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临床试验/NCT04219878
NCT04219878已完成不适用

Engaging African American and Hispanic/Latino MSM for HIV Testing and Prevention Services Through Technology

Emory University2 个研究点 分布在 1 个国家目标入组 2,195 人开始时间: 2020年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,195
试验地点
2
主要终点
Number of participants initiating HIV treatment

研究概览

简要总结

This study will use online materials and strategies to recruit 3600 Black and Hispanic men who have sex with men (MSM) and transgender women (TGW) to participate in a study evaluating the effectiveness of the Know@Home mobile app compared to control condition with respect to linkage of participants to appropriate services, as well as cost-effectiveness outcomes.

详细描述

To evaluate the effectiveness of mailing out rapid HIV home-testing kits and additional testing promotion components among African-American or black and Hispanic or Latino gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW), the study "Implementation of Rapid HIV Self-Testing among MSM Project", known as iSTAMP, is being conducted in 11 US states. This study is interested in the most cost-effective ways to recruit people at high risk for HIV infection. The researchers want to study a sample of 3600 adult MSM and TGW who are not known to be living with HIV; 1800 black/African-American and 1800 Hispanic/Latino participants will be enrolled.

All participants will be mailed two rapid HIV self-test kits upon randomization. All participants, regardless of study arm, will also complete a follow-up survey at the end of a 4-month follow-up period. At the end of the 4-month follow-up period, participants will be mailed a dried blood spot (DBS) collection kit for research purposes, as well as another rapid HIV self-test kit for immediate testing. Participants in each of the arms will have access to videoconferencing-delivered prevention counseling, and all participants, regardless of assigned arm, will be contacted if they report seroconversion and/or a preliminary positive test during the study period for active linkage to care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of participants initiating HIV treatment

时间窗: Up to Month 4

Effectiveness of the interventions will be assessed by linkage of participants to HIV treatment.

Cost of different online venues for HIV test results returned

时间窗: Month 1

The cost (in US dollars) of HIV tests returned within 1 month of enrollment will be compared between the study arms. The costs involved with having HIV tests returned include: * Online banner advertisement placement * Study staff time managing enrollment, validating participant eligibility, monitoring and evaluation of enrollment data * HIV test kits * Shipping for HIV test kits * Staff/personnel time to manage mailing/return of test kits * Other general and administrative time, office supplies, equipment, rents, utilities

Cost of different online venues for identifying new HIV diagnoses

时间窗: Month 1

The cost (in US dollars) of identifying established HIV infections will be compared between the study arms. The costs involved with identifying established HIV infections include: * Online banner advertisement placement * Study staff time managing enrollment, validating participant eligibility, monitoring and evaluation of enrollment data * HIV test kits * Shipping for HIV test kits * Staff/personnel time to manage mailing/return of test kits * Study staff time to manage monitoring and evaluation of HIV test result data * Study staff time to provide phone counseling to those with established infections * Other general and administrative time, office supplies, equipment, rents, utilities

Cost of different online venues for study enrollment

时间窗: Baseline

Enrollment in the study defined as completion of the baseline survey and downloading of the study app. The cost (in US dollars) to enroll participants (online banner advertisement placement, study staff time to manage enrollment, validating participant eligibility, monitoring and evaluation of enrollment data) will be compared between the study arms.

Number of participants initiating PrEP treatment

时间窗: Up to Month 4

Effectiveness of the interventions will be assessed by linkage of participants to PrEP treatment.

Number of participants testing for STIs

时间窗: Up to Month 4

Effectiveness of the interventions will be assessed by linkage of participants to STI testing.

Number of participants engaging in HIV prevention services

时间窗: Up to Month 4

Effectiveness of the interventions will be assessed by linkage of participants to HIV prevention services.

Number of participants engaging in HIV social services

时间窗: Up to Month 4

Effectiveness of the interventions will be assessed by linkage of participants to HIV social services.

次要结局

  • Cost of linkage to HIV counseling(Month 4)
  • Cost of linkage to STI treatment(Month 4)
  • Cost of linkage to PrEP uptake(Month 4)
  • Cost of linkage to PrEP counseling(Month 4)
  • Cost of Sexually Transmitted Infection (STI) testing(Month 4)
  • Cost of linkage to HIV treatment(Month 4)

研究者

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

Patrick S Sullivan

Professor

Emory University

研究点 (2)

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