Understanding advanced HIV disease in patients starting antiretroviral therapy in Zambia
Advanced HIV Disease During the First Six Months on Antiretroviral Therapy in Zambia
This study looks at patients in Zambia who have advanced HIV and are starting treatment to see how their backgrounds and experiences affect their health outcomes in the first six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 11800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston University Academic / other |
| Locations | 1 site (Lusaka) |
| Trial ID | NCT06904456 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients in Zambia who present with advanced HIV disease when initiating or re-initiating antiretroviral therapy (ART). It aims to gather detailed information about these patients, including their demographic profiles, HIV care histories, and short-term outcomes during the first six months on ART. By analyzing the characteristics and behaviors of these patients, the study seeks to identify factors that contribute to disengagement from care and mortality. The findings will help improve service delivery and treatment outcomes for individuals with advanced HIV disease.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are presenting for HIV diagnosis or care and are not currently on ART.
Not a fit: Patients who are pregnant or too ill to participate at the time of screening may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and better health outcomes for patients with advanced HIV disease.
How similar studies have performed: Other studies have shown success in improving HIV treatment outcomes through targeted interventions, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Cohort 1 Inclusion * ≥18 years old * Presenting at a study site clinic for HIV diagnosis or care * Not currently on ART (or on ART for up to 1 month if enrolled at next visit after AHD screening) * Screened for AHD by clinic, prior to or within 1 month of ART initiation * Written informed consent to participate Exclusion * Pregnant and/or presenting for antenatal care * Too ill at the time of AHD screening and at the next clinic visit to participate in the study * Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant Cohort 2 Inclusion * ≥18 years old * Living with HIV and screened for AHD at a study site within 12 months of the start of study prospective data collection at that site * All inclusion criteria for the full cohort * Initiated/re-initiated ART within the past 6 months * Returns to the study site for a clinic visit during the study enrollment period * Written informed consent to participate Exclusion * Pregnant and/or presenting for antenatal care as reported in records * All exclusion criteria for the full cohort * Too ill at the time of study enrollment visit to participate in the study * Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant * Been on ART \>6 months Cohort 3 Inclusion * ≥18 years old * Living with HIV * Admitted for inpatient care related to AHD * Initiated or re-initiated ART within the last 6 months * Written informed consent to participate Exclusion * Pregnant and/or presenting for antenatal care * Not physically, mentally, or emotionally able to participate in the study prior to discharge, in the opinion of facility or study staff * Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant * Confined to tuberculosis isolation ward; intensive care unit; or other ward specifically for clients with acute infectious disease. Cohort 4 Inclusion * Employed by or at the study site for at least 6 months * Directly interact with clients presenting with AHD * Written informed consent to participate Exclusion * None
Where this trial is running
Lusaka
- CHAI-Zambia — Lusaka, Zambia (Recruiting)
Study contacts
- Principal investigator: Thandiwe Ngoma — CHAI-Zambia
- Study coordinator: Sydney Rosen, MPA
- Email: sbrosen@bu.edu
- Phone: (857) 207-7909
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.