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Barua P.,Regional Medical Research Center | Mahanta J.,Regional Medical Research Center | Medhi G.K.,Regional Medical Research Center | Dale J.,National AIDS Research Institute NARI | And 2 more authors.
Indian Journal of Medical Research, Supplement | Year: 2012

Background & objectives: Female sex workers (FSWs) of north-east India form a unique group as they are exposed to an enormous injecting drug user (IDU) clientele. This association makes them more vulnerable to blood borne viral infections. Over and above some of them also indulge in drug injecting practices along with their partners. The present study was carried out on FSWs to assess the prevalence of hepatitis C virus (HCV) infection and possibility of sexual transmission of HCV and associated risk factors among them. Methods: A sample of 426 FSWs was recruited cross-sectionally using respondent driven sampling methods. Univariate and multivariate logistic regression analysis was carried out to determine the factors associated with HCV infection. Results: The seroprevalence of HCV among 426 FSWs was 9.6 per cent, antibody to HIV was present in 13.4 per cent, 4.9 per cent were co-infected with HIV and HCV. Seroprevalence of HCV among participants without history of injecting drugs use, tattooing or blood transfusion was 7.5 per cent. An increased risk of HCV seropositivity was associated with history of injecting drug use (OR 10.41, CI 4.30-25.22), use of oral drugs (OR 4.7, CI 2.4-9.08), having sexual partners who were injecting drug users (OR 2.9, CI 1.5-5.6), having live-in relationship (OR 7.1, CI 1.59-31.52), HIV seropositivity (OR 10.18, CI 5.05-20.54) and HSV-2 seropositivity (OR 2.86, CI 1.45-5.43) in univariate analysis. In the multivariate analysis, history of injecting drug use, HIV and HSV-2 seropositivity were found to be significantly associated with HCV seropositivity. Interpretation & conclusion: Although acquisition of HCV by sexual route may not be as efficient as parenteral route, yet sexual transmissibility of HCV among FSWs poses high risk to the community.

Nhama A.,National Institute of Health INS | Bassat Q.,Barcelona Center for International Health Research | Enosse S.,National Institute of Health INS | Mutemba R.,National Malaria Control Programme NMCP | And 11 more authors.
Malaria Journal | Year: 2014

Background: Mozambique adopted artemisinin-based combination therapy (ACT) for the treatment of uncomplicated Plasmodium falciparum malaria in the year 2006, and since 2009 artemether-lumefantrine (AL) and artesunate-amodiaquine (ASAQ) have been proposed as alternative first-line treatments. A multicentre study was conducted in five sites across the country to assess the in vivo efficacy and tolerability of these two drugs. Methods. Children aged six to 59 months with uncomplicated malaria were recruited between June 2011 and January 2012 in five sites across Mozambique (Montepuez, Dondo, Tete, Chokwe, and Manhiça), and treated with AL or ASAQ in a non-randomized study. Follow-up was organized following standard WHO recommendations for in vivo studies, and included daily visits during the three-day-long supervised treatment course, followed by weekly visits up to day 28. The study primary outcome was the day 28 PCR-corrected early treatment failure (ETF), late clinical failure (LCF), late parasitological failure (LPF), and adequate clinical and parasitological response (ACPR). PCR was performed centrally for all cases of recurrent parasitaemia from day 7 onwards to distinguish recrudescence from re-infection. Results: Four-hundred and thirty-nine (AL cohort; five sites) and 261 (ASAQ cohort, three sites) children were recruited to the study. Day 28 PCR-corrected efficacy for AL was 96.0% (335/339; 95% CI: 93.4-97.8), while for ASAQ it was 99.6% (232/233; 95% CI: 97.6-99.9). The majority of recurring parasitaemia cases throughout follow-up were shown to be re-infections by PCR. Both drugs were well tolerated, with the most frequent adverse event being vomiting (AL 4.5% [20/439]; ASAQ 9.6% [25/261]) and no significant events deemed related to the study drugs. Conclusion: This study confirms that both AL and ASAQ remain highly efficacious and well tolerated for the treatment of uncomplicated malaria in Mozambican children. Studies such as these should be replicated regularly in the selected surveillance sentinel sites to continuously monitor the efficacy of these drugs and to rapidly detect any potential signs of declining efficacy to ACT, the mainstay of malaria treatment. © 2014 Nhama et al.; licensee BioMed Central Ltd.

Karim Q.A.,Center for the Program of Research in South Africa | Karim Q.A.,Columbia University | Karim S.S.A.,Center for the Program of Research in South Africa | Karim S.S.A.,Columbia University | And 15 more authors.
Science | Year: 2010

