INTERVAL: Varying Intervals of ART to Improve Outcomes in HIV (INTERVAL)
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|ClinicalTrials.gov Identifier: NCT03101592|
Recruitment Status : Terminated (Enrollment completed. Outcomes measured after only 1 yr due to loss of funding.)
First Posted : April 5, 2017
Results First Posted : October 27, 2020
Last Update Posted : October 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV-1-infection||Other: Three-month ART dispensing Other: Six-month ART dispensing||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9118 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Primary Purpose:||Health Services Research|
|Official Title:||INTERVAL: Varying Intervals of ART to Improve Outcomes in HIV|
|Actual Study Start Date :||May 31, 2017|
|Actual Primary Completion Date :||September 30, 2019|
|Actual Study Completion Date :||August 10, 2020|
No Intervention: Standard of care ART dispensing
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.
Experimental: Three-month ART dispensing
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.
Other: Three-month ART dispensing
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.
Experimental: Six-month ART dispensing
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.
Other: Six-month ART dispensing
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.
- 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.
- Virologic Suppression at 12 Months [ Time Frame: 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.
- Provider Cost Per Patient by Outcome (USD) (Mean, 95% CI) [ Time Frame: 12 months ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101592
|Partners in Hope|
|Principal Investigator:||Risa M Hoffman, MD, MPH||University of California, Los Angeles|