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临床试验/NCT03127397
NCT03127397Unknown不适用

Contribution of "Praise Messages" to HIV Treatment Retention and Adherence Among Female Sex Workers in Ethiopia

Reed College1 个研究点 分布在 1 个国家目标入组 810 人开始时间: 2017年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
810
试验地点
1
主要终点
Retention in care at 1 month

研究概览

简要总结

This study evaluates the effects of praise message phone calls on antiretroviral therapy (ART) initiation, adherence, and prescription refills. The investigators will use randomization to assign newly (diagnosed) HIV positive, ART naive, female sex workers (FSWs) in Ethiopia to a praise message phone call study arm or to a standard of care control study arm.

详细描述

This study evaluates the effects of praise message phone calls on antiretroviral therapy (ART) initiation, adherence, and prescription refills. The investigators will use randomization to assign newly (diagnosed) HIV positive, ART naive, female sex workers (FSWs) in Ethiopia to a praise message phone call study arm or to a standard of care control study arm.

Inadequate adherence to ART medication, missed clinics visits and loss-to-follow-up, and failure to refill prescriptions are major barriers to achieving viral suppression. Non-adherence is associated with a range of individual, social, community, and structural factors, including low health literacy, a lack of social support, low socioeconomic status, substance abuse, stigma and discrimination, and a lack of access to a reliable source of ART drugs. ART patients' perceptions about a lack of health provider respect and mutual trust are a possible further barrier to adherence.

Provision of HIV therapy within the MULU/MARPs drop-in-centers has attempted to mitigate some of the structural and social barriers to ART initiation and retention in care by bringing FSW friendly treatment services closer to clients and providing intensive counseling services, social and economic support services, and referrals to additional health services. Improving client perceptions of health care provider attitudes may further improve retention in care and adherence to treatment among FSW in Ethiopia. This study will measure the effects of praise message phone calls delivered the day after, and two weeks after, completing a ART appointment (i.e. initiation and/or prescription refill) on subsequent ART refills/HIV clinic visits.

This study will be conducted within PSI/Ethiopia's USAID-funded MULU/MARPs program, which provides HIV testing, treatment, and other services to female sex workers (FSW) through a network of drop-in-centers (DICs) across Ethiopia. Consenting FSWs who are living with HIV, who are ART naive, and who are referred for ART initiation to one of the 25 drop-in-centers (DICs) selected for "Test and Start" implementation will be enrolled in the study. Pre-study analysis indicates that each DIC enrolls between 3-4 FSWs living with HIV on ART each month (mean: 3.6). Over the course of our 9 month study, the investigators expect to enroll a total of 810 study participants.

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
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Written consent,
  • ART naive,
  • Female sex worker,
  • Living with HIV,
  • And, seeking care at a participating clinic

排除标准

  • No consent,
  • Previous ART,
  • Has not exchanged sex for money in past 12 months,
  • HIV negative,
  • And/or, has not sought care at a participating clinic

研究组 & 干预措施

Standard of Care

No Intervention

Praise Message

Experimental

Receives up to two praise message phone calls after each completed ART appointment.

干预措施: Praise message phone call (Behavioral)

结局指标

主要结局

Retention in care at 1 month

时间窗: 1 month

ART adherence at 1 month

时间窗: 1 month

ART adherence at 6 months

时间窗: 6 months

Retention in care at 3 months

时间窗: 3 months

Viral suppression at 6 months

时间窗: 6 months

ART adherence at 3 months

时间窗: 3 months

Retention in care at 6 months

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
Reed College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicholas Wilson

Associate Professor of Economics

Reed College

研究点 (1)

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