HIVRAPID-VLNCT03553693
Rapid HIV Viral Load Monitoring in High Risk Patients In Uganda
A study testing RAPID-VL study intervention in people with HIV, run by University of California, San Francisco at 1 site in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- HIV
- What is being tested?
- RAPID-VL study intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,443 participants
- Where
- 1 siteUganda
- Study dates
- 16 Jul 2018to 16 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- Pregnant or breastfeeding women: Inclusion criteria: (1) pregnant or breastfeeding at any time during Phase 1, confirmed by clinic documentation
- Children/adolescents: Inclusion criteria: (1) age 2-17 years, (2) no documentation of pregnancy in clinical record
- 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
- 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
Show all 23Show fewer
- "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:
- Pregnant or breastfeeding women: Inclusion criteria: (1) currently pregnant or breastfeeding, confirmed by clinic standard documentation
- 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
- 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
- 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:
- Pregnant or breastfeeding women: Inclusion criteria: (1) pregnant or breastfeeding at any time during Phase 2, confirmed by clinic documentation
- 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
- 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
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing HIV Viral Load Monitoring and Outcomes for High Risk Populations
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.
Read the 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.
- Conditions
- HIV
- Being tested
- RAPID-VL study intervention
- Keywords
- HIV, Viral Load, Counseling, Costs and Costs Analysis, Point-Of-Care Systems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAPID-VL study interventionOther
- Viral load (VL) ordering flowsheet with periodic health facility performance feedback
- Rapid near-point-of-care VL testing and telephone delivery of results
- Structured VL counseling package
| Study group | Role | What they receive |
|---|---|---|
| Intervention Clinics | Experimental | 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. Receives: Other: RAPID-VL study intervention |
| Control Clinics | No intervention | Standard of care VL testing and counseling procedures consistent with country guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful VL ordering
Proportion of patients who had a VL ordered when indicated by country guidelines
Measured: 1 year
VL turnaround time
Mean turnaround time in days from VL ordering to delivery of results to patient
Measured: 1 year
Secondary outcomes (5)
VL suppression 12 months after the start of Phase 2 of trial
Proportion of subjects suppressed 12 months after start of RAPID-VL participation
Measured: 12 months after the start of Phase 2 of trial
Viral re-suppression after positive VL
Proportion of patients with a positive (unsuppressed) VL whose next subsequent VL was suppressed
Measured: 1 year
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
Measured: 1 year
CPHL integration process
Establishment of a process for data transfer to Uganda's Central Public Health Laboratory (CPHL) (yes/no)
Measured: 12 months after the start of Phase 2 of trial
VL results in CPHL database
Proportion of VL results generated in study that are present in CPHL database at study end
Measured: 12 months after the start of Phase 2 of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start16 Jul 2018
- Primary completion16 Nov 2020
- Study completion16 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative effectiveness cluster-randomized trial
- Masking
- None (open label)
- Enrolment
- 2,443 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Infectious Diseases Research Collaboration, Uganda, Makerere University
- Responsible party
- Sponsor
- Investigators
- Vivek Jain, MD, MAS, Principal investigator, University of California, San FranciscoMoses R Kamya, MBChB, MMed, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553693
- Sponsor's protocol ID
- RAPID-VL
- Acronym
- RAPID-VL
- Status last verified
- Jan 2020
- First submitted
- 18 May 2018
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Working Group on Modelling of Antiretroviral Therapy Monitoring Strategies in Sub-Saharan Africa; Phillips A, Shroufi A, Vojnov L, Cohn J, Roberts T, Ellman T, Bonner K, Rousseau C, Garnett G, Cambiano V, Nakagawa F, Ford D, Bansi-Matharu L, Miners A, Lundgren JD, Eaton JW, Parkes-Ratanshi R, Katz Z, Maman D, Ford N, Vitoria M, Doherty M, Dowdy D, Nichols B, Murtagh M, Wareham M, Palamountain KM, Chakanyuka Musanhu C, Stevens W, Katzenstein D, Ciaranello A, Barnabas R, Braithwaite RS, Bendavid E, Nathoo KJ, van de Vijver D, Wilson DP, Holmes C, Bershteyn A, Walker S, Raizes E, Jani I, Nelson LJ, Peeling R, Terris-Prestholt F, Murungu J, Mutasa-Apollo T, Hallett TB, Revill P. Sustainable HIV treatment in Africa through viral-load-informed differentiated care. Nature. 2015 Dec 3;528(7580):S68-76. doi: 10.1038/nature16046.
PubMed 26633768Rutstein SE, Golin CE, Wheeler SB, Kamwendo D, Hosseinipour MC, Weinberger M, Miller WC, Biddle AK, Soko A, Mkandawire M, Mwenda R, Sarr A, Gupta S, Mataya R. On the front line of HIV virological monitoring: barriers and facilitators from a provider perspective in resource-limited settings. AIDS Care. 2016;28(1):1-10. doi: 10.1080/09540121.2015.1058896. Epub 2015 Aug 17.
PubMed 26278724Roberts 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.
PubMed 26743094Shafiee H, Wang S, Inci F, Toy M, Henrich TJ, Kuritzkes DR, Demirci U. Emerging technologies for point-of-care management of HIV infection. Annu Rev Med. 2015;66:387-405. doi: 10.1146/annurev-med-092112-143017. Epub 2014 Nov 12.
