HIV Pre-Exposure Prophylaxis Among an Unrecognized Sexual Minority Population (PrEP4Kink)

February 21, 2025 updated by: The Alternative Sexualities Health Research Alliance

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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."

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Rio Vista, California, United States, 94571
        • TASHRA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
experimental group, receiving 3 exposures to the kink-focused video intervention
Other: video informational/educational intervention
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.
Other: Group B
control group, receiving no exposure to the kink-focused video, but seeing the generic / standard video
Other: video informational/educational intervention
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.
Other: Group C
group that receives 1 exposure to the generic / standard video, and later 2 exposures to the kink-focused video
Other: video informational/educational intervention
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.
Other: Group D
group that receives 2 exposures to the generic / standard video, and later 1 exposure to the kink-focused video
Other: video informational/educational intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP Uptake
Time Frame: one year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Treatment Persistence
Time Frame: one year
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
PrEP Adherence
Time Frame: one year
Self-report number of pills missed in previous 7 days will be measured every 3 months throughout the implementation period.
one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge of PrEP
Time Frame: one year
9 item questionnaire, not a scale
one year
difficulty in initiating PrEP uptake
Time Frame: one year
self-efficacy of initiating PrEP uptake; 8 item questionnaire, not a scale
one year
Susceptibility to HIV
Time Frame: one year
3 item modeled on Champion's Health Belief Model Scale, not a scale in this study
one year
Perceived barriers to PrEP uptake
Time Frame: one year
9 item questionnaire, not a scale
one year
Perceived benefits and effectiveness of PrEP uptake
Time Frame: one year
3 item questionnaire, not a scale
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Alternative Sexualities Health Research Alliance

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

November 16, 2022

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • T2022-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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