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

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ClinicalTrials.gov Identifier: NCT03098654
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : April 8, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Muhimbili University of Health and Allied Sciences
Information provided by (Responsible Party):
Michael Sweat, 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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Diabetes Mellitus, Type 2 Hypertension Diagnostic Test: Blood glucose and blood pressure testing Behavioral: Diet and lifestyle counseling Drug: DM/HTN medications as needed Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Impact of Integrated HIV/NCD Screening on HIV Testing Uptake and Engagement in HIV Care: An RCT In Kisarawe, Tanzania
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 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.
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.
Other Names:
  • Biosense V2 monitor
  • Lifesource 767 PV

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.
Other Names:
  • Glucophage
  • Metformin
  • Thiazide

No Intervention: 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.



Primary Outcome Measures :
  1. Uptake of community-level HIV testing [ Time Frame: 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.

  2. Engagement in HIV care [ Time Frame: 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.

  3. Retention in HIV care [ Time Frame: 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 :
  1. Adherence to DM/HTN/ARV medication [ Time Frame: 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.

  2. Adherence to physical activity intervention [ Time Frame: 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).

  3. Adherence to dietary intervention [ Time Frame: 24 months ]
    A food frequency questionnaire developed for use specifically in Tanzania and surrounding countries will be used to assess dietary changes.

  4. Biological, Psychological, and Social adverse events associated with the study intervention [ Time Frame: 24 months ]
    Self-reported and staff-reported adverse events (biological, psychological, or social) experienced as an outcome of receiving the intervention.

  5. Cost-effectiveness of integrating NCD screening and care with HIV screening and care [ Time Frame: 24 months ]
    Cost will be measured through regular cost worksheets that the investigators will collect throughout the duration of the study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098654


Contacts
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Contact: Michael D. Sweat, PhD 843-792-1082 SWEATM@MUSC.EDU
Contact: Claire P. Bailey, MPH +255-767-566-302 BAILEYCL@MUSC.EDU

Locations
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Tanzania
Muhimbili University of Health and Allied Sciences Recruiting
Dar Es Salaam, Tanzania
Contact: Jessie Mbwambo, MD       jmbwambo@gmail.com   
Sponsors and Collaborators
Medical University of South Carolina
National Institute of Mental Health (NIMH)
Muhimbili University of Health and Allied Sciences
Investigators
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Principal Investigator: Michael D. Sweat, PhD Medical University of South Carolina

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Responsible Party: Michael Sweat, Professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03098654     History of Changes
Other Study ID Numbers: Pro00064733
1R01MH111366-01 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Sweat, Medical University of South Carolina:
Human Immunodeficiency Virus
Community Health Services
Chronic Disease
Integrated Delivery of Health Care
Tanzania
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Diabetes Mellitus, Type 2
Immunologic Deficiency Syndromes
Immune System Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs