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

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Hypertension; Human Immunodeficiency Virus; Diabetes Mellitus, Type 2

Treatments: Behavioral: Diet and lifestyle counseling; Diagnostic Test: Blood glucose and blood pressure testing; Drug: DM/HTN medications as needed

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03098654

1R01MH111366-01 (U.S. NIH Grant/Contract)

Pro00064733

Details and patient eligibility

About

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.

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria for Screening:

• Be aged 18 years or above.

Inclusion Criteria for Intervention and Control Cohorts:

• Be aged 18 years or above.
• Recently enrolled in HIV care and treatment

Exclusion Criteria:

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

Enhanced Intervention

Experimental group

Description:

Members will have DM and HTN managed at the CTC together with their HIV care. Interventions include: 1. Community mobilization activities to inform community members of available services 2. 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. 3. HIV counseling and serial rapid HIV testing 4. Blood glucose and blood pressure testing 5. DM/HTN medications as needed 6. 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.

Treatment:

Drug: DM/HTN medications as needed

Diagnostic Test: Blood glucose and blood pressure testing

Behavioral: Diet and lifestyle counseling

Control

No Intervention group

Description:

Members in the control arm will receive community-level rapid HIV testing at the CTCs, which is the standard of care. HIV testing performed by the CTC is according to the National HIV Testing Algorithm (serial rapid testing using Determine HIV 1/2 and Uni-Gold HIV 1/2) which follows Tanzanian and international (WHO/CDC) standards for provision of HIV counseling and testing. Those who test positive for HIV will be referred to the CTC for the standard Tanzanian level of HIV care, which includes counseling and ART medication managed at the CTCs.