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Evaluation of a workplace HIV treatment programme in South Africa
Global Health Sciences Literature Digest
Published November 5, 2007
Journal Article

Charalambous S, Innes C, Muirhead D, Kumaranayake L, Fielding K, Pemba L, et al. Evaluation of a workplace HIV treatment programme in South Africa. AIDS 2007 Jul;21 Suppl 3:S73-8.

Objective

To review the experience of implementing a workplace HIV care program in South Africa and describe treatment outcomes in sequential cohorts of individuals starting antiretroviral therapy (ART).

Study Design

This study was a cohort analysis of a workplace HIV treatment program between October 2002 and December 2005.

Setting

This paper evaluates an employer (Anglo American)-funded ART program delivered via routine workplace health services and managed by a health systems and research unit in South Africa. In 2002, this organization had approximately 140,000 employees, with an estimated HIV prevalence of 24%. Of the estimated 33,400 HIV-infected employees, 10% (3,400) were thought to require ART immediately (based on limited published data, which assumes that individuals with CD4 cell counts below 200 cells/µL require ART). The program provides free HIV treatment and care for employees in 70 delivery sites throughout South Africa in both rural and urban areas. Clinic sites range from well-equipped hospitals to small occupational health clinics with a doctor visiting 1-2 days a week.

Participants

A total of 4,064 patients were started on ART, of which 2,262 (55.7%) gave formal consent to participate in the program evaluation. The majority of these patients were men (94.7%), and the median age was 41 years (interquartile range 36-47).

Intervention

The ART program is nurse-based and centrally managed. It includes HIV specialist support, training, data management, and laboratory and pharmaceutical services. The criteria for starting ART are WHO stage 4, irrespective of CD4 cell count; CD4 between 250 and 350 and WHO stage 3; and CD4 cell count less than 250 cells/µL, irrespective of WHO stage. The first-line regimen consists of two nucleoside reverse transcriptase inhibitors (zidovudine and lamivudine) and one non-nucleoside reverse transcriptase inhibitor (efavirenz). In women of child-bearing potential, nevirapine is used in place of efavirenz. The second-line regimen is abacavir, didanosine and lopinavir/ritonavir. After starting ART, patients are seen every two weeks until eight weeks and then every three months. Blood monitoring for hematological and hepatic toxicity is performed at zero, two, six, and 12 weeks and then every three months. CD4 cell counts and viral loads are measured at baseline, six weeks and six months, and then every six months thereafter. When patients leave employment, the program attempts to refer them to another ART program for continued treatment; however, information on transfers out was not routinely collected during this period. Monitoring and reporting sites are monitored regularly to ensure adherence to guidelines and accurate and complete data. After each visit, a monitoring report is made available to the site. Monthly and quarterly progress reports are provided to sites and companies. All patient data are kept confidentially. Economic costs of ART provision are collected and analyzed prospectively alongside implementation of the program. The cost analysis is incremental to existing health facilities and adopts an employer-provider perspective. Economic costs are measured using an ingredients costing approach. Costs are comprehensive and include drugs, laboratory, patient visits, senior management time, infrastructure required, monitoring, and administration. Cost per patient virally suppressed include costs for all those who had the opportunity to have six, 12, 18, or 24 months on treatment, whether or not a 'successful' outcome was obtained. Employees were included until termination of employment through ill health retirement, death, or other reasons. A discount rate of 10% was used. Drugs costs reflect prevailing African access prices, and laboratory tests reflect private sector prices.

Primary Outcomes

Treatment outcomes were determined for sequential cohorts of patients starting ART in each six-month period between October 2002 and December 2005. Outcomes reported include the numbers enrolled into the HIV program and starting ART, side effects and serious adverse events, adherence to treatment, and discontinuation of treatment.

Results

At the start of ART, the median CD4 cell count was 158 cells/µL, the median viral load was 50,366 copies/µL, and the majority of the patients had either WHO HIV stage 3 (45.4%) or 4 (27.4%) disease. By December 2005, the estimated ART coverage was 83% based on 104,528 employees, an average HIV prevalence of 23%, and assuming that 25% of all HIV-infected employees (diagnosed or undiagnosed) fulfilled the company criteria for starting ART. A total of 93.6% of patients at 14,752 clinic visits reported not missing any tablets over the previous three days. Almost half the patients (46.8%, 1,058/2,262) experienced one or more adverse events (any clinical event, whether drug-related or not). Of those patients who had an adverse event, 22.0% (225) experienced one or more severe or life-threatening (grade 3 or 4) adverse events. Of the 374 grade 3 or 4 adverse events, the majority were caused by hematological (46.3%) or liver function test (19.8%) abnormalities. By the end of December 2005, 30% (680/2,262) of patients were no longer on ART because of death (112, 5.0%), termination of employment (185, 8.2%), defaulting or stopped treatment (261, 11.5%), or other reasons (122, 5.4%). Of the 2,262 evaluable patients, the median CD4 cell count increased by 90, 113 and 164 cells/µL at six, 12 and 24 months, respectively. At six weeks, a >1 log reduction of viral load was observed in 85%. Some 75% of patients had viral suppression below 400 copies/µL at six months, and 72% at 12, 18 and 24 months, respectively. The mean weight increased by 2.8, 3.8 and 4.6 kg by six, 12 and 24 months, respectively. The monthly cost per patient on treatment across sites averaged over 12 months of program implementation ranged fromUS$160-345, decreasing to between US $145 and 229 for 24 months of program implementation. The average cost per patient virally suppressed across sites with sample sizes sufficient for calculation to December 2005 (14 sites covering 88% of patients on program) was cumulatively US $1,752 [95% confidence interval (CI) US$1,500-2,004] at 6 months, US $3,887 (95% CI US$3,259-4,514) at 12 months, and US $6,950 (95% CI US$5,710-8,191) at 24 months. Early treatment outcomes (proportion with a >1 log reduction in viral load at six weeks) improved over time, whereas later treatment outcomes (proportion with a viral load <400 copies/µL at six, 12 and 24 months) have remained relatively stable. The proportion lost from the program was lower in the early compared with the later cohorts.

