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Impact of peer support on virologic failure in HIV-infected patients on antiretroviral therapy - a cluster randomized controlled trial in Vietnam

Cuong, Do Duy; Sönnerborg, Anders; Van Tam, Vu; El-Khatib, Ziad; Santacatterina, Michele; Marrone, Gaetano; Chuc, Nguyen Thi Kim; Diwan, Vinod; Thorson, Anna; Le, Nicole K; An, Pham Nhat; Larsson, Mattias
BACKGROUND:The effect of peer support on virologic and immunologic treatment outcomes among HIVinfected patients receiving antiretroviral therapy (ART) was assessed in a cluster randomized controlled trial in Vietnam. METHODS:Seventy-one clusters (communes) were randomized in intervention or control, and a total of 640 patients initiating ART were enrolled. The intervention group received peer support with weekly home-visits. Both groups received first-line ART regimens according to the National Treatment Guidelines. Viral load (VL) (ExaVir™ Load) and CD4 counts were analyzed every 6 months. The primary endpoint was virologic failure (VL >1000 copies/ml). Patients were followed up for 24 months. Intention-to-treat analysis was used. Cluster longitudinal and survival analyses were used to study time to virologic failure and CD4 trends. RESULTS:Of 640 patients, 71% were males, mean age 32 years, 83% started with stavudine/lamivudine/nevirapine regimen. After a mean of 20.8 months, 78% completed the study, and the median CD4 increase was 286 cells/μl. Cumulative virologic failure risk was 7.2%. There was no significant difference between intervention and control groups in risk for and time to virologic failure and in CD4 trends. Risk factors for virologic failure were ART-non-naïve status [aHR 6.9;(95% CI 3.2-14.6); p < 0.01]; baseline VL ≥100,000 copies/ml [aHR 2.3;(95% CI 1.2-4.3); p < 0.05] and incomplete adherence (self-reported missing more than one dose during 24 months) [aHR 3.1;(95% CI 1.1-8.9); p < 0.05]. Risk factors associated with slower increase of CD4 counts were: baseline VL ≥100,000 copies/ml [adj.sq.Coeff (95% CI): -0.9 (-1.5;-0.3); p < 0.01] and baseline CD4 count <100 cells/μl [adj.sq.Coeff (95% CI): -5.7 (-6.3;-5.4); p < 0.01]. Having an HIV-infected family member was also significantly associated with gain in CD4 counts [adj.sq.Coeff (95% CI): 1.3 (0.8;1.9); p < 0.01]. CONCLUSION:There was a low virologic failure risk during the first 2 years of ART follow-up in a rural low-income setting in Vietnam. Peer support did not show any impact on virologic and immunologic outcomes after 2 years of follow up. TRIAL REGISTRATION:NCT01433601 .
PMCID:5162085
PMID: 27986077
ISSN: 1471-2334
CID: 5015282

Inferences and conjectures in clinical trials: a systematic review of generalizability of study findings [Letter]

Santacatterina, M; Bottai, M
PMID: 26126506
ISSN: 1365-2796
CID: 5043952

Correlates of mobile phone use in HIV care: Results from a cross-sectional study in South Africa

Madhvani, Naieya; Longinetti, Elisa; Santacatterina, Michele; Forsberg, Birger C; El-Khatib, Ziad
OBJECTIVE:Human Immunodeficiency Virus (HIV) is a major disease burden worldwide. Challenges include retaining patients in care and optimizing adherence to Antiretroviral Therapy (ART). One possible solution is using mobile phones as reminder tools. The main aim of our study was to identify patient demographic groups least likely to use mobile phones as reminder tools in HIV care. DESIGN/METHODS:The data came from a cross-sectional study at the Chris Hani Baragwanath Hospital, Soweto Township, South Africa. METHODS:A comprehensive questionnaire was used to interview 883 HIV infected patients receiving ART. Logistic regression analysis was performed to identify the influence of age, gender, education level, marital status, number of sexual partners in the last three months, income level, and employment status on the use of mobile phone as reminders for clinic appointments and taking medication. RESULTS:Patient groups significantly associated with being less likely to use mobile phones as clinic appointment reminders were: a) patients 45 years or older, b) women, and c) patients with only primary or no schooling level. Patient groups significantly associated with being less likely to use mobile phones as medication reminders were: a) patients 35 years or older and b) patients with a lower monthly income. CONCLUSIONS:In this setting being a woman, of older age, lower education, and socio-economic level were risk factors for the low usage of mobile phones as reminder aids. Future studies should assimilate reasons for this, such that patient-specific barriers to implementation are identified and interventions can be tailored.
PMCID:4721279
PMID: 26844111
ISSN: 2211-3355
CID: 5015272

