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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH130216 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Antiretroviral Therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HIV viral suppression at 12 months | HIV viral suppression is defined as <1,000 copies/mL | 12 months (+/- 2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| HIV viral suppression at 6 months | HIV viral suppression is defined as <1,000 copies/mL | 6 months (+/- 2 months) |
| Antiretroviral therapy adherence among those virally unsuppressed at 12 months |
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Inclusion Criteria:
Inclusion criteria for data abstraction only:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Layla Anderson | Contact | 206-744-5594 | anderla@uw.edu | |
| Kelli O'Laughlin, MD, MPH | Contact | kolaugh@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kelli N. O'Laughlin, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Diseases Institute, Makerere University | Recruiting | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41758805 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2023 | Nov 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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|
assessed by determining tenofovir diphosphate blood concentrations among those virally unsuppressed
| 12 months (+/- 2 months) |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |