HIV InfectionsHeadStARTNCT06126913
HeadStART: Evaluating the Effectiveness of Community ART Delivery for People Newly Diagnosed With HIV
A study testing Community Antiretroviral Therapy in people with HIV Infections and Hiv, run by University of Washington at 1 site in Uganda.
Trial summary
This is a cluster randomized controlled trial at 12 health centers in refugee settlements in Uganda aiming to evaluate effectiveness of expansion of community antiretroviral therapy (ART) delivery to people newly diagnosed with HIV in achieving HIV viral suppression. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections, Hiv
- What is being tested?
- Community Antiretroviral Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,720 participants
- Where
- 1 siteUganda
- Study dates
- 15 Jan 2024to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Adult ≥18 years of age or mature minors or emancipated minor. Mature minors are defined as individuals 14-17 years of age who have drug or alcohol dependency or a sexually transmitted infection. Emancipated minors are defined as individuals below the age of majority (18 years) who are pregnant, married, have a child, or are self-sufficient.
- Tested HIV positive in the past 6 months and not already known to be HIV positive.
- Able to communicate in one of the following 5 study languages: Kiswahili, Runyankore, Kinyarwanda, Somali, or English.
- Adult ≥18 years of age or mature minors or emancipated minor.
- Tested HIV positive in the past 6 months and not already known to be HIV positive.
Who cannot join
- Pregnant and breastfeeding women.
- Clients deemed by the clinician(s) unfit for community-based care secondary to medical need.
- Concurrently enrolled in another biomedical clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kelli O'Laughlin, MD, MPH contact
Uganda1 site, 1 recruiting
- Recruiting
Infectious Diseases Institute, Makerere University
Kampala
Timothy Muwonge
About this study
Official title: Achieving HIV Viral Suppression in Refugee Settlements in Uganda With Head StART: A Cluster Randomized Trial Evaluating the Effectiveness of Community ART Delivery for People Newly Diagnosed With HIV
This is a cluster randomized controlled trial at 12 health centers in refugee settlements in Uganda aiming to evaluate effectiveness of expansion of community antiretroviral therapy (ART) delivery to people newly diagnosed with HIV in achieving HIV viral suppression.
Read the detailed description
Community antiretroviral therapy (ART) delivery is a differentiated care model that fosters social support and reduces time and transportation barriers yielding improved engagement in HIV care. In Uganda, to participate in community ART delivery, clients must be "stable" in care (> 1 year on ART and viral load < 1,000 copies/mL). Therefore, persons newly diagnosed with HIV are not eligible for community ART delivery. Community ART delivery may benefit persons newly diagnosed with HIV in refugee settlements by bolstering social support and by bringing ART closer to individuals living in these expansive rural settlements. The primary objective of this research is to evaluate the effectiveness of expanding community ART delivery to clients newly diagnosed with HIV.
- Conditions
- HIV Infections, Hiv
- Being tested
- Community Antiretroviral Therapy
- Keywords
- community ART delivery, HIV, Antiretroviral therapy, Uganda, refugee, humanitarian
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Antiretroviral TherapyOther
Newly diagnosed individuals (diagnosed in the prior 6 months) at intervention sites will be offered community ART delivery on a rolling basis during the enrollment window, initiating individuals into groups as close to their date of diagnosis as possible. Newly enrolled individuals will join existing community ART delivery groups, or when a new group is needed based on group size or geographic location, a new group will be formed.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | At sites randomized to standard care, participants newly diagnosed will receive facility-based care per Uganda Ministry of Health (MoH) protocols |
| Community Antiretroviral Therapy | Experimental | Newly diagnosed individuals (diagnosed in the prior 6 months) at intervention sites will be offered community ART delivery on a rolling basis during the enrollment window, initiating individuals into groups as close to their date of diagnosis as possible. Newly enrolled individuals will join existing community ART delivery groups, or when a new group is needed based on group size or geographic location, a new group will be formed. Receives: Other: Community Antiretroviral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV viral suppression at 12 months
HIV viral suppression is defined as <1,000 copies/mL
Measured: 12 months (+/- 2 months)
Secondary outcomes (2)
HIV viral suppression at 6 months
HIV viral suppression is defined as <1,000 copies/mL
Measured: 6 months (+/- 2 months)
Antiretroviral therapy adherence among those virally unsuppressed at 12 months
assessed by determining tenofovir diphosphate blood concentrations among those virally unsuppressed
Measured: 12 months (+/- 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start15 Jan 2024
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kelli O'Laughlin, University of Washington
- Investigators
- Kelli N. O'Laughlin, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126913
- Sponsor's protocol ID
- STUDY00016473
- Other IDs
- R01MH130216
- Acronym
- HeadStART
- Status last verified
- Jan 2025
- First submitted
- 27 Sep 2023
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klabbers RE, Mugyenyi A, Nsubuga R, Asaba G, Faustin Z, Kiragga A, Drown L, Mujugira A, Mugambi M, Sharma M, Drain P, Middleton NA, Sveum EM, Lewis S, Muwonge TR, O'Laughlin KN. Protocol for Head StART: A hybrid type II cluster randomized controlled trial evaluating community ART delivery for people newly diagnosed with HIV in refugee settlements in Uganda. PLoS One. 2026 Feb 27;21(2):e0340916. doi: 10.1371/journal.pone.0340916. eCollection 2026.
