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Accepted for/Published in: Journal of Medical Internet Research

Date Submitted: Feb 8, 2025
Date Accepted: May 21, 2025

The final, peer-reviewed published version of this preprint can be found here:

Weekly Text Messages to Support Adherence to Oral Pre-Exposure Prophylaxis (PrEP) Among Gay, Bisexual, and Other Cisgender Men Who Have Sex With Men (MSM) and Transgender Women: Pilot Randomized Controlled Trial Nested in PrEP Brasil Study

Marins LMS, Torres TS, Moreira RI, Leite IC, Cunha M, Hoagland B, Freitas LA, Castanheira D, Coutinho C, Jalil EM, Silva MST, Madruga JV, Grinsztejn B, Veloso VG

Weekly Text Messages to Support Adherence to Oral Pre-Exposure Prophylaxis (PrEP) Among Gay, Bisexual, and Other Cisgender Men Who Have Sex With Men (MSM) and Transgender Women: Pilot Randomized Controlled Trial Nested in PrEP Brasil Study

J Med Internet Res 2025;27:e72360

DOI: 10.2196/72360

PMID: 40680163

PMCID: 12294642

Randomized controlled pilot trial of weekly text messages to support adherence to oral pre-exposure prophylaxis (PrEP) among gay, bisexual and other cisgender men who have sex with men (MSM) and transgender women: PrEP Brasil SMS Substudy

  • Luana Monteiro Spindola Marins; 
  • Thiago Silva Torres; 
  • Ronaldo Ismerio Moreira; 
  • Iuri Costa Leite; 
  • Marcelo Cunha; 
  • Brenda Hoagland; 
  • Lucilene Araujo Freitas; 
  • Debora Castanheira; 
  • Carolina Coutinho; 
  • Emilia Moreira Jalil; 
  • Mayara Secco Torres Silva; 
  • Jose Valdez Madruga; 
  • Beatriz Grinsztejn; 
  • Valdilea Gonçalves Veloso

ABSTRACT

Background:

Mobile phones have become popular tools to support public health interventions (mHealth). Text messaging, including Short Message Service (SMS), is a simple, low-cost approach for health communication to a large population and offers valuable tools in improving health outcomes. Despite the global advances in HIV treatment and prevention, the HIV epidemic continues to disproportionately affect certain key populations such as gay, bisexual and other men who have sex with men (MSM) and transgender women, including in Latin America.

Objective:

We evaluated the effectiveness of SMS in improving adherence after one year provision of oral PrEP among MSM and transgender women in Brazil.

Methods:

andomized controlled pilot trial (SMS substudy) nested in PrEP Brasil study, a prospective, multicenter, 48-week open-label demonstration study assessing PrEP delivery for MSM and transgender women at higher vulnerability to HIV in the context of the Brazilian Public Health System. Those who agreed to participate in the SMS substudy were randomized 1:1 to standard-of-care (SOC) or intervention (SMS) arms. SMS messages were launched fully automated weekly to participants for 48 weeks. Adequate adherence to PrEP has been defined as having: (1) tenofovir-diphosphate (TFV-DP) concentration ≥700 fmol/punch; (2) medication possession rate (MPR) ≥ 1.07; (3) pill count ≥ 90.1%; (4) self-report (structured questionnaire) ≥ 99.9%. Adequate adherence outcomes at week 48 were compared between arms (SMS vs. SOC) using univariate logistic regression (odds ratio [OR] and 95% confidence interval [95% CI]). Comparisons were also performed for two groups: young MSM aged 18-24 years and transgender women.

Results:

From 450 participants enrolled on PrEP Brasil, 417 (92.7%) were randomized to the SMS substudy: 210 to SOC and 207 to SMS. Until week 48, participants received a total of 14,099 SMS with the message: "Are you okay?", and 6,959 (49.4%) messages were replied. Of these, the vast majority replied "Yes" (97.2%). A total of 347 (83.2%) participants completed the study with no difference between arms for the four adherence outcomes measured at week 48. Conversely, young MSM who received SMS had 2.50 increased odds of having adequate PrEP adherence measured by MPR (p=0.05). Most participants found SMS service very useful or useful (76.0%) and would recommend SMS as a support strategy for persons using PrEP (80.2%). Most participants think SMS should be offered to all persons using PrEP (77.2%) and 16.2% think SMS should be offered only to persons using PrEP with adherence problems. Weekly messages were found adequate by 80.2%.

Conclusions:

SMS intervention improved adequate PrEP adherence among young MSM and can be a useful tool for PrEP coverage and persistence. Future interventions using other mHealth tools such as WhatsApp messages and apps tailored to support PrEP adherence should be evaluated among MSM and transgender women in Brazil. Clinical Trial: NCT01989611. Date of first registration: 21/11/2013, https://clinicaltrials.gov/ct2/show/NCT01989611


 Citation

Please cite as:

Marins LMS, Torres TS, Moreira RI, Leite IC, Cunha M, Hoagland B, Freitas LA, Castanheira D, Coutinho C, Jalil EM, Silva MST, Madruga JV, Grinsztejn B, Veloso VG

Weekly Text Messages to Support Adherence to Oral Pre-Exposure Prophylaxis (PrEP) Among Gay, Bisexual, and Other Cisgender Men Who Have Sex With Men (MSM) and Transgender Women: Pilot Randomized Controlled Trial Nested in PrEP Brasil Study

J Med Internet Res 2025;27:e72360

DOI: 10.2196/72360

PMID: 40680163

PMCID: 12294642

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