search
Back to results

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

Primary Purpose

Human Immunodeficiency Virus, Diabetes Mellitus, Type 2, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Blood glucose and blood pressure testing
Diet and lifestyle counseling
DM/HTN medications as needed
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring Human Immunodeficiency Virus, Community Health Services, Chronic Disease, Integrated Delivery of Health Care, Tanzania

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Muhimbili University of Health and Allied Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Enhanced Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Uptake of community-level HIV testing
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
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
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

Adherence to DM/HTN/ARV medication
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
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).
Adherence to dietary intervention
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
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
Cost will be measured through regular cost worksheets that the investigators will collect throughout the duration of the study.

Full Information

First Posted
March 22, 2017
Last Updated
October 26, 2022
Sponsor
Medical University of South Carolina
Collaborators
National Institute of Mental Health (NIMH), Muhimbili University of Health and Allied Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT03098654
Brief Title
Impact of Integrated HIV/NCD Screening on HIV Testing Uptake and Engagement in HIV Care In Kisarawe, Tanzania
Official Title
Impact of Integrated HIV/NCD Screening on HIV Testing Uptake and Engagement in HIV Care: An RCT In Kisarawe, Tanzania
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
August 5, 2022 (Actual)
Study Completion Date
August 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute of Mental Health (NIMH), Muhimbili University of Health and Allied Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, Diabetes Mellitus, Type 2, Hypertension
Keywords
Human Immunodeficiency Virus, Community Health Services, Chronic Disease, Integrated Delivery of Health Care, Tanzania

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Once two similar HIV Care and Treatment Centers (CTCs) are matched, they will be randomized to receive either the intervention or control condition.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood glucose and blood pressure testing
Other Intervention Name(s)
Biosense V2 monitor, Lifesource 767 PV
Intervention Description
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
Behavioral
Intervention Name(s)
Diet and lifestyle counseling
Intervention Description
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
Drug
Intervention Name(s)
DM/HTN medications as needed
Other Intervention Name(s)
Glucophage, Metformin, Thiazide
Intervention Description
Subjects will receive DM or HTN medications prescribed by the CTC clinician as needed.
Primary Outcome Measure Information:
Title
Uptake of community-level HIV testing
Description
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.
Time Frame
12 months
Title
Engagement in HIV care
Description
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.
Time Frame
12 months
Title
Retention in HIV care
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Adherence to DM/HTN/ARV medication
Description
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.
Time Frame
24 months
Title
Adherence to physical activity intervention
Description
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).
Time Frame
24 months
Title
Adherence to dietary intervention
Description
A food frequency questionnaire developed for use specifically in Tanzania and surrounding countries will be used to assess dietary changes.
Time Frame
24 months
Title
Biological, Psychological, and Social adverse events associated with the study intervention
Description
Self-reported and staff-reported adverse events (biological, psychological, or social) experienced as an outcome of receiving the intervention.
Time Frame
24 months
Title
Cost-effectiveness of integrating NCD screening and care with HIV screening and care
Description
Cost will be measured through regular cost worksheets that the investigators will collect throughout the duration of the study.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D. Sweat, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muhimbili University of Health and Allied Sciences
City
Dar Es Salaam
Country
Tanzania

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs