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Design of a randomized controlled trial of zinc supplementation to improve markers of mortality and HIV disease progression in HIV-positive drinkers in St. Petersburg, Russia.

ABSTRACT: Background Russia continues to have an uncontrolled HIV epidemic and its per capita alcohol consumption is among the highest in the world. Alcohol use among HIV-positive individuals is common and is associated with worse clinical outcomes. Alcohol use and HIV each lead to microbial translocation, which in turn results in inflammation. Zinc supplementation holds potential for lowering levels of biomarkers of inflammation, possibly as a consequence of its impact on intestinal permeability. This paper describes the protocol of a double-blinded randomized placebo-controlled trial of zinc supplementation in St. Petersburg, Russia. Methods Participants (n = 254) were recruited between October 2013 and June 2015 from HIV and addiction clinical care sites, and non-clinical sites in St. Petersburg, Russia. Participants were randomly assigned, to receive either zinc (15 mg for men; 12 mg for women) or placebo, daily for 18 months. The following outcomes were assessed at 6, 12, and 18 months: (1) mortality risk (primary outcome at 18 months); (2) HIV disease progression; (3) cardiovascular risk; and (4) microbial translocation and inflammation. Adherence was assessed using direct (riboflavin) and indirect (pill count, self-report) measures. Conclusion Given the limited effectiveness of current interventions to reduce alcohol use, zinc supplementation merits testing as a simple, low-cost intervention to mitigate the consequences of alcohol use in HIV-positive persons despite ongoing drinking.

SUBMITTER: Gnatienko N

PROVIDER: S-EPMC5957784 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Design of a randomized controlled trial of zinc supplementation to improve markers of mortality and HIV disease progression in HIV-positive drinkers in St. Petersburg, Russia.

Gnatienko Natalia N Freiberg Matthew S MS Blokhina Elena E Yaroslavtseva Tatiana T Bridden Carly C Cheng Debbie M DM Chaisson Christine E CE Lioznov Dmitry D Bendiks Sally S Koerbel Glory G Coleman Sharon M SM Krupitsky Evgeny E Samet Jeffrey H JH

HIV clinical trials 20180417 3

Background Russia continues to have an uncontrolled HIV epidemic and its per capita alcohol consumption is among the highest in the world. Alcohol use among HIV-positive individuals is common and is associated with worse clinical outcomes. Alcohol use and HIV each lead to microbial translocation, which in turn results in inflammation. Zinc supplementation holds potential for lowering levels of biomarkers of inflammation, possibly as a consequence of its impact on intestinal permeability. This pa ...[more]

PMID: 29663871

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Project description:IntroductionPolice violence against people who inject drugs (PWID) is common in Russia and associated with HIV risk behaviours. Sexual violence from police against women who use drugs has been reported anecdotally in Russia. This mixed-methods study aimed to evaluate sexual violence from police against women who inject drugs via quantitative assessment of its prevalence and HIV risk correlates, and through qualitative interviews with police, substance users and their providers in St. Petersburg, Russia.MethodsCross-sectional analyses with HIV-positive women who inject drugs (N=228) assessed the associations between sexual violence from police (i.e. having been forced to have sex with a police officer) and the following behaviours: current drug use, needle sharing and injection frequency using multiple regression models. We also conducted in-depth interviews with 23 key informants, including PWID, police, civil society organization workers, and other stakeholders, to explore qualitatively the phenomenon of sexual violence from police in Russia and strategies to address it. We analyzed qualitative data using content analysis.ResultsApproximately one in four women in our quantitative study (24.1%; 95% CI, 18.6%, 29.7%) reported sexual violence perpetrated by police. Affected women reported more transactional sex for drugs or money than those who were not; however, the majority of those reporting sexual violence from police were not involved in these forms of transactional sex. Sexual violence from police was not significantly associated with current drug use or needle sharing but with more frequent drug injections (adjusted incidence rate ratio 1.43, 95% CI 1.04, 1.95). Qualitative data suggested that sexual violence and coercion by police appear to be entrenched as a norm and are perceived insurmountable because of the seemingly absolute power of police. They systematically add to the risk environment of women who use drugs in Russia.ConclusionsSexual violence from police was common in this cohort of Russian HIV-positive women who inject drugs. Our analyses found more frequent injection drug use among those affected, suggesting that the phenomenon represents an underappreciated human rights and public health problem. Addressing sexual violence from police against women in Russia will require addressing structural factors, raising social awareness and instituting police trainings that protect vulnerable women from violence and prevent HIV transmission.

Project description:BackgroundThe HIV epidemic in Russia is concentrated among injection drug users (IDUs). This is especially true for St. Petersburg where high HIV incidence persists among the city's estimated 80,000 IDUs. Although sterile syringes are legally available, access for IDUs may be hampered. To explore the feasibility of using pharmacies to expand syringe access and provide other prevention services to IDUs, we investigated the current access to sterile syringes at the pharmacies and the correlation between pharmacy density and HIV prevalence in St. Petersburg.Methods965 pharmacies citywide were mapped, classified by ownership type, and the association between pharmacy density and HIV prevalence at the district level was tested. We selected two districts among the 18 districts--one central and one peripheral--that represented two major types of city districts and contacted all operating pharmacies by phone to inquire if they stocked syringes and obtained details about their stock. Qualitative interviews with 26 IDUs provided data regarding syringe access in pharmacies and were used to formulate hypotheses for the pharmacy syringe purchase test wherein research staff attempted to purchase syringes in all pharmacies in the two districts.ResultsNo correlation was found between the density of pharmacies and HIV prevalence at the district level. Of 108 operating pharmacies, 38 (35%) did not sell syringes of the types used by IDUs; of these, half stocked but refused to sell syringes to research staff, and the other half did not stock syringes at all. Overall 70 (65%) of the pharmacies did sell syringes; of these, 49 pharmacies sold single syringes without any restrictions and 21 offered packages of ten.ConclusionsTrainings for pharmacists need to be conducted to reduce negative attitudes towards IDUs and increase pharmacists' willingness to sell syringes. At a structural level, access to safe injection supplies for IDUs could be increased by including syringes in the federal list of mandatory medical products sold by pharmacies.

Dataset Information

Design of a randomized controlled trial of zinc supplementation to improve markers of mortality and HIV disease progression in HIV-positive drinkers in St. Petersburg, Russia.

Publications

Design of a randomized controlled trial of zinc supplementation to improve markers of mortality and HIV disease progression in HIV-positive drinkers in St. Petersburg, Russia.

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