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
Summary: Background: Global scale-up of HIV pre-exposure prophylaxis (PrEP) includes services to HIV-negative people in partnerships with people living with HIV (serodifferent couples). Data are needed on HIV outcomes, including uptake and adherence to PrEP and antiretroviral treatment (ART), to de...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-10-01
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| Series: | EClinicalMedicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589537022003418 |
| _version_ | 1811310360925306880 |
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| author | Renee Heffron Timothy R. Muwonge Katherine K. Thomas Florence Nambi Lylianne Nakabugo Joseph Kibuuka Dorothy Thomas Erika Feutz Allison Meisner Norma C. Ware Monique A. Wyatt Jane M. Simoni Ingrid T. Katz Herbert Kadama Jared M. Baeten Andrew Mujugira Renee Heffron, (protocol chair) Jared M. Baeten Jane Simoni Deborah Donnell Ruanne Barnabas Katherine K. Thomas Dorothy Thomas Erika Feutz Cole Grabow Allison Meisner Kristin Ciccarelli Caitlin Scoville Katrina Ortblad Andrew Mujugira Timothy R. Muwonge Joseph Kibuuka Lylianne Nakabugo Florence Nambi Mai Nakitende Diego Izizinga Vicent Kasita Brenda Kamusiime Alisaati Nalumansi Collins Twesige Grace Kakoola Charles Brown Sylvia Namanda Herbert Kadama Norma C. Ware Monique A. Wyatt Emily Pisarski Ingrid T. Katz |
| author_facet | Renee Heffron Timothy R. Muwonge Katherine K. Thomas Florence Nambi Lylianne Nakabugo Joseph Kibuuka Dorothy Thomas Erika Feutz Allison Meisner Norma C. Ware Monique A. Wyatt Jane M. Simoni Ingrid T. Katz Herbert Kadama Jared M. Baeten Andrew Mujugira Renee Heffron, (protocol chair) Jared M. Baeten Jane Simoni Deborah Donnell Ruanne Barnabas Katherine K. Thomas Dorothy Thomas Erika Feutz Cole Grabow Allison Meisner Kristin Ciccarelli Caitlin Scoville Katrina Ortblad Andrew Mujugira Timothy R. Muwonge Joseph Kibuuka Lylianne Nakabugo Florence Nambi Mai Nakitende Diego Izizinga Vicent Kasita Brenda Kamusiime Alisaati Nalumansi Collins Twesige Grace Kakoola Charles Brown Sylvia Namanda Herbert Kadama Norma C. Ware Monique A. Wyatt Emily Pisarski Ingrid T. Katz |
| author_sort | Renee Heffron |
| collection | DOAJ |
| description | Summary: Background: Global scale-up of HIV pre-exposure prophylaxis (PrEP) includes services to HIV-negative people in partnerships with people living with HIV (serodifferent couples). Data are needed on HIV outcomes, including uptake and adherence to PrEP and antiretroviral treatment (ART), to describe the impact of integrating PrEP into an existing HIV program. Methods: Using a stepped-wedge cluster randomized trial design, we launched PrEP delivery for HIV-negative members of serodifferent couples in Uganda by integrating PrEP into existing ART programs for people living with HIV. The program provided PrEP training for ART providers, ongoing technical assistance, and a provisional supply chain mechanism for PrEP medication. Primary data on PrEP initiation, PrEP refills, ART initiation, and HIV viremia at 6 months (measured at 42-270 days) were collected through data abstraction of medical records from HIV-serodifferent couples sequentially enrolling at the ART clinics. Modified Poisson regression models, controlling for time and cluster, compared viral suppression (<1000 copies/ml) before and after launch of the PrEP program. This trial was registered at ClinicalTrials.gov, NCT03586128. Findings: From June 1, 2018-December 15, 2020, 1,381 HIV-serodifferent couples were enrolled across 12 ART clinics in Kampala and Wakiso, Uganda, including 