Randomized Control Trial of Peer-Delivered, Modified Directly Observed Therapy for HAART in Mozambique

Department of Psychology, University of Washington, Seattle, WA 98195-1525, USA.
JAIDS Journal of Acquired Immune Deficiency Syndromes (Impact Factor: 4.56). 10/2007; 46(2):238-44. DOI: 10.1097/QAI.0b013e318153f7ba
Source: PubMed


To assess the efficacy of a peer-delivered intervention to promote short-term (6-month) and long-term (12-month) adherence to HAART in a Mozambican clinic population.
A 2-arm randomized controlled trial was conducted between October 2004 and June 2006.
Of 350 men and women (> or = 18 years) initiating HAART, 53.7% were female, and 97% were on 1 fixed-dose combination pill twice a day.
Participants were randomly assigned to receive 6 weeks (Monday through Friday; 30 daily visits) of peer-delivered, modified directly observed therapy (mDOT) or standard care. Peers provided education about treatment and adherence and sought to identify and mitigate adherence barriers.
Participants' self-reported medication adherence was assessed 6 months and 12 months after starting HAART. Adherence was defined as the proportion of prescribed doses taken over the previous 7 days. Statistical analyses were performed using intention-to-treat (missing = failure).
Intervention participants, compared to those in standard care, showed significantly higher mean medication adherence at 6 months (92.7% vs. 84.9%, difference 7.8, 95% confidence interval [CI]: 0.0.02, 13.0) and 12 months (94.4% vs. 87.7%, difference 6.8, 95% CI: 0.9, 12.9). There were no between-arm differences in chart-abstracted CD4 counts.
A peer-delivered mDOT program may be an effective strategy to promote long-term adherence among persons initiating HAART in resource-poor settings.

