A Randomized Controlled Trial of the Shikamana Intervention to Promote Antiretroviral Therapy Adherence Among Gay, Bisexual, and Other Men Who Have Sex with Men in Kenya: Feasibility, Acceptability, Safety and Initial Effect Size

Abstract

Gay, bisexual, and other men who have sex with men (GBMSM) living with HIV in rights-constrained settings need support for antiretroviral therapy (ART) adherence due to barriers including stigma. The Shikamana intervention combined modified Next Step Counseling by providers with support from trained peers to improve adherence among GBMSM living with HIV in Kenya. A randomized controlled trial with 6-month follow-up was used to determine feasibility, acceptability, safety, and initial intervention effects. Generalized estimating equations examined differences in self-reported adherence and virologic suppression. Sixty men enrolled, with 27 randomly assigned to the intervention and 33 to standard care. Retention did not differ by arm, and no adverse events occurred. Feedback on feasibility and acceptability was positive based on exit interviews. After adjustment for baseline viral suppression and confounding, the intervention group had a sixfold increased odds of viral suppression during follow-up. A larger trial of a scaled-up intervention is needed.

Resumen

Los hombres homosexuales, bisexuales y hombres que tienen sexo con hombres (HSH) que viven con VIH en entornos con derechos limitados necesitan apoyo para la adherencia a la terapia antirretroviral (ARV) debido a diversas barreras incluyendo el estigma. La intervención de Shikamana combinó consejería del próximo paso modificada (modified Next Step Counseling) realizada por proveedores con el apoyo de pares capacitados para mejorar la adherencia entre la poblacion HSH viviendo con VIH en Kenia. Se realizó un ensayo controlado aleatorizado con un seguimiento de 6 meses para determinar la factibilidad, aceptabilidad, seguridad y los efectos de la intervención inicial. Las ecuaciones de estimación generalizadas examinaron las diferencias en la adherencia autoinformada y la supresión virológica. Sesenta hombres fueron inscritos, 27 fueron asignados al azar a la intervención y 33 a la atención estándar. La retención no difirió entre ambos grupos y no ocurrieron efectos adversos. La retroalimentación según las entrevistas de salida sobre la viabilidad y aceptabilidad fue positiva. Después del ajuste de la linea basal de supresión viral y los factores de confusión, el grupo de intervención tuvo una probabilidad 6 veces mayor de supresión viral durante el seguimiento. Es necesario realizar un ensayo de intervención más amplia.

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Acknowledgements

We thank the men who participated in all phases of the Shikamana intervention development and RCT for their contributions. We express special gratitude to our seven dedicated and hard-working peers. We thank the staff of the HIV/STI project at the KEMRI-Wellcome Trust Research Programme in Kilifi for their commitment to serving GBMSM, as well as Dr. Anisa Omar of the Kenyan Ministry of Health. We are also grateful for support and guidance provided by the KWRTP to carry out research with stigmatized and vulnerable populations.

Funding

Support for this study was provided by NIH Grant R34 MH099946 (PI: SMG). SMG was also supported by the Robert W. Anderson Endowed Professorship in Medicine. JMS was supported by NIH Grant K24 MH093243. DO was supported by R24 HD07796. The KWRTP at the Centre for Geographical Medicine Research-Kilifi is supported by core funding from the Wellcome Trust (#203077/Z/16/Z). Additional infrastructure funding was provided by the University of Washington Center for AIDS Research, an NIH funded program (P30 AI027757) supported by the following NIH Institutes and Centers (NIAID, NCI, NIMH, NIDA, NICHD, NHLBI, NIA, NIGMS, NIDDK). Our work with GBMSM has also been funded by the International AIDS Vaccine Initiative (IAVI) with the generous support of USAID and other donors; a full list of IAVI donors is available at www.iavi.org. The views expressed in this publication are those of the authors and do not necessarily represent the official views the United States Government. This report was published with permission from the Director of the KEMRI-Wellcome Trust Research Programme.

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Correspondence to Susan M. Graham.

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All procedures were in accordance with the ethical standards of the Ethical Review Boards of KEMRI and the University of Washington and with the 1964 Helsinki declaration and its later amendments. KEMRI (#2835) and the University of Washington (#47589) approved the study protocol and monitored study progress. All men provided written, informed consent to participate. The study protocol was registered at clinicaltrials.gov at NCT02301533.

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Graham, S.M., Micheni, M., Chirro, O. et al. A Randomized Controlled Trial of the Shikamana Intervention to Promote Antiretroviral Therapy Adherence Among Gay, Bisexual, and Other Men Who Have Sex with Men in Kenya: Feasibility, Acceptability, Safety and Initial Effect Size. AIDS Behav 24, 2206–2219 (2020). https://doi.org/10.1007/s10461-020-02786-5

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Keywords

  • HIV
  • Antiretroviral therapy
  • Medication adherence
  • Counseling
  • Peer group

Palabras clave

  • VIH
  • terapia antirretroviral
  • adherencia a la medicación
  • consejería
  • grupo de pares