The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- The time between HIV diagnosis and linkage to pre-ART care.
研究概览
简要总结
The purpose of this study is to evaluate the impact of follow-up counselling after HIV diagnosis through home-based HIV counselling and testing (HBHCT), on linkage to pre-antiretroviral therapy (pre-ART) care in Uganda.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •HIV-infected participants
- •Inclusion Criteria:
- •HIV-infected adult (≥18 years)
- •Willing to provide informed consent
- •Willing to receive follow-up counselling at home
排除标准
- •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
结局指标
主要结局
The time between HIV diagnosis and linkage to pre-ART care.
时间窗: 6 months
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.
时间窗: 6 months
次要结局
- The time between learning that a participant is eligible for ART and ART initiation(6 months)
- Time between blood draw for CD4 cell count testing and attending clinic to receive the results among participants that link to pre-ART care(6 months)
- 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.(6 months)