Weidle PJ, Wamai N, Solberg P, Liechty C, Sendagala S, Were W, Mermin J, Buchacz K, Behumbiize P, Ransom RL, Bunnell R. Adherence to Antiretroviral Therapy in a Home-Based AIDS Care Programme in Rural Uganda. Lancet. 2006 Nov 4;368(9547):1587-94.
To assess adherence to antiretroviral therapy (ART) over time among HIV-infected adults participating in a home-based AIDS care program in rural Uganda.
This was a longitudinal follow-up study of participants who were enrolled in a randomized controlled trial evaluating the efficacy of antiretroviral therapy delivered and monitored in a rural setting (the Home-Based AIDS Care or HBAC project). The adherence study presented here evaluated patients in the trial who started ART between July 2003 and May 2004, and were followed through June 30, 2005.
Tororo and Busia districts, eastern Uganda; these are poor, rural areas comprised mostly of subsistence farmers.
Nine hundred eighty-seven HIV-positive anti-retroviral-naïve adults were enrolled and started on ART; criteria for initiating therapy included a CD4 cell count <250 cells/µL, severe HIV disease (WHO stage 3 or 4), or a history of recurrent herpes zoster. Participants were clients of the Ugandan AIDS Support Organization called TASO, and lived within a 100 km2 area of the study site. Forty-three percent of the clients were between 36-45 years of age; only 24% were educated beyond primary school; and 41% were clinically depressed. The median CD4 count and viral load were 124 cells/µL and 217,000 copies/µL, respectively.
Participants received individual and group sessions on HIV prevention, care, and treatment; family members received education in the home. Each client identified a "medicine companion," or someone who committed to observing the client take at least one ART dose per day for six months. Field officers delivered medications to the home on a weekly basis, collected all unused medication, and completed brief surveys to determine symptoms of HIV disease, drug side effects, and self-reported adherence. This information was relayed to clinicians who determined whether changes in medical regimen were required.
Primary outcomes included pill count adherence (PCA) or the proportion of total pills that were taken as determined by inspection; medication possession ratio (MPR) or the proportion of days' supply of drug used; viral load; and CD4 count. On a weekly basis, pharmacists reviewed the returned pill boxes and field-officer and medicine-companion forms. As part of the parent trial, all clients had baseline and quarterly measurements of viral load and CD4 counts.
The mean proportion of pills used and of daily doses taken was 98-99%. In any quarterly follow-up period, only 0.7-2.6% of clients took less than 95% of their pills, and 3.3-11.1% took less than 95% of daily doses. During the fourth quarter of follow-up, 96% of participants had a viral load <1000 copies/µL. Independent predictors of high viral load (≥1000 copies/µL) included pill usage less than 95% odds ratio (OR)=10.6 [95% confidence interval (CI): 2.5-45.7] and taking less than 95% of daily dosages of medication (MPR), OR=9.4 [95% CI: 3.4-26.2].
The authors conclude that high levels of adherence--leading to successful response to ART--can be achieved in a rural African setting using a home-based care and monitoring approach.
Based on the Newcastle-Ottawa rating system for evaluating cohort studies, this study was of high quality. This study had a few limitations. Because it was an observational study without a control group, it is not possible to determine the extent to which the program itself contributed to high levels of adherence. It would have been interesting to know which factors were associated with poorer adherence, and whether there was any influence of the parent-study trial arms on adherence.
This very interesting study demonstrates that high levels of adherence to ART can be achieved in rural areas of Africa, at least in the short term. This program uniquely and successfully provides therapy and monitoring directly to the home, in an area where transportation and access to clinic-based care are difficult. High rates of adherence and low levels of program drop-out are similar to those achieved in other sub-Saharan countries undergoing ART rollout.(1) Retention and adherence may be influenced by the availability of free medication, provided here through the PEPFAR program.(2,3,4) When patients must pay for all or part of their ART, drop-out often occurs, because costs of medications are high.(5,6,7) This cohort may not be representative of other sub-Saharan African populations who have less community-based support, and/or do not already receive other support services in the home.
This study demonstrates that ART adherence and retention in care in resource-limited settings can be excellent. Programs need to devise systems of care and ART distribution that take into consideration the difficulty of needing to travel long distances to receive medication and obtain regular follow-up, in order to evaluate response to therapy and side effects. A combination of facility-based and community-outreach models, in which trained peripheral health workers distribute medications and collect basic information for clinicians, may be useful. Because this program is relatively new, the length of follow-up is short. It remains to be seen whether this model will remain effective as patients continue on ART for longer periods of time and begin to develop serious side effects, toxicity, and viral failure.
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