Clinical trial NCT05815030: HIV Pre-Exposure Prophylaxis Among an Unrecognized Sexual Minority Population
Official title: PrEP4Kink: Testing the Effects of an Interactive Educational Intervention on PrEP Uptake Among Kink-Involved Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pre-Exposure Prophylaxis
Keywords: PrEP
HIV Prevention
Kink
Lead sponsor: The Alternative Sexualities Health Research Alliance
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

In TASHRA's 2016 Kink Health Survey of 1,139 kink-involved individuals, the rate of HIV was approximately 10 times the national index. 37 (80.4%) of a total of 46 persons living with HIV were cis-male men who have sex with men (MSM) and men who have sex with men and women (MSMW). Seven (15.2%) were persons who had ever used intravenous drugs. Of those living with HIV, 38 (82.6%) were engaged in kink activities at high risk of blood exposure, 8 (17.4%) were engaged in activities at low risk of blood exposure, and none were engaged only in activities considered to have no risk of blood exposure. It should be noted that the sample for the 2016 Kink Health Survey was limited in racial and ethnic diversity, while having a high degree of gender and sexual orientation diversity.

Educational interventions appear to be effective in increasing PrEP uptake. One study of 116 African American women found that an avatar-led eHealth video that focused on education about PrEP from relatable characters did have a significant impact on intentions to seek out PrEP and to recommend PrEP to other women. Social cognitive theory predicts that perceived similarity of models enhances imitation and observational learning (together called vicarious learning). Social cognitive theory also proposes efficacy as an important element in the learning process by enhancing perseverance in learning and behavior. Efficacy is strongly affected by vicarious learning opportunities and verbal persuasion, which are key pathways for entertainment-education interventions. Entertainment-education through digital storytelling engages learners and enhances discussion and aids understanding of the content.

PrEP4Kink will provide kink-involved participants with an opportunity to receive PrEP information that is culturally tailored to their sexual and community identities, which does not exist in current promotional materials.

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; sexual orientation identity; and sexual attraction.

The primary endpoint is participant-reported uptake of PrEP. This is measured by survey at 3 months, 6 months, 9 months and 12 months of the study. Another primary outcome includes the number of people who persist in using PrEP during the study and the number of pills taken according to clinical guidelines (adherence) since the previous data collection period for each person reporting persistant use of PrEP. These measures will be self-reports at T2 (3 months), T3 (6 months), T4 (9 months) and T5 (12 months) (Please see attachments titled "PrEP4Kink Measures" and "PrEP4Kink Theoretical Framework."

The secondary endpoints are Knowledge about PrEP and Attitudes towards PrEP. The Knowledge about PrEP measure comprises participant-reported items designed to measure key constructs in the Health Belief Model. These participant-reported items will measure perceived benefits of PrEP, the perceived effectiveness of PrEP; perceived risk of HIV acquisition; and perceived susceptibility to HIV acquisition. Items on the survey will also measure perceived barriers to PrEP uptake. Another section of the survey instrument will measure Attitudes towards PrEP. This section will comprise items to measure self-efficacy of initiating PrEP treatment. Another set of items will measure PrEP stigma, including shame, character judgment, and perceived level of social support. Please see attachments titled "PrEP4Kink Measures" and "PrEP4Kink Theoretical Framework."

Eligibility criteria: 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

Primary outcomes:
measure: PrEP Uptake
timeFrame: one year
Secondary outcomes:
measure: PrEP Adherence
timeFrame: one year
measure: Percentage of Treatment Persistence
timeFrame: one year
Other outcomes:
measure: Knowledge of PrEP
timeFrame: one year
measure: difficulty in initiating PrEP uptake
timeFrame: one year
measure: Susceptibility to HIV
timeFrame: one year
measure: Perceived barriers to PrEP uptake
timeFrame: one year
measure: Perceived benefits and effectiveness of PrEP uptake
timeFrame: one year
Locations:
city: Rio Vista
country: United States
facility: TASHRA
state: California
Study officials:
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