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Intrapersonal, interpersonal, and environmental factors are assessed by audio computer-assisted self-interview survey. Primary outcomes include sexual risk behaviors e.
The study's anticipated findings will be of interest to a broad audience and lead to more informed prevention efforts, including effective policies and interventions, that achieve the goals of the updated U. This is an open access article distributed under the terms of the Creative Commons Attributionwhich permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
The funders had no role in study de, data collection and analysis, decision to publish, or preparation of the manuscript. Competing interests: The authors have declared that no competing interests exist. In the United States U. These stark racial differences are most evident among sexual minority populations, especially gay, bisexual and other men who have sex with men collectively referred to as MSM herein.
Lastly, in terms of geography, the rate of new HIV infections in the U. Taken together, these data highlight that the rates of HIV among African American MSM in Mississippi and Georgia are amongst the highest in the nation [ 78 ] and that public health researchers must intensify their efforts to identify relevant determinants that may mitigate HIV acquisition and transmission in this high-risk population in order to achieve the goals of the updated U. HIV epidemic [ 1011 ]. Other studies that consider macro-level, or distal, factors e.
Casual sex partners in Durant Mississippi addition, evidence from sexual network studies reveal that multiple contexts within the sexual dyad, including having commercial e. Finally, an emerging literature suggests that structural stigma, neighborhood residential segregation, and other neighborhood-level characteristics are associated with HIV risk among African American MSM [ 43 — 45 ].
The Institute of Medicine recommends the prioritization of HIV prevention research among MSM to utilize theoretical frameworks such as the socio-ecological model to fully characterize the environmental 'riskscape' i.
The socio-ecological model is a promising multi-level approach that considers the complex interplay between individual or intrapersonalinterpersonal, environmental e. This paper describes the de, sampling methods, and data collection and management methods of the ongoing MARI Study. The Open Arms Healthcare Center www. Thus, these clinics serve as primary portals for the medical care of underserved and highly marginalized populations, including African American MSM.
In particular, the study is deed, a priorito enroll approximately equal s of African American MSM from the two study sites. Participants at the Jackson, MS site are recruited from urban and rural areas in the five-county MSA of Copiah, Hinds which includes the city of Jackson, the capital and largest city in the state of MississippiMadison, Rankin, and Simpson counties. Given the demographic composition of the Jackson Inclusion criteria further require a self-report of 1 ased biological male sex at birth; 2 being 18 years or older; and, 3 engaging in oral or anal sex with another man in the six Casual sex partners in Durant Mississippi prior to study enrollment Table 1.
Recruitment will occur between July at the Jackson site and January at the Atlanta site and until the aforementioned recruitment targets are reached or December 31, Building on our experience addressing HIV among African American MSM in our current and past portfolio, we utilize a variety of population-based sampling methods in the current study.
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Second, face-to-face recruitment is conducted at local venues bars and clubs frequented by African American MSM and during HIV prevention interventions and testing events, and other various community events hosted by the local CBOs. Importantly, research staff wear promotional t-shirts that contain details about the study to increase visibility and garner interest in the study. Third, social and geospatial networking 'apps' are utilized to recruit study participants.
A recruitment script, with probes, gives research staff flexibility to communicate with potential participants, and thereby develop a rapport and sense of trust with these individuals. The main theme of the script focuses on improving the overall health of African American men.
Finally, word of mouth referrals such as from participants who have already completed the study, local agencies and organizations that serve African American MSM, and clinical staff at Open Arms Healthcare Center and AID Atlanta Health Services Clinic, are utilized to recruit study participants.
Research staff complete an eligibility screening questionnaire validated using two focus groups containing nine African American Casual sex partners in Durant Mississippi prior to study initiation February to screen interested individuals for study eligibility See Table 1.
Reminder calls or text messages Casual sex partners in Durant Mississippi made the day before the scheduled appointment as well as at least one hour before the scheduled appointment to confirm or reschedule the appointment. Additionally, since transportation is often a barrier to participation in HIV prevention services among African American MSM [ 55 ], participants are offered transportation services to the study site at no cost.
