Patient-Selected Treatment Partners Did Not Protect Against Drug Resistance During First-Line NNRTI-Based HAART in a Randomized Trial

Taiwo, Babafemi; Idoko, John; Marcelin, Anne–Geneviève; Otoh, Ihedinachi; Reddy, Susheel; Iyaji, Paul G; Agbaji, Oche; Penugonda, Sudhir; Agaba, Patricia A; Murphy, Robert L.

doi:10.1097/qai.0b013e3181e5112f

Cited by 3 publications

(2 citation statements)

References 7 publications

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“…A study conducted in Jos, Nigeria, showed a beneficial effect on drug adherence (measured as clinic-based pill counts) and viral load for participants with patient-selected treatment partners; however, there was no durable effect on viral suppression [20]. A sub-study designed to examine the impact of treatment partners on drug resistance showed no association [21]. A randomized controlled trial of trained patient nominated treatment supporters providing partial directly observed antiretroviral therapy in Cape Town, South Africa, showed no effect on virologic outcomes but greater CD4 cell count increases at 6-month follow-up visits [22].…”

Section: Introductionmentioning

confidence: 99%

How Treatment Partners Help: Social Analysis of an African Adherence Support Intervention

et al. 2011

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Treatment partnering is an adherence intervention developed in sub-Saharan Africa. This paper describes the additional social functions that treatment partners serve and shows how these functions contribute to health and survival for patients with HIV/AIDS. Ninety-eight minimally structured interviews were conducted with twenty pairs of adult HIV/AIDS patients (N = 20) and treatment partners (N = 20) treated at a public HIV-care setting in Tanzania. Four social functions were identified using inductive, category construction and interpretive methods of analysis: (1) encouraging disclosure; (2) combating stigma; (3) restoring hope; and (4) reducing social difference. These functions work to restore social connections and reverse the isolating effects of HIV/AIDS, strengthening access to essential community safety nets. Besides encouraging ARV adherence, treatment partners contribute to the social health of patients. Social health as well as HIV treatment success is essential to survival for persons living with HIV/AIDS in sub-Saharan Africa.

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Section: Introductionmentioning

confidence: 99%

How Treatment Partners Help: Social Analysis of an African Adherence Support Intervention

et al. 2011

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“…Third, similar to other studies [24-27,32], our study will assess the persistence of any treatment arm differences that emerge during the intervention period at a post-intervention follow-up visit. Fourth, as has been done in other studies [33-35], we will assess the effect of DAART on the acquisition of new drug resistance mutations. Finally, ours will be among the few studies to measure adherence with EAM in both the DAART and SAT arms [24].…”

Section: Discussionmentioning

confidence: 97%

Study design and participant characteristics of a randomized controlled trial of directly administered antiretroviral therapy in opioid treatment programs

et al. 2011

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BackgroundHIV-infected drug users are at higher risk of non-adherence and poor treatment outcomes than HIV-infected non-drug users. Prior work from our group and others suggests that directly administered antiretroviral therapy (DAART) delivered in opioid treatment programs (OTPs) may increase rates of viral suppression.Methods/DesignWe are conducting a randomized trial comparing DAART to self-administered therapy (SAT) in 5 OTPs in Baltimore, Maryland. Participants and investigators are aware of treatment assignments. The DAART intervention is 12 months. The primary outcome is HIV RNA < 50 copies/mL at 3, 6, and 12 months. To assess persistence of any study arm differences that emerge during the active intervention, we are conducting an 18-month visit (6 months after the intervention concludes). We are collecting electronic adherence data for 2 months in both study arms. Of 457 individuals screened, a total of 107 participants were enrolled, with 56 and 51 randomly assigned to DAART and SAT, respectively. Participants were predominantly African American, approximately half were women, and the median age was 47 years. Active use of cocaine and other drugs was common at baseline. HIV disease stage was advanced in most participants. The median CD4 count at enrollment was 207 cells/mm3, 66 (62%) had a history of an AIDS-defining opportunistic condition, and 21 (20%) were antiretroviral naïve.ConclusionsThis paper describes the rationale, methods, and baseline characteristics of subjects enrolled in a randomized clinical trial comparing DAART to SAT in opioid treatment programs.Trial RegistrationClinicalTrials.gov: NCT00279110

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Immuno-virologic outcomes and immuno-virologic discordance among adults alive and on anti-retroviral therapy at 12 months in Nigeria

et al. 2013

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BackgroundPredictors of immuno-virologic outcomes and discordance and their associations with clinical, demographic, socio-economic and behavioral risk factors are not well described in Nigeria since HIV viral load testing is not routinely offered in public HIV treatment programs.MethodsThe HACART study was a multi-center observational clinic-based cohort study of 2585 adults who started HAART between April 2008 and February 2009. A total of 628 patients were randomly selected at 12 months for immuno-virologic analyses.ResultsVirologic suppression rate (<400 copies/ml) was 76.7%, immunologic recovery rate (CD4 change from baseline ≥50 cells/mm3) was 77.4% and immuno-virologic discordance rate was 33%. In multivariate logistic regression, virologic failure was associated with age <30 years (OR 1.79; 95% CI: 1.17-2.67, p=0.03), anemia (Hemoglobin < 10 g/dl) (OR 1.71; 95% CI: 1.22-2.61, p=0.03), poor adherence (OR 3.82; 95% CI: 2.17-5.97, p=0.001), and post-secondary education (OR 0.60; 95% CI: 0.30-0.86, p=0.02). Immunologic failure was associated with male gender (OR 1.46; 95% CI: 1.04-2.45, p=0.04), and age <30 years (OR 1.50; 95% CI: 1.11-2.39, p=0.03). Virologic failure with immunologic success (VL-/CD4+) was associated with anemia (OR 1.80; 95% CI: 1.13-2.88, p=0.03), poor adherence (OR 3.90; 95% CI: 1.92-8.24, p=0.001), and post-secondary education (OR 0.40; 95% CI: 0.22-0.68, p=0.005).ConclusionsAlthough favorable immuno-virologic outcomes could be achieved in this large ART program, immuno-virologic discordance was observed in a third of the patients. Focusing on intensified treatment preparation and adherence, young patients, males, persons with low educational status and most importantly baseline anemia assessment and management may help address predictors of poor immuno-virologic outcomes, and improve overall HIV program impact. Viral load testing in addition to the CD4 testing should be considered to identify, characterize and address negative immuno-virologic outcomes and discordance.

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Patient-Selected Treatment Partners Did Not Protect Against Drug Resistance During First-Line NNRTI-Based HAART in a Randomized Trial

Cited by 3 publications

References 7 publications

How Treatment Partners Help: Social Analysis of an African Adherence Support Intervention

How Treatment Partners Help: Social Analysis of an African Adherence Support Intervention

Study design and participant characteristics of a randomized controlled trial of directly administered antiretroviral therapy in opioid treatment programs

Immuno-virologic outcomes and immuno-virologic discordance among adults alive and on anti-retroviral therapy at 12 months in Nigeria

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