Genotype-Informed Versus Empiric Management of VirEmia (GIVE MOVE)
HIV-1-infection
About this trial
This is an interventional diagnostic trial for HIV-1-infection focused on measuring HIV-1, acquired immunodeficiency syndrome, drug resistance, treatment failure, child, adolescent, Lesotho, Tanzania
Eligibility Criteria
Inclusion Criteria:
- In care in a study site
- Age ≥6 months and <19 years
- Latest HIV viral load result ≥400 c/mL
- On an unchanged ART regimen for ≥6 months
- Phlebotomy for latest viral load test <4 months before screening
- Consent given
Exclusion Criteria:
- Indication for treatment switch according to WHO guidelines at screening
- 1st enhanced adherence counselling (EAC) session initiated >2 weeks prior to screening
- Intention to transfer out of the study site (and not into a different study site) within 3 months after randomisation
- Already enrolled in another study if judged as non-compatible by the (Local) Principal Investigator
- Pregnant or breastfeeding at screening (no exclusion based on pregnancy or breastfeeding after enrolment)
- Acute illness requiring hospitalisation at screening (no exclusion based on hospitalisation after enrolment)
- Received a resistance test in the last 12 months
Sites / Locations
- Seboche Mission Hospital
- Baylor Clinic Leribe
- Baylor Clinic Butha-Buthe
- Baylor Clinic Maseru
- Baylor Clinic Mohale's Hoek
- Baylor Clinic Mokhotlong
- One-Stop Clinic and Chronic Diseases Clinic (CDCI) at St Francis Referral Hospital
- Mbagala Rangi Tatu Hospital
- Temeke Regional Referral Hospital
- Upendano Dispensary
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention
Control
The viral load ≥400 c/mL before enrolment triggers genotypic resistance testing (GRT), followed by GRT-informed patient management and counselling. Onward treatment is informed by the resistance profile determined through GRT, with a GRT Expert Committee issuing a treatment recommendation.
Standard of care according to national guidelines and recommendations of the World Health Organization: The viral load ≥400 c/mL before enrolment is followed by 3 sessions of enhanced adherence counselling and a follow-up viral load test. Onward treatment is informed by viral load testing.