Clinical trial NCT03553693: Rapid HIV Viral Load Monitoring in High Risk Patients In Uganda
Official title: Optimizing HIV Viral Load Monitoring and Outcomes for High Risk Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Viral Load
Counseling
Costs and Costs Analysis
Point-Of-Care Systems
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Infectious Diseases Research Collaboration, Uganda
name: Makerere University
First posted: 2018-06-12
Enrollment: 2443
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative effectiveness cluster-randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The RAPID-VL study will take place in 20 HIV care health facilities in Southwestern Uganda. The study will test the hypothesis that a multi-component intervention package that targets barriers to efficient and timely HIV viral load (VL) testing will improve test ordering, speed up result turnaround times, and improve the quality of VL results counseling to patients. Phase 1 of the study will consist of a 1-year retrospective medical record review in all participating health facilities. In Phase 2 the intervention will be introduced in 10 randomly chosen health facilities, while the remaining 10 sites will continue with standard VL testing and counseling operations. The study will measure the speed and efficiency of VL testing, experiences of patients and clinicians with the intervention, and the cost of the intervention.

Detailed description: We will test the hypothesis that a multi-component intervention grounded in implementation science principles and that targets key barriers to optimal HIV viral load (VL) processing will improve viral load ordering, speed up viral load turnaround, and improve the quality of viral load counseling of results to patients within a Ugandan network of HIV care clinics. Specific objectives are as follows: Objective 1: Determine the comparative effectiveness of the RAPID-VL intervention on VL ordering and VL turnaround time: We will randomize 20 HIV clinics to the RAPID-VL multi-component intervention vs. standard of care VL procedures (n=10 clinics each, 60 patients/health facility). Objective 2: Identify facilitators and barriers to implementation, and perceived utility of the RAPID-VL intervention from both the patient and clinician perspectives. Objective 3: Determine the costs, cost-effectiveness, and incremental change costs of the RAPID-VL intervention.

Eligibility criteria: Inclusion Criteria:

Phase 1, Intervention and Control Clinics:

"High risk" subgroups of patients (n=10 each per clinic, total of 40 per clinic): registered for care, with a clinic visit within a year of the Phase 1 start date, plus the following:

1. Pregnant or breastfeeding women: Inclusion criteria: (1) pregnant or breastfeeding at any time during Phase 1, confirmed by clinic documentation
2. Children/adolescents: Inclusion criteria: (1) age 2-17 years, (2) no documentation of pregnancy in clinical record
3. Persons with most recent VL unsuppressed (i.e. detectable): Inclusion criteria: (1) any age, (2) most recent VL documented in the medical record within the last 1 year, with a value of \>1000 copies/mL on any assay, (3) no documentation of pregnancy in clinical record
4. Persons with no VL in last one year: Inclusion criteria: (1) any age, (2) last VL is dated \>1 year ago (if ever started on ART) or no VL on file (if never started ART) (3) no documentation of pregnancy in clinical record

"Non-high-risk" patients (n=20 per clinic): Inclusion criteria (1) adult (age ≥18 years), (2) registered for care, with clinic visit within a year of the Phase 1 start date, (3) already on ART or starting ART at time of study enrollment, (4) do not meet any of the inclusion criteria of a "high risk" subgroup

Phase 2, Intervention Clinics:

We will select 60 patients in each of the 10 intervention clinics (600 patients total; different than the 60 patients in each clinic studied in Phase 1), with inclusion criteria as follows:

"High risk" subgroups of patients (n=10 each per clinic, total of 40 per clinic): registered for care, with a clinic visit within a year of the Phase 2 start date; able to consent for study participation; plus the following:

1. Pregnant or breastfeeding women: Inclusion criteria: (1) currently pregnant or breastfeeding, confirmed by clinic standard documentation
2. Children/adolescents: Inclusion criteria: (1) age 2-17 years, (2) parent/guardian able and willing to provide affirmative consent for study participation, except in the case of mature or emancipated minors, (3) no documentation of pregnancy in the clinic record
3. Persons with most recent VL unsuppressed: Inclusion criteria: (1) any age, (2) most recent VL documented in the medical record within the last 1 year, with a value of \>1000 copies/mL on any assay, (3) no documentation of pregnancy in the clinical record
4. Persons with no VL in last 1 year: Inclusion criteria: (1) any age, (2) last VL is dated \>1 year ago (if ever started ART) or no VL on file (if never started ART , (3) no documentation of pregnancy in the clinical record

"Non-high-risk" patients (n=20 per clinic): Inclusion criteria: (1) adult (age ≥18 years), (2) registered in the general HIV clinic, (3) already on ART or starting ART at time of study enrollment, (4) do not meet any of the inclusion criteria of a "high risk" subgroup

Phase 2, Control Clinics:

We will select 60 patients in each of the 10 control clinics (600 patients total; different than the 60 patients in each clinic studied in Phase 1), with inclusion criteria as follows

"High risk" subgroups of patients (n=10 each per clinic, total of 40 per clinic): registered for care, with a clinic visit within a year of the Phase 1 start date; able to provide consent; plus the following:

1. Pregnant or breastfeeding women: Inclusion criteria: (1) pregnant or breastfeeding at any time during Phase 2, confirmed by clinic documentation
2. Children/adolescents: Inclusion criteria: (1) age 2-17 years, (2) parent/guardian able and willing to provide affirmative consent for study participation, except in the case of mature or emancipated minors, (3) no documentation of pregnancy in clinical record
3. Persons with most recent VL suppressed: Inclusion criteria: (1) any age, (2) most recent VL documented in the medical record within the last 1 year, with a value of \>1000 copies/mL on any assay, (3) no documentation of pregnancy in clinical record
4. Persons with no VL in last 1 year: Inclusion criteria: (1) any age, (2) last VL is dated \>1 year ago (if ever started ART) or no VL on file (if never started ART), (3) no documentation of pregnancy in clinical record

"Non-high-risk" patients (n=20 per clinic): Inclusion criteria: (1) adult (age ≥18 years), (2) registered for care, with clinic visit within a year of the Phase 2 start date, (3) already on ART or starting ART at time of study enrollment, (4) do not meet any of the inclusion criteria of a "high risk" subgroup

Exclusion criteria: None

Primary outcomes:
measure: Successful VL ordering
timeFrame: 1 year
measure: VL turnaround time
timeFrame: 1 year
Secondary outcomes:
measure: VL suppression 12 months after the start of Phase 2 of trial
timeFrame: 12 months after the start of Phase 2 of trial
measure: Viral re-suppression after positive VL
timeFrame: 1 year
measure: Number of patients changed from 1st line to 2nd line ART
timeFrame: 1 year
measure: CPHL integration process
timeFrame: 12 months after the start of Phase 2 of trial
measure: VL results in CPHL database
timeFrame: 12 months after the start of Phase 2 of trial
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Southwestern Uganda
Study officials:
affiliation: University of California, San Francisco
name: Vivek Jain, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere University
name: Moses R Kamya, MBChB, MMed
role: PRINCIPAL_INVESTIGATOR
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