跳至主要内容
临床试验/NCT04719364
NCT04719364Unknown不适用

A Cross-Sectional Survey of PrEP Awareness, Barriers and Facilitators for PrEP Uptake, and the Impact of Dosing Mechanisms on Willingness to Take PrEP Among MSM Indicated for PrEP Use in Philadelphia

Drexel University1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
330
试验地点
1
主要终点
Facilitators of PrEP use

研究概览

简要总结

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.

详细描述

This mixed-methods project will evaluate PrEP awareness and potential impact of new dosing strategies/modalities on PrEP uptake among men who have sex with men (MSM)-the target group at highest risk for infection and at highest priority for PrEP use based on high risk sexual behaviors (condomless anal intercourse). The proposed project utilizes both qualitative analysis of focus group data from MSM study participants, as well as quantitative analysis of results from a survey informed by results of the qualitative phase of our project. It should be noted that while the investigators will target a racially diverse MSM study population, participation in our study may include MSM who also inject drugs (MSM-PWID) who express interest in study participation.

The investigators propose 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.

Recruitment for both qualitative and quantitative parts of our project will occur through events sponsored by the Philly Ballroom Community, freeHIVTest.Net, GALAEI and COLOURS (CBOs), and Drexel's HIV Clinical Center, the Partnership Comprehensive Care Practice. For our quantitative survey, the investigators plan to enhance our recruitment using online social media sites that especially target BMSM and HLMSM, and Google Words-the investigators will display links to our study that will enable recruitment.

For qualitative work, the investigators plan to conduct six focus groups of 5 MSM each (total = 30 participants), each restricted by race and age (Black, White, or Hispanic/Latino (either Black or White) and age (18-39 yrs. of age and > 40 yrs. of age). Four to six focus groups are usually recommended to reach saturation. Given probable cultural and age-specific differences of PrEP awareness and knowledge, as well as barriers or facilitators, and preference for specific treatment modalities, the investigators plan to restrict group participation by race and age as outlined above.

Data collected from the 30 focus group participants will be analyzed using standard qualitative analytic approaches (Months 7-8). Drexel University's Dornsife School of Public Health have available a wide range of qualitative data analysis software and strategies for more sophisticated coding, retrieval, and concept development of the information collected in the focus groups. The investigators will utilize standard qualitative techniques, including inductive code identification and development and associated documentation through marginal remarks and memos. Inductive coding ("open coding") involves a data-based approach to the identification of key themes (codes). This approach encourages a conceptualization and organizational framework of the data from a grounded perspective. NVivo, a system for the management, interpretation and analysis of qualitative data, will be used in this process. Results from the qualitative phase of our project will be used to inform/add to the content of our study instrument to collect data during the second, quantitative phase of our project. For the quantitative, cross-sectional survey, the investigators plan to enroll equal numbers of White, Black, and Hispanic/Latino MSM (100 members per racial/ethnic group, for a total of 300 participants).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Facilitators of PrEP use

时间窗: Baseline

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

Barriers to PrEP use

时间窗: Baseline

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

Injectable PrEP treatment modality preference

时间窗: Baseline

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

Implantable PrEP treatment modality preference

时间窗: Baseline

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

Intersectional day-to-day discrimination index

时间窗: Baseline

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)

condomless anal intercourse

时间窗: Baseline

frequency of condomless intercourse with other men

Long-acting oral PrEP treatment modality preference

时间窗: Baseline

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

Intersectional anticipated discrimination scale

时间窗: Baseline

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)

Awareness of PrEP

时间窗: Baseline

Survey item adapted from the NHBS-- yes/no

Likelihood of daily PrEP use

时间窗: Baseline

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

Intersectional major discrimination index

时间窗: Baseline

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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seth Welles

Professor of Epidemiology

Drexel University

研究点 (1)

Loading locations...

相似试验