROMOTE trial (NCT00993031), a prospective, longitudinal cohort study in Tororo, Uganda. HHFI was common; the prevalence of severe, moderate, and little to no household hunger was 7.3, 39.9, and 52.8 %, respectively. Poor maternal nutritional status was common and women in households experiencing moderate to severe household hunger (MSHH) had statistically significantly lower body mass index (BMIs) at enrollment (21.3 vs. 22.5, p < 0.01) and prior to delivery (22.6 vs. 23.8, p < 0.01). BMI across time during pregnancy, but not gestational weight gain, was significantly lower for MSHH [adjusted beta (95 % CI) -0.79 (-1.56, -0.02), p = 0.04; -2.06 (-4.31, 0.19), p = 0.07], respectively. The prevalence (95 % CI) of EBF at 6 months was 67.2 % (59.7-73.5 %), and the proportion of women BF at 12 months was 80.4 % (73.3-85.7 %). MSHH was not associated with prevalence of EBF at 6 months or BF at 12 months. However, among those women still EBF at 4 months (81.4 % of population), those experiencing MSHH were significantly more likely to cease EBF between 4 and 6 months (aHR 2.38, 95 % CI 1.02-5.58). The prevalence of HHFI, maternal malnutrition, and suboptimal infant feeding practices are high and the causal relationships among these phenomena must be further explored.
PMCID:4419705
PMID: 24585398
ISSN: 1092-7875
CID: 894552

Risk Factors for Preterm Birth among HIV-Infected Pregnant Ugandan Women Randomized to Lopinavir/ritonavir- or Efavirenz-based Antiretroviral Therapy

Koss, Catherine A; Natureeba, Paul; Plenty, Albert; Luwedde, Flavia; Mwesigwa, Julia; Ades, Veronica; Charlebois, Edwin D; Clark, Tamara D; Achan, Jane; Ruel, Theodore; Nzarubara, Bridget; Kamya, Moses R; Havlir, Diane V; Cohan, Deborah
BACKGROUND:: Protease inhibitor-based antiretroviral therapy (ART) has been associated with preterm birth in some studies. We examined risk factors for preterm birth among women randomized to lopinavir/ritonavir- or efavirenz-based ART. METHODS:: This was a planned secondary analysis of the PROMOTE-Pregnant Women and Infants Study, an open-label, randomized controlled trial comparing the risk of placental malaria among HIV-infected, ART-naive pregnant Ugandan women assigned to initiate lopinavir/ritonavir- or efavirenz-based ART at 12 to 28 weeks gestation. Gestational age was determined based on last menstrual period and ultrasound biometry. All women received bednets and trimethoprim-sulfamethoxazole. Stillbirths, spontaneous abortions, and multiple gestations were excluded from the primary analysis. Potential risk factors for preterm birth (<37 weeks gestation) were evaluated by univariate and multivariate logistic regression. RESULTS:: 356 women were included in this analysis. At enrollment, median gestational age was 21 weeks, median CD4 cell count was 368 cells/mm. 14.7% of deliveries in the efavirenz arm and 16.2% in the lopinavir/ritonavir arm were preterm. Preterm birth was associated with gestational weight gain below 0.1 kg/week versus 0.1 kg/week or more (OR = 2.49, 95% CI: 1.38-4.47, p = 0.003). Neither ART regimen of lopinavir/ritonavir versus efavirenz (OR = 1.12, 95% CI: 0.63-2.00, p = 0.69) nor placental malaria (OR = 0.74, 95% CI: 0.38-1.44, p = 0.37) was associated with preterm birth. CONCLUSIONS:: Lopinavir/ritonavir was not associated with an increased risk of preterm birth compared to efavirenz. However, interventions are needed to address modifiable risk factors for preterm birth, such as nutritional status. (ClinicalTrials.gov, NCT00993031.).
PMCID:4414017
PMID: 25072616
ISSN: 1525-4135
CID: 1090072

Neonatal Mortality in HIV-Exposed Infants Born to Women Receiving Combination Antiretroviral Therapy in Rural Uganda

