Leveraging Adaptive Implementation Strategies to Achieve Universal Coverage of Antiretroviral Treatment in Senegal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 596
- 试验地点
- 4
- 主要终点
- Viral suppression among study participants measured through biological samples using either aliquots of serum or dried blood spots (DBS).
研究概览
简要总结
Senegal plans a rapid scale up of HIV treatment for all people living with HIV, regardless of cluster of differentiation 4 (CD4) count or viral suppression. However, limited data exist on how to achieve sustained viral suppression outside of a controlled setting, and with significant barriers to effective antiretroviral therapy delivery, uptake, and adherence. The purpose of this study is to develop and assess the feasibility, fidelity, and cost-effectiveness of a universal coverage of Antiretroviral Treatment (ART) intervention among people living with HIV who are not virally suppressed in Dakar and Ziguinchor, Senegal.
详细描述
The overarching goal of this study is to assess the feasibility, fidelity, and cost-effectiveness of a universal coverage of Antiretroviral Treatment (ART) intervention among individuals living with HIV who are not virally suppressed in Dakar and Ziguinchor, Senegal. Specific aims and hypotheses are as follows:
Specific Aim 1: Compare the effectiveness and durability of (a) the existing Standard of Care (SOC) in Senegal versus (b) individual Case Management (CM) programs to achieve sustained viral suppression (SVS) among people living with HIV in Senegal.
Hypothesis 1: The null hypothesis is that standard of care and case management will be equally effective at achieving sustained viral suppression. The alternate hypothesis is that case management will be 30% more effective at sustained viral suppression at 12 months compared to standard of care.
Specific Aim 2: Determine the cost-effectiveness of the universal treatment approach using the CM intervention.
Hypothesis 1: A Case Management approach will be more cost-effective at achieving sustained viral suppression among people living with HIV (PLHIV) versus the existing standard of care in Senegal.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Is mentally sound and capable of providing consent to participate
- •Agrees to complete HIV and syphilis testing
- •Speaks either French, Wolof or both
- •Has provided informed consent to participate in the study
- •Resident of Senegal for the past 3 months
- •Intention to live in Dakar or Ziguinchor for the next 12 months
- •Agrees to complete all required biological testing described in the consent form and receive results
排除标准
- •Under 18 years of age
- •Demonstrates mental incapacity, under the influence of substances, or any other illness preventing comprehension of the study procedures and informed consent
- •Does not agree to complete all required biological testing described in the consent form or receive results
- •Has not provided informed consent to participate in the study
结局指标
主要结局
Viral suppression among study participants measured through biological samples using either aliquots of serum or dried blood spots (DBS).
时间窗: Viral suppression at 12 months of follow up
Biological samples using either aliquots of serum or dried blood spots will be taken at baseline, 6 months, and 12 months to support HIV viral load testing. Biological testing taken at baseline and will include testing currently being implemented through the SOC, and testing conducted at the additional visits will be supported by the study. All participants will also have the opportunity to receive referrals for additional medical care as needed at the clinics in which the study sites are housed. Sustained viral suppression is defines as quantitative viral load assessment with \<1000 copies/ml at 12 months after initial randomization
次要结局
- Cost-effectiveness of the universal treatment approach using the CM intervention(12 months)
- Loss-to-follow-up of study participation among study participants(Loss to follow up at 12 months)
- Acceptability of CM intervention among study participants through self-reported measure.(12 months)