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[PMID]: | 28746164 |
[Au] Autor: | Husnik MJ; Brown ER; Marzinke M; Livant E; Palanee-Phillips T; Hendrix CW; Matovu Kiweewa F; Nair G; Soto-Torres LE; Schwartz K; Hillier SL; Baeten JM; MTN-020 ASPIRE Study Team |
[Ad] Endereço: | *Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA; †University of Washington, Seattle, WA; ‡Johns Hopkins University School of Medicine, Baltimore, MD; §Magee-Womens Research Institute & Foundation, University of Pittsburgh Medical Center, Pittsburgh, PA; ‖Wits Reproductive Health and HIV Institute, University of Witwatersrand, Hillbrow Health Precinct, Johannesburg, South Africa; ¶Makerere University-John Hopkins University Research Collaboration, Kampala, Uganda; #Center for AIDS Programme of Research in South Africa, Durban, South Africa; **Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health Rockville, MD; ††FHI 360, Durham, NC; and ‡‡Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA. |
[Ti] Título: | Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial. |
[So] Source: | J Acquir Immune Defic Syndr;76(3):330-337, 2017 11 01. | [Is] ISSN: | 1944-7884 |
[Cp] País de publicação: | United States |
[La] Idioma: | eng |
[Ab] Resumo: | BACKGROUND: Placebo-controlled HIV-1 prevention trials of pre-exposure prophylaxis (PrEP) have not generally used concurrent measurement of adherence because of the potential risk of unblinding. However, several pre-exposure prophylaxis trials for HIV-1 prevention among women failed to show effectiveness because of low product adherence. Evaluation of product adherence objectively during a study provides the opportunity for strengthening adherence activities at sites having low adherence. METHODS: During MTN-020/ASPIRE, a phase III, placebo-controlled trial of the dapivirine intravaginal ring, we implemented an adherence monitoring system. Monitoring began in quarter 1 (Q1) 2013 and continued through the conclusion of the trial. Blood plasma was collected quarterly and tested for dapivirine concentrations while maintaining blinding among study team members involved in participant management. Dapivirine concentrations >95 pg/mL, reflecting >8 hours of continuous use, were assessed as signaling product use. Study leadership monitored results on a monthly basis and provided feedback to site investigators. Experiences were shared across sites to motivate staff and counsel participants to strive toward higher adherence levels. RESULTS: An upward trend in adherence was observed (P < 0.0001); the proportion of samples from subjects in the active arm with dapivirine >95 pg/mL increased from 63% in Q1 2013 to 84% by Q1 2015. CONCLUSIONS: Ongoing drug level testing as a marker of adherence in MTN-020/ASPIRE demonstrates the feasibility of real-time adherence monitoring while maintaining study blinding at the level of participants, sites, and study leadership. This approach is novel for large-scale effectiveness studies for HIV-1 prevention. |
[Mh] Termos MeSH primário: |
Fármacos Anti-HIV/uso terapêutico Infecções por HIV/prevenção & controle HIV-1 Adesão à Medicação/estatística & dados numéricos Pirimidinas/uso terapêutico
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[Mh] Termos MeSH secundário: |
Administração Intravaginal Adulto Fármacos Anti-HIV/sangue Estudos de Viabilidade Feminino Seres Humanos Monitorização Fisiológica/métodos Profilaxia Pré-Exposição Pirimidinas/sangue Adulto Jovem
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[Pt] Tipo de publicação: | CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL; RESEARCH SUPPORT, NON-U.S. GOV'T |
[Nm] Nome de substância:
| 0 (Anti-HIV Agents); 0 (Pyrimidines); TCN4MG2VXS (Dapivirine) |
[Em] Mês de entrada: | 1710 |
[Cu] Atualização por classe: | 180223 |
[Lr] Data última revisão:
| 180223 |
[Sb] Subgrupo de revista: | IM; X |
[Da] Data de entrada para processamento: | 170727 |
[St] Status: | MEDLINE |
[do] DOI: | 10.1097/QAI.0000000000001503 |
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