Ades, Veronica; Mwesigwa, Julia; Natureeba, Paul; Clark, Tamara D; Plenty, Albert; Charlebois, Edwin; Achan, Jane; Kamya, Moses R; Havlir, Diane V; Cohan, Deborah; Ruel, Theodore D
As human immunodeficiency virus (HIV)-infected women gain access to combination antiretroviral therapy throughout sub-Saharan Africa, a growing number of infants are being born HIV-exposed but uninfected. Data about neonatal mortality and the impact of premature delivery, in this population are limited. We describe the 28-day mortality outcomes in a cohort of HIV-exposed infants who had ultrasound-confirmed gestational age in rural Uganda. There were 13 deaths among 351 infants, including 9 deaths in the perinatal period. Premature delivery was a strong predictor of mortality. The prevention of HIV transmission to infants is now possible in rural low-resource settings but the frequency of neonatal death among HIV-exposed infants remains extremely high, calling for new comprehensive interventions to reduce mortality in this growing population.
PMCID:3842848
PMID: 23764539
ISSN: 0142-6338
CID: 700632

Hair and plasma data show that lopinavir, ritonavir, and efavirenz all transfer from mother to infant in utero, but only efavirenz transfers via breastfeeding

Gandhi, Monica; Mwesigwa, Julia; Aweeka, Francesca; Plenty, Albert; Charlebois, Edwin; Ruel, Theodore D; Huang, Yong; Clark, Tamara; Ades, Veronica; Natureeba, Paul; Luwedde, Flavia A; Achan, Jane; Kamya, Moses R; Havlir, Diane V; Cohan, Deborah
BACKGROUND: As efforts intensify to eliminate perinatal HIV transmission, understanding kinetics of maternal-to-child transfer of antiretrovirals during pregnancy and breastfeeding is critical. Antiretroviral levels in plasma, cord blood, and breastmilk reflect exposure over short intervals. Hair concentrations reflect cumulative exposure and can uniquely quantify in utero transfer of maternal medications to infants. We measured plasma and hair antiretroviral levels in HIV-infected Ugandan mothers and their infants at delivery and during breastfeeding to assess transfer. METHODS: HIV-infected pregnant women were randomized to lopinavir/ritonavir- or efavirenz-based therapy in a larger trial (the Prevention of Malaria and HIV disease in Tororo, PROMOTE). At 0, 8, and 12 weeks postpartum, plasma antiretroviral levels were measured in 117 mother-infant pairs; hair levels were assayed at 12 weeks. Ratios and correlations of infant:maternal concentrations were calculated. RESULTS: By 12 weeks, 90.4% of mothers reported exclusive breastfeeding. Hair and plasma levels over time suggest moderate (47%) to extensive (87%) in utero transfer of lopinavir and ritonavir, respectively, but negligible transfer of either via breastfeeding. Moderate transfer of efavirenz occurs during pregnancy and breastfeeding (40% cumulative; 15% during breastfeeding). Despite differences in exposure, no infant seroconversions or correlations between infant hair/plasma antiretroviral levels and adverse effects were observed. CONCLUSIONS: Using a unique approach combining hair and plasma data, we found that different antiretrovirals have distinct kinetics of mother-to-infant transfer. Efavirenz transfers during both pregnancy and breastfeeding, whereas lopinavir and ritonavir transfer only in utero. Further study of the degree and timing of maternal-to-child transfer by antiretroviral will help optimize strategies that protect infants and minimize toxicities during periods of risk.
PMCID:3800282
PMID: 24135775
ISSN: 1525-4135
CID: 894532

WHO option B+: early experience of antiretroviral therapy sequencing after cessation of breastfeeding and risk of dermatologic toxicity [Letter]

Cohan, Deborah; Mwesigwa, Julia; Natureeba, Paul; Aliba Luwedde, Flavia; Ades, Veronica; Plenty, Albert; Kakuru, Abel; Achan, Jane; Clark, Tamara; Osterbauer, Beth; Kamya, Moses; Havlir, Diane
PMCID:3738916
PMID: 23924639
ISSN: 1525-4135
CID: 894512