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    • "§ Lester, [30]; Sarna, [31]; Fairall, [32]; Naidoo, [29]. † Stubbs, [33]; Pearson, [34]. "
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    ABSTRACT: The success of adherence to combination antiretroviral therapy (cART) in sub-Saharan Africa is hampered by factors that are unique to this setting. Home based interventions have been identified as possible strategies for decentralizing ART care and improving access and adherence to cART. There is need for evidence at individual- or community-level of the benefits of home-based interventions in improving HIV suppression in African patients receiving cART. We conducted a systematic review and meta-analysis of the literature to assess the effect of home-based interventions on virologic outcomes in adults receiving cART in Africa. A total of 260 publications were identified by the search strategy, 249 were excluded on initial screening and 11 on full review, leaving 5 publications for analysis. The overall OR of virologic suppression at 12 months after starting cART of home-based interventions to standard of care was 1.13 (95% CI: 0.51-2.52). There was insufficient data to know whether there is a difference in HIV suppression at 12 months in the home-based arm compared with the standard of care arm in adults receiving cART in Africa. Given the few trials conducted from Africa, there is need for further research that measures the effects of home-based models on HIV suppression in African populations.
    BMC Public Health 03/2014; 14(1):239. DOI:10.1186/1471-2458-14-239 · 2.26 Impact Factor
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    • "One mechanism through which laboratory monitoring may improve outcomes appears to be to mitigate some of the negative consequences of poor adherence by identifying poor adherers earlier and enabling interventions. Several past and recent studies suggest that several effective interventions that improve ART adherence exist [28-30]. However the effects are small and also transient - there is no simple strategy for intervention [31]. "
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    ABSTRACT: Adherence is one of the most important determinants of viral suppression and drug resistance in HIV- infected people receiving antiretroviral therapy (ART). We examined the association between long-term mortality and poor adherence to ART in DART trial participants in Uganda and Zimbabwe randomly assigned to receive laboratory and clinical monitor- ing (LCM), or clinically driven monitoring (CDM). Since over 50% of all deaths in the DART trial occurred during the first year on ART, we focussed on participants continuing ART for 12 months to investigate the implications of longer-term adherence to treatment on mortality. Participants' ART adherence was assessed by pill counts and structured questionnaires at 4-weekly clinic visits. We studied the effect of recent adherence history on the risk of death at the individual level (odds ra- tios from dynamic logistic regression model), and on mortality at the population level (population attributable fraction based on this model). Analyses were conducted separately for both randomiza- tion groups, adjusted for relevant confounding factors. Adherence behaviour was also confounded by a partial factorial randomization comparing structured treatment interruptions (STI) with continuous ART (CT). In the CDM arm a significant association was found between poor adherence to ART in the previous 3-9 months with increased mortality risk. In the LCM arm the association was not significant. The odds ratios for mortality in participants with poor adherence against those with optimal adherence was 1.30 (95% CI 0.78,2.10) in the LCM arm and 2.18 (1.47,3.22) in the CDM arm. The estimated proportions of deaths that could have been avoided with optimal adherence (population attributable fraction) in the LCM and CDM groups during the 5 years follow-up period were 16.0% (95% CI 0.7%,31.6%) and 33.1% (20.5%,44.8%), correspondingly. Recurrent poor adherence determined even through simple measures is associated with high mortality both at individual level as well as at the ART programme level. The number of lives saved through effective interventions to improve adherence could be considerable particularly for individuals mon- itored without using CD4 cell counts. The findings have important implications for clinical practice and for developing interventions to enhance adherence.
    BMC Infectious Diseases 08/2013; 13(1):395. DOI:10.1186/1471-2334-13-395 · 2.61 Impact Factor
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    • "In contrast, we found that patients attending sites with peer educator programs had higher odds of non-adherence and of having a detectable viral load. While some studies suggest that peer support is associated with better adherence, particularly if it includes implementation of directly observed therapy [42], [43], a recent large cluster randomised study from Uganda found no impact of peer educators on adherence and viral suppression up to 96 weeks [44]. As the cross-sectional nature of our study precludes us from ruling out reverse causality, such that sites which experienced poor adherence and treatment response preferentially implemented peer educator programs, further studies are needed to understand the role of peer educator programs in this setting. "
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    ABSTRACT: Generalizable data are needed on the magnitude and determinants of adherence and virological suppression among patients on antiretroviral therapy (ART) in Africa. We conducted a cross-sectional survey with chart abstraction, patient interviews and site assessments in a nationally representative sample of adults on ART for 6, 12 and 18 months at 20 sites in Rwanda. Adherence was assessed using 3- and 30-day patient recall. A systematically selected sub-sample had viral load (VL) measurements. Multivariable logistic regression examined predictors of non-perfect (<100%) 30-day adherence and detectable VL (>40 copies/ml). Overall, 1,417 adults were interviewed and 837 had VL measures. Ninety-four percent and 78% reported perfect adherence for the last 3 and 30 days, respectively. Eighty-three percent had undetectable VL. In adjusted models, characteristics independently associated with higher odds of non-perfect 30-day adherence were: being on ART for 18 months (vs. 6 months); younger age; reporting severe (vs. no or few) side effects in the prior 30 days; having no documentation of CD4 cell count at ART initiation (vs. having a CD4 cell count of <200 cells/µL); alcohol use; and attending sites which initiated ART services in 2003-2004 and 2005 (vs. 2006-2007); sites with ≥600 (vs. <600 patients) on ART; or sites with peer educators. Participation in an association for people living with HIV/AIDS; and receiving care at sites which regularly conduct home-visits were independently associated with lower odds of non-adherence. Higher odds of having a detectable VL were observed among patients at sites with peer educators. Being female; participating in an association for PLWHA; and using a reminder tool were independently associated with lower odds of having detectable VL. High levels of adherence and viral suppression were observed in the Rwandan national ART program, and associated with potentially modifiable factors.
    PLoS ONE 01/2013; 8(1):e53586. DOI:10.1371/journal.pone.0053586 · 3.23 Impact Factor
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