AIDS
Conditions
Keywords
HIV, Africa, Adherence, HIV viral load, Sexual behavior, Voluntary counseling and testing
Brief summary
The study is a 3-year, randomized trial to compare ART delivery through two different models: a) ART delivered through health facilities by clinically qualified staff and b) home-based care in which lay workers, i.e. non-medically qualified people, play a major role in the ART delivery and clients are followed up at health facilities less frequently. The primary objective is to measure the effects of these strategies on HIV viral load. We will also examine the effects on treatment failure, disease progression, survival, adherence, family member HIV testing, sexual behavior, and cost-effectiveness.
Detailed description
The study is a randomized trial to compare ART delivery through two different models: a) ART delivered through health facilities by clinically qualified staff and b) home-based care in which lay workers, i.e. non-medically qualified people, play a major role in the ART delivery and clients are followed up at health facilities less frequently. The primary objective is to measure the effects of these strategies on plasma HIV viral load. We will also examine the effects on treatment failure, disease progression, survival, adherence, family member HIV testing, sexual behavior, and cost-effectiveness. The trial is conducted with The AIDS Support Organization (TASO) clinic in Jinja, Uganda. Randomization is conducted through geographic clusters, defined using sub-counties in the district, and stratified by distance from fixed health facilities, and urban/rural. Just over 800 participants, living in 40 clusters, will be recruited over a period of 3-6 months and followed-up over a period of 3 years.
Interventions
DRUGAntiretroviral therapy
Sponsors
British Medical Research Council
The AIDS Support Organization
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
HIV infection Plan to remain resident in the area for at least 12 months CD4 cell count \<200 cells/mm3 or severe symptomatic HIV (WHO stage 3 or 4) Identify a medicine companion who will assist in adherence to ART treatment Age 18 years or above.
Exclusion criteria
Abnormal liver and renal function test results (AST or ALT ≥ 5x upper limit of normal Calculated creatinine clearance \< 25 ml/min). The tests are conducted only in individuals in whom they are clinically indicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HIV viral load | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment failure | — |
| Morbidity | — |
| Survival | — |
| Medication adherence | — |
| Family member HIV testing | — |
| cost-effectiveness | — |
| Sexual behavior | — |
Countries
Uganda
Outcome results
None listed