HIV
Conditions
Keywords
HIV, Differentiated service delivery, Malawi
Brief summary
To achieve global goals for the treatment of HIV, many countries are piloting and scaling up differentiated service delivery models (DSD). A handful of efforts have been formally described and evaluated in the literature; many others are being implemented formally or informally under routine care, without a research or evaluation goal. For most countries however, the investigators have little evidence on progress and challenges at the facility level-the number of patients actually participating in DSD models, health outcomes and non-health outcomes, effects on service delivery capacity and clinic efficiency and operations, and costs to providers and patients. AMBIT is a set of data synthesis, data collection, and data analysis activities aimed at generating information for near- and long-term decision making and creating an approach and platform for ongoing evaluation of differentiated models of HIV treatment delivery. The first AMBIT protocol, "Gathering Records to Evaluate Antiretroviral Treatment" (GREAT, Malawi NHRC 2376), collects and analyzes comprehensive patient medical record data, allowing us to assess the effect of DSD models on patients' clinical outcomes and to evaluate uptake of DSD models at scale. The Sentinel-Malawi study, the second AMBIT protocol, is examining the effect of DSD models on patient and provider satisfaction, service delivery capacity and quality, costs to patients, and other outcomes for which data are not routinely collected in patient-level medical records. The first round of Sentinel-Malawi was conducted in 2021. The investigators are now amending the protocol to allow up to two additional annual rounds of data collection, in 2022-2023. The investigators collected clinic aggregate data, conducted surveys of patients and providers, and observed operations at a selected set of 12 Malawian healthcare facilities and their affiliated DSD models in Round 1. Round 2 and 3 will collect the same types of data at 12 facilities in Malawi and will expand the study's research questions to include differentiated models of HIV testing and linkage to care. Results are expected to inform Malawian policy makers and other local and international stakeholders on the actual implications of DSD models for patients, health system operations, and healthcare budgets.
Interventions
OTHERNo intervention
Observational data collection only.
Sponsors
Boston University
Health Economics and Epidemiology Research Office (HE2RO), University of the Witwatersrand
Clinton Health Access Initiative-Malawi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria for the time and motion study are: * Patient-facing or patient-supporting service provider at the study site (patient-supporting providers include data clerks, pharmacists, etc.) * Directly or indirectly involved in the site's implementation of ART and DSD models * Employed in current role at the study site for at least six months * Provides written informed consent to participate Inclusion criteria for provider interviews are: * Direct or indirect service provider at the study site (indirect providers include supervisors, technical advisors, etc.) * Directly or indirectly involved in the site's implementation of ART and DSD models * Employed in current role at the study site for at least six months * Provides written informed consent to participate. Inclusion criteria for the patient survey are: * Living with HIV and on ART for at least six months at the study site * ≥ 16 years old (16 and older considered adult for research purposes in Malawi) * Enrolled in a specified model of care (including conventional care) up to the target number of participants for that model and have received at least one medication refill under this model * Provide written informed consent to participate. Inclusion criteria for the testing survey are: * Undergoing HIV testing at the study site or other testing site within the catchment area * ≥ 16 years old (16 and older considered adult for research purposes in Malawi) * Provide written informed consent to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patient survey participants with HIV viral suppression ≤400 copies/ml at most recent test | 12 months after enrollment | Viral suppression among ART patients enrolled and not enrolled in differentiated service delivery models |
Countries
Malawi
Contacts
PRINCIPAL_INVESTIGATORSydney Rosen, MPA
Department of Global Health, BU School of Public Health
Outcome results
None listed