Last data update: May 06, 2024. (Total: 46732 publications since 2009)
Records 1-7 (of 7 Records) |
Query Trace: Girde S[original query] |
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Adverse fetal and infant outcomes among HIV-infected women who received either NNRTI- or PI-based ART for PMTCT
Masaba R , Borkowf CB , Girde S , Zeh C , Ndivo R , Nyang'au I , Achola K , Thomas TK , Lecher SL . AIDS 2018 32 (12) 1625-1632 BACKGROUND: For HIV-infected pregnant and breastfeeding women, antiretroviral therapy (ART) is known to reduce the mother's risk of passing the infection to her child. However, concerns remain about possible associations between various components of different ART regimens and adverse fetal and infant outcomes. As part of a clinical trial in western Kenya for the prevention of mother-to-child transmission (PMTCT) of HIV, pregnant women received one of two different ART regimens. METHODS: The original PMTCT study conducted in Kenya enrolled 522 HIV-infected, ART-naive pregnant women. These women were assigned to receive an ART regimen that included either nevirapine, a nonnucleoside reverse transcriptase inhibitor (NNRTI), or nelfinavir, a protease inhibitor. This substudy involves 384 women from the original study who had baseline CD4 counts at least 250 cells/mul, and compares the risks of adverse fetal and infant outcomes between the two ART regimens. RESULTS: There were 386 live births (including multiples) and 7 (1.8%) stillbirths. Among live births, there were 67 preterm deliveries, 37 low-birth weight infants, and 14 infant deaths by 6 months. There were no statistically significant differences between the two ART regimens for any of the reported adverse outcomes. CONCLUSION: Although these data do not show significant differences between the NNRTI-based or protease inhibitor-based regimens in serious adverse fetal and infant outcomes, more studies need to be done and careful vigilance is needed to ensure infant safety. |
Correlation of adherence by pill count, self-report, MEMS and plasma drug levels to treatment response among women receiving ARV therapy for PMTCT in Kenya
Mudhune V , Gvetadze R , Girde S , Ndivo R , Angira F , Zeh C , Thomas T , Lecher SL . AIDS Behav 2017 22 (3) 918-928 Success of antiretroviral therapy depends on adherence to effective treatment. We evaluated four adherence methods and their correlation with immunological and virologic response among women receiving PMTCT. Univariable and multivariable analyses were used to assess how adherence by pill count (n = 463), self-report (n = 463), MEMS (n = 129) and plasma drug level (n = 89) was associated with viral load suppression within a 6 months period. Longitudinal analysis was performed to determine the correlation of CD4 cell count with each measure of adherence. For all measures of adherence, sustained viral suppression was less likely for participants in the lowest category of adherence. Although CD4 cell count increased substantially over time, there was no significant association with adherence by the methods. Multiple strategies can be used successfully to monitor treatment adherence. Persons with ≥95% adherence by any method used in this study were more likely to have a favorable treatment outcome. |
Determinants and experiences of repeat pregnancy among HIV-positive Kenyan women - a mixed-methods analysis
Akelo V , McLellan-Lemal E , Toledo L , Girde S , Borkowf CB , Ward L , Ondenge K , Ndivo R , Lecher SL , Mills LA , Thomas TK . PLoS One 2015 10 (6) e0131163 OBJECTIVE: To identify factors associated with repeat pregnancy subsequent to an index pregnancy among women living with HIV (WLWH) in western Kenya who were enrolled in a 24-month phase-II clinical trial of triple-ART prophylaxis for prevention of mother-to-child transmission, and to contextualize social and cultural influences on WLWH's reproductive decision making. METHODS: A mixed-methods approach was used to examine repeat pregnancy within a 24 month period after birth. Counselor-administered questionnaires were collected from 500 WLWH. Forty women (22 with a repeat pregnancy; 18 with no repeat pregnancy) were purposively selected for a qualitative interview (QI). Simple and multiple logistic regression analyses were performed for quantitative data. Thematic coding and saliency analysis were undertaken for qualitative data. RESULTS: Eighty-eight (17.6%) women had a repeat pregnancy. Median maternal age was 23 years (range 15-43 years) and median gestational age at enrollment was 34 weeks. In multiple logistic regression