In Jackson, MS, Open Arms Healthcare Center or the research staff provide transportation services for potential participants to and from the study site. A Certificate of Confidentiality from the CDC protects the privacy of research study participants against compulsory legal demands, such as court orders and subpoenas, as participants report on potentially illegal behaviors. At the time of enrollment into the study, participants are informed of the Certificate of Confidentiality.
The study visit includes several health screenings and a study questionnaire, which lasts approximately 1. The informed consent process takes place at each study site in a private interview room by research staff specifically trained in this process. Participants provide written informed consent and are given a copy of the consent document for their record.
After the health screenings, participants complete a study questionnaire. The procedures for these study components are described in greater detail below.
After informed consent, participants are escorted to a private restroom and instructed to change into a light-weight surgical scrub suit provided by each study site. Each study site provides participants with a safe place to store clothing and valuables. After a five minute wait in a quiet room, research staff ascertain two blood pressure systolic and diastolic and pulse rate measurements, taken one minute apart, from the right arm of seated participants whose back and arm were supported using an appropriately sized cuff.
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Research staff collecting anthropometric and blood pressure measures are non-clinical professionals who have been trained by a registered nurse with more than 20 years of nursing experience and experience working with cohort studies such as the Jackson Heart Study.
Research staff certified in HIV counseling, testing and referral first administer a paper-based questionnaire to ascertain a history of HIV and syphilis infection. Accordingly, research staff perform rapid HIV testing after risk reduction counseling for HIV-uninfected participants or participants unaware of their status. Participants aware of their HIV infection an Authorization for the Release of Health Information form, which allows the PI to obtain HIV infection information such as date of infection, engagement in care, CD4 count and viral load for the past 12 months.
Next, whole blood is collected from each participant using a Vacutainer blood collection tube venipuncture for syphilis testing.
After venipuncture, participants are escorted to a private restroom and instructed on the self-collection of pharyngeal and rectal swabs as well as a urine specimen for gonorrhea and Chlamydia testing. Instructions, with illustrations, are posted in visible areas in the restroom at each study site Figs 1 and 2. Prior work among MSM shows that self-collected pharyngeal and rectal swabs are equally reliable in detecting gonorrhea and Chlamydia infections as compared to swabs collected by trained health professionals [ 56 ].
After participants remove the scrub suit and redress in their own attire, participants are accompanied to Casual sex partners in Durant Mississippi private interview room to complete a study questionnaire. The list of study measures contained in the study questionnaire is provided in Table 2. We selected measures that capture the multi-level constructs necessary to typify the HIV environmental 'riskscape' of African American MSM and to address our primary study aims, including the potential confounders or effect modifiers of our hypothesized associations.
All questions have been pilot tested using two focus groups with 9 African American MSM in each group prior to study initiation February and revised accordingly prior to administration in the study. An ACASI was chosen as the method of administration versus interviewer-administration in order to decrease the misclassification of sensitive questions such as experiences of sexual abuse in childhood and under-reporting of socially undesirable behaviors such as condomless anal sex [ 83 ].
At the end of the study visit, research staff perform an exit interview to provide participants with a brief interpretation of their anthropometric and blood pressure measurements and preliminary HIV test result as well as, if applicable, to ensure completion of the study questionnaire and confirm the participant's contact information for delivery of their STI test. This ensures that all participants with a reactive HIV test are linked to the appropriate care services as each study site is a primary healthcare facility that provides a range of HIV care services and maintains a referral network of other community social and clinical resources.
The selection of study measures is guided by the socio-ecological model for MSM [ 48 ], which provides a multi-level framework of proximal and distal determinants of HIV risk. Importantly, the socio-ecological model framework allows for the inclusion of micro e.
Sexual risk behaviors and prevalent HIV and STIs Chlamydia, gonorrhea and syphilis have been selected as the primary outcomes because they facilitate the acquisition and transmission of HIV. Many of the study measures have been validated for use among African American MSM in studies. However, when validated measures are Casual sex partners in Durant Mississippi available, we revised existing measures for use in the current study.
We plan to develop separate manuscripts that will describe and document the psychometrics of several socio-cultural measures e. Residential mailing addresses for the past five years are ascertained from study participants and will be retrospectively geocoded [ 8485 ]. This will allow us to develop an innovative measure of mobility as well as link to publically and commercially-available neighborhood-level measures such as neighborhood disadvantage [ 8182 ] and LGBT hate crimes [ 86 ] to study data, which is a major strength of the study.
