Evaluating HIV treatment delivery models in Zambia
Outcomes of Differentiated Models of Service Delivery for HIV Treatment at Sentinel Sites in Zambia (Sentinel-Zambia)
This study is testing different ways to deliver HIV treatment in Zambia to see which methods help patients better and make the process more efficient.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 8280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston University Academic / other |
| Locations | 1 site (Lusaka) |
| Trial ID | NCT05902572 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess differentiated service delivery (DSD) models for HIV treatment in Zambia. It focuses on understanding the participation rates, health outcomes, and operational efficiency of these models at the facility level. By collecting data from patient-facing and supporting service providers, as well as patients living with HIV, the study seeks to generate valuable insights for improving HIV treatment delivery. The findings will inform both near- and long-term decision-making regarding ART delivery in Zambia.
Who should consider this trial
Good fit: Ideal candidates for this study are adults living with HIV who have been on antiretroviral therapy (ART) for at least six months.
Not a fit: Patients who are not living with HIV or 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 effectiveness and efficiency 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 both relevant and potentially impactful.
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 * ≥ 18 years old (18 and older considered adult for research purposes in Zambia) * 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 * ≥ 18 years old (18 and older considered adult for research purposes in Zambia) * 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
Lusaka
- Clinton Health Access Initiative-Zambia — Lusaka, Zambia (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.