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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05318053
Other study ID # T2021-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date July 31, 2028

Study information

Verified date November 2023
Source The Alternative Sexualities Health Research Alliance
Contact Richard A Sprott, PhD
Phone 510-919-4488
Email richard@tashra.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study design is an observational, longitudinal study with data collected online via a computer-assisted survey. Subjects will be recruited through non-probability snowball sampling. Objectives: 1. to document the prevalence of injuries and medical complications arising from kink activities 2. to document how healthcare is utilized by kink-involved people 3. to document the health outcomes particular to a large sample of kink-involved people 4. to test whether the centrality of kink identity and degree of community belongingness affect injuries, health outcomes, and healthcare utilization


Description:

In 2016, TASHRA conducted the first ever health survey of the U.S. kink community, examining issues of injuries, risky behavior, health status, and healthcare access and utilization, and patient satisfaction. It included measures of kink identity centrality, coming out, and kink community involvement as predictive factors. The findings provided a broad map of possible health disparities in a manner that was intended to direct future research. As such, several included measures did not ask any further questions to collect more detail of the context of health disparities or injuries, or their impact on the participant. The 2016 Kink Health Survey was an anonymous online survey that collected data from kink-involved people, from April 2016 to October 2016 (six month window). 1,118 individuals completed the survey. The results indicated the following (Sprott, Randall, Smith & Woo, 2021): - The percentage of people who reported past experiences of kink-related injury : 13.5% - The percentage of people who reported delaying or avoiding healthcare because of perceived stigma: 19.0%. - Past negative experiences with healthcare clinicians increased the odds of delaying or avoiding care significantly, with those participants four times more likely to avoid/delay care compared to participants who did not have negative experiences. - A significant portion of participants had not disclosed their kink identity or behavior with their physical healthcare clinician (58.3%), nor with their therapist or mental healthcare clinician (49.6%). The following health disparities were noted: - 4.1% of the sample reported being HIV positive. This is approximately 10x the national average. - 24% reported having attempted suicide at some point in their lives. This is approximately 5x the national average. - 17.98% reported having PTSD. This is 2.6x the national average. The current proposal, the International Kink Health Survey, proposes to follow up and expand on the previous 2016 survey in the following ways: - to expand the collection of data beyond the United States, to other English-speaking populations - to clarify the timing of health status measures and health disparities in relation to the initiation of kink activities - to expand measures of stigma and discrimination, paying closer attention to questions of multiple minority status and intersectionality, and their relation to health status and health disparities - to collect more in-depth information on kink community involvement, paying attention to online activities as part of community involvement in light of the COVID-19 pandemic - to collect more fine-grained information about injuries or medical complications that arise from engagement in kink scenes/activities - To collect more fine-grained information about suicidal behavior, mental health hospitalizations, and peoples' perceptions of the role of kink in relation to these mental health challenges - to measure future intentions to disclose kink involvement to healthcare providers The current proposed study will also address asexual people who engage in kink/BDSM behaviors (bondage, sadomasochism, and power exchange). The 2016 Kink Health Survey included this sexual orientation group, and we will continue to address this group. The study design is an observational, longitudinal study with data collected online via a computer-assisted survey. Subjects will be recruited through non-probability snowball sampling. Interested individuals will initially be screened for inclusion criteria. All completed questionnaires will be reviewed to ascertain whether inclusion criteria are met or exclusion criteria are met. Those who meet the inclusion criteria will be sent a message asking them to read and sign the Informed Consent form if they wish to enroll in the study. Those who meet the exclusion criteria or who do not complete an Informed Consent form after 3 contacts will have their information on the screening questionnaire in Ripple de-identified. In order to characterize the prescreening sample for reporting purposes, the de-identified data will be retained and may be analyzed. If they provide their consent, prospective participants will be considered enrolled in the study and will be sent email invitations to fill out survey instrument 1, and then every week sent an email to fill out survey instrument 2, and so on, as appropriate. IKHS Survey Instrument 1: Demographics Kink Behaviors Kink Fantasies Kink/Sexual Desire IKHS Survey Instrument 2: Future Disclosure COVID IKHS Survey Instrument 3: Kink Injury IKHS Survey Instrument 4: Physical Health IKHS Survey Instrument 5: Mental Health IKHS Survey Instrument 6: Healthcare Utilization IKHS Survey Instrument 7: Sex Work Consent Violations Kink and Past Trauma Stigma Family Support Sexual Shame and Pride Scale IKHS Survey Instrument 8: Adverse Childhood Events / Sensation-Seeking Alcohol / Drug


Recruitment information / eligibility

Status Recruiting
Enrollment 3164
Est. completion date July 31, 2028
Est. primary completion date March 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Successful completion of screening checklist to indicate one of the following conditions: 1. recurring, long-standing fantasies that focus on kink, in areas such as: power exchange (Dominant/submissive roles), bondage, sadomasochism, or fetish activities. By fetish, we mean a type of sexual desire in which gratification depends on or is significantly increased by particular objects, clothing items, parts of the body, or types of persons. 2. OR currently engaging, or have engaged in the past, in consensual kink activities such as power exchange (Dominant/submissive roles), bondage, sadomasochism, or fetish activities. 2. Age of majority in the legal jurisdiction (geographic location) where the survey is taken (usually age 18) 3. English-language proficiency sufficient to understand the study instruments 4. Completion of an electronically signed and dated informed consent form Exclusion Criteria: People who respond "no" to the following question on the screening checklist - I am familiar with the importance of consent and I endorse negotiation and safe words or safe signals in my sexual or kink play - Clearly fraudulent use of the internet survey, such as: evidence of non-human data entry via an internet "bot", duplicative or prank data entry that entails contradictory or clearly fraudulent data. - Any condition that, in the professional judgement of the Principal Investigator, should exclude an individual from participation in the study.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States TASHRA Rio Vista California

Sponsors (1)

Lead Sponsor Collaborator
The Alternative Sexualities Health Research Alliance

Country where clinical trial is conducted

United States, 

References & Publications (2)

Sprott RA, Randall A, Smith K, Woo L. Rates of Injury and Healthcare Utilization for Kink-Identified Patients. J Sex Med. 2021 Oct;18(10):1721-1734. doi: 10.1016/j.jsxm.2021.08.001. Epub 2021 Sep 2. — View Citation

Waldura JF, Arora I, Randall AM, Farala JP, Sprott RA. Fifty Shades of Stigma: Exploring the Health Care Experiences of Kink-Oriented Patients. J Sex Med. 2016 Dec;13(12):1918-1929. doi: 10.1016/j.jsxm.2016.09.019. Epub 2016 Oct 27. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Kink Injury self-report of injury or medical complication while engaged in kink activities; type of injury; frequency of injury Year 1
Primary Healthcare Utilization self-report of: types of care; frequency of care; patient satisfaction; experiences of discrimination in healthcare interactions Year 1
Primary Health Disparities self-report of: mental health issues; suicidality; obesity; sexually transmitted infections; blood-borne pathogens; alcohol/drug use Year 1
Secondary Community Belongingness self-report of sense of belonging to a kink community Year 1
Secondary Centrality of Kink Identity self-report of felt centrality of kink identity to sense of self Year 1
Secondary Concealment / Disclosure of Kink Involvement self-report of behavior on disclosure of kink identity or kink involvement Year 1
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