Pre-Exposure ProphylaxisPrEP4KinkNCT05815030
HIV Pre-Exposure Prophylaxis Among an Unrecognized Sexual Minority Population
A study testing video informational/educational intervention in people with Pre-Exposure Prophylaxis, run by The Alternative Sexualities Health Research Alliance at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre-Exposure Prophylaxis
- What is being tested?
- video informational/educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
Read the 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."
- Conditions
- Pre-Exposure Prophylaxis
- Being tested
- video informational/educational intervention
- Keywords
- PrEP, HIV Prevention, Kink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video informational/educational interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | experimental group, receiving 3 exposures to the kink-focused video intervention Receives: Other: video informational/educational intervention |
| Group B | Other | control group, receiving no exposure to the kink-focused video, but seeing the generic / standard video Receives: 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 Receives: 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 Receives: Other: video informational/educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (2)
PrEP Adherence
Self-report number of pills missed in previous 7 days will be measured every 3 months throughout the implementation period.
Measured: one year
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).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start11 Apr 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Why it stopped: difficulty enrolling participants in study created too long a delay
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Pre-Exposure ProphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alternative Sexualities Health Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815030
- Sponsor's protocol ID
- T2022-02
- Acronym
- PrEP4Kink
- Status last verified
- Feb 2025
- First submitted
- 16 Nov 2022
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bauer, R. Queer BDSM intimacies: Critical consent and pushing boundaries. Palgrave: Houndmills 2014.
Bauer, R. Desiring masculinities while desiring to question masculinity? How embodied masculinities are renegotiated in les-bi-trans-queer BDSM practices. Norma, 11: 237-254.
Bernstein IH, Keith JB. Reexamination of Eisen, Zellman, and McAlister's Health Belief Model questionnaire. Health Educ Q. 1991 Summer;18(2):207-20. doi: 10.1177/109019819101800206.
PubMed 2055778Bowleg L, Huang J, Brooks K, Black A, Burkholder G. Triple jeopardy and beyond: multiple minority stress and resilience among black lesbians. J Lesbian Stud. 2003;7(4):87-108. doi: 10.1300/J155v07n04_06.
PubMed 24831386Cantor JM. Is homosexuality a paraphilia? The evidence for and against. Arch Sex Behav. 2012 Feb;41(1):237-47. doi: 10.1007/s10508-012-9900-3.
PubMed 22282324Costello, A. B., & Osborne, J. (2005). Best practices in exploratory factor analysis: Four recommendations for getting the most from your analysis. Practical Assessment, Research, And Evaluation, 10(1), 7.
Cramer RJ, Johnson KL, Nobles MR, Holley SR, Desmarais SL, Gemberling TM, Wright S, Wilsey CN, Van Dorn RA. Lifetime Suicide-Related Behavior, Violent Victimization, and Behavioral Health Outcomes: Results From a Vulnerable Population Needs Assessment. J Interpers Violence. 2021 Jun;36(11-12):5860-5871. doi: 10.1177/0886260518801941. Epub 2018 Sep 28.
PubMed 30261811Cyril S, Smith BJ, Possamai-Inesedy A, Renzaho AM. Exploring the role of community engagement in improving the health of disadvantaged populations: a systematic review. Glob Health Action. 2015 Dec 18;8:29842. doi: 10.3402/gha.v8.29842. eCollection 2015.
PubMed 26689460Dawson SJ, Bannerman BA, Lalumiere ML. Paraphilic Interests: An Examination of Sex Differences in a Nonclinical Sample. Sex Abuse. 2016 Feb;28(1):20-45. doi: 10.1177/1079063214525645. Epub 2014 Mar 14.
PubMed 24633420Gonzales G, Dedania R, Driscoll R. Health Insurance Coverage and Access to Care Among US-Born and Foreign-Born Sexual Minorities. J Immigr Minor Health. 2019 Jun;21(3):540-548. doi: 10.1007/s10903-018-0774-x.
PubMed 29946865Hammers, C., & Brown III, A. D. (2004). Towards a feminist-queer alliance: a paradigmatic shift in the research process. Social Epistemology, 18(1), 85-101.
Holvoet L, Huys W, Coppens V, Seeuws J, Goethals K, Morrens M. Fifty Shades of Belgian Gray: The Prevalence of BDSM-Related Fantasies and Activities in the General Population. J Sex Med. 2017 Sep;14(9):1152-1159. doi: 10.1016/j.jsxm.2017.07.003. Epub 2017 Aug 7.
PubMed 28781214Jacobs LA. Health beliefs of first-degree relatives of individuals with colorectal cancer and participation in health maintenance visits: a population-based survey. Cancer Nurs. 2002 Aug;25(4):251-65. doi: 10.1097/00002820-200208000-00001.
PubMed 12181494Jaffee KD, Shires DA, Stroumsa D. Discrimination and Delayed Health Care Among Transgender Women and Men: Implications for Improving Medical Education and Health Care Delivery. Med Care. 2016 Nov;54(11):1010-1016. doi: 10.1097/MLR.0000000000000583.