Gender perspective of risk factors associated with disclosure of HIV status, a cross-sectional study in Soweto, South Africa

Longinetti, Elisa; Santacatterina, Michele; El-Khatib, Ziad
BACKGROUND:Human Immunodeficiency Virus (HIV) status disclosure has been shown to provide several benefits, both at the individual and societal levels. AIM/OBJECTIVE:To determine risk factors associated with disclosing HIV status among antiretroviral therapy (ART) recipients in South Africa. SETTING/METHODS:A cross-sectional study on risk factors for viremia and drug resistance took place at two outpatient HIV clinics in 2008, at a large hospital located in Soweto, South Africa. METHODS:We conducted a secondary data analysis on socio-economic characteristics and HIV status disclosure to anyone, focusing on gender differences. Descriptive and multivariable logistic regression analyses were performed to model the associations between risk factors and HIV status disclosure. Additionally, descriptive analysis was conducted to describe gender differences of HIV status disclosure to partner, parents, parents in law, partner, child, family, employer, and other. PATIENTS/METHODS:A total of 883 patients were interviewed. The majority were women (73%) with median age of 39 years. RESULTS:Employed patients were less likely to disclose than unemployed (odds ratio (OR) 0.36; 95% confidence interval (CI) 0.1-1.0; p = 0.05)). Women with higher income were more likely to disclose (OR 3.25; 95% CI 0.90-11.7; p = 0.07) than women with lower income, while men with higher income were less likely (OR 0.20; 95% CI 0.02-1.99; p = 0.17) than men with lower income. Men were more likely than women to disclose to their partner (p<0.01), and to partner and family (p<0.01), women were more likely than men to disclose to child and family (p<0.01), to child, family and others (p = 0.01). CONCLUSION/CONCLUSIONS:Being employed imposed a risk factor for HIV status disclosure, additionally we found an interaction effect of gender and income on disclosure. Interventions designed to reduce workplace discrimination and gender-sensitive interventions promoting disclosure are strongly recommended.
PMCID:3990640
PMID: 24743189
ISSN: 1932-6203
CID: 5015232

The state-led large scale public private partnership 'Chiranjeevi Program' to increase access to institutional delivery among poor women in Gujarat, India: How has it done? What can we learn?

De Costa, Ayesha; Vora, Kranti S; Ryan, Kayleigh; Sankara Raman, Parvathy; Santacatterina, Michele; Mavalankar, Dileep
BACKGROUND:Many low-middle income countries have focused on improving access to and quality of obstetric care, as part of promoting a facility based intra-partum care strategy to reduce maternal mortality. The state of Gujarat in India, implements a facility based intra-partum care program through its large for-profit private obstetric sector, under a state-led public-private-partnership, the Chiranjeevi Yojana (CY), under which the state pays accredited private obstetricians to perform deliveries for poor/tribal women. We examine CY performance, its contribution to overall trends in institutional deliveries in Gujarat over the last decade and its effect on private and public sector deliveries there. METHODS:District level institutional delivery data (public, private, CY), national surveys, poverty estimates, census data were used. Institutional delivery trends in Gujarat 2000-2010 are presented; including contributions of different sectors and CY. Piece-wise regression was used to study the influence of the CY program on public and private sector institutional delivery. RESULTS:Institutional delivery rose from 40.7% (2001) to 89.3% (2010), driven by sharp increases in private sector deliveries. Public sector and CY contributed 25-29% and 13-16% respectively of all deliveries each year. In 2007, 860 of 2000 private obstetricians participated in CY. Since 2007, >600,000 CY deliveries occurred i.e. one-third of births in the target population. Caesareans under CY were 6%, higher than the 2% reported among poor women by the DLHS survey just before CY. CY did not influence the already rising proportion of private sector deliveries in Gujarat. CONCLUSION/CONCLUSIONS:This paper reports a state-led, fully state-funded, large-scale public-private partnership to improve poor women's access to institutional delivery - there have been >600,000 beneficiaries. While caesarean proportions are higher under CY than before, it is uncertain if all beneficiaries who require sections receive these. Other issues to explore include quality of care, provider attrition and the relatively low coverage.
PMCID:4006779
PMID: 24787692
ISSN: 1932-6203
CID: 5015242