analyses, living in the same compound with a husband (adjusted odds ratio (AOR): 2.33; 95% confidence interval (CI): 1.14, 4.75) was associated with increased odds of repeat pregnancy (p ≤ 0.05). Being in the 30-43 age group (AOR: 0.25; 95% CI: 0.07, 0.87), having talked to a partner about family planning (FP) use (AOR: 0.53; 95% CI: 0.29, 0.98), and prior usage of FP (AOR: 0.45; 95% CI: 0.25, 0.82) were associated with a decrease in odds of repeat pregnancy. QI findings centered on concerns about modern contraception methods (side effects and views that they 'ruined the womb') and a desire to have the right number of children. Religious leaders, family, and the broader community were viewed as reinforcing cultural expectations for married women to have children. Repeat pregnancy was commonly attributed to contraception failure or to lack of knowledge about post-delivery fertility. CONCLUSIONS: In addition to cultural context, reproductive health programs for WLWH may need to address issues related to living circumstances and the possibility that reproductive-decision making may extend beyond the woman and her partner. |
A comparison of methods for analyzing viral load data in studies of HIV patients
Rose CE , Gardner L , Craw J , Girde S , Wawrzyniak AJ , Drainoni ML , Davila J , DeHovitz J , Keruly JC , Westfall AO , Marks G . PLoS One 2015 10 (6) e0130090 HIV RNA viral load (VL) is a pivotal outcome variable in studies of HIV infected persons. We propose and investigate two frameworks for analyzing VL: (1) a single-measure VL (SMVL) per participant and (2) repeated measures of VL (RMVL) per participant. We compared these frameworks using a cohort of 720 HIV patients in care (4,679 post-enrollment VL measurements). The SMVL framework analyzes a single VL per participant, generally captured within a "window" of time. We analyzed three SMVL methods where the VL binary outcome is defined as suppressed or not suppressed. The omit-participant method uses a 8-month "window" (-6/+2 months) around month 24 to select the participant's VL closest to month 24 and removes participants from the analysis without a VL in the "window". The set-to-failure method expands on the omit-participant method by including participants without a VL within the "window" and analyzes them as not suppressed. The closest-VL method analyzes each participant's VL measurement closest to month 24. We investigated two RMVL methods: (1) repeat-binary classifies each VL measurement as suppressed or not suppressed and estimates the proportion of participants suppressed at month 24, and (2) repeat-continuous analyzes VL as a continuous variable to estimate the change in VL across time, and geometric mean (GM) VL and proportion of participants virally suppressed at month 24. Results indicated the RMVL methods have more precision than the SMVL methods, as evidenced by narrower confidence intervals for estimates of proportion suppressed and risk ratios (RR) comparing demographic strata. The repeat-continuous method had the most precision and provides more information than other considered methods. We generally recommend using the RMVL framework when there are repeated VL measurements per participant because it utilizes all available VL data, provides additional information, has more statistical power, and avoids the subjectivity of defining a "window." |
Enhanced personal contact with HIV patients improves retention in primary care: a randomized trial in six U.S. HIV clinics
Gardner LI , Giordano TP , Marks G , Wilson TE , Craw JA , Drainoni ML , Keruly JC , Rodriguez AE , Malitz F , Moore RD , Bradley-Springer LA , Holman S , Rose CE , Girde S , Sullivan M , Metsch LR , Saag M , Mugavero MJ . Clin Infect Dis 2014 59 (5) 725-34 BACKGROUND: To determine whether enhanced personal contact with HIV-infected patients across time improves retention in care compared with existing standard of care (SOC) practices, and whether brief skills training improves retention beyond enhanced contact. METHODS: The study, conducted at 6 US HIV clinics, included 1,838 patients with a recent history of inconsistent clinic attendance, and new patients. Each clinic randomized participants to one of three arms and continued to provide SOC practices to all enrollees: Enhanced contact with interventionist (EC; brief face-to-face meeting upon returning for care visit, interim visit call, appointment reminder calls, missed visit call); EC+skills (organization, problem solving, and communication skills); or SOC-only. The intervention was delivered by project