Browsing by Author "Glenn Fowler, Mary"
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Item Distribution of haematological and chemical pathology values among infants in Malawi and Uganda(Paediatrics and international child health, 2012) Kumwenda, Newton I.; Khonje, Tiwonge; Mipando, Linda; Nkanaunena, Kondwani; Katundu, Pauline; Lubega, Irene; Bolton, Steve; Bagenda, Danstan; Mubiru, Michael; Glenn Fowler, Mary; Taha, Taha E.; Ali, ElbireerData on paediatric reference laboratory values are limited for sub-Saharan Africa. Objective: To describe the distribution of haematological and chemical pathology values among healthy infants from Malawi and Uganda. Methods: A cross-sectional study was conducted among healthy infants, 0–6 months old, born to HIVuninfected mothers recruited from two settings in Blantyre, Malawi and Kampala, Uganda. Chemical pathology and haematology parameters were determined using standard methods on blood samples. Descriptive analyses by age-group were performed based on 2004 Division of AIDS Toxicity Table age categories. Mean values and interquartile ranges were compared by site and age-group. Results: A total of 541 infants were included altogether, 294 from Malawi and 247 from Uganda. Overall, the mean laboratory values were comparable between the two sites. Mean alkaline phosphatase levels were lower among infants aged (21 days while aspartate aminotransferase, creatinine, total bilirubin and gamma-glutamyl transferase were higher in those aged 0–7 days than in older infants. Mean haematocrit, haemoglobin and neutrophil counts were higher in the younger age-groups (,35 days) and overall were lower than US norms. Red and white blood cell counts tended to decrease after birth but increased after y2 months of age. Mean basophil counts were higher in Malawi than in Uganda in infants aged 0–1 and 2– 7 days; mean counts for eosinophils (for age groups 8–21 or older) and platelets (for all age groups) were higher in Ugandan than in Malawian infants. Absolute lymphocyte counts increased with infant age. Conclusion: The chemical pathology and haematological values in healthy infants born to HIV-uninfected mothers were comparable in Malawi and Uganda and can serve as useful reference values in these settings.Item Feasibility and Safety of ALVAC-HIV vCP1521 Vaccine in HIVexposed Infants in Uganda: Results from the First HIV Vaccine Trial in Infants in Africa(Journal of acquired immune deficiency syndromes, 2013) Kintu, Kenneth Guay; Andrew, Philip; Musoke, Philippa; Richardson, Paul; Asiimwe- Kateera, Brenda; Nakyanzi, Teopista; Wang, Lei; Glenn Fowler, Mary; Emel, Lynda; Ou, San-San; Baglyos, Lynn; Gurunathan, Sanjay; Zwerski, Sheryl; Jackson, J. Brooks; Guay, LauraThe development of a safe and effective vaccine against human immunodeficiency virus type 1 (HIV-1) for prevention mother-to-child transmission of HIV would significantly advance the goal of eliminating HIV infection in children. Safety and feasibility results from Phase I, randomized, double blind, placebo-controlled trial of ALVACHIV vCP1521 in infants born to HIV-1-infected women in Uganda are reported. Methods—HIV exposed infants were enrolled at birth and randomized (4:1) to receive vaccine or saline placebo intramuscular injections at birth, 4, 8 and 12 weeks of age. Vaccine reactogenicity was assessed at vaccination, and days 1 and 2 post-vaccination. Infants were followed until 24 months of age. HIV infection status was determined by HIV DNA PCR. Findings—From October 2006 to May 2007, 60 infants (48 vaccine, 12 placebo) were enrolled with 98% retention at 24 months. One infant was withdrawn, but there were no missed visits or vaccinations among the 59 infants retained. Immune responses elicited by Diptheria, Polio, Hepatitis B and Heamophilus influenzae type B and measles vaccination were similar in the two arms. The vaccine was well tolerated with no severe or life-threatening reactogenicity events. Adverse events were equally distributed across both study arms. Four infants were diagnosed as HIV infected [3 at birth (2 vaccine, 1 placebo) and one in vaccine arm at 2 weeks of age]. Interpretation—The ALVAC-HIV vCP1521 