Jaffar S, Amuron B, Foster S, et al. Rates of virological failure in patients treated in a home-based versus a facility-based HIV-care model in Jinja, southeast Uganda: a cluster-randomised equivalence trial. Lancet 2009 Dec 19;374(9707):2080-9.
The shortage of clinical staff and the poor availability of transportation from rural areas to clinics is challenging to the large and increasing number of persons in need of antiretroviral therapy (ART). The World Health Organization (WHO) advocates decentralized ART delivery programs, and studies have demonstrated good clinical outcomes using nurse-led centers with simplified protocols.(1, 2, 3) A home-based care program in Uganda had good results but relied on lay health workers visiting patients weekly,(4) which limited its ability to be widely implemented.
To compare directly the clinical outcomes of patients receiving ART in a home-based and a facility-based care program
Jinja district, southeast Uganda
A cluster-randomized equivalence trial
Patients who initiated ART at a clinic that serves rural and semi-rural patients
Rate of virologic failure
Patients at the AIDS Support Organisation (TASO) clinic were eligible if they met WHO criteria for ART. Patients were recruited from February 2005 to December 2006. Follow-up continued through January 2009. The catchment area was divided into nine strata based upon the ratio of urban to rural participants and distance from the clinic. Each stratum was divided into geographical clusters, each of which had a similar estimated number of patients. All patients initiated ART at the clinic. Clusters were randomized to home- or clinic-based care by drawing sealed cards from a box.
Clinic-based care was provided by physicians, nurses, pharmacists, laboratory staff, and counselors. Medications were distributed at the clinic each month and were reviewed by the physician and counselor two and three months after initiating therapy and every three months thereafter. Care beyond the scheduled reviews was provided by clinic nurses assisted by physicians when needed. A field officer did follow-up in the home for patients who missed appointments.
Home-based care included monthly visits by trained or qualified field officers who dispensed medications and monitored patients with a clinical checklist of the signs and symptoms of drug toxicity and disease progression. When needed, patients were referred to telephone calls with physicians who assessed the need for further referral. The medical officer reviewed the field officers' notes of the patient visits. Patients were seen at the clinic for medical reviews with the medical officer and counselor at two and six months after initiating ART and every six months thereafter. Medications were not dispensed at the clinic visits.
Patients in clinic- and home-based care were instructed to come to the clinic whenever they did not feel well. There were infrequent opportunities for a medical team that included a physician to provide home-based care to bedridden patients.
An economic analysis that included recurrent and capital costs associated with care also was conducted. Costs were allocated in three steps: 1) the proportion of all TASO clients who were receiving ART; 2) the percentage of clients on ART who entered the trial; and 3) costs to facility and home groups. Drug prices included purchase cost, insurance, and freight to Uganda. Costs incurred by patients were established with a questionnaire. Health-services costs included the costs of staff, transportation, drugs, laboratory tests, radiographs, ultrasound, community education, training, teambuilding workshops, utilities, supervision, overhead, and capital costs. Patient costs consisted of cost of transport, childcare, and lunches, if applicable, median weighted by proportion ($2.88 for women and $3.46 for men). Lost work time was also counted in patient costs, using World Bank economic data for 300 working days per year, at Uganda's mean per-head gross domestic product (GDP) for 2005-2008.
Of 859 patients enrolled in home-based and 594 enrolled in clinic-based care 729 and 483, respectively were analyzed; 662 and 441, respectively, were alive at the end of the study. Sixteen percent of patients in home-based compared with 17% in clinic-based care experienced virologic failure. The rate of viral failure (defined as plasma RNA >500 copies/mL) was 8.19 per 100 person years (95% confidence interval [CI]: 6.84-9.82) in home care and 8.67 per 100 person years (95% CI: 6.96-10.79) in clinic care. Defining viral failure as plasma RNA >500 copies/mL (if undetectable at six months) or an increase of 1,000 copies between two consecutive tests (if detectable) produced failure rates of 7.33 per 100 person years (95% CI: 6.06-8.86) in the home-based group and 7.88 per 100 person years (95% CI: 6.28-9.90) in the clinic-based group. There were 117 deaths in the home-based and 80 in the clinic-based care group, resulting in mortality rates of 5.40 and 5.41 per 100 person years, respectively. Outcomes did not differ significantly between groups.
The mean cost of health services per patient per year was $793 for home-based care and $838 for facility-based care. The patient's cost was $29 for the first year for home-based care compared with $60 for clinic-based care.
Home-based care was as clinically effective as clinic-based care but at a lower cost. It also provided improved and equitable care in resource-constrained areas.
This study met the criteria for a high-quality randomized clinical trial.
This study has two very important implications. First, home-based care is feasible, acceptable, and as effective as clinic-based care but at a reduced cost. It also appears to be a viable care option for patients in rural and semi-rural areas because it reduces travel time and costs between their homes and the clinic. Second, the study shows that it is feasible to conduct a randomized trial of care options, which has been difficult in the past.
- Gilks CF, Crowley S, Ekpini R, et al. The WHO public-health approach to antiretroviral treatment against HIV in resource-limited settings. Lancet 2006;368:505-10.
- Ferradini L, Jeannin A, Pinoges L, et al. Scaling up of highly active antiretroviral therapy in a rural district of Malawi: an effectiveness assessment. Lancet 2006;367:1335-42.
- Stringer JS, Zulu I, Levy J, et al. Rapid scale-up of antiretroviral therapy at primary care sites in Zambia: feasibility and early outcomes. JAMA 2006;296:782-93.
- Mermin J, Were W, Ekwaru JP, et al. Mortality in HIV-infected Ugandan adults receiving antiretroviral treatment and survival of their HIV-uninfected children: a prospective cohort study. Lancet 2008;371:752-59.