staff for 12 months following randomization. The outcomes during that 12-month period were (1) percentage of participants attending at least one primary care visit in three consecutive 4-month intervals (visit constancy), and (2) proportion of kept/scheduled primary care visits (visit adherence). RESULTS: Log-binomial risk ratios comparing intervention arms against the SOC arm demonstrated better outcomes in both the EC and EC+skills arms (visit constancy: RRs=1.22 (1.09-1.36) and 1.22 (1.09-1.36); visit adherence: RR=1.08 (1.05-1.11) and 1.06 (1.02-1.09), all ps<0.01). Intervention effects were observed in numerous patient subgroups, although lower in patients reporting unmet needs or illicit drug use. CONCLUSION: Enhanced contact with patients improved retention in HIV primary care compared to existing SOC practices. A brief patient skill-building component did not improve retention further. Additional intervention elements may be needed for patients reporting illicit drug use or who have unmet needs. |
Outcomes in a cohort of women who discontinued maternal triple-antiretroviral regimens initially used to prevent mother-to-child transmission during pregnancy and breastfeeding-Kenya, 2003-2009
Minniear TD , Girde S , Angira F , Mills LA , Zeh C , Peters PJ , Masaba R , Lando R , Thomas TK , Taylor AW . PLoS One 2014 9 (4) e93556 BACKGROUND: In 2012, the World Health Organization (WHO) amended their 2010 guidelines for women receiving limited duration, triple-antiretroviral drug regimens during pregnancy and breastfeeding for prevention of mother-to-child transmission of HIV (tARV-PMTCT) (Option B) to include the option to continue lifelong combination antiretroviral therapy (cART) (Option B+). We evaluated clinical and CD4 outcomes in women who had received antiretrovirals for prevention of mother-to-child transmission and then discontinued antiretrovirals 6-months postpartum. METHODS AND FINDINGS: The Kisumu Breastfeeding Study, 2003-2009, was a prospective, non-randomized, open-label clinical trial of tARV-PMTCT in ARV-naive, Kenyan women. Women received tARV-PMTCT from 34 weeks' gestation until 6-months postpartum when women were instructed to discontinue breastfeeding. Women with CD4 count (CD4) <250cells/mm3 or WHO stage III/IV prior to 6-months postpartum continued cART indefinitely. We estimated the change in CD4 after discontinuing tARV-PMTCT and the adjusted relative risk [aRR] for factors associated with declines in maternal CD4. We compared maternal and infant outcomes following weaning-when tARV-PMTCT discontinued-by maternal ARV status through 24-months postpartum. Compared with women who continued cART, discontinuing antiretrovirals was associated with infant HIV transmission and death (10.1% vs. 2.4%; P = 0.03). Among women who discontinued antiretrovirals, CD4<500 cells/mm3 at either initiation (21.8% vs. 1.5%; P = 0.002; aRR: 9.8; 95%-confidence interval [CI]: 2.4-40.6) or discontinuation (36.9% vs. 8.3%; P<0.0001; aRR: 4.4; 95%-CI: 1.9-5.0) were each associated with increased risk of women requiring cART for their own health within 6 months after discontinuing. CONCLUSIONS: Considering the serious health risks to the woman's infant and the brief reprieve from cART gained by stopping, every country should evaluate the need for and feasibility to implement WHO Option B+ for PMTCT. Evaluating CD4 at antiretroviral initiation or 6-months postpartum can identify pregnant women who would most benefit from continuing cART in settings unable to implement WHO Option B+. |
Nelfinavir and its active metabolite, hydroxyl-t-butylamidenelfinavir (M8), are transferred in low quantities to breast milk and do not result in biologically significant concentrations in breast-feeding infants whose mothers are taking nelfinavir
Weidle PJ , Zeh C , Martin A , Lando R , Angira F , Osoga J , Ogindo P , Girde S , Minniear TD , Thomas TK . Antimicrob Agents Chemother 2011 55 (11) 5168-71 Antiretroviral drugs cross from maternal plasma to breast milk and from breast milk to the infant in different concentrations. We measured concentrations of nelfinavir and its active metabolite (M8) in maternal plasma and breast milk from women and in dried blood spots collected from their infants at delivery and postnatal weeks 2, 6, 14, and 24 in the Kisumu Breastfeeding Study, Kisumu, Kenya. Nelfinavir-based antiretroviral regimens given to mothers as PMTCT do not expose the breastfeeding infant to biologically significant concentrations of nelfinavir or M8. |
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