Efficacy of the Dapivirine Vaginal Ring Accounting for Imperfect Adherence.
Product adherence is critical to obtaining objective estimates of efficacy of pre-exposure prophylactic interventions against HIV-1 infection. With imperfect adherence, intention-to-treat analyses assess the collective effects of complete, sub-optimal and non-adherence, providing a biased and attenu...
| Publicado en: | AIDS & Behavior Vol. 28; no. 11; pp. 3873 - 3883 |
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| Autores principales: | , , , , , , , , , , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Springer Nature
Nov2024
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=180235246&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 180235246 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10907165 G1T jtl: AIDS & Behavior issn: 10907165 maglogo: N pubinfo: dt: Nov2024 vid: 28 iid: 11 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 180235246 179081629 180235246 180235246 10.1007/s10461-024-04463-3 180235246 ppf: 3873 ppct: 10 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Efficacy of the Dapivirine Vaginal Ring Accounting for Imperfect Adherence. aug: au: Husnik, Marla J. Heffron, Renee Hughes, James P. Richardson, Barbra van der Straten, Ariane Palanee-Phillips, Thesla Soto-Torres, Lydia Singh, Devika Mirembe, Brenda Gati Livant, Edward Gaffoor, Zakir Mansoor, Leila E. Siva, Samantha S. Dadabhai, Sufia Kiweewa, Flavia Matovu Baeten, Jared M. affil: https://ror.org/00cvxb145 Department of Epidemiology, University of Washington, Seattle, WA, USA sug: subj: HIV Infections Prevention and Control Cervical Caps Utilization Pre-Exposure Prophylaxis Anti-Retroviral Agents Administration and Dosage Drug Efficacy Evaluation Women's Health HIV Infections Drug Therapy Patient Compliance Human Funding Source Female Descriptive Statistics Cochlear Implant Drug Delivery Systems Models, Statistical Models, Structural Female ab: Product adherence is critical to obtaining objective estimates of efficacy of pre-exposure prophylactic interventions against HIV-1 infection. With imperfect adherence, intention-to-treat analyses assess the collective effects of complete, sub-optimal and non-adherence, providing a biased and attenuated estimate of the average causal effect of an intervention. Using data from the MTN-020/ASPIRE phase III trial evaluating HIV-1 efficacy of the dapivirine vaginal ring, we conducted per-protocol, and adherence-adjusted causal inference analyses using principal stratification and marginal structural models. We constructed two adherence cut offs of ≥ 0.9 mg (low cutoff) and > 4.0 mg (high cutoff) that represent drug released from the ring over a 28-day period. The HIV-1 efficacy estimate (95% CI) was 30.8% (3.6%, 50.3%) (P = 0.03) from the per-protocol analysis, and 53.6% (16.5%, 74.3%) (P = 0.01) among the highest predicted adherers from principal stratification analyses using the low cutoff. Marginal structural models produced efficacy estimates (95% CIs) ranging from 48.8 (21.8, 66.4) (P = 0.0019) to 56.5% (32.8%, 71.9%) (P = 0.0002). Application of adherence-adjusted causal inference methods are useful in interpreting HIV-1 efficacy in secondary analyses of PrEP clinical trials. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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