A Data Safety and Monitoring Board , consisting of Kazakhstan-based researchers, has been recognized and meets on an annual foundation to review all ongoing research knowledge and human subjects points. Standardized protocols and trainings are used to guarantee consistency and constancy to the intervention and assessments throughout multiple study sites. Research assistants, clinical coordinators, and facilitators obtain standard coaching of their areas of duty, including procedural manuals and checklists.
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Like the baseline behavioral questionnaire, the comply with-up behavioral questionnaires tackle the primary consequence variables, moderators and mediators of curiosity to the examine. The follow-up questionnaires also embrace extra questions to assess how HIVRR+MF participants have utilized the vocational training and monetary literacy coaching that they’ve acquired.
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The use of CASI for baseline and follow-up behavioral assessments ensures that every participant is receiving the same version of the questionnaire, and that there isn’t a response bias. Each website receives daily supervision from a website coordinator, who is responsible for reviewing research data and reporting any irregularities or protocol violations to the examine team. Data management employees on the examine group are answerable for coordinating information assortment across multiple databases. Weekly Skype meetings with research investigators are used to deal with any issues or challenges. Participants who test positive for any STI are supplied with referrals and treatment.
Finally, our research addresses lots of the scientific limitations of earlier research. As we have described above, the particular target population of our intervention has been largely absent in previous HIV-threat-reduction interventions. While combination HIVRR and microfinance interventions have been proven to scale back HIV threat and empower women to guard themselves, these research not often women of kazakhstan concentrate on women who use or inject medication. Both our intervention and our assessments are tailored to the wants and realities of ladies who share the twin dangers of intercourse work and drug use. HIVRR intervention periods fastidiously included core components of the intersection of drug use and sexual risk, and danger-discount strategies with paying companions.
If individuals obtain a positive speedy check for HIV, the clinical coordinator refers them to the native AIDS heart for confirmatory testing and therapy. HIV-constructive participants signal a further waiver allowing our examine access to remedy data on the native HIV clinic. Clinical coordinators collect data on confirmatory testing , viral-load take a look at outcomes, CD4 test outcomes, and antiretroviral treatment historical past at every assessment interval for each participant. Follow-up assessments happen as early as 1 week earlier than the precise follow-up date, and as late as three weeks after the precise comply with-up date.
As mentioned above, individuals receive incentive funds (US$12/session) for every FLT or VT session attended. During the FLT intervention, individuals receive support to open a personal savings account in a associate financial institution, and are inspired to deposit their session attendance incentives in this account. Throughout the remainder of the remedy intervention period, for each dollar of their incentive fee cash deposited in their private account, the project will deposit an equal amount in a separate, project-controlled account underneath the participant’s name. Participant’s funds will solely be matched as much as the whole amount that they have obtained from incentive funds for session attendance – this limit ensures that girls are not earning earnings by way of sex work for his or her matched financial savings.
If a participant decides to save one hundred% of her incentive after every session, she may have saved a complete of US$360 and would receive an identical US$360 for a total of US$720. Due to lack of documentation, lingering distrust of the banking system, or different limitations, some women could elect to never open a bank account. These individuals have the choice to store cash with the program employees in an off-the-cuff account till the time of withdrawal, and these informal accounts are also matched in a separate, project-controlled account underneath the participant’s name.
Sessions are held three times per week over 2 weeks for a total of six classes. Sessions are performed in Russian by trained female facilitators, and final for about 2 h. Participants obtain small monetary incentives (US$12) and safe-intercourse kits for periods attended. There is a small but rising body of empirical studies carried out worldwide which have sought to show the influence of microfinance interventions on HIV prevention and care . These studies have utilized a variety of the microfinance strategies listed above, both introducing them individually or in combination with behavioral interventions for HIV-danger discount .
Our use of a longitudinal examine design, assessing outcomes over a 12-month submit-intervention period, permits for us to look at the long-lasting results of our intervention and assess the sustainability of its outcomes. Our blended-methods strategy, which includes biological assessments, behavioral questionnaires, in-depth interviews, and price knowledge, allows us to assess the influence of our intervention on multiple levels. The qualitative element of our examine makes use of in-depth interviews to probe deeper into the barriers to savings and vocational entry experienced by FSW, in addition to providing information on the feasibility and acceptability of the intervention.
During weeks 3 and 4 of the intervention period, the therapy arm only receives Financial Literacy Training . The FLT intervention was adapted from the monetary literacy intervention used in the Undarga study . FLT sessions concentrate on facilitating access to banking services , household budgeting , quick- and lengthy-time period savings, debt management and financial negotiations. Sessions are designed to increase participant data, expertise, and self-efficacy related to managing and controlling finances, which could enhance their capacity for financial savings. Participants proceed to construct upon the objective-setting abilities that they developed in the HIVRR classes, and facilitators proceed to conduct security verify-ins.
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Among the method analysis measures included are intervention session attendance , vocational coaching attendance and matched financial savings deposits and spending , and retention measures. These process measures are used for numerous reasons, including supervision, evaluation of standardization and fidelity to the intervention, and to be used in booster training occasions throughout the study period. Eligible participants are scheduled for examine intake procedures and the baseline assessment at the project area office location as soon as possible after the screening. During this baseline go to, analysis assistants describe the main points of the research to potential members and lead them through an knowledgeable consent process.
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The HIVRR and FLT periods are led by trained study facilitators, supervised by examine workers and investigators. A number of quality assurance measures have been put into place to ensure standardization throughout sessions and facilitators. Sessions are audio-recorded, and tapes are randomly selected for review by native scientific supervisors and US-based mostly study investigators. Clinical supervisors observe adherence to the intervention protocol and handle any areas of instant concern instantly with the facilitators. Team supervision is held once a month with US-based research investigators through Skype calls to discuss the challenges faced by facilitators in conducting the classes and adhering to the protocol.
STIs acquired and handled between the baseline and month-9 assessment or between the month-9 and month-15 assessment at an exterior clinic are only included as an endpoint whether it is self-reported by individuals on their month-9 and month-15 assessments. The scientific coordinator refers individuals who display constructive for syphilis to the local Skin and Venereal Disease Dispensary to obtain additional confirmatory testing for syphilis, consultations with a doctor, and remedy for energetic types of syphilis. Treatment for HCV is not widely available in Kazakhstan, and medical coordinators refer individuals who check positive for HCV to specialised clinics for added examination, monitoring, and therapy.
From week 3 until the end of the intervention period at the end of month three, the remedy arm receives the matched savings component of the intervention. The matched savings part of the HIVRR+MF intervention is also adapted from the Undarga program . Building assets prior to shifting sources of income or moving to new or self-employment may improve the likelihood for elevated income from different sources than intercourse work.