730 enrolled before and 651 after the launch of PrEP delivery. During the baseline period, 99.4% of partners living with HIV initiated ART and 85.0% were virally suppressed at 6 months. Among HIV-negative partners enrolled after PrEP launched, 81.0% (527/651) initiated PrEP within 90 days of enrolling; among these 527, 11.2% sought a refill 6 months later. In our powered intent-to-treat analysis, 82.1% and 76.7% of partners living with HIV were virally suppressed, respectively, which was not a statistically significant difference (RR=0.94, 95% CI: 0.82-1.07) and was stable across sensitivity analyses. Interpretation: Integration of PrEP into ART clinics reached a high proportion of people in HIV-serodifferent relationships and did not improve the already high frequency of HIV viral suppression among partners living with HIV. Funding: National Institute of Mental Health (R01MH110296). |
| first_indexed | 2024-04-13T09:57:37Z |
| format | Article |
| id | doaj.art-76c4d798a74d4d4eab0e403c6d777a38 |
| institution | Directory Open Access Journal |
| issn | 2589-5370 |
| language | English |
| last_indexed | 2024-04-13T09:57:37Z |
| publishDate | 2022-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EClinicalMedicine |
| spelling | doaj.art-76c4d798a74d4d4eab0e403c6d777a382022-12-22T02:51:19ZengElsevierEClinicalMedicine2589-53702022-10-0152101611PrEP 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 trialRenee Heffron0Timothy R. Muwonge1Katherine K. Thomas2Florence Nambi3Lylianne Nakabugo4Joseph Kibuuka5Dorothy Thomas6Erika Feutz7Allison Meisner8Norma C. Ware9Monique A. Wyatt10Jane M. Simoni11Ingrid T. Katz12Herbert Kadama13Jared M. Baeten14Andrew Mujugira15Renee Heffron, (protocol chair)Jared M. BaetenJane SimoniDeborah DonnellRuanne BarnabasKatherine K. ThomasDorothy ThomasErika FeutzCole GrabowAllison MeisnerKristin CiccarelliCaitlin ScovilleKatrina OrtbladAndrew MujugiraTimothy R. MuwongeJoseph KibuukaLylianne NakabugoFlorence NambiMai NakitendeDiego IzizingaVicent KasitaBrenda KamusiimeAlisaati NalumansiCollins TwesigeGrace KakoolaCharles BrownSylvia NamandaHerbert KadamaNorma C. WareMonique A. WyattEmily PisarskiIngrid T. KatzUniversity of Washington, 325 Ninth Avenue, Box 359927 Seattle, Washington, USA; University of Alabama Birmingham, Birmingham, Alabama, USA; Corresponding author at: 325 Ninth Avenue, Box 359927, Seattle, Washington 98104, USA.Infectious Diseases Institute, Makerere University, Kampala, UgandaUniversity of Washington, 325 Ninth Avenue, Box 359927 Seattle, Washington, USAInfectious Diseases Institute, Makerere University, Kampala, UgandaInfectious Diseases Institute, Makerere University, Kampala, UgandaInfectious Diseases Institute, Makerere University, Kampala, UgandaUniversity of Washington, 325 Ninth Avenue, Box 359927 Seattle, Washington, USAUniversity of Washington, 325 Ninth Avenue, Box 359927 Seattle, Washington, USAUniversity of Washington, 325 Ninth Avenue, Box 359927 Seattle, Washington, USAHarvard Medical School, 25 Shattuck St., Boston, Massachusetts, USA; Brigham and Women's Hospital, Harvard Medical School, 75 Francis St, Boston, Massachusetts, USAHarvard Medical School, 25 Shattuck St., Boston, Massachusetts, USAUniversity of Washington, 325 Ninth Avenue, Box 359927 Seattle, Washington, USABrigham and Women's Hospital, Harvard Medical School, 75 Francis St, Boston, Massachusetts, USA; Brigham and Women's Hospital, Harvard Medical School, 75 Francis St, Boston, Massachusetts, USAMinistry of Health, Box 7272, Kampala, UgandaUniversity of Washington, 325 Ninth Avenue, Box 359927 Seattle, Washington, USA; Gilead Sciences LLC, Foster