Effectiveness of an intervention to improve ART adherence among men who have sex with men living with HIV: a randomized controlled trial in three public HIV clinics in Mexico

ABSTRACT

We conducted a parallel-group randomized controlled trial in three HIV clinics in Mexico to evaluate a user-centred habit-formation intervention to improve ART adherence among MSM living with HIV. We randomized 74 participants to the intervention group and 77 to the control group. We measured adherence at one, four, and ten months through medication possession ratio and self-reported adherence. Additionally, we measured viral load, CD4 cell count, major depression disorder symptoms, and alcohol and substance use disorder at baseline, fourth and tenth months. We found no statistically significant effect on adherence between groups. However, the intervention demonstrated positive results in major depression disorder symptoms (21% vs. 6%, p = 0.008) and substance use disorder (11% vs. 1%, p = 0.018) in the fourth month. The latter is relevant because, in addition to its direct benefit, it might also improve the chances of maintaining adequate adherence in the long term. This trial was retrospectively registered at ClinicalTrials.gov (trial number NCT03410680) on 8 January 2018.

Trial registration: ClinicalTrials.gov identifier: NCT03410680.

KEYWORDS:

• HIV
• MSM
• ART adherence
• mental health

Acknowledgements

The authors would like to thank the patients and clinic staff from the clinics Hospital Civil de Guadalajara “Dr. Juan I. Menchaca” and Instituto Nacional de Nutrición y Ciencias Médicas Salvador Zubirán, who contributed to the design of the intervention. To the patients from the clinics Hospital Civil de Guadalajara “Dr. Juan I. Menchaca”, Hospital General de Occidente and CAPASITS Tabasco, who participated in the clinical trial. To Dr. Brenda Crabtree Ramírez, from the Instituto Nacional de Nutrición y Ciencias Médicas Salvador Zubirán, who participated in the formative work phase of the study. To Luis Fernando Barraza-Araiza, MD MSc who participated in the formative, pilot and implementation phase of the study and his valuable support in the design and implementation of the intervention. To Liliana Alejandra Reynoso García, MD; Elizabeth López Villalobos, and Pablo David Morales Díaz, LCP for their valuable support and feedback during the pilot and implementation phase. To Marisol Apaez Iglesias, MD; Itzel Yuritzi Heredia Pérez, MD; Lizandy Zuñiga Pérez, MD; Leslie Jackeline Rodríguez Covarrubias, MD; Lourdes Alicia Lozano Mercado, BSPH; and Julián Sánchez Alcudia, LCP; for their valuable support during the implementation phase. To Nina Munteanu at the University of Toronto to proofread the manuscript. “We dedicate this manuscript to Prof. Sandra G. Sosa-Rubi, who participated in the formative work phase of the study and passed away in March 2021. We miss you, Sandra. Thank you for being our friend and an amazing researcher”.

Abbreviations

ACTG: AIDS Clinical Trials Group; ART: Antiretroviral Therapy; BSPH: Bachelor of Science in Public Health; DID: Difference-in-difference; HSI: Habit strength index; HCGJIM: Hospital Civil de Guadalajara “Dr. Juan I. Menchaca”; HIV: Human immunodeficiency virus; HGO: Hospital General de Occidente; IRB: Institutional review board; LMIC: Low- and middle-income countries; LCP: Licensed Clinical Psychologist; MD: Medical doctor; MPR: Medication possession ratio; MSc: Master in Science; MSM: Men who have sex with men; PLHIV: People living with HIV; RCT: Randomized controlled trial; SRA: Self-reported adherence; VL: Viral load.

Authors’ contributions

SBA conceived the study. SBA, ZAR and LCR designed the study. ZAR, SBA, LCR, JSAP and GAT developed the study protocol. ZAR, SBA, LCR and JSAP designed the intervention. ZAR, LCR and LEOS conducted the literature review for the introduction section and ZAR and LEOS for the discussion section. GLHF, ZAR, LEOS and SBA did the analysis. ZAR, GLHF, LEOS and SBA drafted the article. ZAR, GLHF, LEOS, SBA, LCR, JSAP, GAT, LCL and TAM critically revised the article for important intellectual content. TAM provided administrative support. All authors contributed to the refinement of the article, read, and approved the final manuscript.

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. Code availability: The custom code used during the analysis of the current study is available from the corresponding author on reasonable request.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Ethics approval

The study protocol, including recruitment, consent, and intervention materials, were approved by the following Institutional review boards (IRB): National Institute of Public Health of Mexico (study ref number: CI-1285), Hospital Civil de Guadalajara “Dr. Juan I. Menchaca” (ref: 0131/16) in 2016, and Hospital General de Occidente (ref: 512/17) in 2017. Consent to participate Written informed consent was obtained from all individual participants included in the study. Consent for publication: Not applicable.

Additional information

Funding

This study was funded by the Consejo Nacional de Ciencia y Tecnología of Mexico (CONACYT) [grant number SALUD-2014-1-233508] and by the National Center for the Prevention and Control of HIV and AIDS (CENSIDA) [grant number Proy2da-2018-0002]. The funders did not have any role in the writing of the protocol, the design of the study, data collection or any other part of the study.