Principal Investigator: Ontlametse T Bareng Bsc

Study Objectives:

The aim of the study is to:

  1. Determine the virologic responses of individuals on DTG based first line therapy in Botswana from June 2016-to date.

Specific objectives

  1. 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.
  1. 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

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