Not provided
Not provided
Not provided
Not provided
Enrollment completed. Outcomes measured after only 1 yr due to loss of funding.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boston University | OTHER |
| Equip, Lesotho | OTHER |
| Ministry of Health, Malawi | OTHER_GOV |
| Ministry of Health, Zambia |
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Three-month ART dispensing | Other | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Provider Cost Per Patient by Outcome (USD) (Mean, 95% CI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Risa M Hoffman, MD, MPH | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Partners in Hope | Lilongwe | Malawi | ||||
| EQUIP Zambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33865471 | Derived | 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. | |
| 32363910 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment relied on active identification and referral of stable patients by clinic staff. Clinics were randomized to a study arm, and enrolled individuals initiated the study drug dispensing interval to which the clinic had been randomly assigned.
A total of 14,430 individuals were screened from May 2017- April 2018 across 30 study sites.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. 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. |
| FG002 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics were summarized for just the participants for whom endpoint data was available. 399 participant files could not be located for recording outcome data, so they were excluded from these analyses.
| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care ART Dispensing (SOC) | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | For each demographic variable analyzed, some responses were missing, so could not be included. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The sample includes only those participants for whom outcome data was available (n=8719). As described in the participant flow, 399 participant files could not be located to analyze final outcome data at the endpoint. | Posted | Count of Participants | Participants | 12 months |
|
From enrollment through 1 year of follow-up with all participants
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care ART Dispensing (SOC) | 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. |
Not provided
Not provided
As an implementation science study of service delivery, we faced limitations common in real-world interventions. Most participants did not have routine viral load tests and funding limitations reduced the follow-up period to one year.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Risa Hoffman, MD, MPH; Director of GHP; Associate Professor of Clinical Medicine | David Geffen School of Medicine at UCLA | 310 825-7225 | rhoffman@mednet.ucla.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2017 | Aug 11, 2020 | Prot_SAP_000.pdf |
Not provided
| OTHER_GOV |
| Partners in Hope, Inc. | INDUSTRY |
| Right to Care | OTHER |
| United States Agency for International Development (USAID) | FED |
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.
Not provided
Not provided
Not provided
Not provided
| Six-month ART dispensing | Other | 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. |
|
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). |
| 12 months |
| Lusaka |
| Zambia |
| Derived |
| Phiri 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. |
| 29029644 | Derived | Hoffman 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. |
| Three-month ART Dispensing (3MD) |
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. 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. |
| BG002 | Six-month ART Dispensing (6MD) | 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. 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. |
| BG003 | Total | Total of all reporting groups |
| clinics |
|
| Median |
| Inter-Quartile Range |
| years |
| Participants |
|
|
| Sex: Female, Male | In the SOC arm, there was 1 missing data point for sex. | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Number | participants | Participants |
|
|
| Disclosure of HIV status to primary partner | The number that disclosed HIV status was among those who reported having a primary partner. Additionally, there were missing/not answered data for each arm: in the standard of care arm, 3 were missing; in 3MD 3 were missing; and in 6MD, 1 was missing. | Count of Participants | Participants | Participants |
|
|
| Median years on ART | Medians calculated among those with data available | Median | Inter-Quartile Range | years | Participants |
|
|
| Marital status | In the 3MD arm and 6MD arm, there was 1 missing from each. | Count of Participants | Participants | Participants |
|
|
| Median household size | Calculated by arm and overall | Median | Inter-Quartile Range | People in household | Participants |
|
|
| School (highest level completed) | Missing/not answered: SOC arm- 7; 3MD arm- 4; 6MD arm- 17 | Count of Participants | Participants | Participants |
|
|
| Work status | 6 missing/not answered from the SOC arm, 4 from the 3MD arm, and 4 from the 6MD arm | Count of Participants | Participants | Participants |
|
|
| Missed work to attend current ART clinic visit | Missing/Unanswered for SOC arm = 8, 3MD arm = 6, 6MD arm =4. | Count of Participants | Participants | Participants |
|
|
| Average monthly earnings | Average monthly earnings among those who reported working in US dollars | Median | Inter-Quartile Range | USD | Participants |
|
|
| Transport method to ART clinic | Count of Participants | Participants | Participants |
|
|
| Median one-way travel time to clinic | Medians overall and by arm among those for whom data were reported. | Median | Inter-Quartile Range | minutes | Participants |
|
|
| Proportion of patients incurring transport costs to clinic | Count of Participants | Participants | Participants |
|
|
| For those incurring transport costs, median one-way cost | For those who did incur transport costs. | Median | Inter-Quartile Range | USD | Participants |
|
|
| Median time spent at ART clinic | Medians by arm and overall. | Median | Inter-Quartile Range | minutes | Participants |
|
|
| Median ART dispensing interval in year prior | Medians by arm and overall | Median | Inter-Quartile Range | days | Participants |
|
|
| Among reproductive age women, received contraception in last three months | This variable was just among women of reproductive age. In each arm, there were missing/unanswered among this group: in the SOC arm= 204, 3MD arm = 212, 6MD arm = 220. | Count of Participants | Participants | Participants |
|
|
| OG001 |
| Three-month ART Dispensing (3MD) |
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. 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. |
| OG002 | Six-month ART Dispensing (6MD) | 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. 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. |
|
|
|
| Secondary | 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. | Viral load was originally listed as a secondary outcome. However, given the nature of this implementation science project, and under real world conditions, Viral Load testing was not done due to the early state of viral load scale-up in both Malawi and Zambia. | Posted | 12 months |
|
|
| Secondary | 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). | For the cost analysis, we excluded 179 participants whose visit data were unclear, leaving an analytic sample of 8,540 patients. | Posted | Mean | 95% Confidence Interval | US Dollars | 12 months |
|
|
|
| 11 |
| 3,012 |
| 0 |
| 3,012 |
| 0 |
| 3,012 |
| EG001 | Three-month ART Dispensing (3MD) | 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. 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. | 8 | 2,726 | 0 | 2,726 | 0 | 2,726 |
| EG002 | Six-month ART Dispensing (6MD) | 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. 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. | 8 | 2,981 | 0 | 2,981 | 0 | 2,981 |
Not provided
Not provided
| Male |
|
| Zambia |
|
| No |
|
| Single or no long-term partner |
|
| Widowed, divorced, or separated |
|
| Primary school |
|
| Secondary school |
|
| University/Graduate |
|
| Informal employment |
|
| Not working |
|
| Bicycle |
|
| Bus or minibus |
|
| Bicycle taxi |
|
| Personal or friend's vehicle |
|
| Other |
|
| Did not achieve primary outcome |
|
| All patients |
|