vaccination was feasible and safe in infants born to HIV-infected women in Uganda. The conduct of high quality infant HIV vaccine trials is achievable in Africa.Item Greater involvement of HIV-infected peer-mothers in provision of reproductive health services as “family planning champions” increases referrals and uptake of family planning among HIV-infected mothers(BMC health services research, 2017) Mudiope, Peter; Musingye, Ezra; Onyango Makumbi, Carolyne; Bagenda, Danstan; Homsy, Jaco; Nakitende, Mai; Mubiru, Mike; Barlow Mosha, Linda; Kagawa, Mike; Namukwaya, Zikulah; Glenn Fowler, MaryIn 2012, Makerere University Johns - Hopkins University, and Mulago National Referral Hospital, with support from the National Institute of Health (under Grant number: NOT AI-01-023) undertook operational research at Mulago National Hospital PMTCT/PNC clinics. The study employed Peer Family Planning Champions to offer health education, counselling, and triage aimed at increasing the identification, referral and family planning (FP) uptake among HIV positive mothers attending the clinic. Methods: The Peer Champion Intervention to improve FP uptake was introduced into Mulago Hospital PMTCT/PNC clinic, Kampala Uganda. During the intervention period, peers provided additional FP counselling and education; assisted in identification and referral of HIV Positive mothers in need of FP services; and accompanied referred mothers to FP clinics. We compiled and compared the average proportions of mothers in need that were referred and took up FP in the pre-intervention (3 months), intervention (6 months), and post-intervention(3 months) periods using interrupted time series with segmented regression models with an autoregressive term of one. Results: Overall, during the intervention, the proportion of referred mothers in need of FP increased by 30.4 percentage points (P < 0.001), from 52.7 to 83.2 percentage points. FP uptake among mothers in need increased by over 31 percentage points (P < 0.001) from 47.2 to 78.5 percentage points during the intervention. There was a positive non-significant change in the weekly trend of referral β3 = 2.9 percentage points (P = 0.077) and uptake β3 = 1.9 percentage points (P = 0.176) during the intervention as compared to the pre-intervention but this was reversed during the post intervention. Over 57% (2494) mothers took up Depo-Provera injectable-FP method during the study. Conclusions: To support overstrained health care work force in post-natal clinics, peers in trained effective family planning can be a valuable addition to clinic staff in limited-resource settings. The study provides additional evidence on the utilization of peer mothers in HIV care, improves health services uptake including family planning which is a common practice in many donor supported programs. It also provides evidence that may be used to advocate for policy revisions in low-income countries to include peers as support staff especially in busy clinic settings with poor services uptake.Item Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow-up of the HIVNET 012 randomised trial(The Lancet, 2003) Jackson, J. Brooks; Musoke, Philippa; Fleming, Thomas; Guay, Laura A.; Bagenda, Danstan; Allen, Melissa; Nakabiito, Clemensia; Sherman, Joseph; Bakaki, Paul; Owor, Maxensia; Ducar, Constance; Deseyve, Martina; Mwatha, Anthony; Emel, Lynda; Duefield, Corey; Mirochnick, Mark; Glenn Fowler, Mary; Mofenson, Lynne; Miotti, Paolo; Gigliotti, Maria; Bray, Dorothy; Mmiro, FrancisIn 1999, we reported safety and efficacy data for short-course nevirapine from a Ugandan perinatal HIV-1 prevention trial when 496 babies were followed up to age 14–16 weeks. Safety and efficacy data are now presented for all babies followed up to 18 months of age. Methods From November, 1997, to April, 1999, HIV-1 infected pregnant women in Kampala, Uganda, were randomly assigned nevirapine (200 mg at labour onset and 2 mg/kg for babies within 72 h of birth; regimen A) or zidovudine (600 mg orally at labour onset and 300 mg every 3 h until delivery, and 4 mg/kg orally twice daily for babies for 7 days, regimen B). Infant HIV-1 testing was done at birth, age 6–8 and 14–16 weeks, and age 12 months by HIV-1 RNA PCR, and by HIV-1 antibody at 18 months. HIV-1 transmission and HIV-1-free survival were assessed using Kaplan-Meier analysis. We recorded adverse experiences through 6–8 weeks postpartum for mothers, and 18 months for babies. Efficacy analyses were by intention to treat. Findings We enrolled 645 mothers to the study: 313 were assigned regimen A, 313 regimen B, and 19 placebo. Eight mothers were lost to follow-up before delivery. 