NCT03098654

Impact of Integrated HIV/NCD Screening on HIV Testing Uptake and Engagement in HIV Care in Kisarawe, Tanzania

Impact of Integrated HIV/NCD Screening on HIV Testing Uptake and Engagement in HIV Care: an RCT in Kisarawe, Tanzania

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: 1. Whether integrating DM and HTN screening with HIV testing will increase the uptake of community-level HIV testing. 2. If integrating DM/HTN care with HIV care enhances engagement in HIV care. 3. Whether integration of DM/HTN care with HIV care enhances retention in HIV care for those newly enrolled in HIV care. 4. 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.

Conditions

• Human Immunodeficiency Virus
• Diabetes Mellitus, Type 2
• Hypertension

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood glucose and blood pressure testing	Diabetes will be assessed using a 6-question risk assessment on a 10-point scale (based on a field-tested and culturally adapted International Diabetes Federation formula on DM risk factors and symptoms) and a random blood glucose test with a portable finger stick glucose monitor. Those with either: (1) a risk score of 5 or more, or (2) a random blood glucose with a value greater than 140 mg/dl, will be asked to return after fasting for at least 8 hours to have a fasting glucose test taken. Blood pressure will be assessed using a portable battery operated automatic BP cuff. The BP test will include three values taken at least 5-minutes apart and the 3 will be averaged to determine the final value.
BEHAVIORAL	Diet and lifestyle counseling	All participants with elevated glucose or BP will receive personalized lifestyle counseling by trained counselors informed by lab results and that includes education on diabetes, hypertension, dietary assessment and recommendations, advice on physical activity, and the need to regularly monitor their glucose, BP, and adjust their diet, activity level, as needed. Personalized risk reduction plans will be negotiated with the client during their scheduled visits.
DRUG	DM/HTN medications as needed	Subjects will receive DM or HTN medications prescribed by the CTC clinician as needed.

Timeline

• Start date: 2018-02-05
• Primary completion: 2022-08-05
• Completion: 2022-08-05
• First posted: 2017-04-04
• Last updated: 2024-10-30

Locations

1 site across 1 country: Tanzania