Principal Investigator: Ontlametse T Bareng Bsc
Study Objectives:
The aim of the study is to:
- Determine the virologic responses of individuals on DTG based first line therapy in Botswana from June 2016-to date.
Specific objectives
- To determine the overall and annual prevalence of:
- viral suppression
- low-level viremia
- viral blips
- virologic failure among individuals on DTG first-line based ART in Botswana from June 2016-to date.
- To determine the predictive factors of subsequent VF among PWH on DTG-based ART from June/July 2016-to date.
Study Design:
The study will be a prospective cohort study of two groups of children. Group 1 will include 20 children living with HIV; Group 2 will include 20 children, similar in age to Group 1, who are not living with HIV; this group will serve as a comparator group.
Study Population:
For objective 1: Viral load and other clinical demographics of PWH who are enrolled on Botswana ARV program from June 2016-to date will be utilized. The study will be included individuals who are on DTG based first line therapy for at-least 6 months. Each virologic response including viral suppression, low level viremia, viral blips and virologic failure will be assessed. Viral suppression will be defined as VL below 50 copies/mL.
LLV will be defined as VL between 50 and 1000 copies/mL; which will be further categorized into low, medium and high LLV for VL ranges of 50-200 copies/ml, 201-400 copies/mL and 401-999 copies/mL respectively.
Viral blips will be defined by detectable VL> 50 copies/mL preceded by viral suppression.
Virologic failure will be detectable VL ≥1000 copies/mL.
Objective 2: Individuals with a follow-up VL will be used in a longitudinal analysis to determine predictive factors associated with virologic failure. The primary outcome for participants will be VF during the follow-up period. VF will be defined as any single detectable VL ³ 1000 copies/mL preceded by VL between 50-1000 copies/mL.
Sample size:
All PWH on DTG based first line therapy with viral load data enrolled on Botswana ARV national program will be analysed for the prevalence of viral suppression, low-level viremia, viral blips and virologic failure and for identification of predictive factors associated with virologic failure. The current HIV prevalence in Botswana is 20.3% (UNAIDS), 2017) and figure 1 shows the prevalence of HIV stratified by towns and villages in Botswana and according to the UNAIDS 95-95-95 targets (figure 2), a total of 97.9% of PWH in Botswana are on ART, therefore using IPMS will provide a good representation of Botswana population.
Study duration: 3 years
Study Results: Study is on-going and no results yet.
Sponsor: Botswana Harvard Health Partnership