99% of babies were breastfed (median duration 9 months). Estimated risks of HIV-1 transmission in the zidovudine and nevirapine groups were 10·3% and 8·1% at birth (p=0·35); 20·0% and 11·8% by age 6–8 weeks (p=0·0063); 22·1% and 13·5% by age 14–16 weeks (p=0·0064); and 25·8% and 15·7% by age 18 months (p=0·0023). Nevirapine was associated with a 41% (95% CI 16–59) reduction in relative risk of transmission through to age 18 months. Both regimens were well-tolerated with few serious side-effects. Interpretation Intrapartum/neonatal nevirapine significantly lowered HIV-1 transmission risk in a breastfeeding population in Uganda compared with a short intrapartum/neonatal zidovudine regimen. The absolute 8·2% reduction in transmission at 6–8 weeks was sustained at age 18 months (10·1% [95% CI 3·5–16·6]). This simple, inexpensive, welltolerated regimen has the potential to significantly decrease HIV-1 perinatal transmission in less-developed countries.Item Kinetics of Nevirapine and Its Impact on HIV-1 RNA Levels in Maternal Plasma and Breast Milk Over Time After Perinatal Single-Dose Nevirapine(JAIDS Journal of Acquired Immune Deficiency Syndromes, 2012) Aizire, Jim; McConnell, Michelle S.; Mudiope, Peter; Mubiru, Michael; Matovu, Flavia; Parsons, Teresa L.; Elbireer, Ali ,; Nolan, Monica; Janoff, Edward N.; Glenn Fowler, MaryTo determine kinetics after single-dose nevirapine and the impact on HIV RNA [viral load (VL)] in maternal plasma and breast milk (BM). Methods: Cohort of 120 HIV-1–infected pregnant Ugandan women received perinatal single-dose nevirapine alone and followed up with their infants through 24 weeks postdelivery. We assessed the relationship of nevirapine concentration (tandem mass spectroscopy) and HIV-1 VL (Roche AMPLICOR HIV-1 Kit, version 1.5) in maternal plasma and BM over time. Results: At week 1 postpartum, NVP ($10 ng/mL) was detected in all 53 plasma and 47 of 51 (92.2%) BM samples with median (inter- quartile ranges) of, respectively, 171 (78–214) ng/mL and 112 (64–158) ng/mL, P = 0.075, which decreased subsequently with traces persisting through week 4 in plasma. Plasma and BM VL dropped by week 1 and were highly correlated at delivery (R = 0.71, P , 0.001) and week 1 (R = 0.69, P , 0.001) but not thereafter. At week 1, VL correlated inversely with NVP concentra- tion in plasma (R = 0.39, P = 0.004) and BM (R = 0.48, P = 0.013). There was a VL rebound in both compartments, which peaked at week 4 to levels greater than those at week 1 [significantly in plasma (P , 0.001) but not in BM] and remained stable thereafter. Median VL was consistently greater (11- to 50-fold) in plasma than BM at all time points (all P , 0.001). Conclusions: After single-dose nevirapine, NVP concentration was comparably high through week 1, accompanied by suppression of plasma and BM VL. A longer “tail” (.1 week) of potent postnatal antiretroviral drugs is warranted to minimize the observed VL rebound and potential for NVP resistance as a result of persistent NVP tracesItem Maternal Human Immunodeficiency Virus (HIV) Drug Resistance Is Associated With Vertical Transmission and Is Prevalent in Infected Infants(Clinical Infectious Diseases, 2021) Boyce, Ceejay L.; Sils, Tatiana; Ko, Daisy; Wong-on-Wing, Annie; Beck, Ingrid A.; Styrchak, Sheila M.; DeMarrais, Patricia; Tierney, Camlin; Stranix-Chibanda, Lynda; Flynn, Patricia M.; Taha, Taha E.; Owor, Maxensia; Glenn Fowler, Mary; Frenkel, Lisa M.We aimed to assess if maternal human immunodeficiency virus (HIV) drug resistance is associated with an increased risk of HIV vertical transmission and to describe the dynamics of drug resistance in HIV-infected infants. Methods. This was a case-control study of