Population Effectiveness of Dolutegravir Implementation in Sub-Saharan Africa

An observational study of HIV-1-infection, run by Massachusetts General Hospital at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1-infection
What is being tested?: This is an observational study only.
How many people: 999 participants
Where: 2 sitesin 2 countries
Study dates: 14 May 2019to 31 May 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

There are no specific exclusion criteria. Both men and women will be theoretically eligible. We note that decision to use TLD in patients at the recruitment clinic will be made by clinic staff, and referral for study procedures will not be made until after this decision is made. We also note that, as of the time of this protocol draft, TLD use might be limited to men, women of non-child bearing ages, and women confirmed to be on contraception. This study will follow both national guidelines and clinician discretion about use of TLD in the clinic population.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

South Africa1 site

Africa Health Research Institute
Somkele, KwaZulu-Natal

Other trials in South Africa

Uganda1 site

Mbarara University of Science and Technology
Mbarara

Other trials in Uganda

About this study

Official title: Population Effectiveness of Dolutegravir Implementation in Sub-Saharan Africa: A Prospective Observational Cohort Study

Read the detailed description

This study is a prospective observational cohort study at three government-supported HIV clinics in rural South Africa and Uganda. We will enroll 1,000 adults living with HIV who are switched from first-line antiretroviral therapy (ART) containing non-nucleoside reverse transcriptase inhibitors (NNRTIs) to TLD. We will follow participants for one year with study visits at enrollment, 24 weeks, and 48 weeks. Study procedures include interviews, body measurements, chart review, and collection of blood and urine specimens for retrospective testing, including viral load, drug resistance testing, antiretroviral drug level testing, and tests to evaluate the effects of TLD on renal, liver, metabolic, and other organ function.

Aim 1: To determine the contributions of resistance prior to switch to TLD from a NNRTI-based regimen to risk of treatment failure after six and twelve months on TLD. Hypothesis: People living with HIV who experience virologic failure on TLD will have increased odds of NRTI mutations prior to TLD exposure, compared to controls with virologic suppression.

Aim 2: Explore pharmacologic measures of adherence to distinguish virologic failure on TLD due to suboptimal adherence versus resistance using 2a) urine tenofovir (TFV) levels and 2b) tenofovir diphosphate (TFV-DP) in dried blood spots (DBS). Hypothesis: Absence of TFV in urine and TFV-DP concentrations in DBS will distinguish ART failure with versus without resistance.

Conditions: HIV-1-infection
Being tested: This is an observational study only.
Keywords: HIV Integrase Inhibitors, Sub-Saharan Africa, Anti-HIV Agents, Medication Adherence, Virologic Failure, Viral Drug Resistance, South Africa, Uganda, HIV-1
Medical subject headings: Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

This is an observational study only.Other
This is an observational study only.

Study groups in NCT04066036
Study group	Role	What they receive
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. Receives: Other: This is an observational study only.

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Participants With Virologic Failure (HIV-1 RNA >= 200 Copies/mL)
HIV-1 RNA >= 200 copies/mL
Measured: 48 weeks

Secondary outcomes (2)

Proportion of Participants With Virologic Failure (HIV-1 RNA >= 1,000 Copies/mL)
HIV-1 RNA >= 1,000 copies/mL
Measured: 48 weeks
Proportion of Participants With HIV Drug Resistance
Proportion of participants with International AIDS Society-defined drug resistance mutations to their current regimen
Measured: 24 and 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 May 201931 May 2023

First posted22 Aug 2019
Study start14 May 2019
Primary completion31 May 2023
Study completion31 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV-1-infectionStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 999 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04066036
Sponsor's protocol ID: 2019P000898-A
Other IDs: K23AI143470, 212215, WT108082AIA
Acronym: DISCO
Status last verified: Jul 2026
First submitted: 21 Aug 2019
Last updated: 5 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data will be made public and accessible through request after completion of the primary analysis.