Temporal trends in the Swedish HIV-1 epidemic: increase in non-B subtypes and recombinant forms over three decades

Neogi, Ujjwal; Häggblom, Amanda; Santacatterina, Michele; Bratt, Göran; Gisslén, Magnus; Albert, Jan; Sonnerborg, Anders
BACKGROUND:HIV-1 subtype B (HIV-1B) still dominates in resource-rich countries but increased migration contributes to changes in the global subtype distribution. Also, spread of non-B subtypes within such countries occurs. The trend of the subtype distribution from the beginning of the epidemic in the country has earlier not been reported in detail. Thus the primary objective of this study is to describe the temporal trend of the subtype distribution from the beginning of the HIV-1 epidemic in Sweden over three decades. METHODS:HIV-1 pol sequences from patients (n = 3967) diagnosed in Sweden 1983-2012, corresponding to >40% of patients ever diagnosed, were re-subtyped using several automated bioinformatics tools. The temporal trends of subtypes and recombinants during three decades were described by a multinomial logistic regression model. RESULTS:All eleven group M HIV-1 subtypes and sub-subtypes (78%), 17 circulating recombinant forms (CRFs) (19%) and 32 unique recombinants forms (URF) (3%) were identified. When all patients were analysed, there was an increase of newly diagnosed HIV-1C (RR, 95%CI: 1.10, 1.06-1.14), recombinants (1.20, 1.17-1.24) and other pure subtypes (1.11, 1.07-1.16) over time compared to HIV-1B. The same pattern was found when all patients infected in Sweden (n = 1165) were analysed. Also, for MSM patients infected in Sweden (n = 921), recombinant forms and other pure subtypes increased. SIGNIFICANCE/CONCLUSIONS:Sweden exhibits one of the most diverse subtype epidemics outside Africa. The increase of non-B subtypes is due to migration and to a spread among heterosexually infected patients and MSM within the country. This viral heterogeneity may become a hotspot for development of more diverse and complex recombinant forms if the epidemics converge.
PMCID:4055746
PMID: 24922326
ISSN: 1932-6203
CID: 5015252

Antibiotic prescribing in women during and after delivery in a non-teaching, tertiary care hospital in Ujjain, India: a prospective cross-sectional study

Sharma, Megha; Sanneving, Linda; Mahadik, Kalpana; Santacatterina, Michele; Dhaneria, Suryaprakash; Stålsby Lundborg, Cecilia
OBJECTIVES/OBJECTIVE:Antibacterial drugs (hereafter referred to as antibiotics) are crucial to treat infections during delivery and postpartum period to reduce maternal mortality. Institutional deliveries have the potential to save lives of many women but extensive use of antibiotics, add to the development and spread of antibiotic resistance. The aim of this study was to present antibiotic prescribing among inpatients during and after delivery in a non-teaching, tertiary care hospital in the city of Ujjain, Madhya Pradesh, India. METHODS:A prospective cross-sectional study was conducted including women having had either a vaginal delivery or a cesarean section in the hospital. Trained nursing staff collected the data on daily bases, using a specific form attached to each patient file. Statistical analysis, including bivariate and multivariable logistic regression was conducted. RESULTS:Of the total 1077 women, 566 (53%) had a vaginal delivery and 511 (47%) had a cesarean section. Eighty-seven percent of the women that had a vaginal delivery and 98% of the women having a cesarean section were prescribed antibiotics. The mean number of days on antibiotics in hospital for the women with a vaginal delivery was 3.1 (±1.7) and for the women with cesarean section was 6.0 (±2.5). Twenty-eight percent of both the women with vaginal deliveries and the women with cesarean sections were prescribed antibiotics at discharge. The most commonly prescribed antibiotic group in the hospital for both the women that had a vaginal delivery and the women that had a cesarean section were third-generation cephalosporins (J01DD). The total number of defined daily doses (DDD) per100 bed days for women that had a vaginal delivery was 101, and 127 for women that had a cesarean section. CONCLUSIONS:The high percentage of women having had a vaginal delivery that received antibiotics and the deviation from recommendation for cesarean section in the hospital is a cause of concern. Improved maternal health and rational use of antibiotics are intertwined. Specific policy and guidelines on how to prescribe antibiotics during delivery at health care facilities are needed. Additionally, monitoring system of antibiotic prescribing and resistance needs to be developed and implemented.
PMCID:4366931
PMID: 25848538
ISSN: 2052-3211
CID: 5015262