PROMISE study participants. “Cases” were mother-infant pairs with HIV vertical transmission during pregnancy or breastfeeding and “controls” were mother-infant pairs without transmission matched 1:3 by delivery date and clinical site. Genotypic HIV drug resistance analyses were performed on mothers’ and their infants’ plasma at or near the time of infant HIV diagnosis. Longitudinal analysis of genotypic resistance was assessed in available specimens from infants, from diagnosis and beyond, including antiretroviral therapy (ART) initiation and last study visits. Results. Our analyses included 85 cases and 255 matched controls. Maternal HIV drug resistance, adjusted for plasma HIV RNA load at infant HIV diagnosis, enrollment CD4 count, and antepartum regimens, was not associated with in utero/peripartum HIV transmission. In contrast, both maternal plasma HIV RNA load and HIV drug resistance were independent risk factors associated with vertical transmission during breastfeeding. Furthermore, HIV drug resistance was selected across infected infants during infancy. Conclusions. Maternal HIV drug resistance and maternal viral load were independent risk factors for vertical transmission during breastfeeding, suggesting that nevirapine alone may be insufficient infant prophylaxis against drug-resistant variants in maternal breast milk. These findings support efforts to achieve suppression of HIV replication during pregnancy and suggest that breastfeeding infants may benefit from prophylaxis with a greater barrier to drug resistance than nevirapine alone.Item PMTCT Option B+ 2012 to 2018 — Taking stock: barriers and strategies to improve adherence to Option B+ in urban and rural Uganda(NISC (Pty) Ltd, 2020) King, Rachel; Namale Matovu, Joyce; Rujumba, Joseph; Wavamunno, Priscilla; Musoke, Philippa; Seeley, Janet,; Amone, Alexander; Gabagaya, Grace; Glenn Fowler, Mary; Homsy, JacoSince 2012, PMTCT Option B+ has been recommended by the World Health Organization to reduce vertical transmission but numerous adherence challenges remain. We conducted a qualitative study at baseline using six focus group discussions and 14 in-depth interviews to explore knowledge, beliefs, attitudes and challenges towards the Option B+ strategy for PMTCT among HIV-infected pregnant and post-partum women and health workers engaged in Uganda’s national Option B+ PMTCT programme. Data were analysed using a thematic approach to capture latent and manifest content with the social ecological model as a theoretic foundation in order to make contextual sense of key stakeholders’ needs for an effective Option B+ intervention. Overall, among all study participants, we found multi-level barriers to adhering to Option B+ cutting across all levels of the social ecological model. In line with the model, our study revealed barriers at personal, relational, organizational and societal levels. Some personal beliefs such as that the baby’s health is more important that the mother’s, organizational (negative attitudes and behaviour of health workers), structural such as poverty, work conflicts, fear and lack of disclosure related to community stigma were all critical obstacles to women adhering to the Option B+ programme. We found that both health workers and participants in the programme have a relatively clear understanding of the benefits of adhering to their treatment; though a more nuanced understanding and thus emphasis in counselling on side effects, is critical to helping patients adhere.Item Pregnancy outcomes of women conceiving on antiretroviral therapy (ART) compared to those commenced on ART during pregnancy.