PubMed 27314263Johnson MJ, Nemeth LS. Addressing health disparities of lesbian and bisexual women: a grounded theory study. Womens Health Issues. 2014 Nov-Dec;24(6):635-40. doi: 10.1016/j.whi.2014.08.003. Epub 2014 Oct 5.
PubMed 25287354
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEP4Kink: Testing the Effects of an Interactive Educational Intervention on PrEP Uptake Among Kink-Involved Adults
- ClinicalTrials.gov ID
- NCT05815030
- Acronym / sponsor ID
- PrEP4Kink / T2022-02
- Conditions
- Pre-Exposure Prophylaxis
- Keywords
- PrEP, HIV Prevention, Kink
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty enrolling participants in study created too long a delay
- Enrolment
- 57 participants (actual)
- Lead sponsor
- The Alternative Sexualities Health Research AllianceUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: video informational/educational interventionexperimental group, receiving 3 exposures to the kink-focused video intervention |
| Group B | Other | Other: video informational/educational interventioncontrol group, receiving no exposure to the kink-focused video, but seeing the generic / standard video |
| Group C | Other | Other: video informational/educational interventiongroup that receives 1 exposure to the generic / standard video, and later 2 exposures to the kink-focused video |
| Group D | Other | Other: video informational/educational interventiongroup that receives 2 exposures to the generic / standard video, and later 1 exposure to the kink-focused video |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Age of majority in the legal jurisdiction (geographic location) where the survey is taken (usually age 18)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video informational/educational interventionVideos 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 A, Group B, Group C, Group D |
Primary outcome
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.
2 secondary outcomes
PrEP Adherence
Time frame: one year
Percentage of Treatment Persistence
Time frame: one year
Results and safety
The study was stopped early (reason given: difficulty enrolling participants in study created too long a delay). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- BackgroundBauer, R. Queer BDSM intimacies: Critical consent and pushing boundaries. Palgrave: Houndmills 2014.
- BackgroundBauer, R. Desiring masculinities while desiring to question masculinity? How embodied masculinities are renegotiated in les-bi-trans-queer BDSM practices. Norma, 11: 237-254.
- Background: PubMed 2055778Bernstein IH, Keith JB. Reexamination of Eisen, Zellman, and McAlister's Health Belief Model questionnaire. Health Educ Q. 1991 Summer;18(2):207-20. doi: 10.1177/109019819101800206.
- Background: PubMed 24831386Bowleg L, Huang J, Brooks K, Black A, Burkholder G. Triple jeopardy and beyond: multiple minority stress and resilience among black lesbians. J Lesbian Stud. 2003;7(4):87-108. doi: 10.1300/J155v07n04_06.
- Background: PubMed 22282324Cantor JM. Is homosexuality a paraphilia? The evidence for and against. Arch Sex Behav. 2012 Feb;41(1):237-47. doi: 10.1007/s10508-012-9900-3.
- BackgroundCostello, A. B., & Osborne, J. (2005). Best practices in exploratory factor analysis: Four recommendations for getting the most from your analysis. Practical Assessment, Research, And Evaluation, 10(1), 7.
- Background: PubMed 30261811Cramer RJ, Johnson KL, Nobles MR, Holley SR, Desmarais SL, Gemberling TM, Wright S, Wilsey CN, Van Dorn RA. Lifetime Suicide-Related Behavior, Violent Victimization, and Behavioral Health Outcomes: Results From a Vulnerable Population Needs Assessment. J Interpers Violence. 2021 Jun;36(11-12):5860-5871. doi: 10.1177/0886260518801941. Epub 2018 Sep 28.
- Background: PubMed 26689460Cyril S, Smith BJ, Possamai-Inesedy A, Renzaho AM. Exploring the role of community engagement in improving the health of disadvantaged populations: a systematic review. Glob Health Action. 2015 Dec 18;8:29842. doi: 10.3402/gha.v8.29842. eCollection 2015.
- Background: PubMed 24633420Dawson SJ, Bannerman BA, Lalumiere ML. Paraphilic Interests: An Examination of Sex Differences in a Nonclinical Sample. Sex Abuse. 2016 Feb;28(1):20-45. doi: 10.1177/1079063214525645. Epub 2014 Mar 14.
- Background: PubMed 29946865Gonzales G, Dedania R, Driscoll R. Health Insurance Coverage and Access to Care Among US-Born and Foreign-Born Sexual Minorities. J Immigr Minor Health. 2019 Jun;21(3):540-548. doi: 10.1007/s10903-018-0774-x.
- BackgroundHammers, C., & Brown III, A. D. (2004). Towards a feminist-queer alliance: a paradigmatic shift in the research process. Social Epistemology, 18(1), 85-101.
- Background: PubMed 28781214Holvoet L, Huys W, Coppens V, Seeuws J, Goethals K, Morrens M. Fifty Shades of Belgian Gray: The Prevalence of BDSM-Related Fantasies and Activities in the General Population. J Sex Med. 2017 Sep;14(9):1152-1159. doi: 10.1016/j.jsxm.2017.07.003. Epub 2017 Aug 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video informational/educational intervention in people with Pre-Exposure Prophylaxis, run by The Alternative Sexualities Health Research Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulty enrolling participants in study created too long a delay). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP Uptake (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05815030, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.