HIV-1-infectionINTERVALNCT03101592
INTERVAL: Varying Intervals of ART to Improve Outcomes in HIV
A study testing Three-month ART dispensing and Six-month ART dispensing in people with HIV-1-infection, run by University of California, Los Angeles at 2 sites in 2 countries.
Trial summary
This is an unblinded cluster-randomized study to evaluate the effectiveness of two strategies for scripting/dispensing of antiretroviral therapy (ART) on retention, virologic suppression, and cost compared to the standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Three-month ART dispensing and Six-month ART dispensing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,118 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 31 May 2017to 10 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age.
- Willing and able to provide written informed consent for participation in this study.
- Confirmed HIV-1 infection based on country standard of care for testing.
- On antiretroviral treatment (ART) for at least six months.
- On a first-line ART regimen as defined by country-specific guidelines.
- No drug toxicity/tolerability issues with ART regimen within the prior six months.
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- No period of more than one month without ART medication possession within the last six months.
- No active opportunistic infection suspected (including tuberculosis) and not treated for an opportunistic infection in the last 30 days.
- No active comorbidity (including hypertension) and not treated for a comorbidity in the last 30 days.
- No viral load of more than 1000 copies/ml (using standard assay) within the last six months.
- Not currently pregnant.
- At least six months postpartum if recently delivered a baby.
- Not currently breastfeeding or planning to breastfeed.
Who cannot join
- Under 18 years of age.
- Viral load of 1000 copies/ml or greater (using standard assay) within the last six months.
- On alternative first-line or second-line ART regimen.
- One month or more without medication possession within the last six months.
- Experienced an ART toxicity/tolerability issue within the last six months.
- Currently receiving treatment for tuberculosis or receiving treatment for any other opportunistic infection or comorbidity (including hypertension).
Show all 11Show fewer
- Pregnant or less than six months postpartum.
- Women who are breastfeeding.
- Unwilling or unable to provide informed consent.
- Previously enrolled in the study.
- Currently enrolled in any other research study at the site that involves adherence/retention or alters delivery of HIV care.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This is an unblinded cluster-randomized study to evaluate the effectiveness of two strategies for scripting/dispensing of antiretroviral therapy (ART) on retention, virologic suppression, and cost compared to the standard of care. The study will be conducted in Malawi and Zambia among approximately 8,200 HIV-1-infected adults (18 years or older) who are stable on ART. Clusters will be randomized to one of three study arms: (1) standard of care (SOC) ART scripting (varies by country, region, clinic, and/or provider), (2) three-month ART scripting, and (3) six-month ART scripting. 30 clusters will be selected for the study, 15 in Malawi and 15 in Zambia, and will be randomized to a study arm.
Read the detailed description
This study will be conducted among approximately 8,200 HIV-infected individuals age 18 years or older who are stable on antiretroviral therapy (ART) in 30 clusters in Malawi and Zambia. Individuals will be screened at routine clinic visits and enrolled if they meet inclusion criteria. Enrolled individuals will receive standard of care at their site with the exception of their ART dispensing interval based on the assigned randomization. Outcomes will be assessed after 12 months, but all participants will be under observational follow-up for 36 months, with annual re-assessment of retention, virologic suppression, and cost-effectiveness.
There will be no contact with study participants during the period of follow-up.
Endpoints will be determined by chart review after the primary endpoint is reached (12 months). Endpoint data collection will include:
- Retention in care on strategy
- Suppressed viral load of <1,000 copies done as part of standard of care viral load monitoring
In a subset of participants in Malawi (n=1,500), we will perform a review of participants' health passports, a record of patient clinic visits, general health information, and medications that is possessed by patients in Malawi, after the 12-month endpoint has been completed. Data will be collected on interim clinic visits, such as reason for visit/services received (sick, family planning, non-communicable disease treatment), frequency of visits, and location of clinic services.