(Clinical Infectious Diseases, 2021) Theron, Gerhard; Brummel, Sean; Fairlie, Lee; Pinilla, Mauricio; McCarthy, Katie; Owor, Maxensia; Chinula, Lameck; Makanani, Bonus; Violari, Avy; Moodley, Dhayendre; Chakhtoura, Nahida; Browning, Renee; Hoffman, Risa; Glenn Fowler, MaryGlobally, the number of HIV-infected women of child-bearing age conceiving on ART is increasing. Evidence of ART safety at conception and during pregnancy and adverse pregnancy outcomes remains conflicting. The PROMISE 1077 breastfeeding (BF) and formula feeding (FF) international multisite trials provide an opportunity to examine the impact of ART at conception on pregnancy outcomes with subsequent pregnancies. Methods The PROMISE 1077BF/1077FF trials were designed to address key questions in the management of HIV-infected women who did not meet clinical guidelines for ART treatment during the time of the trials. After the period of risk of mother-to-child transmission was over, women were randomized to either continue or discontinue ART. We compared subsequent pregnancy outcomes of non-breastfeeding women randomized to continue ART following delivery, or breastfeeding women randomized to continue ART following breastfeeding cessation who conceived while on ART to women randomized to discontinue ART, who re-started ART after pregnancy was diagnosed. Results Pregnancy outcomes of 939 subsequent pregnancies of 826 mothers were recorded. The intention-to-treat analyses showed increased incidence of low birth weight (<2500gm) for women who conceived while on ART {relative risk 2.65 (95% CI 1.20, 5.81)}, and also a higher risk of spontaneous abortion, stillbirth, or neonatal death {hazard ratio 1.40 (0.99, 1.98)} compared to women who re-started ART after they were found to be pregnant during trial follow up. Downloaded from https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciaa805/5860458 by guest on 22 June 2020 Accepted Manuscript Conclusions We found an increased risk for adverse pregnancy outcomes in women conceiving on ART emphasising the need for improved obstetric and neonatal care for this group.Item Prevalence of undetectable and suppressed viral load in HIV‑infected pregnant women initiating Option B+ in Uganda: an observational study nested within a randomized controlled trial(Springer Nature, 2021) Gabagaya, Grace; Rukundo, Gordon; Amone, Alexander; Wavamunno, Priscilla; Namale‑Matovu, Joyce; Lubega, Irene; Nakabiito, Clemensia; Namukwaya, Zikulah; Nolan, Monica; Malamba, Samuel S.; King, Rachel; Homsy, Jaco ,; Glenn Fowler, Mary; Musoke, PhilippaViral load (VL) testing is key in monitoring adherence to antiretroviral therapy (ART) and documenting HIV treatment response. As per HIV treatment guidelines in Uganda, the first VL test is recommended 6 months after initiation of ART. Undetectable VL (uVL) at ART initiation may be helpful in detecting elite controllers in the absence of previous ART use. We investigated viral suppression at ART initiation among a cohort of HIV-positive pregnant women enrolled in the Friends for Life Circles (FLC) for Option B+ randomized controlled trial (RCT). Methods: Pregnant women ≥ 18 years of age testing positive for HIV at their first antenatal care visit and starting on ART Option B+ as per the National PMTCT Program guidelines were enrolled into the FLC for Option B+ RCT in urban Kampala and rural Mityana districts of Uganda. Each participant had whole blood samples collected at enrolment to assess baseline VL. Plasma HIV-1 RNA was quantified using COBAS Ampliprep /COBAS Taqman. Baseline VL below 400 RNA copies/ml was considered as viral suppression while baseline VL below 20 RNA copies/ml was considered uVL. Results: The mean duration from the date of ART initiation to time of sample collection for baseline VL assessment was 4.4 days (SD 3.6). Of the 532 HIV-positive pregnant women enrolled in the FLC for Option B+ study and newly starting Option B+ without a self-reported history of prior ART use, 29 (5.5%) had uVL and 113 (21.4%) had suppressed VL at baseline. There was no association between participants’ age, gravidity, marital status, mean monthly income, educational level, disclosure of HIV status to partner, and uVL or viral suppression at baseline. However, nondisclosure of HIV status to any other person was associated with decreased odds of viral suppression at baseline (OR 0.640; 0.416–0.982). Conclusion: Twenty-one percent of HIV-positive Ugandan pregnant women initiating ART (Option B+) showed virological suppression at baseline and were presumed to be “elite controllers” or to have misreported being ART-naive.Item Prevention of HIV-1 transmission through breastfeeding: Efficacy and safety of maternal antiretroviral therapy versus