A Randomized Controlled Trial to Assess the Effect of Group Peer Support to Children With HIV in Relation to Adherence, Virological Treatment Failure as Well as Physical Development

Main Aim To study the impact of peer support to children with HIV on antiretroviral treatment (ART) in relation to adherence, virological treatment failure, HIV drug resistance development as well as physical development using a randomised controlled trial (RCT) design comparing enhanced treatment support (ETS) and conventional treatment (CT).

Specific Aims

1. To assess the rate and risk factors for virological treatment failure among children on ART for more than 6 months using HIV viral load in blood in relation to clinical and socioeconomic indicators.
2. To recruit 520 HIV+ children 0-12 years of age on ART and randomize to either enhanced treatment support (ETS) or conventional treatment (CT).
3. To monitor ART adherence, CD4+ T-cell count, HIV viral load, clinical status, physical and cognitive development AIDS-associated events and/or mortality during every 6 months during a 36 months follow up period.
4. To assess the effect of ETS compared to CT with respect to the primary endpoint, virological treatment failure and specific ART mutations as well as the secondary endpoints, immunological failure, ART adherence, physical and cognitive development, and mortality and/or AIDS events.
5. To conduct a cost effectiveness assessment comparing ETS and CT.

This is a multi center study that includes the National Pediatric Hospital in Hanoi and the two major pediatric hospitals in Ho Chi Minh City. A study population of 520 HIV+ children receiving ARTs will be recruited from these hospitals. The reason for selecting children on ART is to see if treatment support can be initiated successfully after initiation of ART. Each HIV+ patient is examined according to WHO guidelines. HIV+ children will receive a complete physical examination including clinical staging of HIV infection, opportunistic infections and evidence of tuberculosis. Laboratory testing will include full blood count, CD4+ T-cell count (for children under five years of age CD4 %), viral load using ExaVirR viral load and liver enzymes. If indicated (e.g. prolonged cough and/or fever) chest X-ray, sputum microscopy for AFB will be done.

Opportunistic infections in HIV+ patients will be treated according to national guidelines. HIV+ children and their caregivers receive counselling and clinical follow ups. Tuberculosis (TB) will be managed in collaboration with the National Tuberculosis Program.