Rapid HIV Viral Load Monitoring in High Risk Patients In Uganda (RAPID-VL)

University of California San Francisco (UCSF)

Status: Completed

Conditions: HIV

Treatments: Other: RAPID-VL study intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03553693

RAPID-VL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,443 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,443 participants in 2 patient groups

Intervention Clinics

Experimental group

Description:

RAPID-VL study intervention testing and counseling package, which includes near point-of-care viral load (VL) testing at local testing hubs, structured VL counseling, forms to track VL ordering and testing, with feedback and performance evaluations at regular intervals.

Treatment:

Other: RAPID-VL study intervention

Control Clinics

No Intervention group

Description:

Standard of care VL testing and counseling procedures consistent with country guidelines.