Pre-Exposure Prophylaxis Clinical Trial
— PrEP4KinkOfficial title:
PrEP4Kink: Testing the Effects of an Interactive Educational Intervention on PrEP Uptake Among Kink-Involved Adults
The Alternative Sexualities Health Research Alliance (TASHRA) will work collaboratively with Gilead Sciences, Inc. to study Pre-Exposure Prophylaxis (PrEP) uptake and adherence; levels of stigma around PrEP use; and changes in health beliefs around PrEP use. The study design will compare kink-involved or bondage/discipline/dominance/submission/sadism/masochism (BDSM)-involved individuals responses to generic vs. kink-focused printed and educational-entertaining video materials in a 12 month crossover study. The primary objective of the study is to examine factors that increase the uptake of PrEP in a novel sexual subculture by testing the impact of an entertainment-education intervention designed to be highly relatable to kink-involved individuals. Secondary Objectives: PrEP4Kink will measure knowledge of PrEP and attitudes towards PrEP uptake over time. These are elements identified by the Health Belief Model: perceived risk of HIV; susceptibility to HIV; perceived barriers to PrEP uptake; perceived benefits of PrEP uptake; perceived effectiveness of PrEP; and self-efficacy of initiating PrEP uptake. Moderating and ancillary factors will be measured, and their relation to the elements of the Health Belief Model will be analyzed. Moderating factors include the centrality of kink identity; the level of kink community involvement; the types and frequencies of kink and sex behaviors. Demographic variables will be measured and their relation to elements of the Health Belief Model will be analyzed, including age; number of years involved in kink; gender identity; sex assigned at birth; racial/ethnic identity; educational attainment; income level; insurance coverage; sexual orientation identity; and sexual attraction.
Status | Recruiting |
Enrollment | 536 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: - Successful completion of screening checklist to indicate one of the following conditions: o currently engaging, or have engaged in the last 3 months, in consensual kink activities 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. - Successful completion of screening checklist to indicate the following conditions: - weigh at least 35 kg; - report negative HIV serostatus, OR report that they "don't know" their HIV serostatus; - has never taken PrEP or been involved in any investigation trial of PrEP medication - Age of majority in the legal jurisdiction (geographic location) where the survey is taken (usually age 18) - English-language proficiency sufficient to understand the study instruments - Completion of an electronically signed and dated informed consent form Exclusion Criteria: Individuals will be ineligible for participation if they: - Are younger than 18 years of age - Weigh less than 35 kg - Are currently on PrEP - Enrolled in an investigational trial of PrEP medication - Have a self-reported positive HIV serostatus - Have previously used PrEP but was required to discontinue use due to serious side effects or medical contraindications - Have been diagnosed with renal failure or are dialysis dependent - Are currently pregnant |
Country | Name | City | State |
---|---|---|---|
United States | TASHRA | Rio Vista | California |
Lead Sponsor | Collaborator |
---|---|
The Alternative Sexualities Health Research Alliance |
United States,
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* Note: There are 34 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Knowledge of PrEP | 9 item questionnaire, not a scale | one year | |
Other | difficulty in initiating PrEP uptake | self-efficacy of initiating PrEP uptake; 8 item questionnaire, not a scale | one year | |
Other | Susceptibility to HIV | 3 item modeled on Champion's Health Belief Model Scale, not a scale in this study | one year | |
Other | Perceived barriers to PrEP uptake | 9 item questionnaire, not a scale | one year | |
Other | Perceived benefits and effectiveness of PrEP uptake | 3 item questionnaire, not a scale | one year | |
Primary | PrEP Uptake | Number of participants who test HIV-negative and begin using PrEP, divided by the number of participants who test HIV-negative and are provided information on PrEP through the study. This is a dichotomous variable reported as a percentage. | one year | |
Secondary | PrEP Adherence | Self-report number of pills missed in previous 7 days will be measured every 3 months throughout the implementation period. | one year | |
Secondary | Percentage of Treatment Persistence | Number of people who continue to use PrEP at each T measurement during the study after self-report of starting PrEP, divided by the number of people who use PrEP at previous T measurement (reported as a percentage). | one year |
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