Dataset Information

Treatment as Prevention: Characterization of Partner Infections in the HIV Prevention Trials Network 052 Trial.

ABSTRACT: HIV Prevention Trials Network 052 demonstrated that antiretroviral therapy (ART) prevents HIV transmission in serodiscordant couples. HIV from index-partner pairs was analyzed to determine the genetic linkage status of partner infections. Forty-six infections were classified as linked, indicating that the index was the likely source of the partner's infection. Lack of viral suppression and higher index viral load were associated with linked infection. Eight linked infections were diagnosed after the index started ART: 4 near the time of ART initiation and 4 after ART failure. Linked infections were not observed when the index participant was stably suppressed on ART.

SUBMITTER: Eshleman SH

PROVIDER: S-EPMC5140698 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Treatment as Prevention: Characterization of Partner Infections in the HIV Prevention Trials Network 052 Trial.

Eshleman Susan H SH Hudelson Sarah E SE Redd Andrew D AD Swanstrom Ronald R Ou San-San SS Zhang Xinyi Cindy XC Ping Li-Hua LH Piwowar-Manning Estelle E Porcella Stephen F SF Sievers Matthew F MF Martens Craig A CA Bruno Daniel D Dukhovlinova Elena E McCauley Marybeth M Gamble Theresa T Fogel Jessica M JM Sabin Devin D Quinn Thomas C TC Gunde Laurence L Maliwichi Madalitso M Nhando Nehemiah N Akelo Victor V Moyo Sikhulile S Panchia Ravindre R Kumarasamy Nagalingeswaran N Chotirosniramit Nuntisa N Melo Marineide Gonçalves de MG Pilotto Jose J Grinsztejn Beatriz B Mayer Kenneth K Chen Ying Q YQ Hughes James P JP Cohen Myron S MS

Journal of acquired immune deficiency syndromes (1999) 20170101 1

HIV Prevention Trials Network 052 demonstrated that antiretroviral therapy (ART) prevents HIV transmission in serodiscordant couples. HIV from index-partner pairs was analyzed to determine the genetic linkage status of partner infections. Forty-six infections were classified as linked, indicating that the index was the likely source of the partner's infection. Lack of viral suppression and higher index viral load were associated with linked infection. Eight linked infections were diagnosed after ...[more]

PMID: 27532476

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Project description:Obtaining the definitive data necessary to determine the safety and efficacy of using antiretroviral treatment (ART) to reduce the sexual transmission of HIV in heterosexual couples encountered an array of ethical challenges that threatened to compromise HIV Prevention Trials Network (HPTN) 052, the multinational clinical trial addressing this issue that has profound public health implications.To describe and analyze the major ethical challenges faced in HPTN 052.The ethical issues and modifications of HPTN 052 in response to these issues were cataloged by the principal investigator, the lead coordinator, and the ethicist working on the trial. The major ethical issues that were unique to the trial were then described and analyzed in light of the published literature as well as guidances and policies. The ethical challenges that must be addressed in many clinical trials, such as those related to obtaining informed consent and making provisions for ancillary care, are not described.When HPTN 052 was being designed, ethical questions emerged related to the relevance of the research question itself given data from observational research and a range of beliefs about the appropriate means of preventing and treating HIV infection and AIDS. Furthermore, ethical challenges were faced regarding site selection since there was a scientific need to conduct the research in settings where HIV incidence was high, but alternatives to study participation should be available. As in most HIV-prevention research, ethical questions surrounded the determination of the appropriate prevention package for all of those enrolled. During the course of the trial, guidance documents and policies emerged that were of direct relevance to the research questions, calling for a balancing of concerns for the research subjects and trial integrity. When the study results were made public, there was a need to ensure access to the treatment shown to be effective that in some cases differed from the guidelines used at the sites where the research was being conducted. In addition, questions were raised about whether there was an obligation to notify subjects about 'unlinked' transmissions of HIV, that is, infections acquired from someone other than the designated sexual partner enrolled in the study.The ethical issues described are limited to those discerned by the authors and not those of other stakeholders who may have identified additional issues or had a different perspective in analyzing them.Understanding the ethical challenges faced in HPTN 052 promises to inform the design and conduct of future complex, long-term clinical trials aimed at addressing critical scientific and public health questions, where data and practice patterns emerge over the course of the trial.

Project description:BackgroundHIV partner services can accelerate the use of antiretroviral-based HIV prevention tools (antiretroviral therapy [ART] and preexposure prophylaxis [PrEP]), but its population impact on long-term HIV incidence reduction is challenging to quantify with traditional partner services metrics of partner identified or HIV screened. Understanding the role of partner services within the portfolio of HIV prevention interventions, including using it to efficiently deliver antiretrovirals, is needed to achieve HIV prevention targets.MethodsWe used a stochastic network model of HIV/sexually transmitted infection transmission for men who have sex with men, calibrated to surveillance-based estimates in the Atlanta area, a jurisdiction with high HIV burden and suboptimal partner services uptake. Model scenarios varied successful delivery of partner services cascade steps (newly diagnosed "index" patient and partner identification, partner HIV screening, and linkage or reengagement of partners in PrEP or ART care) individually and jointly.ResultsAt current levels observed in Atlanta, removal of HIV partner services had minimal impact on 10-year cumulative HIV incidence, as did improving a single partner services step while holding the others constant. These changes did not sufficiently impact overall PrEP or ART coverage to reduce HIV transmission. If all index patients and partners were identified, maximizing partner HIV screening, partner PrEP provision, partner ART linkage, and partner ART reengagement would avert 6%, 11%, 5%, and 18% of infections, respectively. Realistic improvements in partner identification and service delivery were estimated to avert 2% to 8% of infections, depending on the combination of improvements.ConclusionsAchieving optimal HIV prevention with partner services depends on pairing improvements in index patient and partner identification with maximal delivery of HIV screening, ART, and PrEP to partners if indicated. Improving the identification steps without improvement to antiretroviral service delivery steps, or vice versa, is projected to result in negligible population HIV prevention benefit.

Dataset Information

Treatment as Prevention: Characterization of Partner Infections in the HIV Prevention Trials Network 052 Trial.

Publications

Treatment as Prevention: Characterization of Partner Infections in the HIV Prevention Trials Network 052 Trial.

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