Impact of Integrated HIV/NCD Screening on HIV Testing Uptake and Engagement in HIV Care: an RCT in Kisarawe, Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Uptake of community-level HIV testing
研究概览
简要总结
This study focuses on the integration of HIV and NCD screening and care. The investigators will conduct a randomized controlled trial examining the efficacy and cost-effectiveness of the intervention strategy in Kisarawe District, Tanzania, a rural area 40 KM southwest of Dar es Salaam. The study will match two similar HIV care and treatment centers (CTC) in the District, one of which will be randomized to receive the enhanced intervention which will integrate diabetes (DM) and hypertension (HTN) screening with the existing HIV testing program, and integrate care for DM and HTN into the HIV care program. Comparisons of the community HIV testing rates in the two communities, engagement in HIV care among those testing positive, and 24-month retention in HIV care will be assessed among a cohort of 107 newly enrolled patients per community.
Specifically, the aims are to determine:
- Whether integrating DM and HTN screening with HIV testing will increase the uptake of community-level HIV testing.
- If integrating DM/HTN care with HIV care enhances engagement in HIV care.
- Whether integration of DM/HTN care with HIV care enhances retention in HIV care for those newly enrolled in HIV care.
- The cost-effectiveness of integrating NCD screening and care with HIV screening and care with regard to the incremental cost per HIV infected client engaged in HIV care, and cost per newly enrolled HIV client retained in HIV care over 24-months.
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
- 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
- 未提供
排除标准
- •Potentially vulnerable populations (incarcerated, under age of consent, unable to understand the procedures planned, etc.).
- •Individuals under the influence of drugs or alcohol and anyone presenting with mental disability that would preclude ability to understand study procedure, risks, and benefits.
- •Inability or unwillingness of subject to provide informed consent.
研究组 & 干预措施
Enhanced Intervention
Members will have DM and HTN managed at the CTC together with their HIV care. Interventions include:
- Community mobilization activities to inform community members of available services
- Support at the local health center to aid clinicians in managing uncontrolled cases of DM and HTN, including training for clinical staff, glucometers/test strips, and BP monitors.
- HIV counseling and serial rapid HIV testing
- Blood glucose and blood pressure testing
- DM/HTN medications as needed
- Personalized diet and lifestyle counseling for all participants with elevated glucose or BP that includes education, dietary assessment and recommendations, advice on physical activity, and the need to regularly monitor their glucose/BP.
干预措施: Blood glucose and blood pressure testing (Diagnostic Test)
Enhanced Intervention
Members will have DM and HTN managed at the CTC together with their HIV care. Interventions include:
- Community mobilization activities to inform community members of available services
- Support at the local health center to aid clinicians in managing uncontrolled cases of DM and HTN, including training for clinical staff, glucometers/test strips, and BP monitors.
- HIV counseling and serial rapid HIV testing
- Blood glucose and blood pressure testing
- DM/HTN medications as needed
- Personalized diet and lifestyle counseling for all participants with elevated glucose or BP that includes education, dietary assessment and recommendations, advice on physical activity, and the need to regularly monitor their glucose/BP.
干预措施: Diet and lifestyle counseling (Behavioral)
Enhanced Intervention
Members will have DM and HTN managed at the CTC together with their HIV care. Interventions include:
- Community mobilization activities to inform community members of available services
- Support at the local health center to aid clinicians in managing uncontrolled cases of DM and HTN, including training for clinical staff, glucometers/test strips, and BP monitors.
- HIV counseling and serial rapid HIV testing
- Blood glucose and blood pressure testing
- DM/HTN medications as needed
- Personalized diet and lifestyle counseling for all participants with elevated glucose or BP that includes education, dietary assessment and recommendations, advice on physical activity, and the need to regularly monitor their glucose/BP.
干预措施: DM/HTN medications as needed (Drug)
结局指标
主要结局
Uptake of community-level HIV testing
时间窗: 12 months
Uptake of HIV testing will be measured as the annual cumulative number of unique persons receiving HIV testing as a proportion of the community size in each HIV CTC venue using clinic records from the government CTC.
Engagement in HIV care
时间窗: 12 months
Engagement will be measured as proportion of persons testing positive for HIV who advance to successful enrollment in HIV care at the CTC. Persons will be documented with biometric fingerprint matching against those who tested for HIV in the study area. Comparisons will be made across the enhanced and comparison CTCs.
Retention in HIV care
时间窗: 24 months
Retention in HIV care will be measured in several ways, including the Human Resources and Services Administration HIV/AIDS Bureau definition of 2 or more outpatient visits at least 3-months apart during each year, the number of missed clinic visits, and appointment adherence (number of completed visits/number of scheduled visits) during the study period.
次要结局
- Adherence to dietary intervention(24 months)
- Biological, Psychological, and Social adverse events associated with the study intervention(24 months)
- Cost-effectiveness of integrating NCD screening and care with HIV screening and care(24 months)
- Adherence to DM/HTN/ARV medication(24 months)
- Adherence to physical activity intervention(24 months)