The Centre for the AIDS Program of Research in South Africa (CAPRISA) 004 trial assessed the effectiveness and safety of a 1% vaginal gel formulation of tenofovir, a nucleotide reverse transcriptase inhibitor, for the prevention of HIV acquisition in women. A double-blind, randomized controlled trial was conducted comparing tenofovir gel (n = 445 women) with placebo gel (n = 444 women) in sexually active, HIV-uninfected 18- to 40-year-old women in urban and rural KwaZulu-Natal, South Africa. HIV serostatus, safety, sexual behavior, and gel and condom use were assessed at monthly follow-up visits for 30 months. HIV incidence in the tenofovir gel arm was 5.6 per 100 women-years (person time of study observation) (38 out of 680.6 women-years) compared with 9.1 per 100 women-years (60 out of 660.7 women-years) in the placebo gel arm (incidence rate ratio = 0.61; P = 0.017). In high adherers (gel adherence > 80%), HIV incidence was 54% lower (P = 0.025) in the tenofovir gel arm. In intermediate adherers (gel adherence 50 to 80%) and low adherers (gel adherence < 50%), the HIV incidence reduction was 38 and 28%, respectively. Tenofovir gel reduced HIV acquisition by an estimated 39% overall, and by 54% in women with high gel adherence. No increase in the overall adverse event rates was observed. There were no changes in viral load and no tenofovir resistance in HIV seroconverters. Tenofovir gel could potentially fill an important HIV prevention gap, especially for women unable to successfully negotiate mutual monogamy or condom use.

Medhi G.K.,Regional Medical Research Center | Mahanta J.,Regional Medical Research Center | Adhikary R.,Family Health International FHI | Akoijam B.S.,Regional Institute of Medical science | And 4 more authors.
BMC Public Health | Year: 2011

Background: Injecting drugs is the major driving force of human immunodeficiency virus (HIV) epidemic in Northeastern India. We have assessed the spatial distribution of locations where injecting drug users (IDU) congregate, as well as the risk behaviour and key characteristics of IDUs to develop new strategies strengthening intervention measures for HIV prevention in this region. Methods. Locations of IDUs congregation for buying and injecting drugs were identified through Key Informants (KI). Verification of the location and its characteristics were confirmed through field visits. We also conducted semi-structured and structured interviews with IDUs to learn more about their injecting behaviour and other characteristics. Results: Altogether, 2462 IDU locations were identified in 5 states. The number of IDU locations was found to be greater in the states bordering Myanmar. Private houses, parks, abandoned buildings, pharmacies, graveyards, and isolated places were the most frequently chosen place for injecting drugs. Many injecting locations were visited by IDUs of varying ages, of which about 10-20% of locations were for females. In some locations, female IDUs were also involved in sex work. Sharing of needle and syringes was reported in all the states by large proportion of IDUs, mainly with close friends. However, even sharing with strangers was not uncommon. Needle and syringes were mainly procured from pharmacies, drug peddlers and friends. Lack of access to free sterile needles and syringes, and inconsistent supplies from intervention programs, were often given as the cause of sharing or re-use of needles and syringes by IDUs. Most of the IDUs described a negative attitude of the community towards them. Conclusion: We highlight the injection of drugs as a problem in 5 Northeastern India states where this is the major driving force of an HIV epidemic. Also highlighted are the large numbers of females that are unrecognized as IDUs and the association between drug use and sex work. Understanding of risk behaviours and other key charecteristics of IDUs in the region will help in strengthening harm reduction efforts that can prevent HIV transmission. © 2011 Medhi et al; licensee BioMed Central Ltd.

Schwartz J.L.,Eastern Virginia Medical School | Rountree W.,Family Health International FHI | Rountree W.,Duke Human Vaccine Institute | Kashuba A.D.M.,University of North Carolina at Chapel Hill | And 5 more authors.
PLoS ONE | Year: 2011

Background: Tenofovir (TFV) gel is being evaluated as a microbicide with pericoital and daily regimens. To inhibit viral replication locally, an adequate concentration in the genital tract is critical. Methods and Findings: Forty-nine participants entered a two-phase study: single-dose (SD) and multi-dose (MD), were randomized to collection of genital tract samples (endocervical cells [ECC], cervicovaginal aspirate and vaginal biopsies) at one of seven time points [0.5, 1, 2, 4, 6, 8, or 24 hr(s)] post-dose following SD exposure of 4 mL 1% TFV gel and received a single dose. Forty-seven were randomized to once (QD) or twice daily (BID) dosing for 2 weeks and to collection of genital tract samples at 4, 8 or 24 hrs after the final dose, but two discontinued prior to gel application. Blood was collected during both phases at the seven times post-dose. TFV exposure was low in blood plasma for SD and MD; median C max was 4.0 and 3.4 ng/mL, respectively (C≤29 ng/mL). TFV concentrations were high in aspirates and tissue after SD and MD, ranging from 1.2×10 4 to 9.9×10 6 ng/mL and 2.1×10 2 to 1.4×10 6 ng/mL, respectively, and did not noticeably differ between proximal and distal tissue. TFV diphosphate (TFV-DP), the intracellular active metabolite, was high in ECC, ranging from 7.1×10 3 to 8.8×10 6 ng/mL. TFV-DP was detectable in approximately 40% of the tissue samples, ranging from 1.8×10 2 to 3.5×10 4 ng/mL. AUC for tissue TFV-DP was two logs higher after MD compared to SD, with no noticeable differences when comparing QD and BID. Conclusions: Single-dose and multiple-dose TFV gel exposure resulted in high genital tract concentrations for at least 24 hours post-dose with minimal systemic absorption. These results support further study of TFV gel for HIV prevention. Trial registration: ClinicalTrials.gov NCT00561496. © 2011 Schwartz et al.

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