infant nevirapine prophylaxis for duration of breastfeeding in HIV-1-infected women with high CD4 cell count (IMPAACT PROMISE): a randomized, open label, clinical trial(Journal of acquired immune deficiency syndromes, 2018) Flynn, Patricia M.; Taha, Taha E.; Cababasay, Mae; Glenn Fowler, Mary; Mofenson, Lynne M.; Owor, Maxensia; Fiscus, Susan; Stranix-Chibanda, Lynda; Coutsoudis, Anna; Gnanashanmugam, Devasena; Chakhtoura, Nahida; McCarthy, Katie; Mukuzunga, Cornelius; Makanani, Bonus; Moodley, Dhayendre; Nematadzira, Teacler; Kusakara, Bangini; Patil, Sandesh; Vhembo, Tichaona; Bobat, Raziya; Mmbaga, Blandina T.; Masenya, Maysseb; Nyati, Mandisa; Theron, Gerhard; Mulenga, Helen; Butler, Kevin; Shapiro, David E.No randomized trial has directly compared the efficacy of prolonged infant antiretroviral prophylaxis versus maternal antiretroviral therapy (mART) for prevention of mother-to-child transmission throughout the breastfeeding period. Setting—Fourteen sites in sub-Saharan Africa and India. Methods—A randomized, open label strategy trial was conducted in HIV-1-infected women with CD4 counts ≥350 cells/mm3 (or ≥country-specific ART threshold if higher) and their breastfeeding HIV-1-uninfected newborns. Randomization at 6-14 days postpartum was to mART or infant nevirapine prophylaxis (iNVP) continued until 18 months post-delivery or breastfeeding cessation, infant HIV-1 infection, or toxicity, whichever occurred first. The primary efficacy outcome was confirmed infant HIV-1 infection. Efficacy analyses included all randomized mother-infant pairs except those with infant HIV-1 infection at entry. Results—Between June 2011-October 2014, 2431 mother-infant pairs were enrolled; 97% of women were WHO Clinical Stage I, median screening CD4 count 686 cells/mm3. Median infant gestational age/birthweight were 39 weeks/2.9 kilograms. Seven of 1219 (0.57%) and seven of 1211 (0.58%) analyzed infants in the mART and iNVP arms, respectively, were HIV-infected (hazard ratio [HR] 1.0, 96% repeated confidence interval 0.3-3.1); infant HIV-free survival was high (97.1%, mART and 97.7%, iNVP, at 24 months). There were no significant differences between arms in median time to breastfeeding cessation (16 months) or incidence of severe, life-threatening or fatal adverse events for mothers or infants (14 and 42 per 100 person-years, respectively). Conclusion—Both mART and iNVP prophylaxis strategies were safe and associated with very low breastfeeding HIV-1 transmission and high infant HIV-1-free survival at 24 months.Item Risk Factors for Adverse Birth Outcomes in the PROMISE 1077BF/1077FF Trial(Journal of acquired immune deficiency syndromes, 2019) Sebikari, Dorothy; Farhad, Mona; Fenton, Terry; Owor, Maxensia; Stringer, Jeffrey S. A.; Qin, Min; Chakhtoura, Nahida; Chi, Benjamin H.; Saidi, Friday; Nevrekar, Neetal; Violari, Avy; Chipato, Tsungai; McIntyre, James A.; Moodley, Dhayendre; Taha, Taha E.; Theron, Gerhard; Glenn Fowler, MaryIn the multi-country PROMISE 1077BF trial, the risk of low birth weight (LBW; <2500g) and preterm delivery (PTD; <37 weeks) was higher among women initiating a protease inhibitor (PI)-based antiretroviral treatment (ART) regimen than in those receiving ZDV alone. Among those assigned to a PI regimen, tenofovir/emtricitibine was associated with the more severe outcomes of very LBW (VLBW; <1500g) and very PTD (VPTD; <34 weeks) compared to zidovudine/lamivudine. Methods: We used multivariate logistic regression to further explore treatment findings, taking into account demographic baseline clinical and post-entry obstetrical factors. We evaluated individual adverse outcomes and composites that included stillbirth and early loss/spontaneous abortion. Results: Among 3333 women delivering at least one live infant, median maternal age at enrollment was 26 years; 661 (20%) were primiparous, and 110 (3.3%) reported at least one prior PTD. Seventeen percent of newborns were LBW, 1% were VLBW, 17% had PTD, and 3% VPTD. Treatment allocation remained strongly associated with multiple adverse outcomes after controlling for other risk factors with both ART regimens exhibiting increased risk relative to ZDV alone. Other