Advanced HIV Disease During the First Six Months on Antiretroviral Therapy in Zambia

Launched by BOSTON UNIVERSITY · Mar 28, 2025

Keywords

ClinConnect Summary

This clinical trial, called the Advanced HIV Disease (AHD) study in Zambia, is focused on understanding the experiences of people who are starting antiretroviral therapy (ART) for advanced HIV disease. Many individuals diagnosed with HIV in Zambia are coming to treatment with serious health issues. The goal of this study is to gather important information about these patients, including their health conditions, backgrounds, and the care they receive. By learning more about these patients during their first six months on treatment, the researchers hope to improve their chances of staying healthy and connected to care.

To participate in this study, individuals must be at least 18 years old and either starting or restarting ART for HIV. They should not currently be on ART or have been on it for more than six months. Participants will be asked to share their health details and experiences through surveys and discussions. The study will also involve healthcare providers who work directly with these patients. This research is crucial for informing better treatment strategies and guidelines to help improve health outcomes for individuals with advanced HIV disease in Zambia.

Gender

ALL

Eligibility 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