Evaluating HIV treatment delivery models in Malawi
Outcomes of Differentiated Models of Service Delivery for HIV Treatment at Sentinel Sites in Malawi (Sentinel-Malawi)
This study is trying to see how different ways of delivering HIV treatment in Malawi can help patients feel better and improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15520 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Boston University Academic / other |
| Locations | 1 site (Lilongwe) |
| Trial ID | NCT05901727 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the implementation and effectiveness of differentiated service delivery (DSD) models for HIV treatment in Malawi. It focuses on collecting data from healthcare providers and patients to understand participation rates, health outcomes, service delivery capacity, and associated costs. The study involves patient-facing service providers and patients living with HIV who have been on antiretroviral therapy (ART) for at least six months. By synthesizing this data, the study seeks to inform future decision-making and improve HIV treatment delivery.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals living with HIV who have been on ART for at least six months and are 16 years or older.
Not a fit: Patients who are not living with HIV or those who have not been on ART for the required duration will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the efficiency and effectiveness of HIV treatment delivery, ultimately improving patient outcomes.
How similar studies have performed: Other studies have shown success in evaluating differentiated service delivery models for HIV, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Exclusion Criteria: 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.
Where this trial is running
Lilongwe
- CHAI-Malawi — Lilongwe, Malawi (Recruiting)
Study contacts
- Principal investigator: Sydney Rosen, MPA — Department of Global Health, BU School of Public Health
- Study coordinator: Sydney Rosen, MPA
- Email: sbrosen@bu.edu
- Phone: 8572077909
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.