|D018352||Coronavirus Infections NIH||0.04|
There is one clinical trial.
Many countries in sub-Saharan Africa are implementing a policy of six-month dispensing of antiretroviral (ARV) medications for HIV. Under the new guidelines, stable patients can receive a six-month supply of ARV medications at once, reducing the number of clinic visits required for medication refills. South Africa is considering this policy but has not yet adopted it and has requested evidence of its feasibility, effectiveness, and costs to the healthcare system and to patients. The decision on whether to implement a six-month dispensing policy has become urgent due to the SARS-Cov-2 epidemic, as clinic visits to refill prescriptions pose COVID-19 transmission risks to both patients and providers. To generate the required evidence, South Africa is implementing a pilot program that will allow for a cluster-randomized evaluation of 6-month dispensing. This protocol is for that evaluation. It aims to provide supporting evidence to inform future policy and procurement decisions by the National Department of Health (NDOH). All interventions will be conducted as part of routine care by Department of Health staff. In the pilot program, the NDOH will randomize 28 clinics in two provinces 1:1 to receive the six month dispensing intervention or continue standard of care, which currently allows for 2-3 month dispensing. The researchers will assess the patient outcomes of six month dispensing, administer a cross-sectional patient questionnaire, conduct semi-structured in-depth interviews with care providers and implementers, and estimate the costs to NDOH and to patients of six month dispensing. A maximum of 150,545 patients will be followed through their medical records and 400 patients and providers will be consented to be interviewed at baseline and after 6 months (total maximum sample size = 150,945).
Description: Proportion of patients eligible for 6 multi-month dispensing (6MMD) who enroll in 6MMD at intervention sitesMeasure: Uptake of 6MMD Time: Baseline
Description: Proportion of patients eligible for 6MMD who are retained in care at 6 monthsMeasure: Retention in care Time: 6 months
Description: Proportion of patients eligible for 6MMD who are virally suppressed at 12 monthsMeasure: Viral suppression Time: 12 months
Description: Acceptability of 6MMD to healthcare providers, based on interview responsesMeasure: Provider acceptability of 6MMD before intervention Time: Baseline
Description: Acceptability of 6MMD to healthcare providers, based on interview responsesMeasure: Provider acceptability of 6MMD after intervention Time: 6 months
Description: Acceptability of 6MMD to patients, based on survey responsesMeasure: Patient acceptability at baseline Time: Baseline
Description: Acceptability of 6MMD to patients, based on survey responsesMeasure: Patient acceptability at 6 months Time: 6 months
Description: Costs to healthcare provider (study clinics) of 6MMD, compared to standard of careMeasure: Provider costs Time: 12-months
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports