Dataset Information

Improving HIV service delivery for people who inject drugs in Kazakhstan: study protocol for the Bridge stepped-wedge trial.

ABSTRACT: BACKGROUND:People who inject drugs (PWID) in Kazakhstan face many barriers to HIV testing as well as to accessing HIV care, to retention in HIV care, and to initiating and adhering to anti-retroviral treatment (ART). Needle and syringe programs (NSPs) are an opportune setting for integrated interventions to link PWID to HIV care. METHODS:This Hybrid Type II study employs a stepped-wedge design to evaluate both effectiveness and implementation outcomes of Bridge, an intervention to identify, test, and link HIV-positive PWID to HIV care. The study is conducted at 24 NSPs in three different regions of Kazakhstan, to assess outcomes on the individual, organizational, and policy levels. DISCUSSION:This trial responds to an identified need for new models of HIV service delivery for PWID through harm reduction settings. TRIAL REGISTRATION:NCT02796027 on June 10, 2016.

SUBMITTER: McCrimmon T

PROVIDER: S-EPMC6570938 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Improving HIV service delivery for people who inject drugs in Kazakhstan: study protocol for the Bridge stepped-wedge trial.

McCrimmon Tara T Gilbert Louisa L Hunt Timothy T Terlikbayeva Assel A Wu Elwin E Darisheva Meruyert M Primbetova Sholpan S Kuskulov Azamat A Davis Alissa A Dasgupta Anindita A Schackman Bruce R BR Metsch Lisa R LR Feaster Daniel J DJ Baiserkin Baurzhan B El-Bassel Nabila N

Implementation science : IS 20190614 1

<h4>Background</h4>People who inject drugs (PWID) in Kazakhstan face many barriers to HIV testing as well as to accessing HIV care, to retention in HIV care, and to initiating and adhering to anti-retroviral treatment (ART). Needle and syringe programs (NSPs) are an opportune setting for integrated interventions to link PWID to HIV care.<h4>Methods</h4>This Hybrid Type II study employs a stepped-wedge design to evaluate both effectiveness and implementation outcomes of Bridge, an intervention to ...[more]

PMID: 31200757

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Project description:ObjectivesThe HIV epidemic in India is concentrated in key populations such as people who inject drugs (PWID). New HIV infections are high among young PWID (≤30 years of age), who are hard to engage in services. We assessed perspectives of young PWID to guide development of youth-specific services.SettingWe conducted focus group discussions (FGDs) with PWID and staff at venues offering services to PWID in three Indian cities representing historical and emerging drug use epidemics.ParticipantsPWID were eligible to participate if they were between 18 and 35 years, had initiated injection as adolescents or young adults and knew adolescent PWID in their networks. 43 PWID (81% male, 19% female) and 10 staff members participated in FGDs. A semistructured interview guide was used to elicit participants' narratives on injection initiation experiences, barriers to seeking harm reduction services, service delivery gaps and recommendations to promote engagement. Thematic analysis was used to develop an explanatory model for service engagement in each temporal stage across the injection continuum.ResultsInjection initiation followed non-injection opioid dependence. Lack of services for non-injection opioid dependence was a key gap in the preinjection initiation phase. Lack of knowledge and reliance on informal sources for injecting equipment were key reasons for non-engagement in the peri-injection phase. Additionally, low-risk perception resulted in low motivation to seek services. Psychosocial and structural factors shaped engagement after established injection. Housing and food insecurity, and stigma disproportionately affected female PWID while lack of confidential adolescent friendly services impeded engagement by adolescent PWID.ConclusionsDevelopment of youth-specific services for young PWID in India will need to address unique vulnerabilities and service gaps along each stage of the injection continuum. Scaling-up of tailored services is needed for young female PWID and adolescents, including interventions that prevent injection initiation and provision of confidential harm reduction services.

