跳至主要内容
临床试验/NCT03808194
NCT03808194已完成不适用

The Lotto to Link Study: A Prospective, Interventional, Randomized Study of Conditional Incentives to Engage HIV-positive Men in HIV Care in KwaZulu-Natal, South Africa

University of Washington1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2017年10月26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
132
试验地点
1
主要终点
Number of men virally suppressed after 6 months

研究概览

简要总结

In this study the investigators will adapt and strengthen, test effectiveness, and explore implementation of conditional lottery incentive linkage strategies to engage men in HIV care and ART in KwaZulu-Natal, South Africa.

详细描述

Of the 2.6 million South Africans on antiretroviral therapy (ART)1 only a third are men, despite men making up 45% of HIV-positive persons.2 HIV-positive men are underrepresented throughout the HIV prevention and care continuum, being less likely to test, link to care, initiate ART, and more likely to be lost to follow-up. Few strategies have focused on men, and when they have they have not been successful. Even with community-based HIV testing, referral, text message reminders, and lay-counselor support (an optimized testing and linkage to care package), doctors are only able to achieve 60% linkage to HIV care and ART among men. HIV-positive men who are not in care are at risk for HIV-associated morbidity and mortality, and their HIV-negative partners are at risk of HIV acquisition. Innovative strategies are needed to motivate HIV-positive men to engage in care, and specifically to initiate and adhere to ART.

Introducing a gamble, the chance of winning a lottery, into linkage to HIV care interventions could make engagement in care more attractive to men. Men are often risk-takers and linking to care successfully is a gamble: start ART vs. risk no ART. A lottery incentive strategy has been successfully used to increase uptake of HIV prevention; in one recent example, lottery incentives, conditioned on being STI (sexually transmitted infection) negative, decreased HIV incidence by 60% among 'risk-loving' individuals in Lesotho, demonstrating one of the largest effects to date of a behavioral intervention for HIV prevention. Given this prevention success, the investigators hypothesize that lottery incentives have the potential to overcome both structural and behavioral factors for linking HIV positive men to care, addressing logistical challenges and risk preferences specific to men. For scale-up and implementation, the investigators need to sculpt the content of lottery incentive strategies as well as the approach to identify men not in care for whom lottery incentives are likely to work.

In this study the investigators will adapt and strengthen, test effectiveness, and explore implementation of conditional lottery incentive linkage strategies to engage men in HIV care and ART in KwaZulu-Natal, South Africa (the Lotto to Link Study). With the investigators experienced, multi-disciplinary team, the investigators have drawn on their previous successful community-based counseling and testing and linkage to prevention and care work to strengthen linkage strategies for HIV-positive ART eligible men who are not in care.

The investigators will do 1) qualitative interviews to inform the study design, 2) conduct an individual randomized study of conditional lottery incentives compared to an optimized linkage package for HIV-positive men, and 3) finally, estimate the costs associated with conditional incentives and retention in care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

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

  • Reside in the study community for the duration of follow-up
  • Must be 18 years or older
  • Able and willing to provide informed consent for study procedures
  • HIV-positive men must be eligible for ART by national guidelines and not on ART
  • Access to confidential text messaging

排除标准

  • There are no separate exclusion criteria

结局指标

主要结局

Number of men virally suppressed after 6 months

时间窗: 6 months

Conditional lottery incentives, above and beyond an optimized linkage package, will increase the uptake of clinic visits, ART initiation, and viral suppression among HIV-positive men not yet in care.

次要结局

  • Number of men who have a positive alcohol or drug test(6 months)

研究者

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

Ruanne Barnabas

Associate Professor

University of Washington

研究点 (1)

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