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ACTIVE NOT RECRUITING
NCT05652400

HIV Transmission in the Era of Scaling up Antiretroviral Therapy in Ethiopia

Sponsor: Lund University

View on ClinicalTrials.gov

Summary

The goal of this observational study is to understand patterns of HIV transmission in a high-prevalence area in Ethiopia, and to compare viral genetic information in people with HIV who are newly diagnosed and have not been exposed to antiretroviral therapy with persons receiving antiretroviral therapy without viral suppression. The main questions it aims to answer are: * Do people with HIV who fail to achieve viral suppression contribute to the ongoing spread of HIV in Ethiopia, or does HIV transmission mainly occur between persons with no exposure to such therapy? * Are viruses with drug-resistance mutations transmitted onwards from people with HIV receiving antiretroviral therapy who fail to achieve viral suppression? \* Which factors are involved in treatment failure and emergence of drug-resistant viruses longitudinally? Participants will be enrolled with regard to history of antiretroviral therapy exposure (newly diagnosed/treatment-naïve vs. treatment-experienced with lack of viral suppression), using persons on antiretroviral therapy with viral suppression for control. We will compare the following outcomes between these groups: * Clustering of viral genetic sequences at inclusion (implying linked transmission) * Prevalence of drug-resistance-associated mutations at inclusion * Viral suppression and emergence of drug-resistance mutations during follow-up

Official title: HIV Transmission in the Era of Scaling up Access to Antiretroviral Therapy in Ethiopia

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2400

Start Date

2022-07-01

Completion Date

2026-01-31

Last Updated

2025-03-17

Healthy Volunteers

No

Interventions

OTHER

Exposure to antiretroviral therapy

Outcomes will be compared with regard to current or previous exposure to antiretroviral therapy.

Locations (1)

Public hospitals and health centers in the Adama uptake area

Ādama, Oromiya, Ethiopia