Understanding advanced HIV disease in patients starting antiretroviral therapy in Zambia
Official title: Advanced HIV Disease During the First Six Months on Antiretroviral Therapy in Zambia
Run by Boston University · NCT06904456 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 11800 (estimated) |
| Sponsor | Boston University Academic / other |
| Locations | 1 site (Lusaka) |
| Status | Recruiting |
| Started | April 22, 2025 |
| Main results expected | December 2026 |
| Study ends | June 2027 |
| Registry record updated | May 27, 2026 |
| Trial ID | NCT06904456 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients who are pregnant or too ill to participate at the time of screening may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success in improving HIV treatment outcomes through targeted interventions, making this approach promising.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Improving continuity of care for people hospitalized with advanced HIV in Johannesburg.
This project will follow adults hospitalized with advanced HIV to see where and why people stop care after discharge and who stays connected to clinics.
-
Unlocking PrEP: Peer health coaches to expand PrEP access during re-entry
This project will try adding peer health coaches at a Dallas re-entry program to increase PrEP awareness and uptake among people with a history of justice involvement.
-
Reducing mortality in adults with advanced HIV disease using azithromycin
This study is testing if taking azithromycin can help adults with advanced HIV live longer by comparing it to a placebo.
-
Low-dose trimethoprim-sulfamethoxazole treatment for Pneumocystis (PCP) pneumonia
This trial will test whether a lower daily dose of TMP‑SMX works as well but causes fewer side effects than the standard dose in adults with Pneumocystis (PCP) pneumonia who are immunocompromised.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.