City, California, USAInfectious Diseases Institute, Makerere University, Kampala, UgandaSummary: Background: Global scale-up of HIV pre-exposure prophylaxis (PrEP) includes services to HIV-negative people in partnerships with people living with HIV (serodifferent couples). Data are needed on HIV outcomes, including uptake and adherence to PrEP and antiretroviral treatment (ART), to describe the impact of integrating PrEP into an existing HIV program. Methods: Using a stepped-wedge cluster randomized trial design, we launched PrEP delivery for HIV-negative members of serodifferent couples in Uganda by integrating PrEP into existing ART programs for people living with HIV. The program provided PrEP training for ART providers, ongoing technical assistance, and a provisional supply chain mechanism for PrEP medication. Primary data on PrEP initiation, PrEP refills, ART initiation, and HIV viremia at 6 months (measured at 42-270 days) were collected through data abstraction of medical records from HIV-serodifferent couples sequentially enrolling at the ART clinics. Modified Poisson regression models, controlling for time and cluster, compared viral suppression (<1000 copies/ml) before and after launch of the PrEP program. This trial was registered at ClinicalTrials.gov, NCT03586128. Findings: From June 1, 2018-December 15, 2020, 1,381 HIV-serodifferent couples were enrolled across 12 ART clinics in Kampala and Wakiso, Uganda, including 730 enrolled before and 651 after the launch of PrEP delivery. During the baseline period, 99.4% of partners living with HIV initiated ART and 85.0% were virally suppressed at 6 months. Among HIV-negative partners enrolled after PrEP launched, 81.0% (527/651) initiated PrEP within 90 days of enrolling; among these 527, 11.2% sought a refill 6 months later. In our powered intent-to-treat analysis, 82.1% and 76.7% of partners living with HIV were virally suppressed, respectively, which was not a statistically significant difference (RR=0.94, 95% CI: 0.82-1.07) and was stable across sensitivity analyses. Interpretation: Integration of PrEP into ART clinics reached a high proportion of people in HIV-serodifferent relationships and did not improve the already high frequency of HIV viral suppression among partners living with HIV. Funding: National Institute of Mental Health (R01MH110296).http://www.sciencedirect.com/science/article/pii/S2589537022003418PrEPSerodifferent couplesARTViral suppressionStepped-wedge trial |
| spellingShingle | Renee Heffron Timothy R. Muwonge Katherine K. Thomas Florence Nambi Lylianne Nakabugo Joseph Kibuuka Dorothy Thomas Erika Feutz Allison Meisner Norma C. Ware Monique A. Wyatt Jane M. Simoni Ingrid T. Katz Herbert Kadama Jared M. Baeten Andrew Mujugira Renee Heffron, (protocol chair) Jared M. Baeten Jane Simoni Deborah Donnell Ruanne Barnabas Katherine K. Thomas Dorothy Thomas Erika Feutz Cole Grabow Allison Meisner Kristin Ciccarelli Caitlin Scoville Katrina Ortblad Andrew Mujugira Timothy R. Muwonge Joseph Kibuuka Lylianne Nakabugo Florence Nambi Mai Nakitende Diego Izizinga Vicent Kasita Brenda Kamusiime Alisaati Nalumansi Collins Twesige Grace Kakoola Charles Brown Sylvia Namanda Herbert Kadama Norma C. Ware Monique A. Wyatt Emily Pisarski Ingrid T. Katz 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 PrEP Serodifferent couples ART Viral suppression Stepped-wedge trial |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | PrEP Serodifferent couples ART Viral suppression Stepped-wedge trial |
| url | http://www.sciencedirect.com/science/article/pii/S2589537022003418 |
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