HIV Clinical Trial
— RAPID-VLOfficial title:
Optimizing HIV Viral Load Monitoring and Outcomes for High Risk Populations
Verified date | January 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2443 |
Est. completion date | November 16, 2020 |
Est. primary completion date | November 16, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Uganda | Southwestern Uganda | Mbarara |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Centers for Disease Control and Prevention, Infectious Diseases Research Collaboration, Uganda, Makerere University |
Uganda,
Marseille E, Giganti MJ, Mwango A, Chisembele-Taylor A, Mulenga L, Over M, Kahn JG, Stringer JS. Taking ART to scale: determinants of the cost and cost-effectiveness of antiretroviral therapy in 45 clinical sites in Zambia. PLoS One. 2012;7(12):e51993. doi: 10.1371/journal.pone.0051993. Epub 2012 Dec 20. — View Citation
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Roberts T, Cohn J, Bonner K, Hargreaves S. Scale-up of Routine Viral Load Testing in Resource-Poor Settings: Current and Future Implementation Challenges. Clin Infect Dis. 2016 Apr 15;62(8):1043-8. doi: 10.1093/cid/ciw001. Epub 2016 Jan 6. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful VL ordering | Proportion of patients who had a VL ordered when indicated by country guidelines | 1 year | |
Primary | VL turnaround time | Mean turnaround time in days from VL ordering to delivery of results to patient | 1 year | |
Secondary | VL suppression 12 months after the start of Phase 2 of trial | Proportion of subjects suppressed 12 months after start of RAPID-VL participation | 12 months after the start of Phase 2 of trial | |
Secondary | Viral re-suppression after positive VL | Proportion of patients with a positive (unsuppressed) VL whose next subsequent VL was suppressed | 1 year | |
Secondary | Number of patients changed from 1st line to 2nd line ART | Number of patients who switched to a 2nd line ART regimen for any reason | 1 year | |
Secondary | CPHL integration process | Establishment of a process for data transfer to Uganda's Central Public Health Laboratory (CPHL) (yes/no) | 12 months after the start of Phase 2 of trial | |
Secondary | VL results in CPHL database | Proportion of VL results generated in study that are present in CPHL database at study end | 12 months after the start of Phase 2 of trial |
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