AK was a coordinator for the examine and contributed to study protocols. Data assortment for this examine is ongoing, so no materials are presently available. This examine was funded by the National Institute on Drug Abuse , grant number R01 DA036514, to Drs. The funders had no involvement within the design of the study or in collection, analysis, and interpretation of information. We wish to thank all of examine individuals for his or her time and participation.
The use of CASI for baseline and follow-up behavioral assessments ensures that each participant is receiving the identical version of the questionnaire, and that there isn’t a response bias. Each web site receives every day supervision from a site coordinator, who is responsible for reviewing examine records and reporting any irregularities or protocol violations to the examine staff. Data administration workers on the examine group are answerable for coordinating information collection across a number of databases. Weekly Skype conferences with study investigators are used to handle any issues or challenges. Participants who check optimistic for any STI are supplied with referrals and therapy.
A Data Safety and Monitoring Board , consisting of Kazakhstan-based mostly researchers, has been identified and meets on an annual basis to evaluate all ongoing examine information and human topics points. Standardized protocols and trainings are used to assure consistency and constancy to the intervention and assessments across a number of examine sites. Research assistants, medical coordinators, and facilitators obtain commonplace coaching of their areas of duty, including procedural manuals and checklists.
Finally, our research addresses many of the scientific limitations of previous research. As we have described above, the precise target population of our intervention has been largely absent in previous HIV-risk-discount interventions. While combination HIVRR and microfinance interventions have been proven to cut back HIV danger and empower women to protect themselves, these studies not often focus on women who use or inject medicine. Both our intervention and our assessments are tailored to the needs and realities of women who share the dual dangers of intercourse work and drug use. HIVRR intervention classes rigorously incorporated core parts of the intersection of drug use and sexual danger, and risk-discount strategies with paying partners.
Our use of a longitudinal examine design, assessing outcomes over a 12-month post-intervention period, allows for us to look at the long-lasting effects of our intervention and assess the sustainability of its outcomes. Our mixed-methods approach, which incorporates organic assessments, behavioral questionnaires, in-depth interviews, and cost information, allows us to evaluate the influence of our intervention on multiple ranges. The qualitative part of our study makes use of in-depth interviews to probe deeper into the barriers to savings and vocational entry skilled by FSW, as well as providing info on the feasibility and acceptability of the intervention.
STIs acquired and treated between the baseline and month-9 evaluation or between the month-9 and month-15 assessment at an exterior clinic are solely 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 display screen positive for syphilis to the local Skin and Venereal Disease Dispensary to receive extra confirmatory testing for syphilis, consultations with a doctor, and therapy for lively types of syphilis. Treatment for HCV is not broadly available in Kazakhstan, and medical coordinators refer participants who check constructive for HCV to specialised clinics for added examination, monitoring, and therapy.
Recruitment for this examine began in May 2015, and the last cohort of participants was enrolled in July 2017. We anticipate a number of challenges in recruitment and retention of participants. FSW who use medication are extremely marginalized, and infrequently hesitant to hunt healthcare and different services for worry of stigma or authorized repercussions .
Our assessments present much-needed knowledge on the experiences, dangers and desires of this population in Kazakhstan, the variables that moderate and mediate HIV-danger outcomes, and how these differ between treatment and management circumstances. We are the primary examine, to our knowledge, to make use of organic testing to complement self-reported HIV and STI information. Our stringent high quality management measures and using a computerized information collection software ensure standardization and consistency among participants. Ours is the first RCT performed with FSW in Kazakhstan, and one of many few conducted in Central Asia.
Our assessment measures include sensitive information on highly stigmatized behaviors, together with sexual habits historical past and drug use. Finally, given the lengthy time-frame of our examine and the staggered begin dates between the Temirtau and Almaty sites, we suspect that exterior confounding factors may influence participant enrollment and intervention outcomes. For instance, we’ve already observed a fast contraction of Kazakhstan’s economy kazakh girls and a currency devaluation in the summer of 2015, which can impact individuals’ financial savings behavior. Academic literature on microfinance for HIV-risk discount has called for a extra rigorous testing of interventions, examination of the causal pathways between microfinance and decreased threat-behavior outcomes, and the use of biomarkers .
Our determination to recruit at area areas in addition to via a peer-referral system was supposed to increase the attain of our examine to as many FSW as potential. However, there’s some proof that shows that community-primarily based recruitment and venue-primarily based recruitment of FSW yields populations with different sociodemographic traits and even completely different STI prevalence . We goal to resolve this issue by way of random project to check situation, and to conduct analyses that think about recruitment supply, and some other variations potentially identified between research conditions, as a moderating variable. Cluster randomization methods could offset the effects of choice bias, and analyses will compare baseline traits of each therapy and control arms.
If members obtain a optimistic fast test for HIV, the clinical coordinator refers them to the native AIDS heart for confirmatory testing and therapy. HIV-positive individuals signal a further waiver allowing our examine access to therapy data at the native HIV clinic. Clinical coordinators acquire information on confirmatory testing , viral-load check outcomes, CD4 test results, and antiretroviral medication historical past at each assessment interval for every participant. Follow-up assessments happen as early as 1 week earlier than the precise follow-up date, and as late as 3 weeks after the exact observe-up date.