Conclusions

The authors conclude: 1. this large workplace program had similar virological results among those individuals retained in the program, compared to similar program results from developed countries; and more work is needed to improve retention; 2. as this program has matured, the costs of program implementation have reduced; 3. counseling is a central component of an ART program; and 4. challenges in implementing a workplace ART program are similar to the challenges of public-sector programs.

Quality Rating

There is no widely accepted quality rating system for program evaluations such as this. While comprehensive in design, the analysis is limited and may be biased by the high percent (44.3%) of patients on ART who declined participation.

In Context

The virological outcomes of this workplace ART program are comparable with that reported from other ART programs in resource-poor and resource-rich countries. In a Ugandan ART pilot project, in which patients were required to pay for drugs at reduced prices, the proportion who achieved viral load suppression below 400 copies/µL one year after starting treatment ranged from 50% to 65%.(1) Similar results have been reported in Senegal(2) and Haiti.(3) In Baltimore, USA, 68% of patients attending an HIV clinic over a seven-year period achieved viral suppression to less than 400 copies/µL.(4) Similar results have been reported in routine programs in Europe.(5) Costs are higher than previously reported costs from public sector trials or programs(6,7) as a result of both the inclusion of more comprehensive costs and all organizational levels, as well as higher input prices faced in a private sector program.

Programmatic Implications

Given the large demand for ART and the limited resources of most public sector programs, the private sector may play a significant role in ART provision. The immunologic and virologic data in this analysis indicate comparability between public and private sector programs. The high rates of death on ART, however, are a concern, and more data on the cause of death would be useful. Additionally, the high rates of ART discontinuation and incomplete viral suppression (despite high self-reported adherence) indicate the need for improved counseling and support. Migratory workers are common in many parts of the world heavily affected by the HIV/AIDS epidemic, and many patients in this analysis left the company. Bridging of care to another private or public source of ART should therefore be a critical component of any private sector ART program. The cost data for implementation over time and the absolute costs per patient may help other companies determine the economic feasibility of implementing their own ART programs.

References

  1. Weidle PJ, Malamba S, Mwebaze R, Sozi C, Rukundo G, Downing R, et al. Assessment of a pilot antiretroviral drug therapy programme in Uganda: patients' response, survival and drug resistance. Lancet 2002 Jul 6;360(9326):34-40.
  2. Laurent C, Diakhate N, Gueye NFD, Toure MA, Sow PS, Faye MA, et al. The Senegalese government's highly active antiretroviral therapy initiative: an 18-month follow-up study. AIDS 2002 Jul 5;16(10):1363-70.
  3. Severe P, Leger P, Macarthur C, Noel F, Bonhomme G, Bois G, et al. Antiretroviral therapy in a thousand patients with AIDS in Haiti. N Engl J Med 2005 Dec 1;353(22):2325-34.
  4. Moore R, Keruly JC, Gebo KA, Lucas GM. An improvement in virologic response to highly active antiretroviral therapy in clinical practice from 1996 through 2002. J Acquir Immune Defic Syndr. 2005 Jun 1;39(2):195-8.
  5. Grabar S, Le Moing V, Goujard C, Leport C, Kazatchkine MD, Costagliola D, et al. Clinical outcome of patients with HIV-1 infection according to immunologic and virologic response after 6 months of highly active antiretroviral therapy. Ann Intern Med 2000 Sep 19;133(6):401-10.
  6. Badri M, Maartens G, Mandalia S, Bekker LG, Perrod JR, Platt RW, et al. Cost-effectiveness of highly active antiretroviral therapy in South Africa. PLoS Med 2006 Jan;3(1):e4.
  7. Boulle A, Kenyon C, Skordis J, Wood R. Exploring the costs of a limited public sector antiretroviral treatment programme in South Africa. S Afr Med J 2002 Oct;92(10):811-7.