Clinical trial NCT03098654: 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
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Diabetes Mellitus, Type 2
Hypertension
Keywords: Human Immunodeficiency Virus
Community Health Services
Chronic Disease
Integrated Delivery of Health Care
Tanzania
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Muhimbili University of Health and Allied Sciences
First posted: 2017-04-04
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Uptake of community-level HIV testing
timeFrame: 12 months
measure: Engagement in HIV care
timeFrame: 12 months
measure: Retention in HIV care
timeFrame: 24 months
Secondary outcomes:
measure: Adherence to DM/HTN/ARV medication
timeFrame: 24 months
measure: Adherence to physical activity intervention
timeFrame: 24 months
measure: Adherence to dietary intervention
timeFrame: 24 months
measure: Biological, Psychological, and Social adverse events associated with the study intervention
timeFrame: 24 months
measure: Cost-effectiveness of integrating NCD screening and care with HIV screening and care
timeFrame: 24 months
Other outcomes:
Locations:
city: Dar Es Salaam
country: Tanzania
facility: Muhimbili University of Health and Allied Sciences
Study officials:
affiliation: Medical University of South Carolina
name: Michael D. Sweat, PhD
role: PRINCIPAL_INVESTIGATOR
References: