The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda
研究概览
详细说明
Data on linkage to pre-antiretroviral therapy (pre-ART) care after HIV diagnosis through home-based HIV counselling and testing (HBHCT) in sub-Saharan Africa (SSA) are scarce. The few existing data suggest that only 13% to 54% of HIV-infected persons identified through HBHCT enter pre-ART care. No studies have rigorously evaluated interventions aimed at improving linkage to pre-ART care following HBHCT in SSA. This study will evaluate the effect of follow-up counselling after HIV diagnosis through HBHCT on linkage to pre-ART care in Masaka, south-western Uganda.
The study is a cluster randomised trial of the effectiveness of referral to pre-ART care and follow-up counselling (intervention) compared to referral to pre-ART care only (control), for individuals diagnosed with HIV through HBHCT. The intervention will be administered at months 1 and 2, and linkage to care assessed at month 6 post-HBHCT. Data will be collected on socio-demographic characteristics, sexual risk profile, HIV testing history, HIV status disclosure, linkage to care, CD4 count testing and results, cotrimoxazole prophylaxis, and ART initiation. At least 224 HIV-infected participants will be enrolled from 28 clusters (14/study arm). Approximately 84 HIV-uninfected individuals will also be recruited into the study to reduce the possibility of revealing the sero-status of the HIV-infected participants.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Masaka、乌干达
- MRC/UVRI Uganda Research Unit on AIDS
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
HIV-infected participants
Inclusion Criteria:
- HIV-infected adult (≥18 years)
- Willing to provide informed consent
- Willing to receive follow-up counselling at home
Exclusion Criteria:
- Previous or current receipt of HIV care from an ART provider
- On-going participation in other health-related research
- Intending to change residence in the next 6 months
- Conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness
HIV-uninfected participants
Inclusion criteria:
- HIV negative adult (≥18 years)
- Willing to provide informed consent
- Willing to receive follow-up counselling at home
Exclusion criteria:
- Intending to change residence in the next 6 months
- Conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Follow-up counselling
Participants in the experimental arm will receive home-based HIV counselling and testing and referral for HIV care if found to have HIV infection.
Additionally, participants will receive home-based follow-up counselling at 1 and 2 months after HIV diagnosis.
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无干预:Standard of care
Participants in this arm will receive only home-based HIV counselling and testing and referral for HIV care if found to have HIV infection.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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The proportion of HIV-infected participants that register with an anti-retroviral therapy (ART) care provider within 3 and 6 months of HIV diagnosis and referral.
大体时间:6 months
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6 months
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The time between HIV diagnosis and linkage to pre-ART care.
大体时间:6 months
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6 months
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次要结果测量
结果测量 |
大体时间 |
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Time between blood draw for CD4 cell count testing and attending clinic to receive the results among participants that link to pre-ART care
大体时间:6 months
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6 months
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The time between learning that a participant is eligible for ART and ART initiation
大体时间:6 months
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6 months
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The proportion of participants who report adherence to daily cotrimoxazole prophylaxis at 3 and 6 months after HIV diagnosis through HBHCT among those that link to pre-ART care.
大体时间:6 months
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6 months
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其他结果措施
结果测量 |
大体时间 |
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The proportion of individuals who undergo repeat HIV testing within 6 months of testing HIV negative through HBHCT.
大体时间:6 months
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6 months
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合作者和调查者
调查人员
- 首席研究员:Eugene Ruzagira、MRC/UVRI and LSHTM Uganda Research Unit
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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