Active, Not Recruiting

NCT Number: NCT05901727

DSD Models at Malawi Sentinel Sites (SENTINEL 2-Malawi)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHAI-Malawi

Lilongwe, Malawi

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

for the time and motion study are:

● None.

Exclusion criteria

for provider interviews are:

● None.

Exclusion criteria

for the patient survey are:

Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff.
Unwilling to take the time required to complete the questionnaire on the day of consent.

Exclusion criteria

for the testing survey are:

Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff.
Unwilling to take the time required to complete the questionnaire on the day of consent.

Treatment and study plan

No intervention

Other

Observational data collection only.

Primary outcomes

Proportion of patient survey participants with HIV viral suppression ≤400 copies/ml at most recent test

Time frame: 12 months after enrollment

Viral suppression among ART patients enrolled and not enrolled in differentiated service delivery models

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

Clinton Health Access Initiative-Malawi
Health Economics and Epidemiology Research Office (HE2RO), University of the Witwatersrand

Registry information

Official study title

Outcomes of Differentiated Models of Service Delivery for HIV Treatment at Sentinel Sites in Malawi (Sentinel-Malawi)

Acronym: SENTINEL2MW

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2027
First posted: Jun 13, 2023
Registry last updated: Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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