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临床试验/NCT05434390
NCT05434390已完成不适用

Evaluating the Feasibility and Acceptability of a Latino MSM Focused PrEP Uptake Intervention

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2022年10月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
2
主要终点
PrEP initiation

研究概览

简要总结

The clinical study will evaluate the feasibility and acceptability of a culturally tailored behavioral intervention to improve uptake of pre-exposure prophylaxis for HIV prevention among at-risk Latino men who have sex with men.

详细描述

The clinical study will evaluate the feasibility and acceptability of a brief small group and peer navigation behavioral intervention to improve uptake of pre-exposure prophylaxis (PrEP) for HIV prevention among at-risk Latino men who have sex with men. The brief intervention consists of 4 small group sessions with concurrent peer navigation and counseling. Study participants will be randomized to either an intervention or control condition. Participants in the control condition will receive usual care for PrEP promotion (i.e., referral to PrEP services). The study will determine the feasibility and acceptability of the intervention among Latino men who have sex with men and assess the preliminary impact of the intervention compared to control condition in facilitating PrEP uptake.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • 18 years of age or older
  • assigned male at birth
  • Identifies as Latino/Hispanic origin
  • HIV-negative or HIV status unknown
  • Man who has had sex with other men in the past 24 months
  • Not currently using PrEP for HIV prevention

排除标准

  • Male under 18 years of age
  • Not identifying as being of Latino/Hispanic origin
  • Man who has not had sex with other men in the past 24 months
  • Identifies as cisgender or transgender Female/woman
  • Assigned female at birth

研究组 & 干预措施

Latino MSM PrEP intervention

Experimental

The Latino MSM PrEP intervention consists of 4 small group sessions with concurrent peer navigation and counseling.

干预措施: Estoy PrEParado/ I am PrEPared intervention (Behavioral)

Control condition

Active Comparator

The control condition consists of usual care at the study site (i.e., referrals to PrEP services).

干预措施: Usual Care (Behavioral)

结局指标

主要结局

PrEP initiation

时间窗: assessed at 3-month follow-up

We will assess PrEP uptake using evidence of a prescription for Truvada® or Descovy® (participant shows us their prescription bottle in person or via a text photo).

PrEP adherence urine sample

时间窗: assessed at 3-month follow-up

We will assess adherence to the PrEP medication by analyzing participants' urine sample to determine the presence of the medication tenofovir, a key medication in the PrEP medication.

PrEP adherence single measure

时间窗: assessed at 3-month follow-up

We will assess adherence to the PrEP medication using a single-item self-rating adherence measure.

PrEP initiation

时间窗: assessed at 1-month follow-up

We will assess PrEP uptake using evidence of a prescription for Truvada® or Descovy® (participant shows us their prescription bottle in person or via a text photo).

PrEP adherence single measure

时间窗: assessed at 1-month follow-up

We will assess adherence to the PrEP medication using a single-item self-rating adherence measure.

PrEP adherence urine sample

时间窗: assessed at 1-month follow-up

We will assess adherence to the PrEP medication by analyzing participants' urine sample to determine the presence of the medication tenofovir, a key medication in the PrEP medication.

次要结局

  • Changes in Readiness to Adopt PrEP(assessed at 3-month follow-up)
  • Changes in Readiness to Adopt PrEP(assessed at 1-month follow-up)

研究者

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

Ronald Andrew Brooks

Principal Investigator

University of California, Los Angeles

研究点 (2)

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