Project description:BackgroundScaled-up direct-acting antiviral (DAA) treatment of hepatitis C virus (HCV) infection among people who inject drugs (PWID) is crucial to reach the World Health Organization HCV elimination targets within 2030. One of the critical obstacles to HCV care in this population is the lack of treatment models within specialist healthcare adapted to marginalized individuals.MethodsOPPORTUNI-C is a pragmatic stepped wedge cluster randomized trial comparing the efficacy of immediate initiation of HCV treatment with the current standard of care among PWID admitted for inpatient care. Screening for HCV RNA will be performed as soon as possible after admission. The intervention includes immediate non-invasive liver disease assessment, counseling, and initiation of pan-genotypic DAA treatment with individualized follow-up. Standard of care is a referral to outpatient care at discharge. To mimic usual clinical practice as closely as possible, we will use a pragmatic clinical trial approach utilizing clinical infrastructure, broad eligibility criteria, flexible intervention delivery, clinically relevant outcomes, and collection of data readily available from the electronic patient files. The stepped wedge design involves a sequential rollout of the intervention over 16 months, in which seven participating clusters will be randomized from standard of care to intervention in a stepwise manner. Randomization will be stratified according to cluster size to keep high prevalence clusters separated. The trial will include approximately 220 HCV RNA positive individuals recruited from departments of internal medicine, addiction medicine, and psychiatry at Akershus University Hospital, Oslo University Hospital, and Lovisenberg Diaconal Hospital, Oslo, Norway. Individuals not able or willing to give informed consent and those with ongoing HCV assessment or treatment will be excluded. The primary outcome is treatment completion, defined as dispensing of the final prescribed DAA package from the pharmacy within 6 months after inclusion. Secondary outcomes include treatment uptake, virologic response, reinfection incidence, and resistance-associated substitutions.DiscussionRepresenting a novel model of care suited to reach and engage marginalized PWID in HCV care, this study will inform HCV elimination efforts locally and internationally. If the model proves efficacious and feasible, it should be considered for broader implementation, replacing the current standard of care.Trial registrationClinicalTrials.gov, NCT04220645. Registered on 7 January 2020.

Project description:Health system strengthening is needed to improve delivery of secondary prophylaxis against rheumatic heart disease. We undertook a stepped-wedge, randomized trial in northern Australia. Five pairs of Indigenous community clinics entered the study at 3-month steps. Study phases comprised a 12 month baseline phase, 3 month transition phase, 12 month intensive phase and a 3- to 12-month maintenance phase. Clinics received a multicomponent intervention supporting activities to improve penicillin delivery, aligned with the chronic care model, with continuous quality-improvement feedback on adherence. The primary outcome was the proportion receiving ≥80% of scheduled penicillin injections. Secondary outcomes included "days at risk" of acute rheumatic fever recurrence related to late penicillin and acute rheumatic fever recurrence rates. Overall, 304 patients requiring prophylaxis were eligible. The proportion receiving ≥80% of scheduled injections during baseline was 141 of 304 (46%)-higher than anticipated. No effect attributable to the study was evident: in the intensive phase, 126 of 304 (41%) received ≥80% of scheduled injections (odds ratio compared with baseline: 0.78; 95% confidence interval, 0.54-1.11). There was modest improvement in the maintenance phase among high-adhering patients (43% received ≥90% of injections versus 30% [baseline] and 28% [intensive], P<0.001). Also, the proportion of days at risk in the whole cohort decreased in the maintenance phase (0.28 versus 0.32 [baseline] and 0.34 [intensive], P=0.001). Acute rheumatic fever recurrence rates did not differ between study sites during the intensive phase and the whole jurisdiction (3.0 versus 3.5 recurrences per 100 patient-years, P=0.65). This strategy did not improve adherence to rheumatic heart disease secondary prophylaxis within the study time frame. Longer term primary care strengthening strategies are needed. URL: www.anzctr.org.au. Unique identifier: ACTRN12613000223730.

Dataset Information

Improving HIV service delivery for people who inject drugs in Kazakhstan: study protocol for the Bridge stepped-wedge trial.

Publications

Improving HIV service delivery for people who inject drugs in Kazakhstan: study protocol for the Bridge stepped-wedge trial.

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