A Cluster-Randomised Trial to Compare Home-Based with Health Facility-Based Antiretroviral Treatment in Uganda: Study Design and Baseline Findings

MRC/UVRI Uganda Research Unit on AIDS, c/o Medical Research Council/ Uganda Virus Research Institute, P.O. Box 49, Entebbe, Uganda.
The Open AIDS Journal 02/2007; 1(1):21-7. DOI: 10.2174/1874613600701010021
Source: PubMed


The scale-up of antiretroviral therapy is progressing rapidly in Africa but with a limited evidence-base. We report the baseline results from a large pragmatic cluster-randomised trial comparing different strategies of ART delivery. The trial is integrated in normal health service delivery.
1453 subjects were recruited into the study. Significantly more women (71%) than men (29%) were recruited. The WHO HIV clinical stage at presentation did not differ significantly between men and women: 58% and 53% respectively were at WHO stage III or IV (p=0.9). Median CD4 counts (IQR) x 106cells/l were 98 (28, 160) among men and 111 (36, 166) among women. Sixty-four percent of women and 61% men had plasma viral load ≥100,000 copies. Baseline characteristics did not change over time.
Considerably fewer men than women presented for treatment. Both men and women presented at an advanced stage with very low median CD4 count and high plasma viral load.

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Available from: Barbara Amuron, Jan 27, 2014
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    • "With the advent of ART and the emphasis on treatment adherence, many community and lay carers have taken on tasks that were previously the role of formal carers such as tracing non-adherent patients, providing HIV testing and counselling as well as other services (Rohleder and Swartz 2005, Schneider et al. 2008, Sanjana et al. 2009). More formal strategies of 'task-shifting' in HIV care Á involving the delegation of prevention, care and support activities to lower-level cadres (WHO and GHWA 2010) Á have been explored, with some studies suggesting that lay caregivers may be involved in the initiation of ART beyond their role as treatment supporters and that often, lower-level cadres provide equal or better quality of care compared to more qualified health workers (Amuron et al. 2007, Hermann et al. 2009, Callaghan et al. 2010). "
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    ABSTRACT: Abstract In response to the human resource challenges facing African health systems, there is increasing involvement of informal care providers in HIV care. Through social and institutional interactions that occur in the delivery of HIV care, linkages between formal and informal systems of care often emerge. Based on a review of studies documenting the relationships between formal and informal HIV care in sub-Saharan Africa, we suggest that linkages can be conceptualised as either 'actor-oriented' or 'systems-oriented'. Studies adopting an actor-oriented focus examine hierarchical working relationships and communication practices among health systems actors, while studies focusing on systems-oriented linkages document the presence, absence or impact of formal inter-institutional partnership agreements. For linkages to be effective, the institutional frameworks within which linkages are formalised, as well as the ground-level interactions of those engaged in care, ought to be considered. However, to date, both actor- and system-oriented linkages appear to be poorly utilised by policy makers to improve HIV care. We suggest that linkages between formal and informal systems of care be considered across health systems, including governance, human resources, health information and service delivery in order to improve access to HIV services, enable knowledge transfer and strengthen health systems.
    Global Public Health 11/2012; 7(10). DOI:10.1080/17441692.2012.733403 · 0.92 Impact Factor
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    • "In this context, there are legitimate policy concerns about the impacts of HIV-related disease on women. However, many recent studies in Uganda as well as other parts of SSA have consistently shown that although women remain more vulnerable to HIV infection, once infected, men tend to be disadvantaged in terms of access to treatment and care [4–11]. "
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    ABSTRACT: Current data from Uganda indicate that, compared to women, men are under-represented in HIV treatment, seek treatment later and have a higher mortality while on antiretroviral therapy (ART). By focusing on a masculine work ethic as one of the most predominant expressions of masculinity, this study explores why for some men HIV treatment enhances their masculinity while for others it undermines masculine work identity, leading them to discontinue the treatment. Participant observation and 26 in-depth interviews with men were conducted in a gold mining village in Eastern Uganda between August 2009 and August 2010. Interviewees included men who were taking HIV treatment, who had discontinued treatment, who suspected HIV infection but had not sought testing, or who had other symptoms unrelated to HIV infection. Many participants reported spending large proportions of their income, alleviating symptoms prior to confirming their HIV infection. This seriously undermined their sense of masculinity gained from providing for their families. Disclosing HIV diagnosis and treatment to employers and work colleagues could reduce job offers and/or collaborative work, as colleagues feared working with "ill" people. Drug side-effects affected work, leading some men to discontinue the treatment. Despite being on ART, some men believed their health remained fragile, leading them to opt out of hard work, contradicting their reputation as hard workers. However, some men on treatment talked about "resurrecting" due to ART and linked their current abilities to work again to good adherence. For some men, it was work colleagues who suggested testing and treatment-seeking following symptoms. The central role of a work ethic in expressing masculinity can both encourage and discourage men's treatment-seeking for AIDS. HIV testing and treatment may be sought in order to improve health and get back to work, thereby in the process regaining one's masculine reputation as a hard worker and provider for one's family. However, disclosure can affect opportunities for work and drug side-effects disrupt one's ability to labour, undermining the sense of masculinity gained from work. HIV support organizations need to recognize how economic and gender concerns impact on treatment decisions and help men deal with work-related fears.
    Journal of the International AIDS Society 06/2012; 15 Suppl 1(Suppl 1):1-9. DOI:10.7448/IAS.15.3.17368 · 5.09 Impact Factor
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    • "All adult patients (18 years old or more) living within the TASO catchment population and initiating on ART were invited to join and enrolled consecutively. The trial was integrated into normal health service delivery [5-7]. Trial participants were managed identically to non-trial patients by TASO staff using national guidelines. "
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    ABSTRACT: ABSTRACT: There have been few reports of long-term survival of HIV-infected patients on antiretroviral therapy (ART) in Africa managed under near normal health service conditions. Participants starting ART between February 2005 and December 2006 in The AIDS Support (TASO) clinic in Jinja, Uganda, were enrolled into a cluster-randomised trial of home versus facility-based care and followed up to January 2009. The trial was integrated into normal service delivery with patients managed by TASO staff according to national guidelines. Rates of survival, virological failure, hospital admissions and CD4 count over time were similar between the two arms. Data for the present analysis were analysed using Cox regression analyses. 1453 subjects were enrolled with baseline median count of 108 cells/μl. Over time, 119 (8%) withdrew and 34 (2%) were lost to follow-up. 197/1453 (14%) died. Mortality rates (95% CI) per 100 person-years were 11.8 (10.1, 13.8) deaths in the first year and 2.4 (1.8, 3.2) deaths thereafter. The one, two and three year survival probabilities (95% CI) were 0.89 (0.87 - 0.91), 0.86 (0.84 - 0.88) and 0.85 (0.83 - 0.87) respectively. Low baseline CD4 count, low body weight, advanced clinical condition (WHO stages III and IV), not being on cotrimoxazole prophylaxis and male gender were associated independently with increased mortality. Tuberculosis, cryptococcal meningitis and diarrhoeal disease were estimated to be major causes of death. Practical and affordable interventions are needed to enable earlier initiation of ART and to reduce mortality risk among those who present late for treatment with advanced disease.
    AIDS Research and Therapy 10/2011; 8(1):39. DOI:10.1186/1742-6405-8-39 · 1.46 Impact Factor
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