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

NCT ID: NCT03098654

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-05
• Study Completion Date: 2022-08-05

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enhanced Intervention

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.

Group Type: EXPERIMENTAL

Blood glucose and blood pressure testing

Intervention Type: DIAGNOSTIC_TEST

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.

Diet and lifestyle counseling

Intervention Type: BEHAVIORAL

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.

DM/HTN medications as needed

Intervention Type: DRUG

Subjects will receive DM or HTN medications prescribed by the CTC clinician as needed.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: BEHAVIORAL

DM/HTN medications as needed

Subjects will receive DM or HTN medications prescribed by the CTC clinician as needed.

Intervention Type: DRUG

Other Intervention Names

Biosense V2 monitor; Lifesource 767 PV; Glucophage; Metformin; Thiazide

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael D. Sweat, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Muhimbili University of Health and Allied Sciences

Dar es Salaam, , Tanzania

Countries

Tanzania

Other Identifiers

1R01MH111366-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00064733

Identifier Type: -

Identifier Source: org_study_id