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| Name | Class |
|---|---|
| Harvard University | OTHER |
| Makerere University | OTHER |
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Through close collaboration with the Ugandan Ministry of Health, the investigators plan to provide PrEP for HIV-negative members of HIV serodiscordant couples by launching PrEP delivery within 12 public ART clinics in Kampala, Uganda. Intervention delivery will be launched in a staggered fashion among clinics through a stepped wedge cluster randomized trial providing a rigorous research opportunity to measure the effect of the intervention on PrEP and ART initiation and adherence. To measure these outcomes using clinic records and biomarkers, the program will enroll approximately 1440 HIV serodiscordant couples. Additionally, the program will collect qualitative and quantitative data to determine if PrEP-taking is a modeled behavior that facilitates ART use and characterize the way that PrEP and ART use interact within couples and estimate the programmatic costs of the integrated PrEP and ART strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV serodiscordant couples |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEP | Drug | PrEP will be introduced into clinics according to Uganda national guidelines using a stepped wedge design. Uganda guidelines recommend any tenofovir disoproxil fumarate (TDF) containing medication be used for PrEP; this includes emtricitabine (FTC)/TDF, lamivudine (3TC)/TDF or TDF alone. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of HIV-positive members of a discordant partnership who initiate ART | Measure ART initiation of the HIV-positive member of the couple | Up to 24 months |
| HIV viral load suppression of HIV-positive members of a discordant partnership | ART adherence by measuring HIV viral load of the HIV-positive member of the couple | Up to 24 months |
| Number of HIV-negative members of a discordant partnership who initiate PrEP | Measure PrEP initiation of the HIV-negative member of the couple | Up to 24 months |
| PrEP adherence of HIV-negative members of a discordant partnership | Measure PrEP adherence, among HIV-negative members of a discordant partnership who initiated PrEP, by self-report and tenofovir drug level testing. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP-taking as a modeled behavior | Measure the degree to which PrEP-taking behavior is modeled by HIV-negative partners and the degree to which it is witnessed by HIV-positive partners using questionnaires developed for this purpose. | Up to 24 months |
| Facilitators and barriers to use of ART and PrEP |
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Inclusion Criteria:
For both members of the couple
For HIV-positive members of the couples (index participants)
For HIV-negative members of the couples (partner participants)
Exclusion Criteria:
- Otherwise not eligible based on the above inclusion criteria
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HIV serodiscordant couples from the Kampala, Uganda area
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| Name | Affiliation | Role |
|---|---|---|
| Renee Heffron, PhD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Makerere University | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38452111 | Derived | Wyatt MA, Pisarski EE, Nalumansi A, Kasiita V, Kamusiime B, Nalukwago GK, Thomas D, Muwonge TR, Mujugira A, Heffron R, Ware NC; Partners PrEP Program Study Team. How PrEP delivery was integrated into public ART clinics in central Uganda: A qualitative analysis of implementation processes. PLOS Glob Public Health. 2024 Mar 7;4(3):e0002916. doi: 10.1371/journal.pgph.0002916. eCollection 2024. | |
| 35990584 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 30, 2023 | |
| Reset | Dec 22, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 30, 2023 | Dec 22, 2023 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ART | Drug | ART medication will be provided according to Uganda national guidelines for persons living with HIV. |
|
Mixed methods assessment of how integrated PrEP and ART is 1) used among couples and 2) implemented by health care providers using qualitative interviews and questionnaires. These data will be aggregated to understand the facilitators and barriers to use of ART and PrEP. |
| Up to 24 months |
| Programmatic costs of providing integrated PrEP and ART to HIV serodiscordant couples | Conduct micro-costing, cost-effectiveness, and budget impact analyses to estimate the programmatic costs of providing integrated PrEP and ART to HIV serodiscordant couples. | Up to 24 months |
| Derived |
| Heffron R, Muwonge TR, Thomas KK, Nambi F, Nakabugo L, Kibuuka J, Thomas D, Feutz E, Meisner A, Ware NC, Wyatt MA, Simoni JM, Katz IT, Kadama H, Baeten JM, Mujugira A; Partners PrEP Program Team. PrEP uptake and HIV viral suppression when PrEP is integrated into Ugandan ART clinics for HIV-negative members of HIV-serodifferent couples: A stepped wedge cluster randomized trial. EClinicalMedicine. 2022 Aug 11;52:101611. doi: 10.1016/j.eclinm.2022.101611. eCollection 2022 Oct. |
| 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 |