STIs acquired and treated between the baseline and month-9 evaluation or between the month-9 and month-15 assessment at an external clinic are only included as an endpoint if it is self-reported by individuals on their month-9 and month-15 assessments. The scientific coordinator refers participants who screen optimistic for syphilis to the local Skin and Venereal Disease Dispensary to receive additional confirmatory testing for syphilis, consultations with a doctor, and treatment for active forms of syphilis. Treatment for HCV just isn’t broadly available in Kazakhstan, and clinical coordinators refer members who test optimistic for HCV to specialized clinics for additional examination, monitoring, and remedy.
The use of CASI for baseline and observe-up behavioral assessments ensures that each participant is receiving the same model of the questionnaire, and that there isn’t any response bias. Each web site receives every day supervision from a site coordinator, who’s responsible for reviewing examine records and reporting any irregularities or protocol violations to the research group. Data administration employees on the examine staff are responsible for coordinating knowledge assortment across a number of databases. Weekly Skype conferences with research investigators are used to handle any issues or challenges. Participants who check optimistic for any STI are supplied with referrals and therapy.
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Our use of a longitudinal research design, assessing outcomes over a 12-month publish-intervention period, allows for us to look at the lengthy-lasting effects of our intervention and assess the sustainability of its outcomes. Our combined-strategies approach, which includes organic assessments, behavioral questionnaires, in-depth interviews, and value information, allows us to evaluate the impression of our intervention on a number of levels. The qualitative component of our research uses in-depth interviews to probe deeper into the barriers to savings and vocational entry experienced by FSW, in addition to offering data on the feasibility and acceptability of the intervention.
Like the baseline behavioral questionnaire, the comply with-up behavioral questionnaires address the primary outcome variables, moderators and mediators of interest to the research. The comply with-up questionnaires additionally embrace extra inquiries to assess how HIVRR+MF participants have utilized the vocational training and monetary literacy coaching that they have obtained.
Recruitment for this examine began in May 2015, and the last cohort of members was enrolled in July 2017. We count on several challenges in recruitment and retention of members. FSW who use medication are highly marginalized, and infrequently hesitant to hunt healthcare and other providers for fear of stigma or legal repercussions .
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Our assessment measures include delicate data on highly stigmatized behaviors, including sexual habits history and drug use. Finally, given the long time frame of our examine and the staggered begin dates between the Temirtau and Almaty websites, we suspect that external confounding elements might influence participant enrollment and intervention outcomes. For example, we have already observed a fast contraction of Kazakhstan’s economic system and a currency devaluation in the summer of 2015, which may impression individuals’ financial savings conduct. Academic literature on microfinance for HIV-threat reduction has referred to as for a extra rigorous testing of interventions, examination of the causal pathways between microfinance and reduced threat-conduct outcomes, and using biomarkers .
The HIVRR and FLT classes are led by trained study facilitators, supervised by study workers and investigators. A number of quality assurance measures have been put into place to ensure standardization throughout periods and facilitators. Sessions are audio-recorded, and tapes are randomly selected for review by local clinical supervisors and US-based mostly study investigators. Clinical supervisors note adherence to the intervention protocol and tackle any areas of instant concern immediately with the facilitators. Team supervision is held once a month with US-based mostly research investigators via Skype calls to discuss the challenges confronted by facilitators in conducting the periods and adhering to the protocol.
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Finally, our research addresses most of the scientific limitations of previous studies. As we’ve described above, the particular target population of our intervention has been largely absent in past HIV-threat-discount interventions. While combination HIVRR and microfinance interventions have been proven to cut back HIV danger and empower women to guard themselves, these research rarely give attention to women who use or inject drugs. Both our intervention and our assessments are tailored to the wants and realities of women who share the twin risks of intercourse work and drug use. HIVRR intervention sessions fastidiously incorporated core components of the intersection of drug use and sexual risk, and risk-reduction methods with paying companions.
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If participants receive a positive speedy take a look at for HIV, the scientific coordinator refers them to the native AIDS middle for confirmatory testing and remedy. HIV-positive members sign an additional waiver allowing our examine access to remedy data at the local HIV clinic. Clinical coordinators acquire info on confirmatory testing , viral-load take a look at results, CD4 take a look at outcomes, and antiretroviral medicine historical past at every assessment period for every participant. Follow-up assessments happen as early as 1 week before the precise follow-up date, and as late as three weeks after the exact observe-up date.
From week three until the tip of the intervention period at the end of month 3, the treatment arm receives the matched savings part of the intervention. The matched financial savings element of the HIVRR+MF intervention is also tailored from the Undarga program . Building assets prior to shifting sources of earnings or shifting to new or self-employment could enhance the chance for elevated earnings from other sources than intercourse work.
Our assessments present a lot-needed information on the experiences, risks and needs of this population in Kazakhstan, the variables that reasonable and mediate HIV-threat outcomes, and how these differ between remedy and control situations. We are the primary research, to our data, to use organic testing to supplement self-reported HIV and STI data. Our stringent high quality control measures and the usage of a computerized knowledge collection software guarantee standardization and consistency among participants. Ours is the primary RCT performed with FSW in Kazakhstan, and one of many few conducted in Central Asia.
A Data Safety and Monitoring Board , consisting of Kazakhstan-based mostly researchers, has been recognized and meets on an annual basis to review all ongoing study knowledge and human topics issues. Standardized protocols and trainings are used to assure consistency and fidelity to the intervention and assessments across https://yourmailorderbride.com/kazakhstan-women/ a number of examine sites. Research assistants, scientific coordinators, and facilitators obtain commonplace coaching of their areas of accountability, including procedural manuals and checklists.
Our choice to recruit at field areas in addition to through a peer-referral system was supposed to increase the attain of our examine to as many FSW as possible. However, there may be some proof that reveals that community-based recruitment and venue-based mostly recruitment of FSW yields populations with completely different sociodemographic traits and even different STI prevalence . We goal to resolve this problem by way of random task to check situation, and to conduct analyses that consider recruitment supply, and another variations potentially recognized between research situations, as a moderating variable. Cluster randomization strategies may offset the effects of selection bias, and analyses will examine baseline characteristics of each therapy and control arms.
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Among the method analysis measures included are intervention session attendance , vocational training attendance and matched savings deposits and spending , and retention measures. These course of measures are used for a variety of causes, together with supervision, evaluation of standardization and constancy to the intervention, and to be used in booster coaching events throughout the examine period. Eligible members are scheduled for study intake procedures and the baseline evaluation at the project area workplace location as soon as possible after the screening. During this baseline visit, research assistants describe the details of the examine to potential individuals and lead them through an knowledgeable consent course of.