Reducing Post-Hospital Mortality in HIV-infected Adults in Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 16
- 主要终点
- Number of Participant Deaths in the First 12 Months Post-hospitalization
研究概览
简要总结
This research is being done to assess the efficacy of a case management intervention to improve the one year mortality rate of hospitalized, HIV-infected, Tanzanian adults.
详细描述
This research is being done to assess the efficacy of a case management intervention to improve the one year mortality rate of hospitalized, HIV-infected, Tanzanian adults. The study is being conducted at hospitals in Mwanza, Tanzania. 500 participants will be enrolled: 250 will be randomized to the case management intervention and 250 will randomized to routine clinical care. The case management intervention consists of 5 sessions over 90 days, and is designed to link hospitalized, HIV-infected patients to long term care at an HIV clinic. Participants will be followed for two years in order to evaluate primary and secondary study objectives.
Secondary outcome measures time frames have been updated to add the 24-month time point for consistency with the pre-specified endpoints in the study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •HIV-infected
- •ART (anti-retroviral therapy) naïve or have been on ART but have not used ART for > 7 days
- •Lives in the region of Mwanza
- •Able to be referred to an HIV clinic inside the region of Mwanza
- •Has mobile phone or access to mobile phone
- •Planning to stay in the region of Mwanza for the next 24 months
- •Able to speak Kiswahili or English
- •Capable and willing to provide informed consent
- •Willing to provide locator information and two designated contact persons
- •Willing to have a home visits from a study team member
- •Exclusion Criteria
- •On anti-retrovirals at hospital admission and already linked to an HIV clinic
- •Medical, psychiatric or psychological condition that, in the opinion of the site investigator, would interfere with completion of study procedures
排除标准
- 未提供
结局指标
主要结局
Number of Participant Deaths in the First 12 Months Post-hospitalization
时间窗: 12 months
The number of participants who die in the first 12 months post-hospitalization will be recorded. Death will be determined by phone calls to relatives and will be confirmed by verbal autopsies, obituaries, hospital records, or death certificates.
次要结局
- Number of Participants Who Attended HIV Clinic(3, 6, 9,12, and 24 months)
- ART Adherence(3, 6, 9, 12, and 24 months)
- Viral Suppression(12 and 24 months)
- Traditional Health Beliefs(Baseline,12, and 24 months)
- Self-Efficacy(Baseline, 12, and 24 months)
- Stigma(Baseline, 12, and 24 months)
- Social Support(Baseline, 12, and 24 months)
- Perceived Need for HIV Services(Baseline, 12, and 24 months)
- SF-12 Health Survey: Physical and Mental Health(Baseline, 12, and 24 months)
- Acceptability(12 and 24 months)
- Incremental Cost of the Intervention(12 months)
- Cost Per Life Saved(12 months)