In a subset of participants (~240), we will perform a post intervention study visit after the 12-month endpoint is completed. Qualitative interviews will be performed with a subset of participants and will focus on patient experience with assigned dispensing interval, including challenges/barriers and facilitators towards adherence and retention. Focused questions around endpoints (if default, reasons; if virologic failure, reasons including adherence) will also be addressed in the post-intervention visit.
- Conditions
- HIV-1-infection
- Being tested
- Three-month ART dispensing, Six-month ART dispensing
- Keywords
- antiretroviral therapy, retention, ART, cost-effectiveness, virologic suppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-month ART dispensingOther
Patients enrolled in the three-month ART dispensing arm will receive a 90-day supply of ART from their provider for the duration of the study.
Six-month ART dispensingOther
Patients enrolled in the six-month ART dispensing arm will receive a 180-day supply of ART from their provider for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care ART dispensing | No intervention | The standard of care arm will allow ART dispensing based on usual practice at the clinic. Standard of care is anticipated to have variability in how ART is dispensed, although the approach should be consistent with applicable country guidelines at the time of study. |
| Three-month ART dispensing | Experimental | Providers at facilities randomized to three-month ART dispensing will be expected to provide all enrolled patients with a 90-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic. Receives: Other: Three-month ART dispensing |
| Six-month ART dispensing | Experimental | Providers at facilities randomized to six-month ART dispensing will be expected to provide all enrolled patients with a 180-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic. Receives: Other: Six-month ART dispensing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in Care at 12 Months
The primary outcome to be studied is whether scripting/dispensing of ART for intervals of six months is non-inferior to three months with respect to retention in care.
Measured: 12 months
Secondary outcomes (2)
Virologic Suppression at 12 Months
The secondary outcome to be studied is whether scripting/dispensing of ART for intervals of six months is non-inferior to three months with respect to a viral load outcome of <1,000 copies/ml (undetectable) at 12 months.
Measured: 12 months
Provider Cost Per Patient by Outcome (USD) (Mean, 95% CI)
The secondary outcome to be studied is the cost-effectiveness of scripting/dispensing of ART for intervals of six months compared to three months and SOC. Cost-effectiveness will be estimated as the average cost per successful outcome (patient retained at 12 months).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start31 May 2017
- Primary completion30 Sep 2019
- Study completion10 Aug 2020
Why it stopped: Enrollment completed. Outcomes measured after only 1 yr due to loss of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- The study will be a cluster randomized trial comparing three different antiretroviral therapy (ART) dispensing strategies. Clusters will be comprised of individual clinics in Malawi and Zambia. Enrolled individuals will receive standard of care at their site with the exception of the ART dispensing interval based on the assigned randomization. Outcomes will be assessed after 12 months.
- Masking
- None (open label)
- Enrolment
- 9,118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, Equip, Lesotho, Ministry of Health, Malawi, Ministry of Health, Zambia, Partners in Hope, Inc., Right to Care, United States Agency for International Development (USAID)
- Responsible party
- Principal investigator, Risa Hoffman, MD, MPH, University of California, Los Angeles
- Investigators
- Risa M Hoffman, MD, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101592
- Sponsor's protocol ID
- 16-001652
- Acronym
- INTERVAL
- Status last verified
- Oct 2020
- First submitted
- 18 Mar 2017
- Last updated
- 27 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoffman RM, Moyo C, Balakasi KT, Siwale Z, Hubbard J, Bardon A, Fox MP, Kakwesa G, Kalua T, Nyasa-Haambokoma M, Dovel K, Campbell PM, Tseng CH, Pisa PT, Cele R, Gupta S, Benade M, Long L, Xulu T, Sanne I, Rosen S. Multimonth dispensing of up to 6 months of antiretroviral therapy in Malawi and Zambia (INTERVAL): a cluster-randomised, non-blinded, non-inferiority trial. Lancet Glob Health. 2021 May;9(5):e628-e638. doi: 10.1016/S2214-109X(21)00039-5.
