Abstract
Purpose
We evaluated the feasibility, acceptability and preliminary efficacy of a standardized nurse delivered mobile phone intervention to improve adherence to antiretroviral treatment and clinical outcomes.
Methods
Feasibility and acceptability of the phone intervention was assessed with rates of eligibility, completed visits, and attritions. Intervention fidelity was assessed by checking recorded calls and feedback. Efficacy was assessed using a randomized controlled trial in which 120 women living with HIV and psychosocial vulnerabilities, were randomized to Treatment as Usual (TAU = 60) or TAU plus the mobile phone intervention (N = 60). Trained basic nurses delivered the theory-guided, standardized mobile phone intervention for mental health issues and psychosocial risk factors to improve antiretroviral treatment (ART) adherence and retention in care and improve clinical outcomes. Blind raters performed the assessments at 6, 12 and 24 weeks post-randomization.
Results
Adherence diminished over time in the TAU only group, while it was sustained in the TAU Plus group, only dropping at 24 weeks after the intervention had been discontinued. Among participants with depressive symptoms (CESD ≥ 16), the intervention had significant improvement in adherence rates (p < 0.01), psychological quality of life (p < 0.05) and illness perception (p < 0.05) compared to those in the TAU only group. Greater improvements of quality of life subscales were observed in the TAU Plus group among participants with less psychological vulnerability (PSV < 2). HIV RNA was not significantly different between the groups at week 24.
Conclusions
The mobile-delivered counseling intervention was feasible and acceptable and shows promise among women living with HIV and psychosocial vulnerabilities in rural South India.
Trial Registration
ClinicalTrials.gov Identifier: NCT02319330 [Registered on: December 18, 2014].
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Data availability
Data will be made available upon reasonable request.
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Acknowledgements
The study was supported by the US National Institutes of Health (R21MH100939), the Indian Council of Medical Research (HIV/INDOUS/152/9/2012-ECD-II), and the ITRA project, funded by DEITy, India (Ref. No. ITRA/15(57)/Mobile/HumanSense/01). We thank Ms. Amita Sharma for analysing viral load data.
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The sponsors of the study had no role in the design of the original study protocol, data collection, data analysis, data interpretation, writing of the report, or decision to submit the manuscript for publication. PC, NR, MD, VS, and SJ had full access to all the data in the study, PC and NR had final responsibility for the decision to submit for publication, and all authors approved the decision to submit.
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Satyanarayana, V.A., Duggal, M., Jeon, S. et al. Exploring the feasibility, acceptability and preliminary effects of a nurse delivered mhealth intervention for women living with HIV in South India: a pilot randomized controlled trial. Arch Womens Ment Health (2024). https://doi.org/10.1007/s00737-024-01462-0
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DOI: https://doi.org/10.1007/s00737-024-01462-0