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

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus; Hypertension; Diabetes Mellitus, Type 2
• Interventions: Diagnostic Test: Blood glucose and blood pressure testing; Behavioral: Diet and lifestyle counseling; Drug: DM/HTN medications as needed

• Registration Number: NCT03098654
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-27
• Study First Posted: 2017-04-04
• Study Start: 2018-02-05
• Primary Completion: 2022-08-05
• Study Completion: 2022-08-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Intervention	Blood glucose and blood pressure testing	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.
Enhanced Intervention	Diet and lifestyle counseling	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.
Enhanced Intervention	DM/HTN medications as needed	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.

Primary Outcome Measures

Name	Time	Method
Engagement in HIV care	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.
Uptake of community-level HIV testing	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.
Retention in HIV care	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.

Secondary Outcome Measures

Name	Time	Method
Adherence to dietary intervention	24 months	A food frequency questionnaire developed for use specifically in Tanzania and surrounding countries will be used to assess dietary changes.
Biological, Psychological, and Social adverse events associated with the study intervention	24 months	Self-reported and staff-reported adverse events (biological, psychological, or social) experienced as an outcome of receiving the intervention.
Cost-effectiveness of integrating NCD screening and care with HIV screening and care	24 months	Cost will be measured through regular cost worksheets that the investigators will collect throughout the duration of the study.
Adherence to DM/HTN/ARV medication	24 months	Self-reported medication adherence questions adapted from our other NIH-funded study (Dyadic-Based Diagnosis, Care, and Prevention for HIV Discordant Couples) will be used to assess medication adherence. The Self-Reported Medication Nonadherence Measurement tool will be used to assess reasons for nonadherence.
Adherence to physical activity intervention	24 months	Global Physical Activity Questionnaire (GPAQ) to assess DM / HTN lifestyle changes for NCD positive subjects in the intervention arm. The GPAQ is a 12-item survey created by the World Health Organization to measure physical activity (intensity, duration, and frequency) and domains of performance (related to occupation, transportation, and leisure).

Trial Locations

Locations (1)

Muhimbili University of Health and Allied Sciences; 🇹🇿 Dar Es Salaam, Tanzania