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Randomized Controlled Trial
. 2018 Nov 28;32(18):2727-2737.
doi: 10.1097/QAD.0000000000002016.

Randomized controlled trial of a community-based intervention on HIV and nutritional outcomes at 6 months among women living with HIV/AIDS in rural India

Adeline M Nyamathi  1 , Catherine L Carpenter  2 , Maria L Ekstrand  3 , Kartik Yadav  1 , Dana Rose Garfin  1 , Lisa C Muniz  1 , Mariko Kelley  1 , Sanjeev Sinha  4
Affiliations
Randomized Controlled Trial

Randomized controlled trial of a community-based intervention on HIV and nutritional outcomes at 6 months among women living with HIV/AIDS in rural India

Adeline M Nyamathi et al. AIDS. .

Abstract

Objective: To assess the impact of nurse-led Asha (Accredited Social Health Activist)-support behavioral and nutritional intervention among women living with HIV/AIDS (WLH/A) in rural India.

Design: Cluster randomized controlled trial.

Methods: Sixteen Primary Health Centers serving WLH/A in Andhra Pradesh were grouped into four regional clusters that were randomly allocated into one of four arms. All four groups included Asha-support and consisted of: Asha-support only (control group); nutrition education; nutrition supplementation; and the combination of supplementation and education. Differences between baseline and 6-month follow-up for key physiological outcomes (BMI, CD4 cell count) were analyzed using factorial mixed models that accounted for geographic clustering.

Results: At 6 months, all groups improved CD4 cell count: Asha only [mean difference score (D) = 343.97, standard deviation (SD) = 106.94], nutrition education (D = 356.15, SD = 0.69), nutrition supplement (D = 469.66, SD = 116.0), and nutrition supplement and education (D = 530.82, SD = 128.56). In multivariable models, Asha-support and nutrition, and Asha-support and nutrition supplement interventions demonstrated independent significant improvements in CD4 cell count; the interaction term was significant [estimate = 529.9; 95% confidence interval (CI) 512.0, 547.8; P = 0.006]. BMI also increased for all groups: Asha only (D = 0.95, SD = 0.82), Asha and nutrition education (D = 1.28, SD = 0.53), Asha and nutrition supplement (D = 2.38, SD = 0.60), nutrition supplement, and nutrition supplement and education (D = 2.72, SD = 0.84). Nutrition supplementation and nutrition education demonstrated independent effects on BMI; the interaction term was not significant (estimate = 0.27; 95% CI = 2.5, 2.7; P = 0.80).

Conclusion: Interventions supported by community workers were efficacious at improving physiological outcomes and may be beneficial at meeting critical healthcare needs of vulnerable WLH/A in India.

Trial registration: ClinicalTrials.gov NCT02136082.

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Conflict of interest statement

Conflict of Interest: The authors declare that they have no competing interests.

Figures

Figure 1.
Figure 1.
CONSORT Flow Diagram
See this image and copyright information in PMC

References

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