Ndovu Cohort Study

ActiveMulti-country Cohort

Investigating the optimal management of dolutegravir resistance: a multi-country cohort study

Individuals living with HIV from four African nations with high viral load on DTG-containing antiretroviral regimens

Official Ndovu Study Website

Visit the Ndovu Study website for more information

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Study Design

Multi-country observational prospective cohort study over 12 months describing HIV-1 viral suppression in 392 participantswith high viral load (≥ 1,000 copies/mL) after at least six months on DTG-based ART. The study assesses viral suppression rate following enhanced adherence counseling across four African countries.

Primary Endpoint

Viral suppression rate following enhanced adherence counseling

Study Objectives

  • 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

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • Individuals who cannot provide a sample for viral load testing
  • Anyone currently taking concomitant PIs/NNRTIs while on DTG

Study Procedures

1

Screening and enrollment of eligible participants with high viral load

2

Baseline assessments including viral load, CD4 count, and resistance testing

3

Enhanced adherence counseling sessions delivered by trained staff

4

Regular follow-up visits at 3, 6, and 12 months

5

Repeat viral load and resistance testing at specified timepoints

6

Collection of demographic, clinical, and behavioral data

7

Assessment of treatment adherence and barriers to care

8

Documentation of clinical outcomes and adverse events

Study Information

Duration12 months
Target Enrollment392 participants

Study Locations

Kenya
Mozambique
Tanzania
Lesotho

Study Resources

Visit the Ndovu Study website for detailed information, participant resources, and study updates.

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