PubMed 33865471Phiri K, McBride K, Siwale Z, Hubbard J, Bardon A, Moucheraud C, Haambokoma M, Pisa PT, Moyo C, Hoffman RM. Provider experiences with three- and six-month antiretroviral therapy dispensing for stable clients in Zambia. AIDS Care. 2021 Apr;33(4):541-547. doi: 10.1080/09540121.2020.1755010. Epub 2020 May 4.
PubMed 32363910Hoffman R, Bardon A, Rosen S, Fox M, Kalua T, Xulu T, Taylor A, Sanne I. Varying intervals of antiretroviral medication dispensing to improve outcomes for HIV patients (The INTERVAL Study): study protocol for a randomized controlled trial. Trials. 2017 Oct 13;18(1):476. doi: 10.1186/s13063-017-2177-z.
PubMed 29029644
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTERVAL: Varying Intervals of ART to Improve Outcomes in HIV
- ClinicalTrials.gov ID
- NCT03101592
- Acronym / sponsor ID
- INTERVAL / 16-001652
- Conditions
- HIV-1-infection
- Keywords
- antiretroviral therapy, retention, ART, cost-effectiveness, virologic suppression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment completed. Outcomes measured after only 1 yr due to loss of funding.
- Enrolment
- 9,118 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Boston University, Equip, Lesotho, Ministry of Health, Malawi, Ministry of Health, Zambia, Partners in Hope, Inc., Right to Care, United States Agency for International Development (USAID)
- Study start
- 31 May 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Posted 27 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an unblinded cluster-randomized study to evaluate the effectiveness of two strategies for scripting/dispensing of antiretroviral therapy (ART) on retention, virologic suppression, and cost compared to the standard of care. The study will be conducted in Malawi and Zambia among approximately 8,200 HIV-1-infected adults (18 years or older) who are stable on ART. Clusters will be randomized to one of three study arms: (1) standard of care (SOC) ART scripting (varies by country, region, clinic, and/or provider), (2) three-month ART scripting, and (3) six-month ART scripting. 30 clusters will be selected for the study, 15 in Malawi and 15 in Zambia, and will be randomized to a study arm.
Detailed description
This study will be conducted among approximately 8,200 HIV-infected individuals age 18 years or older who are stable on antiretroviral therapy (ART) in 30 clusters in Malawi and Zambia. Individuals will be screened at routine clinic visits and enrolled if they meet inclusion criteria. Enrolled individuals will receive standard of care at their site with the exception of their ART dispensing interval based on the assigned randomization. Outcomes will be assessed after 12 months, but all participants will be under observational follow-up for 36 months, with annual re-assessment of retention, virologic suppression, and cost-effectiveness.
There will be no contact with study participants during the period of follow-up.
Endpoints will be determined by chart review after the primary endpoint is reached (12 months). Endpoint data collection will include:
- Retention in care on strategy
- Suppressed viral load of <1,000 copies done as part of standard of care viral load monitoring
In a subset of participants in Malawi (n=1,500), we will perform a review of participants' health passports, a record of patient clinic visits, general health information, and medications that is possessed by patients in Malawi, after the 12-month endpoint has been completed. Data will be collected on interim clinic visits, such as reason for visit/services received (sick, family planning, non-communicable disease treatment), frequency of visits, and location of clinic services.
In a subset of participants (~240), we will perform a post intervention study visit after the 12-month endpoint is completed. Qualitative interviews will be performed with a subset of participants and will focus on patient experience with assigned dispensing interval, including challenges/barriers and facilitators towards adherence and retention. Focused questions around endpoints (if default, reasons; if virologic failure, reasons including adherence) will also be addressed in the post-intervention visit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study will be a cluster randomized trial comparing three different antiretroviral therapy (ART) dispensing strategies. Clusters will be comprised of individual clinics in Malawi and Zambia. Enrolled individuals will receive standard of care at their site with the exception of the ART dispensing interval based on the assigned randomization. Outcomes will be assessed after 12 months.