The MSDH Public Health Laboratory serves as the central laboratory and maintains a protocol for specimen collection, storage and transport. Urine and blood specimens and pharyngeal and rectal swabs including those shipped to My Brother's Keeper from the Atlanta site via FedEx using the appropriate biohazard packaging are hand-delivered weekly to the MSDH Public Health Laboratory.
The Georgia Public Health Laboratory accepts and processes blood specimens for syphilis testing from the Atlanta study site. Allirrespective of study site, are posted on a secure encrypted online system within seven days of delivery to the respective laboratory. In collaboration with the Atlanta site research team, The MARI Study Coordinating Center maintains a comprehensive data capture and management system along with quality assurance and control procedures to ensure rigorous and high-quality data collection and adherence to study protocols.
Data collection and entry are important processes to ensure good quality data, which lead to sound and reliable conclusions. After the completion of each participant study visit, the Quality Assurance Casual sex partners in Durant Mississippi at each study site reviews each participant's study folder for completion and notes any missing data components or changes in the order of the study procedures e.
Double data entry [ 87 ] is utilized to identify systematic errors in manually entered data. Therefore, a second research staff member periodically enters data collected on paper-based forms e.
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Additionally, the data management team performs several quality control checks e. Finally, The MARI Study Coordinating Center guides the analytics of the study, which will include calculating prevalence estimates of primary outcomes, typifying the HIV environmental 'riskscape', and addressing the aforementioned Specific Aims. It is anticipated that novel and unparalleled findings will result from The MARI Study and will have broad scientific interest and immediate public health applicability.
The research team maintains an intricate plan to disseminate study findings to both professional and lay communities as well as circulate study data to study collaborators. The dissemination plan includes presentations in professional and community meetings e.
Finally, every effort will be made to make these data accessible for research purposes, which includes the development of a Research Writing Casual sex partners in Durant Mississippi that currently meets on a bi-weekly basis to discuss preliminary studydevelop concept sheets for additional scientific manuscripts, and future research ideas.
Study investigators also maintain a Data Distribution Agreement in order to protect the privacy and confidentiality of participants and their families. Both Internal and External researchers and collaborators interested in accessing study data may contact the PI Hickson and must agree to adhere to the requirements of Casual sex partners in Durant Mississippi Data Distribution Agreement. However, evidence from large-scale epidemiologic studies that consider novel theoretical frameworks to understand the multi-faceted and multi-level exposures that contribute to HIV outcomes among African American MSM is lacking [ 22 — 24 ].
These new and unprecedented findings will largely inform prevention efforts and opportunities to intervene to reduce the African American-White HIV disparity. Second, our work will have policy relevance: increasing efforts to combat incarceration rates among young African American MSM through the creation of educational training programs that reduce high school dropout rates and enforcement of laws that limit policing of LGBT or youth of color.
Finally, we will be able to identify geographic locations for HIV prevention interventions, including geographically targeted HIV testing, as we begin to document relationships between environmental characteristics and HIV risk. Therefore, evidence from this study will provide unequivocal evidence into the underlying mechanisms of HIV in African American MSM and inform a variety of prevention efforts and effective federal, state, and local policies for eliminating disparities in this high-risk population.
This approach will allow us to tease apart the complex interplay between individual, interpersonal and neighborhood-level factors and their concomitant influence on HIV risk in this highly marginalized population. Finally, the inclusion of novel individual e. The de of The MARI Study is cross-sectional, so this limits our ability to infer causal inferences and how risk and protective factors are associated with HIV infection over time.
In anticipation of funding for follow-up studies including repeated examinations, we developed several retention procedures, including the collection of detailed contact information, to follow participants more effectively as well as the study de and operations will allow for prospective investigations into incident HIV and other STIs. The careful and robust use of this resource will provide substantial benefits to these communities and will ultimately inform bio-behavioral prevention efforts that eliminate longstanding and pervasive HIV health disparities among African American MSM in the deep South.
Gipson co-I ; Leandro A. Conceived and deed the experiments: DAH. Performed the experiments: NS JS.