Ndovu Cohort Study
Investigating the optimal management of dolutegravir resistance across four African countries — Kenya, Mozambique, Tanzania, and Lesotho.
Duration
12 months
Participants
392
Countries
4 countries
Multi-country observational prospective cohort study over 12 months, describing HIV-1 viral suppression in 392 individuals with high viral load (≥ 1,000 copies/mL) after at least six months on DTG-based ART. The study assesses viral suppression rates following enhanced adherence counseling across four African countries.
Target population: Individuals living with HIV from four African countries with high viral load on DTG-containing antiretroviral regimens.
Primary Endpoint
Viral suppression rate following enhanced adherence counseling
Describe HIV-1 viral suppression rates in people with high viral load after enhanced adherence counseling
Investigate patterns of dolutegravir resistance mutations across different African populations
Assess factors associated with treatment success and failure in DTG-based regimens
Evaluate the effectiveness of enhanced adherence counseling interventions
Document real-world outcomes of DTG-based therapy in resource-limited settings
Build evidence for optimal management strategies of DTG treatment failure
Inclusion
Be at least 1 year of age
Consent to participate in the study
Have documented HIV infection
Be on a DTG-based regimen for at least 6 months
Have an HIV-1 RNA level of ≥ 1,000 copies/mL
Exclusion
Individuals who cannot provide a sample for viral load testing
Anyone currently taking concomitant PIs/NNRTIs while on DTG
Screening and enrollment of eligible participants with high viral load
Baseline assessments including viral load, CD4 count, and resistance testing
Enhanced adherence counseling sessions delivered by trained staff
Regular follow-up visits at 3, 6, and 12 months
Repeat viral load and resistance testing at specified timepoints
Collection of demographic, clinical, and behavioral data
Assessment of treatment adherence and barriers to care
Documentation of clinical outcomes and adverse events