OBJECTIVES: To measure the effects of an HIV-Care-Program, focusing on nutrition and lifestyle, which can be provided at scale to HIV-infected patients, on clinical and anthropometrical parameters, and health status. METHODS: A cluster-randomized trial, including 5 health facilities randomized to intervention n = 100 (HIV-Care-Program) or controln = 101 (Usual-Care). The HIV-Care-Program consisted of counseling lessons for 6 months, on: nutrition, hygiene, coping with stigma and discrimination, embedded in practical activities. Outcome variables were CD4 count after 6 months and time to antiretroviral therapy (ARV) initiation, using analysis of covariance and Kaplan-Meier method, respectively. RESULTS: After 6 months, CD4 count dropped by 46.3 cells (7.7%) (intervention) and 129 (23%) (control) (p = 0.003). Mean time to ARV; 5.9 months 95% CI (5.9, 6.0) (intervention); 4.9 months 95% CI (4.7, 5.2) (control) (p < 0.004). There was a partial correlation between CD4 count and initial viral load (r = -0.190, p = 0.017). CONCLUSIONS: The intervention provides a low-cost alternative improving health status, slowing down CD4 cell decline, delaying initiation of ARV and thus freeing local ARV capacities for patients in urgent need.
RCT Entities:
OBJECTIVES: To measure the effects of an HIV-Care-Program, focusing on nutrition and lifestyle, which can be provided at scale to HIV-infectedpatients, on clinical and anthropometrical parameters, and health status. METHODS: A cluster-randomized trial, including 5 health facilities randomized to intervention n = 100 (HIV-Care-Program) or control n = 101 (Usual-Care). The HIV-Care-Program consisted of counseling lessons for 6 months, on: nutrition, hygiene, coping with stigma and discrimination, embedded in practical activities. Outcome variables were CD4 count after 6 months and time to antiretroviral therapy (ARV) initiation, using analysis of covariance and Kaplan-Meier method, respectively. RESULTS: After 6 months, CD4 count dropped by 46.3 cells (7.7%) (intervention) and 129 (23%) (control) (p = 0.003). Mean time to ARV; 5.9 months 95% CI (5.9, 6.0) (intervention); 4.9 months 95% CI (4.7, 5.2) (control) (p < 0.004). There was a partial correlation between CD4 count and initial viral load (r = -0.190, p = 0.017). CONCLUSIONS: The intervention provides a low-cost alternative improving health status, slowing down CD4 cell decline, delaying initiation of ARV and thus freeing local ARV capacities for patients in urgent need.
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