NCT04719364

Brief Summary

The investigators are conducting a one and one-half year mixed-methods study to evaluate self-reported sexual risk, knowledge and barriers/facilitators of PrEP use, and preferences of oral, injectable, and implantable PrEP treatment modalities-as a function of race and age, and experience with intersectional discrimination. The first qualitative phase of our study would be conducted over the first eight months, followed by a quantitative phase that will collect data via online cross-sectional survey over the remaining ten months.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

November 9, 2020

Last Update Submit

January 20, 2021

Conditions

Keywords

PrEPMSMBarriersFacilitatorsDiscrimination

Outcome Measures

Primary Outcomes (11)

  • condomless anal intercourse

    frequency of condomless intercourse with other men

    Baseline

  • Awareness of PrEP

    Survey item adapted from the NHBS-- yes/no

    Baseline

  • Likelihood of daily PrEP use

    5-point Likert scale measuring likelihood of using daily oral PrEP if freely available and covered by insurance

    Baseline

  • Barriers to PrEP use

    6-item checklist of barriers as previously reported in peer-reviewed literature and confirmed by proposed qualitative research

    Baseline

  • Facilitators of PrEP use

    7-item checklist of facilitators as previously reported in peer-reviewed literature and confirmed by proposed qualitative research

    Baseline

  • Injectable PrEP treatment modality preference

    5- item Likert scale to report likelihood of using monthly injectable PrEP versus daily oral dosing

    Baseline

  • Implantable PrEP treatment modality preference

    5- item Likert scale to report likelihood of using long-acting implantable PrEP versus daily oral dosing

    Baseline

  • Long-acting oral PrEP treatment modality preference

    5- item Likert scale to report likelihood of using long-acting oral PrEP versus daily oral dosing

    Baseline

  • Intersectional anticipated discrimination scale

    5-point Likert scale to measure likelihood of anticipated experiences with discrimination (subscale from Scheim and Bauer,2019; Intersectional Discrimination Index: 0-4 score for each of 11 items which are then averaged for a score of 0-4; higher mean score associated with greater risk of high risk sexual outcome as well as preference for long-acting PrEP treatment modalities that required less interaction with healthcare system)

    Baseline

  • Intersectional day-to-day discrimination index

    4-point frequency scale to measure occurrence of day-to-day experiences with discrimination (subscale from Scheim and Bauer ,2019; Intersectional Discrimination Index: 0-2 score for each of 9 items for a range of values between 0-18; higher score associated with greater risk of high risk sexual outcome as well as preference for long-acting PrEP treatment modalities that required less interaction with healthcare system)

    Baseline

  • Intersectional major discrimination index

    3-frequency scale for major experiences due to discrimination (subscale from Scheim and Bauer, 2019) Intersectional Discrimination Index: 0-2 score for each of 13 items which are then summed for scores of 0-26 (lifetime experience); higher scores associated with greater risk of high risk sexual outcome as well as preference for long-acting PrEP treatment modalities that required less interaction with healthcare system)

    Baseline

Study Arms (2)

Focus Groups

10 black, 10 Latinx, and 10 white MSM will be recuited in this focus group 'cohort'

Quantitative Survey Group

Cross-sectional group of 100 black, 100 Latinx, and 100 white MSM

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailscis Male
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The proposed mixed methods study will evaluate PrEP awareness, barriers and facilitators of uptake, and preference for monthly injectable and annual implantable PrEP versus daily oral medication in a diverse racial/ethnic sample of men who have sex with men (MSM). Specifically, we plan to recruit sufficient numbers (n=300 total) of black MSM (n=100) and Hispanic/Latino MSM (n=100), as well as non-Hispanic/Latino White men (n=100) (at least 18 years of age) to enable our team to evaluate disparities concerning PrEP awareness and knowledge, as well as potential preferences for specific treatment modalities.

You may qualify if:

  • Self-identifying as gay, bisexual or a man who has sex with men (MSM)
  • Being at least 18 years of age; 3) self-reporting as being HIV-negative
  • Having had anal intercourse with a man in the past six months
  • Not in a monogamous partnership with a recently tested, HIV-negative man AND at least one of the following: Any anal sex without condoms (receptive or insertive) in past 6 months or having been diagnosed with a bacterial STI (syphilis, gonorrhea, or chlamydia) in past 6 months.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel Dornsife School of Public Health

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

RacismSocial Stigma

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehaviorSocial Discrimination

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Epidemiology

Study Record Dates

First Submitted

November 9, 2020

First Posted

January 22, 2021

Study Start

February 1, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations