NCT04066036

Brief Summary

This is a prospective observational cohort study enrolling participants in South Africa and Uganda who are prescribed an HIV treatment regimen containing lamivudine, tenofovir, and dolutegravir, which is known as TLD. We hope to better understand how effective TLD will be in sub-Saharan Africa. If treatment failure occurs, we seek to understand the possible reasons, including drug resistance and adherence challenges.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

4 years

First QC Date

August 21, 2019

Last Update Submit

October 18, 2023

Conditions

HIV-1-infection

Keywords

HIV Integrase InhibitorsSub-Saharan AfricaAnti-HIV AgentsMedication AdherenceVirologic FailureViral Drug ResistanceSouth AfricaUgandaHIV-1

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants with virologic failure (HIV-1 RNA >= 200 copies/mL)

    HIV-1 RNA \>= 200 copies/mL

    48 weeks

Secondary Outcomes (2)

  • Proportion of participants with virologic failure (HIV-1 RNA >= 1,000 copies/mL)

    48 weeks

  • Proportion of participants with HIV drug resistance

    24 and 48 weeks

Study Arms (1)

Study Population

The study will enroll a total of 1,000 ART-experienced participants from the study sites in Uganda and South Africa who are being transitioned to TLD from non-nucleoside reverse transcriptase-based antiretroviral therapy.

Other: This is an observational study only.

Interventions

This is an observational study only.OTHER

This is an observational study only.

Study Population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will enroll a total of 1,000 individuals from Uganda and South Africa, who are currently enrolled in care at one of the study clinics who have been taking NNRTI-based ART for a minimum of six months, and who are switching to TLD. 500 participants will be recruited from Uganda, and 500 will be recruited from South Africa.

You may qualify if:

  • Age ≥18 years
  • HIV-positive and in care at one of the study clinics
  • Current use of NNRTI-based, first-line ART for a minimum of 6 months
  • Prescribed change to TLD by clinic staff
  • Residing within 100 kilometers of the treatment clinic without plans to change permanent residence in the next 48 weeks
  • Consents to participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Africa Health Research Institute

Somkele, KwaZulu-Natal, South Africa

Location

Mbarara University of Science and Technology

Mbarara, Uganda

Location

Related Publications (1)

  • McCluskey SM, Muyindike WR, Nanfuka V, Omoding D, Komukama N, Barigye IT, Kansiime L, Tumusiime J, Aung TN, Stuckwisch A, Hedt-Gauthier B, Marconi VC, Moosa MS, Pillay D, Giandhari J, Lessells R, Gupta RK, Siedner MJ. Population Effectiveness of Dolutegravir Implementation in Uganda: A Prospective Observational Cohort Study (DISCO), 48-Week Results. J Infect Dis. 2024 Sep 23;230(3):e622-e630. doi: 10.1093/infdis/jiae260.

    PMID: 38748986DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, buffy coat, plasma, urine

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Suzanne M McCluskey, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Mark J Siedner, MD, MPH

    Massachusetts General Hospital, Africa Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Assistant Physician

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 22, 2019

Study Start

May 14, 2019

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Data will be made public and accessible through request after completion of the primary analysis.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
After completion of the primary analysis
Access Criteria
De-identified data and supporting information will be made available upon request after agreement among the principal investigators, and based on what is allowable in the study informed consent documents.

Locations

UG(1)ZA(1)