OBJECTIVE: To assess risk factors for loss to follow-up (LFU) from the IMPAACT P1041 study, an isoniazid (INH) prophylaxis study conducted in southern Africa. DESIGN:Infants in two cohorts, human immunodeficiency virus-infected (HIV+) and HIV-exposed but non-infected (HIV-), were randomized toINH or placebo for 96 weeks. LFU was evaluated at week 96. RESULTS: Of 1351 infants, 12.9% were LFU (10.4% HIV+, 14.7% HIV-); 65% of the HIV+ cohort was asymptomatic. Among HIV+ infants, large household size (>6 vs. <4 members, P = 0.035) and presence of an elder (≥55 years, P = 0.05) were associated with better retention. Although attenuated in adjusted analysis, these associations held among HIV- infants. Among HIV- infants, having a younger mother increased the risk (P = 0.008) and maternal history of TB reduced the risk of LFU, the latter by nearly 70% (P = 0.048 univariate, 0.09 adjusted). LFU was largely due to inability to contact the participant (58% HIV+, 30% HIV-), and inability to attend the clinic and withdrawal of consent (HIV-). CONCLUSIONS: Household support was an important factor in participant retention, particularly for the non-HIV-infected cohort, as young maternal age was a risk factor for LFU. Retaining study participants from this mobile population can be challenging and may warrant additional support.
RCT Entities:
OBJECTIVE: To assess risk factors for loss to follow-up (LFU) from the IMPAACT P1041 study, an isoniazid (INH) prophylaxis study conducted in southern Africa. DESIGN:Infants in two cohorts, human immunodeficiency virus-infected (HIV+) and HIV-exposed but non-infected (HIV-), were randomized to INH or placebo for 96 weeks. LFU was evaluated at week 96. RESULTS: Of 1351 infants, 12.9% were LFU (10.4% HIV+, 14.7% HIV-); 65% of the HIV+ cohort was asymptomatic. Among HIV+ infants, large household size (>6 vs. <4 members, P = 0.035) and presence of an elder (≥55 years, P = 0.05) were associated with better retention. Although attenuated in adjusted analysis, these associations held among HIV- infants. Among HIV- infants, having a younger mother increased the risk (P = 0.008) and maternal history of TB reduced the risk of LFU, the latter by nearly 70% (P = 0.048 univariate, 0.09 adjusted). LFU was largely due to inability to contact the participant (58% HIV+, 30% HIV-), and inability to attend the clinic and withdrawal of consent (HIV-). CONCLUSIONS: Household support was an important factor in participant retention, particularly for the non-HIV-infected cohort, as young maternal age was a risk factor for LFU. Retaining study participants from this mobile population can be challenging and may warrant additional support.
Authors: Shabir A Madhi; Sharon Nachman; Avy Violari; Soyeon Kim; Mark F Cotton; Raziya Bobat; Patrick Jean-Philippe; George McSherry; Charles Mitchell Journal: N Engl J Med Date: 2011-07-07 Impact factor: 91.245
Authors: Elvin H Geng; David V Glidden; Nneka Emenyonu; Nicolas Musinguzi; Mwebwesa Bosco Bwana; Torsten B Neilands; Winnie Muyindike; Constantin T Yiannoutsos; Steven G Deeks; David R Bangsberg; Jeffrey N Martin Journal: Trop Med Int Health Date: 2010-06 Impact factor: 2.622
Authors: Ian Sanne; Catherine Orrell; Matthew P Fox; Francesca Conradie; Prudence Ive; Jennifer Zeinecker; Morna Cornell; Christie Heiberg; Charlotte Ingram; Ravindre Panchia; Mohammed Rassool; René Gonin; Wendy Stevens; Handré Truter; Marjorie Dehlinger; Charles van der Horst; James McIntyre; Robin Wood Journal: Lancet Date: 2010-07-03 Impact factor: 79.321
Authors: A C Hesseling; M F Cotton; T Jennings; A Whitelaw; L F Johnson; B Eley; P Roux; P Godfrey-Faussett; H S Schaaf Journal: Clin Infect Dis Date: 2009-01-01 Impact factor: 9.079
Authors: B J Marais; R P Gie; H S Schaaf; A C Hesseling; C C Obihara; J J Starke; D A Enarson; P R Donald; N Beyers Journal: Int J Tuberc Lung Dis Date: 2004-04 Impact factor: 2.373
Authors: Sarah M Gerver; Tim R Chadborn; Fowzia Ibrahim; Bela Vatsa; Valerie C Delpech; Philippa J Easterbrook Journal: J Int AIDS Soc Date: 2010-08-04 Impact factor: 5.396
Authors: E R Maritz; G Montepiedra; L Liu; C D Mitchell; S A Madhi; R Bobat; A Violari; A Ogwu; A C Hesseling; M F Cotton Journal: Int J Tuberc Lung Dis Date: 2016-08 Impact factor: 2.373