Publications

Aung TN, Muyindike W, Hoeppner SS, Nanfuka V, Komukama N, Barigye IT, Tumusiime J, Omoding D, Johnson LS, Stuckwisch A, Pinkney JA, Hedt-Gauthier B, Marconi VC, Moosa MS, Pillay D, Gupta RK, Siedner MJ, McCluskey SM. COVID-19 vaccination among people with HIV in Uganda: lessons from a high-risk group with high vaccine uptake for the next pandemic. Vaccine. 2026 Aug 13;88:128912. doi: 10.1016/j.vaccine.2026.128912. Epub 2026 Jul 10.
PubMed 42430873
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.
PubMed 38748986

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

All HIV-1-infection trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Population Effectiveness of Dolutegravir Implementation in Sub-Saharan Africa: A Prospective Observational Cohort Study
ClinicalTrials.gov ID: NCT04066036
Acronym / sponsor ID: DISCO / 2019P000898-A
Conditions: HIV-1-infection
Keywords: HIV Integrase Inhibitors, Sub-Saharan Africa, Anti-HIV Agents, Medication Adherence, Virologic Failure, Viral Drug Resistance, South Africa, Uganda
Study type: Observational
Recruitment status: Completed
Enrolment: 999 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Africa Health Research Institute, Mbarara University of Science and Technology, National Institute of Allergy and Infectious Diseases (NIAID), Wellcome Trust, ViiV Healthcare, Harvard Medical School (HMS and HSDM), University of KwaZulu, Emory University
Study start: 14 May 2019 (actual)
Primary completion: 31 May 2023 (actual)
Study completion: 31 May 2023 (actual)
First posted: 22 Aug 2019 (actual)
Results: Posted 5 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Study Population	–	Other: This is an observational study only.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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (6 listed)

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

Key exclusion criteria (1 listed)

There are no specific exclusion criteria. Both men and women will be theoretically eligible. We note that decision to use TLD in patients at the recruitment clinic will be made by clinic staff, and referral for study procedures will not be made until after this decision is made. We also note that, as of the time of this protocol draft, TLD use might be limited to men, women of non-child bearing ages, and women confirmed to be on contraception. This study will follow both national guidelines and clinician discretion about use of TLD in the clinic population.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
This is an observational study only.This is an observational study only.	Other	Study Population

Primary outcome

Proportion of Participants With Virologic Failure (HIV-1 RNA >= 200 Copies/mL)
Time frame: 48 weeks
HIV-1 RNA >= 200 copies/mL

2 secondary outcomes

Proportion of Participants With Virologic Failure (HIV-1 RNA >= 1,000 Copies/mL)
Time frame: 48 weeks
Proportion of Participants With HIV Drug Resistance
Time frame: 24 and 48 weeks

Results and safety

Results posted to the registry on 5 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Population	999	913

Primary outcome: Proportion of Participants With Virologic Failure (HIV-1 RNA >= 200 Copies/mL)

Time frame: 48 weeks. Count of participants. Unit: Participants

Measure	Study Population n = 999
Value	28

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected passively over 48 weeks of study participation.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Population	12 of 999 (1.2%)	0 of 999 (0%)	8 of 999

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42430873Aung TN, Muyindike W, Hoeppner SS, Nanfuka V, Komukama N, Barigye IT, Tumusiime J, Omoding D, Johnson LS, Stuckwisch A, Pinkney JA, Hedt-Gauthier B, Marconi VC, Moosa MS, Pillay D, Gupta RK, Siedner MJ, McCluskey SM. COVID-19 vaccination among people with HIV in Uganda: lessons from a high-risk group with high vaccine uptake for the next pandemic. Vaccine. 2026 Aug 13;88:128912. doi: 10.1016/j.vaccine.2026.128912. Epub 2026 Jul 10.
Derived from this study: PubMed 38748986McCluskey 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.
Individual participant dataSharing planned: Yes. Data will be made public and accessible through request after completion of the primary analysis.

Related trials for HIV-1-infection

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Suzanne M McCluskey, MD principal investigator

Massachusetts General Hospital

Mark J Siedner, MD, MPH principal investigator

Massachusetts General Hospital, Africa Health Research Institute

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV-1-infection, run by Massachusetts General Hospital at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Africa, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants With Virologic Failure (HIV-1 RNA >= 200 Copies/mL) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04066036, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.