PubMed 41758805
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving HIV Viral Suppression in Refugee Settlements in Uganda With Head StART: A Cluster Randomized Trial Evaluating the Effectiveness of Community ART Delivery for People Newly Diagnosed With HIV
- ClinicalTrials.gov ID
- NCT06126913
- Acronym / sponsor ID
- HeadStART / STUDY00016473
- Conditions
- HIV Infections, Hiv
- Keywords
- community ART delivery, HIV, Antiretroviral therapy, Uganda, refugee, humanitarian
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,720 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cluster randomized controlled trial at 12 health centers in refugee settlements in Uganda aiming to evaluate effectiveness of expansion of community antiretroviral therapy (ART) delivery to people newly diagnosed with HIV in achieving HIV viral suppression.
Detailed description
Community antiretroviral therapy (ART) delivery is a differentiated care model that fosters social support and reduces time and transportation barriers yielding improved engagement in HIV care. In Uganda, to participate in community ART delivery, clients must be "stable" in care (> 1 year on ART and viral load < 1,000 copies/mL). Therefore, persons newly diagnosed with HIV are not eligible for community ART delivery. Community ART delivery may benefit persons newly diagnosed with HIV in refugee settlements by bolstering social support and by bringing ART closer to individuals living in these expansive rural settlements. The primary objective of this research is to evaluate the effectiveness of expanding community ART delivery to clients newly diagnosed with HIV.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –At sites randomized to standard care, participants newly diagnosed will receive facility-based care per Uganda Ministry of Health (MoH) protocols |
| Community Antiretroviral Therapy | Experimental | Other: Community Antiretroviral TherapyNewly diagnosed individuals (diagnosed in the prior 6 months) at intervention sites will be offered community ART delivery on a rolling basis during the enrollment window, initiating individuals into groups as close to their date of diagnosis as possible. Newly enrolled individuals will join existing community ART delivery groups, or when a new group is needed based on group size or geographic location, a new group will be formed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Adult ≥18 years of age or mature minors or emancipated minor. Mature minors are defined as individuals 14-17 years of age who have drug or alcohol dependency or a sexually transmitted infection. Emancipated minors are defined as individuals below the age of majority (18 years) who are pregnant, married, have a child, or are self-sufficient.
- Tested HIV positive in the past 6 months and not already known to be HIV positive.
- Able to communicate in one of the following 5 study languages: Kiswahili, Runyankore, Kinyarwanda, Somali, or English.
Key exclusion criteria (3 listed)
- Pregnant and breastfeeding women.
- Clients deemed by the clinician(s) unfit for community-based care secondary to medical need.
- Concurrently enrolled in another biomedical clinical trial.
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 |
|---|---|---|
| Community Antiretroviral TherapyNewly diagnosed individuals (diagnosed in the prior 6 months) at intervention sites will be offered community ART delivery on a rolling basis during the enrollment window, initiating individuals into groups as close to their date of diagnosis as possible. Newly enrolled individuals will join existing community ART delivery groups, or when a new group is needed based on group size or geographic location, a new group will be formed. | Other | Community Antiretroviral Therapy |
Primary outcome
HIV viral suppression at 12 months
Time frame: 12 months (+/- 2 months)
HIV viral suppression is defined as <1,000 copies/mL
2 secondary outcomes
HIV viral suppression at 6 months
Time frame: 6 months (+/- 2 months)
Antiretroviral therapy adherence among those virally unsuppressed at 12 months
Time frame: 12 months (+/- 2 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Derived from this study: PubMed 41758805Klabbers RE, Mugyenyi A, Nsubuga R, Asaba G, Faustin Z, Kiragga A, Drown L, Mujugira A, Mugambi M, Sharma M, Drain P, Middleton NA, Sveum EM, Lewis S, Muwonge TR, O'Laughlin KN. Protocol for Head StART: A hybrid type II cluster randomized controlled trial evaluating community ART delivery for people newly diagnosed with HIV in refugee settlements in Uganda. PLoS One. 2026 Feb 27;21(2):e0340916. doi: 10.1371/journal.pone.0340916. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
Kelli O'Laughlin, MD, MPH contact
Kelli N. O'Laughlin, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Antiretroviral Therapy in people with HIV Infections and Hiv, run by University of Washington at 1 site in Uganda.
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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Layla Anderson (206-744-5594, anderla@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV viral suppression at 12 months (time frame: 12 months (+/- 2 months)). 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 NCT06126913, which also lists 1 linked publication.
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 9 Jan 2025.