risk factors remaining significant in at least one of the multivariate models included: country, gestational age at entry, maternal age, maternal BMI, prior PTD, history of alcohol use, baseline HIV viral titer, multiple gestation and several obstetric risk factors. Conclusion: ART effects on adverse pregnancy outcomes reported in the randomized PROMISE trial remained strongly significant even after controlling for demographic, baseline clinical and obstetrical risk factors, which were also associated with these outcomes.Item Tenofovir concentrations in hair strongly predict virologic suppression in breastfeeding women(AIDS (London, England), 2019) Murnane, Pamela M.; Bacchetti, Peter; Currier, Judith S.; Brummel, Sean; Okochi, Hideaki; Phung, Nhi; Louie, Alexander; Kuncze, Karen; Hoffman, Risa M.; Nematadzira, Teacler; Soko, Dean K.; Owor, Maxensia; Saidi, Friday; Flynn, Patricia M.; Glenn Fowler, Mary; Gandhi, MonicaAntiretroviral treatment (ART) adherence is often suboptimal in the perinatal period. We measured hair tenofovir (TFV) concentrations as a metric of adherence in postpartum women to understand patterns and predictors of adherence throughout this critical period. Additionally, we examined the association between hair TFV concentrations and virologic outcomes. Methods: Between 12/2012–09/2016, hair samples were collected longitudinally from delivery through breastfeeding from women on ART in the PROMISE study (NCT01061151) in sub-Saharan Africa. Hair TFV levels were measured using validated methods. Using generalized estimating equations, we estimated the association between hair TFV levels and virologic suppression (<400 copies/mL) over time and assessed predictors of hair TFV levels. Results: Hair TFV levels were measured at 370 visits in 71 women from delivery through a median of 14 months (IQR 12–15) of breastfeeding. Levels ranged from below detection (0.002) to 1.067 nanograms/milligram (geometric mean: 0.047). After ≥90 days on ART, 69 women had at least one viral load measured (median 5 measures, range 1–9); 18 (26%) experienced viremia at least once. Each doubling of TFV level more than doubled odds of concurrent virologic suppression (OR 2.35, 95%CI: 1.44–3.84, p=0.0006) and was associated with 1.43 times the odds of future suppression (95%CI: 0.75–2.73, p=0.28). Relative to the first 3 months after delivery, hair levels were highest in months 6–12 (1.42 fold higher, 95%CI: 1.09–1.85, p=0.01). Conclusion: Hair TFV levels strongly predicted concurrent virologic suppression among breastfeeding women. Objective adherence metrics can supplement virologic monitoring to optimize treatment outcomes in this important transition period.Item Total Lymphocyte Count: not a surrogate marker for risk of death in HIV infected Ugandan children(Journal of acquired immune deficiency syndromes, 2008) Musoke, Philippa M.; Young, Alicia M.; Owor, Maxensia A.; Lubega, Irene R.; Brown, Elizabeth R.; Mmiro, Francis A.; Mofenson, Lynne M.; Jackson, J. Brooks; Glenn Fowler, Mary; Guay, Laura A.To determine the utility of Total Lymphocyte Count (TLC) in predicting the 12 month mortality in HIV infected Ugandan children; to correlate TLC and CD4 cell %. Design—This is a retrospective data analysis of clinical and laboratory data collected prospectively on 128 HIV infected children in the HIVNET 012 trial. Methods—TLC and CD4 cell % measurements were obtained at birth, 14 weeks and 12, 24, 36, 48, and 60 months of age and assessed with respect to risk of death within 12 months. Results—Median TLC/ul (CD4 cell %) were 4150 (41%) at birth, 4900 (24%) at 12 months, 4300 (19%) at 24 months, 4150 (19 %) at 36 months, 4100 (18%) at 48 months and 3800 (20%) at 60 months. The highest risk of mortality within 12 months was 34–37% at birth and declined to 13– 15% at 24 months regardless of TLC measurement. The correlation between CD4 cell % and TLC was extremely low overall (r = 0.01). Conclusion—The TLC did not predict a risk of progression to death within 12 months and therefore TLC alone may not be a useful surrogate marker for determining those children in greatest need for antiretroviral therapy in HIV infected Ugandan children.