PubMed 25423597Ouattara EN, Robine M, Eholie SP, MacLean RL, Moh R, Losina E, Gabillard D, Paltiel AD, Danel C, Walensky RP, Anglaret X, Freedberg KA. Laboratory Monitoring of Antiretroviral Therapy for HIV Infection: Cost-Effectiveness and Budget Impact of Current and Novel Strategies. Clin Infect Dis. 2016 Jun 1;62(11):1454-1462. doi: 10.1093/cid/ciw117. Epub 2016 Mar 1.
PubMed 26936666Marseille 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.
PubMed 23284843
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing HIV Viral Load Monitoring and Outcomes for High Risk Populations
- ClinicalTrials.gov ID
- NCT03553693
- Acronym / sponsor ID
- RAPID-VL / RAPID-VL
- Conditions
- HIV
- Keywords
- HIV, Viral Load, Counseling, Costs and Costs Analysis, Point-Of-Care Systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,443 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Infectious Diseases Research Collaboration, Uganda, Makerere University
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparative effectiveness cluster-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Clinics | Experimental | Other: RAPID-VL study interventionRAPID-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. |
| Control Clinics | No intervention | –Standard of care VL testing and counseling procedures consistent with country guidelines. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- "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:
- Pregnant or breastfeeding women: Inclusion criteria: (1) pregnant or breastfeeding at any time during Phase 1, confirmed by clinic documentation
- Children/adolescents: Inclusion criteria: (1) age 2-17 years, (2) no documentation of pregnancy in clinical record
- 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
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAPID-VL study intervention* Viral load (VL) ordering flowsheet with periodic health facility performance feedback * Rapid near-point-of-care VL testing and telephone delivery of results * Structured VL counseling package | Other | Intervention Clinics |
Primary outcome
Successful VL ordering
Time frame: 1 year
Proportion of patients who had a VL ordered when indicated by country guidelines
VL turnaround time
Time frame: 1 year
Mean turnaround time in days from VL ordering to delivery of results to patient
5 secondary outcomes
VL suppression 12 months after the start of Phase 2 of trial
Time frame: 12 months after the start of Phase 2 of trial
Viral re-suppression after positive VL
Time frame: 1 year
Number of patients changed from 1st line to 2nd line ART
Time frame: 1 year
CPHL integration process
Time frame: 12 months after the start of Phase 2 of trial
VL results in CPHL database
Time frame: 12 months after the start of Phase 2 of trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Background: PubMed 26633768Working Group on Modelling of Antiretroviral Therapy Monitoring Strategies in Sub-Saharan Africa; Phillips A, Shroufi A, Vojnov L, Cohn J, Roberts T, Ellman T, Bonner K, Rousseau C, Garnett G, Cambiano V, Nakagawa F, Ford D, Bansi-Matharu L, Miners A, Lundgren JD, Eaton JW, Parkes-Ratanshi R, Katz Z, Maman D, Ford N, Vitoria M, Doherty M, Dowdy D, Nichols B, Murtagh M, Wareham M, Palamountain KM, Chakanyuka Musanhu C, Stevens W, Katzenstein D, Ciaranello A, Barnabas R, Braithwaite RS, Bendavid E, Nathoo KJ, van de Vijver D, Wilson DP, Holmes C, Bershteyn A, Walker S, Raizes E, Jani I, Nelson LJ, Peeling R, Terris-Prestholt F, Murungu J, Mutasa-Apollo T, Hallett TB, Revill P. Sustainable HIV treatment in Africa through viral-load-informed differentiated care. Nature. 2015 Dec 3;528(7580):S68-76. doi: 10.1038/nature16046.
- Background: PubMed 26278724Rutstein SE, Golin CE, Wheeler SB, Kamwendo D, Hosseinipour MC, Weinberger M, Miller WC, Biddle AK, Soko A, Mkandawire M, Mwenda R, Sarr A, Gupta S, Mataya R. On the front line of HIV virological monitoring: barriers and facilitators from a provider perspective in resource-limited settings. AIDS Care. 2016;28(1):1-10. doi: 10.1080/09540121.2015.1058896. Epub 2015 Aug 17.
- Background: PubMed 26743094Roberts 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.
- Background: PubMed 25423597Shafiee H, Wang S, Inci F, Toy M, Henrich TJ, Kuritzkes DR, Demirci U. Emerging technologies for point-of-care management of HIV infection. Annu Rev Med. 2015;66:387-405. doi: 10.1146/annurev-med-092112-143017. Epub 2014 Nov 12.
- Background: PubMed 26936666Ouattara EN, Robine M, Eholie SP, MacLean RL, Moh R, Losina E, Gabillard D, Paltiel AD, Danel C, Walensky RP, Anglaret X, Freedberg KA. Laboratory Monitoring of Antiretroviral Therapy for HIV Infection: Cost-Effectiveness and Budget Impact of Current and Novel Strategies. Clin Infect Dis. 2016 Jun 1;62(11):1454-1462. doi: 10.1093/cid/ciw117. Epub 2016 Mar 1.
- Background: PubMed 23284843Marseille 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Jain, MD, MAS principal investigator
University of California, San Francisco
Moses R Kamya, MBChB, MMed principal investigator
Makerere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAPID-VL study intervention in people with HIV, run by University of California, San Francisco at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful VL ordering (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03553693, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.