| Author | Gross, Robert | |
| Author | Zheng, Lu | |
| Author | La Rosa, Alberto | |
| Author | Sun, Xin | |
| Author | Rosenkranz, Susan L. | |
| Author | Cardoso, Sandra Wagner | |
| Author | Ssali, Francis | |
| Author | Camp, Rob | |
| Author | Godfrey, Catherine | |
| Author | Cohn, Susan E. | |
| Author | Robbins, Gregory K. | |
| Author | Chisada, Anthony | |
| Author | Wallis, Carole L. | |
| Author | Reynolds, Nancy R. | |
| Author | Lu, Darlene | |
| Author | Safren, Steven A. | |
| Author | Hosey, Lara | |
| Author | Severe, Patrice | |
| Author | Collier, Ann C. | |
| Author | ACTG 5234 Team | |
| Access date | 2019-08-21T15:16:11Z | |
| Available date | 2019-08-21T15:16:11Z | |
| Document date | 2015 | |
| Citation | GROSS, Robert et al. Partner-focused adherence intervention for second-line antiretroviral therapy: a multinational randomized trial (ACTG A5234). Lancet HIV, v. 2, n. 1, p. 12-19, Jan. 2015. | pt_BR |
| ISSN | 2405-4704 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/34935 | |
| Language | eng | pt_BR |
| Publisher | Elsevier | pt_BR |
| Rights | open access | pt_BR |
| Title | Partner-focused adherence intervention for second-line antiretroviral therapy: a multinational randomized trial (ACTG A5234) | pt_BR |
| Type | Article | pt_BR |
| DOI | 10.1016/S2352-3018(14)00007-1 | |
| Abstract | Background — Adherence is key to antiretroviral therapy (ART) success. Enhanced partner support may benefit patients with prior treatment failure. Methods — We conducted a 1:1 randomized trial of a partner-based modified directly observed therapy (mDOT) compared with standard of care (SOC) at 9 sites in 8 countries. Participants had failed a first-line regimen with HIV RNA >1000 copies/mL and a willing partner. Randomization was computer generated and balanced by site. Participants and site investigators were not masked to group assignment. ART included lopinavir/ritonavir (400/100 mg) twice daily and emtricitabine/tenofovir disoproxil fumarate (200/300 mg) once daily. Trained partners observed one ART dose daily ≥5 days/week for 24 weeks. Primary outcome was HIV RNA >400 copies/mL before or at week 48 and adherence measured with microelectronic monitors was a secondary outcome. Findings — We randomized 129 participants to mDOT and 128 to SOC, 130 (51%) males, 204 (79%) of African origin, 52 (20%) Latino, with median age 38 years. Partners were parents, 57 (22%), spouses 55 (21%), siblings 50 (19%), friends 41 (16%), and others 54 (21%). Primary outcome occurred in 26% (34/129) of mDOT and 18% (23/128) of SOC participants at week 48 (p=0.13). Median adherence was similar [Q1: 95% vs. 96% p=0.38, Q2: 91% vs. 94% p=0.40, Q3: 90% vs. 93% p=0.17, Q4: 90% vs. 93% p=0.36] in mDOT and SOC, respectively. Interpretation —This intervention had no effect on outcomes. Potential reasons include study visits maximizing adherence in both groups and control partners already providing sufficient support. Partner-based training with mDOT does not appear promising to enhance adherence. Intensive follow-up with clinic staff may be a viable strategy in this setting. | pt_BR |
| Affilliation | University of Pennsylvania Perelman. School of Medicine, Medicine (Infectious Diseases) and Epidemiology. Philadelphia, PA, USA. | pt_BR |
| Affilliation | Harvard School of Public Health, Biostatistics. Boston, MA, USA. | pt_BR |
| Affilliation | Asociacion Civil IMPACTA Salud y Educacion, Lima, Peru. | pt_BR |
| Affilliation | Harvard School of Public Health, Biostatistics. Boston, MA, USA. | pt_BR |
| Affilliation | Harvard School of Public Health, Biostatistics. Boston, MA, USA. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Joint Clinical Research Centre. Kampala, Uganda. | pt_BR |
| Affilliation | EUPATI. Barcelona, Spain. | pt_BR |
| Affilliation | National Institute of Allergy and Infectious Diseases. Bethesda, MD, USA. | pt_BR |
| Affilliation | Northwestern University Feinberg. School of Medicine. Chicago, IL, USA. | pt_BR |
| Affilliation | Massachusetts General Hospital. Boston, MA, USA / Harvard Medical School. Boston, MA, USA. | pt_BR |
| Affilliation | University of Zimbabwe. Harare, Zimbabwe. | pt_BR |
| Affilliation | Lancet Laboratories. Johannesburg, South Africa. | pt_BR |
| Affilliation | Yale University. School of Nursing. New Haven, CT, USA. | pt_BR |
| Affilliation | Harvard School of Public Health, Biostatistics. Boston, MA, USA. | pt_BR |
| Affilliation | Massachusetts General Hospital. Boston, MA, USA / Harvard Medical School. Boston, MA, USA. | pt_BR |
| Affilliation | SSS Inc. Silver Spring, MD, USA. | pt_BR |
| Affilliation | GHESKIO. Port au Prince, Haiti. | pt_BR |
| Affilliation | University of Washington. Seattle, WA, USA. | pt_BR |
| Subject | Antiretroviral therapy | pt_BR |
| Subject | HIV | pt_BR |
| e-ISSN | 2352-3018 | |
| Embargo date | 2020-08-21 | |
