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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098654
• Other study ID #: Pro00064733
• Secondary ID: 1R01MH111366-01
• Status: Completed
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: August 5, 2022

Study information

• Verified date: October 2022
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: August 5, 2022
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Diabetes Mellitus, Type 2
• HIV Infections
• Human Immunodeficiency Virus
• Hypertension
• Immunologic Deficiency Syndromes

Intervention

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.

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.

Locations

Country	Name	City	State
Tanzania	Muhimbili University of Health and Allied Sciences	Dar Es Salaam

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	Muhimbili University of Health and Allied Sciences, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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.	12 months
Primary	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.	24 months
Secondary	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.	24 months
Secondary	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).	24 months
Secondary	Adherence to dietary intervention	A food frequency questionnaire developed for use specifically in Tanzania and surrounding countries will be used to assess dietary changes.	24 months
Secondary	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.	24 months
Secondary	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.	24 months