HIV Pre-Exposure Prophylaxis Among an Unrecognized Sexual Minority Population

NCT05815030 | Terminated DMC

• 1 other identifier: T2022-02
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Exposure Prophylaxis

Keywords

PrEP; HIV Prevention; Kink

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• PrEP Adherence

  one year

• Percentage of Treatment Persistence

  one year

Other Outcomes (5)

• Knowledge of PrEP

  one year

• difficulty in initiating PrEP uptake

  one year

• Susceptibility to HIV

  one year

Study Arms (4)

Group A

EXPERIMENTAL

experimental group, receiving 3 exposures to the kink-focused video intervention

Other: video informational/educational intervention

Group B

OTHER

control group, receiving no exposure to the kink-focused video, but seeing the generic / standard video

Other: video informational/educational intervention

Group C

OTHER

group that receives 1 exposure to the generic / standard video, and later 2 exposures to the kink-focused video

Other: video informational/educational intervention

Group D

OTHER

group that receives 2 exposures to the generic / standard video, and later 1 exposure to the kink-focused video

Other: video informational/educational intervention

Interventions

video informational/educational intervention OTHER

Videos relating to PrEP use, its benefits, side effects, and other information. The educational/round-table video will highlight individuals from diverse backgrounds and identities who will share their experiences using PrEP, including perceived benefits and effectiveness, experienced barriers to PrEP uptake, their reasons for using PrEP, and their own self-efficacy. The control group's (generic / standard video) materials will be focused on PrEP uptake without a kink identity perspective. The treatment group's materials, however, will include videos that feature kink-identified individuals who discuss PrEP uptake through a kink perspective.

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Alternative Sexualities Health Research Alliance: lead

Study Sites (1)

TASHRA

Rio Vista, California, 94571, United States

Location

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: April 18, 2023
• Study Start: April 11, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

US (1)