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临床试验/NCT04201327
NCT04201327已完成不适用

Unified Approach to Address PrEP Care Cascade

University of Connecticut1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2020年1月1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
175
试验地点
1
主要终点
PrEP Linkage

研究概览

简要总结

Stigma related to PrEP interest and uptake, and medication cognitions related to PrEP adherence and persistence remain strong barriers to improving PrEP use. To address these areas, the investigators are proposing to develop an intervention grounded in two novel cognitive/behavioral theories: the HIV Stigma Framework and the Medication Necessity-Concerns Framework. Advances in biomedical HIV prevention, such as the availability of PrEP, will only impact the HIV epidemic if concurrent efforts are made to address the social and behavioral challenges that are associated with achieving sufficient coverage of PrEP among individuals at elevated risk for HIV.

详细描述

Biomedical HIV prevention tools are very promising, but are not sufficiently reaching those in greatest need. BMSM have experienced elevated rates of HIV incidence and prevalence since the beginning of the US epidemic, and the CDC estimates that half of BMSM will be diagnosed with HIV in their lifetime. Although Pre-Exposure Prophylaxis (PrEP) is highly effective for preventing HIV, there is urgent need to improve efforts to deliver PrEP, in particular, for BMSM at-risk for HIV. Current strategies to increase PrEP interest, uptake, and adherence are not adequate and there are formidable barriers (e.g., stigma surrounding PrEP use, and adherence and retention concerns) to sufficient coverage of PrEP that must be addressed. Without considerable and targeted change to our current approach to PrEP delivery, public health initiatives will fail to adequately provide PrEP to those in greatest need. In our PrEP focused preliminary studies with BMSM, the investigators have identified two primary areas in need of critical focus and intervention - (1) stigma related to PrEP use, and (2) medication cognitions such as the perceived costs and benefits of taking PrEP, both of which can impede PrEP interest, uptake, and adherence. To address these areas the investigators have developed an intervention grounded in two novel cognitive/behavioral theories: the HIV Stigma Framework and the Medication Necessity-Concerns Framework. Our study includes: Conducting a pilot test that compares our (a) PrEP information only control (n=25), (b) PrEP counseling (n=50), (c) PrEP counseling with text messages (n=50), and (d) PrEP enhancement counseling with text messaging and on-demand counseling (n=50). Advances in biomedical HIV prevention, such as the availability of PrEP, will only impact the HIV epidemic if concurrent efforts are made to address the social and behavioral challenges that are associated with achieving sufficient coverage of PrEP among individuals at elevated risk for HIV. Low-resource burden, easily implemented, and effective social/behavioral interventions are urgently needed if the full benefits of PrEP are to be realized. If effective and disseminated, this intervention would meet current prevention needs and its potential impact on HIV infections averted could be substantial.

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
Double (Investigator, Outcomes Assessor)

盲法说明

The investigator and the assessment staff are blind to the assignment of participants throughout the data collection phase of the study.

入排标准

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

入选标准

  • •Prior sex with a man, identify as Black, and HIV negative status.

排除标准

  • •Living with HIV

研究组 & 干预措施

PrEP information only arm

Active Comparator

Information to for accessing HIV prevention tools will be provided to participants.

干预措施: Project Jumpstart (Behavioral)

PrEP counseling arm

Experimental

Stigma focused counseling (one-session) aimed at addressing barriers to health care access will be provided.

干预措施: Project Jumpstart (Behavioral)

PrEP counseling plus text messaging arm

Experimental

Stigma focused counseling (one-session) and interactive text messaging aimed at addressing barriers to health care access will be provided.

干预措施: Project Jumpstart (Behavioral)

PrEP counseling plus text messaging and on demand counseling

Experimental

Ongoing stigma focused counseling and interactive text messaging aimed at addressing barriers to health care access will be provided.

干预措施: Project Jumpstart (Behavioral)

结局指标

主要结局

PrEP Linkage

时间窗: 6 months

Number of participants who attend PrEP care appointment. Documentation will be provided from clinic.

PrEP Adherence

时间窗: 6 months

Number of participants who adhere to PrEP medications. Documentation will be provided through self report and urine tests (UrSure).

PrEP Uptake

时间窗: 6 months

Number of participants who receive PrEP prescription from provider. Documentation will be provided from clinic.

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

Lisa Eaton

Professor

University of Connecticut

研究点 (1)

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