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

NCT05652400 | Active Not Recruiting

• 1 other identifier: LundU 2019-02627
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

HIV-1-infection; Antiretroviral Therapy

Keywords

HIV infection; Transmission; Drug resistance; Treatment monitoring; Ethiopia

Outcome Measures

Primary Outcomes (1)

• Clustering of HIV genomic sequences

  Clustering indicating transmission between persons on antiretroviral therapy with lack of viral suppression and persons newly diagnosed with HIV

  2023-2024

Secondary Outcomes (3)

• Clustering of HIV genomic sequences with drug-resistance mutations

  2023-2024

• Lack of viral suppression longitudinally during antiretroviral therapy

  2024-2026

• Emergence of drug-resistance mutations longitudinally during antiretroviral therapy

  2024-2026

Study Arms (1)

Individuals diagnosed with HIV infection

People with HIV

Other: Exposure to antiretroviral therapy

Interventions

Exposure to antiretroviral therapy OTHER

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

Individuals diagnosed with HIV infection

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with HIV. Two categories of participants will be included: 1) persons with no prior or current exposure to antiretroviral therapy; 2) persons with prior or current exposure to antiretroviral therapy. From the latter group, all persons with detectable viremia will be included, with a similar total number of persons with viral suppression (and with no previous recorded lack of viral suppression during antiretroviral therapy).

You may qualify if:

• Written informed consent Positive HIV test result

Sponsors & Collaborators

• Lund University: lead
• Armauer Hansen Research Institute, Ethiopia: collaborator
• Ethiopian Public Health Institute: collaborator
• Oromia Regional Health Bureau: collaborator

Study Sites (1)

Public hospitals and health centers in the Adama uptake area

Ādama, Oromiya, Ethiopia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected from participants at inclusion and longitudinally during follow-up (2 years). Both plasma and whole blood samples will be stored at -80 C using individual codes.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Per Björkman, MD, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

• Alemseged Abdissa, PhD

  Armauer Hansen Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

ET (1)