| Arm | Type | Receives |
|---|---|---|
| Standard of care ART dispensing | No intervention | –The standard of care arm will allow ART dispensing based on usual practice at the clinic. Standard of care is anticipated to have variability in how ART is dispensed, although the approach should be consistent with applicable country guidelines at the time of study. |
| Three-month ART dispensing | Experimental | Other: Three-month ART dispensingProviders at facilities randomized to three-month ART dispensing will be expected to provide all enrolled patients with a 90-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic. |
| Six-month ART dispensing | Experimental | Other: Six-month ART dispensingProviders at facilities randomized to six-month ART dispensing will be expected to provide all enrolled patients with a 180-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- At least 18 years of age.
- Willing and able to provide written informed consent for participation in this study.
- Confirmed HIV-1 infection based on country standard of care for testing.
- On antiretroviral treatment (ART) for at least six months.
- On a first-line ART regimen as defined by country-specific guidelines.
Key exclusion criteria (11 listed)
- Under 18 years of age.
- Viral load of 1000 copies/ml or greater (using standard assay) within the last six months.
- On alternative first-line or second-line ART regimen.
- One month or more without medication possession within the last six months.
- Experienced an ART toxicity/tolerability issue within the last six months.
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 |
|---|---|---|
| Three-month ART dispensingPatients enrolled in the three-month ART dispensing arm will receive a 90-day supply of ART from their provider for the duration of the study. | Other | Three-month ART dispensing |
| Six-month ART dispensingPatients enrolled in the six-month ART dispensing arm will receive a 180-day supply of ART from their provider for the duration of the study. | Other | Six-month ART dispensing |
Primary outcome
Retention in Care at 12 Months
Time frame: 12 months
The primary outcome to be studied is whether scripting/dispensing of ART for intervals of six months is non-inferior to three months with respect to retention in care.
2 secondary outcomes
Virologic Suppression at 12 Months
Time frame: 12 months
Provider Cost Per Patient by Outcome (USD) (Mean, 95% CI)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33865471Hoffman RM, Moyo C, Balakasi KT, Siwale Z, Hubbard J, Bardon A, Fox MP, Kakwesa G, Kalua T, Nyasa-Haambokoma M, Dovel K, Campbell PM, Tseng CH, Pisa PT, Cele R, Gupta S, Benade M, Long L, Xulu T, Sanne I, Rosen S. Multimonth dispensing of up to 6 months of antiretroviral therapy in Malawi and Zambia (INTERVAL): a cluster-randomised, non-blinded, non-inferiority trial. Lancet Glob Health. 2021 May;9(5):e628-e638. doi: 10.1016/S2214-109X(21)00039-5.
- Derived from this study: PubMed 32363910Phiri K, McBride K, Siwale Z, Hubbard J, Bardon A, Moucheraud C, Haambokoma M, Pisa PT, Moyo C, Hoffman RM. Provider experiences with three- and six-month antiretroviral therapy dispensing for stable clients in Zambia. AIDS Care. 2021 Apr;33(4):541-547. doi: 10.1080/09540121.2020.1755010. Epub 2020 May 4.
- Derived from this study: PubMed 29029644Hoffman R, Bardon A, Rosen S, Fox M, Kalua T, Xulu T, Taylor A, Sanne I. Varying intervals of antiretroviral medication dispensing to improve outcomes for HIV patients (The INTERVAL Study): study protocol for a randomized controlled trial. Trials. 2017 Oct 13;18(1):476. doi: 10.1186/s13063-017-2177-z.
- Individual participant dataSharing planned: No
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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.
Risa M Hoffman, MD, MPH principal investigator
University of California, Los Angeles
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three-month ART dispensing and Six-month ART dispensing in people with HIV-1-infection, run by University of California, Los Angeles at 2 sites in 2 countries.
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 13 inclusion and 11 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: stopped early, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malawi, Zambia. 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?
Yes. Results are posted in the registry (first posted 27 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Retention in Care at 12 Months (time frame: 12 months). 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 NCT03101592, which also lists 3 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 27 Oct 2020.