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Background: Differentiated service delivery (DSD) programs for people living with HIV (PWH) limit eligibility to patients established on antiretroviral therapy (ART), yet uncertainty exists regarding the duration on ART necessary for newly-diagnosed PWH to be considered established. We aimed to determine the feasibility, acceptability, and preliminary impact of entry into DSD at six months after ART initiation for newly-diagnosed PWH.

Methods: We conducted a pilot randomized controlled trial in three health facilities in Rwanda. Participants were randomized to: (1) entry into DSD at six months after ART initiation after one suppressed viral load (DSD-1VL); (2) entry into DSD at six months after ART initiation after two consecutive suppressed viral loads (DSD-2VL); (3) treatment as usual (TAU). We examined feasibility by examining the proportion of participants assigned to intervention arms who entered DSD, assessed acceptability through patient surveys and by examining instances when clinical staff overrode the study assignment, and evaluated preliminary effectiveness by comparing study arms with respect to 12-month viral suppression.

Results: Among 90 participants, 31 were randomized to DSD-1VL, 31 to DSD-2VL, and 28 to TAU. Among 62 participants randomized to DSD-1VL or DSD-2VL, 37 (60%) entered DSD at 6 months while 21 (34%) did not enter DSD because they were not virally suppressed. Patient-level acceptability was high for both clinical (mean score: 3.8 out of 5) and non-clinical (mean score: 4.1) elements of care and did not differ significantly across study arms. Viral suppression at 12 months was 81%, 81% and 68% in DSD-1VL, DSD-2VL, and TAU, respectively (p = 0.41).

Conclusions: The majority of participants randomized to intervention arms entered DSD and had similar rates of viral suppression compared to TAU. Results suggest that early DSD at six months after ART initiation is feasible for newly-diagnosed PWH, and support current WHO guidelines on DSD.

Trial Registration: Clinicaltrials.gov NCT04567693; first registered on September 28, 2020.

Titel:	Reducing time to differentiated service delivery for newly-diagnosed people living with HIV in Kigali, Rwanda: a pilot, unblinded, randomized controlled trial.
Autor/in / Beteiligte Person:	Ross, J ; Anastos, K ; Hill, S ; Remera, E ; Rwibasira, GN ; Ingabire, C ; Umwiza, F ; Munyaneza, A ; Muhoza, B ; Zhang, C ; Nash, D ; Yotebieng, M ; Murenzi, G
Link:	Zum Volltext
Zeitschrift:	BMC health services research, Jg. 24 (2024-04-30), Heft 1, S. 555
Veröffentlichung:	London : BioMed Central, [2001-, 2024
Medientyp:	academicJournal
ISSN:	1472-6963 (electronic)
DOI:	10.1186/s12913-024-10950-z
Schlagwort:	Humans Rwanda Pilot Projects Male Female Adult Middle Aged Delivery of Health Care organization & administration Anti-HIV Agents therapeutic use Time Factors Patient Acceptance of Health Care statistics & numerical data HIV Infections drug therapy HIV Infections diagnosis Viral Load
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, N.I.H., Extramural Language: English [BMC Health Serv Res] 2024 Apr 30; Vol. 24 (1), pp. 555. <i>Date of Electronic Publication: </i>2024 Apr 30. MeSH Terms: HIV Infections* / drug therapy ; HIV Infections* / diagnosis ; Viral Load* ; Humans ; Rwanda ; Pilot Projects ; Male ; Female ; Adult ; Middle Aged ; Delivery of Health Care / organization & administration ; Anti-HIV Agents / therapeutic use ; Time Factors ; Patient Acceptance of Health Care / statistics & numerical data References: Gates Open Res. 2020 Jul 29;4:116. (PMID: 32875281) ; J Acquir Immune Defic Syndr. 2021 Feb 1;86(2):147-152. (PMID: 33136818) ; BMJ Open. 2021 Apr 24;11(4):e047443. (PMID: 33895720) ; BMC Health Serv Res. 2022 Nov 28;22(1):1431. (PMID: 36443853) ; Soc Sci Med. 2015 Aug;138:1-11. (PMID: 26026400) ; J Int AIDS Soc. 2020 Jun;23(6):e25544. (PMID: 32585077) ; AIDS Behav. 2013 Jun;17(5):1785-95. (PMID: 23456594) ; Qual Life Res. 2011 Dec;20(10):1727-36. (PMID: 21479777) ; J Acquir Immune Defic Syndr. 2019 Aug 15;81(5):540-546. (PMID: 31021988) ; AIDS Care. 2021 Apr;33(4):541-547. (PMID: 32363910) ; AIDS. 2020 Mar 1;34(3):475-479. (PMID: 31764076) ; PLoS One. 2021 May 13;16(5):e0251645. (PMID: 33984044) ; J Acquir Immune Defic Syndr. 2020 Sep 1;85(1):46-50. (PMID: 32379083) ; J Int AIDS Soc. 2017 Jul 21;20(Suppl 4):21650. (PMID: 28770594) ; J Int AIDS Soc. 2020 Nov;23(11):e25640. (PMID: 33247517) ; J Acquir Immune Defic Syndr. 2020 Nov 1;85(3):280-291. (PMID: 32665460) ; BMC Health Serv Res. 2023 Feb 8;23(1):127. (PMID: 36750840) ; Open Forum Infect Dis. 2018 Jun 28;5(6):ofy104. (PMID: 29992172) ; PLoS Med. 2022 Mar 22;19(3):e1003959. (PMID: 35316272) ; J Int AIDS Soc. 2018 Nov;21(11):e25207. (PMID: 30450699) ; J Int AIDS Soc. 2017 Jul 21;20(Suppl 4):21644. (PMID: 28770589) ; J Int AIDS Soc. 2021 Jun;24(6):e25704. (PMID: 34105884) ; J Int AIDS Soc. 2021 Oct;24 Suppl 6:e25808. (PMID: 34713620) ; Qual Life Res. 2022 Jan;31(1):159-170. (PMID: 34052956) ; PLoS Med. 2019 Oct 29;16(10):e1002959. (PMID: 31661487) ; AIDS Care. 2007 Sep;19(8):1002-12. (PMID: 17851997) ; J Int AIDS Soc. 2021 Oct;24 Suppl 6:e25807. (PMID: 34713575) ; J Int AIDS Soc. 2021 Oct;24 Suppl 6:e25819. (PMID: 34713614) ; J Acquir Immune Defic Syndr. 2020 Jun 1;84(2):162-172. (PMID: 32097252) Grant Information: K23 MH114752 United States MH NIMH NIH HHS Contributed Indexing: Keywords: Differentiated service delivery; HIV; New diagnosis; Rwanda; Sub-Saharan Africa Molecular Sequence: ClinicalTrials.gov NCT04567693 Substance Nomenclature: 0 (Anti-HIV Agents) Entry Date(s): Date Created: 20240501 Date Completed: 20240501 Latest Revision: 20240504 Update Code: 20240504 PubMed Central ID: PMC11062003

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Reducing time to differentiated service delivery for newly-diagnosed people living with HIV in Kigali, Rwanda: a pilot, unblinded, randomized controlled trial.