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We are the primary study, to our data, to make use of organic testing to supplement self-reported HIV and STI information. Our stringent quality control measures and the use of a computerized data assortment software guarantee standardization and consistency amongst participants. Ours is the first RCT carried out with FSW in Kazakhstan, and one of the few performed in Central Asia. Our use of a longitudinal study design, assessing outcomes over a 12-month post-intervention interval, allows for us to look at the lengthy-lasting results of our intervention and assess the sustainability of its outcomes. Our mixed-strategies approach, which incorporates biological assessments, behavioral questionnaires, in-depth interviews, and value information, allows us to evaluate the impact of our intervention on multiple ranges.

As we’ve described above, the particular target inhabitants of our intervention has been largely absent in previous HIV-risk-reduction interventions. While mixture HIVRR and microfinance interventions have been proven to reduce HIV threat and empower women to guard kazakh woman themselves, these studies hardly ever concentrate on women who use or inject medication. Both our intervention and our assessments are tailor-made to the needs and realities of ladies who share the dual risks of sex work and drug use.

Participants who test constructive for any STI are provided with referrals and treatment. Treatment for HCV isn’t widely available in Kazakhstan, and clinical coordinators refer participants who check positive for HCV to specialized clinics for added examination, monitoring, and treatment. If members receive a positive fast check for HIV, the scientific coordinator refers them to the local AIDS middle for confirmatory testing and therapy. HIV-positive individuals sign an additional waiver allowing our research access to therapy data on the local HIV clinic.

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Table1 incorporates an inventory of the specific measures used for each assemble. Among the process evaluation measures included are intervention session attendance , vocational training attendance and matched savings deposits and spending , and retention measures. These process measures are used for a variety of causes, including supervision, evaluation of standardization and fidelity to the intervention, and for use in booster coaching events throughout the study interval. Eligible participants are scheduled for examine consumption procedures and the baseline evaluation at the project subject office location as soon as potential after the screening. During this baseline go to, research assistants describe the main points of the research to potential individuals and lead them by way of an knowledgeable consent process.

However, there is some evidence that shows that community-primarily based recruitment and venue-primarily based recruitment of FSW yields populations with totally different sociodemographic traits and even completely different STI prevalence . We purpose to resolve this concern through random project to study situation, and to conduct analyses that consider recruitment supply, and any other variations doubtlessly identified between examine conditions, as a moderating variable.

HIVRR intervention classes fastidiously integrated core parts of the intersection of drug use and sexual danger, and danger-discount strategies with paying companions. A Data Safety and Monitoring Board , consisting of Kazakhstan-based researchers, has been recognized and meets on an annual basis to review all ongoing research information and human subjects issues. Standardized protocols and trainings are used to assure consistency and fidelity to the intervention and assessments across a number of research sites. Research assistants, medical coordinators, and facilitators receive normal coaching in their areas of duty, together with procedural manuals and checklists.

We wish to thank all of research individuals for their time and participation. Recruitment for this examine started in May 2015, and the final cohort of participants was enrolled in July 2017.

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We expect a number of challenges in recruitment and retention of members. FSW who use medicine are highly marginalized, and infrequently hesitant to hunt healthcare and different services for worry of stigma or legal repercussions . Our decision to recruit at area places as well as via a peer-referral system was meant to extend the reach of our research to as many FSW as potential.

Finally, given the long time frame of our examine and the staggered begin dates between the Temirtau and Almaty sites, we suspect that external confounding components might influence participant enrollment and intervention outcomes. For instance, we have already observed a fast contraction of Kazakhstan’s economic system and a currency devaluation in the summer of 2015, which may impact members’ savings habits. Academic literature on microfinance for HIV-risk discount has known as for a more rigorous testing of interventions, examination of the causal pathways between microfinance and decreased threat-habits outcomes, and using biomarkers . Our assessments provide a lot-wanted knowledge on the experiences, risks and needs of this population in Kazakhstan, the variables that average and mediate HIV-danger outcomes, and how these differ between remedy and control conditions.

The use of CASI for baseline and observe-up behavioral assessments ensures that every participant is receiving the same version of the questionnaire, and that there isn’t any response bias. Each site receives day by day supervision from a website coordinator, who is liable for reviewing study records and reporting any irregularities or protocol violations to the study staff. Data management employees on the examine staff are answerable for coordinating data collection across multiple databases. Weekly Skype conferences with examine investigators are used to address any points or challenges.

Cluster randomization strategies might offset the consequences of selection bias, and analyses will compare baseline traits of both remedy and control arms. Our evaluation measures embrace delicate information on extremely stigmatized behaviors, including sexual habits history and drug use.

The qualitative part of our research uses in-depth interviews to probe deeper into the barriers to savings and vocational entry skilled by FSW, as well as providing information on the feasibility and acceptability of the intervention. Finally, our study addresses many of the scientific limitations of previous studies.

The HIVRR and FLT sessions are led by skilled examine facilitators, supervised by study employees and investigators. A number of high quality assurance measures have been put into place to ensure standardization throughout periods and facilitators. Sessions are audio-recorded, and tapes are randomly chosen for review by local clinical supervisors and US-based mostly examine investigators. Clinical supervisors observe adherence to the intervention protocol and tackle any areas of instant concern directly with the facilitators. Team supervision is held once a month with US-primarily based research investigators via Skype calls to discuss the challenges faced by facilitators in conducting the classes and adhering to the protocol.

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Clinical coordinators acquire info on confirmatory testing , viral-load check outcomes, CD4 test outcomes, and antiretroviral medicine historical past at each assessment period for every participant. Follow-up assessments happen as early as 1 week before the precise observe-up date, and as late as three weeks after the exact observe-up date. Like the baseline behavioral questionnaire, the follow-up behavioral questionnaires address the main consequence variables, moderators and mediators of interest to the study. The follow-up questionnaires additionally embrace extra questions to assess how HIVRR+MF participants have utilized the vocational training and financial literacy training that they have received. Behavioral questionnaires are performed using computer-assisted self-interviewing strategies, with the same survey tool that the analysis assistants use to evaluate examine eligibility and which could be accomplished in approximately 2 h.

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