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NCT Number: NCT03098654

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

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.

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Cardiovascular Diseases Chronic Disease Communicable Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Genital Diseases Glucose Metabolism Disorders HIV Infections Hypertension Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood glucose and blood pressure testing

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.

Other names: Biosense V2 monitor, Lifesource 767 PV

Diet and Lifestyle Counseling

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

Drug

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

Other names: Glucophage, Metformin, Thiazide

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Muhimbili University of Health and Allied Sciences
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2017
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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