Observational study on HIV treatment delivery models in South Africa
Outcomes of Differentiated Models of Service Delivery for HIV Treatment at Sentinel Sites in South Africa (Sentinel-South Africa)
This study looks at different ways to deliver HIV treatment in South Africa, Malawi, and Zambia to see how they affect patients and healthcare providers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15520 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Boston University Academic / other |
| Locations | 1 site (Johannesburg) |
| Trial ID | NCT05886530 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate differentiated service delivery (DSD) models for HIV treatment across multiple healthcare facilities in South Africa, Malawi, and Zambia. It will collect comprehensive data on patient and provider experiences, job satisfaction, quality of life, and resource allocation related to antiretroviral therapy (ART) programs. The study involves surveys and observations of both patients and healthcare providers to assess the effectiveness and efficiency of DSD models in improving HIV care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults living with HIV who have been on antiretroviral therapy for at least six months.
Not a fit: Patients who are not living with HIV or those who have not been on ART for the required duration may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of HIV care and improve the overall experience for both patients and healthcare providers.
How similar studies have performed: Previous studies on differentiated service delivery models have shown promising outcomes, but this specific approach is novel in its comprehensive evaluation of both patient and provider perspectives.
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 South Africa) * 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 South Africa) * 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
Johannesburg
- Health economics and Epidemiology Research Office — Johannesburg, South Africa (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.