Feasibility and impact of online HIV/STI screening addressed to men who have sex with men and transgender women users of pre-exposure prophylaxis (PrEP) in Spain (TESTATE PrEP): a study protocol for a non-blinded randomised controlled trial

Introduction
The objectives of the study are: to design and implement a pilot intervention to offer self-sampling kits to detect HIV, Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Treponema pallidum (TP) among gay, bisexual and other men who have sex with men and transgender women users of pre-exposure prophylaxis (PrEP) as part of PrEP follow-up. To evaluate if the pilot intervention causes a reduction of the retention to PrEP follow-up among the target population. To analyse the capacity of the intervention to reduce the healthcare burden on the PrEP service. To evaluate the acceptability of the intervention among PrEP users and PrEP service healthcare workers and; to validate dried blood samples for treponemal and non-treponemal antibody detection using the Dual Path Platform syphilis screening and confirmatory assay compared with blood drawn by venous puncture.

Methods and analysis
We will perform a non-blinded randomised controlled non-inferiority trial among PrEP users on follow-up. Participants on the control arm will follow the usual follow-up protocol with quarterly face-to-face visits where they will be tested for HIV and sexually transmitted infections (STIs). Participants in the experimental arm will alternate face-to-face meetings with online screening of HIV and STIs. The website https://testate.org/ will include a module for online follow-up visits of participants. Participants of the experimental arm will order self-sampling kits for HIV, CT, NG and TP through the website, will send the samples to the laboratory and check their results online. We will compare the retention to follow up and the healthcare burden in both arms. The acceptability of the intervention among participants and healthcare workers will be assessed.

Ethics and dissemination
The project has been approved by the CEIC-HUGTIP (Reference: PI-22-051). Subjects will be included after giving their informed consent. Final conclusions and recommendations will be shared with stakeholders. Two publications in peer-reviewed journals are expected.

Trial registration number
NCT05752643.

Leggi
Ottobre 2023

Prevalence of and factors associated with the use of gender-affirming hormonal therapy outside the reference regimen among transgender people in a community-led clinic in Metro Manila, Philippines: a retrospective cross-sectional study

Objectives
We aimed to describe the gender-affirming hormonal therapy (GAHT) intake behaviour and regimen and the factors associated with the use of hormones inconsistent with reference GAHT regimen among transgender people in the Philippines.

Design
Cross-sectional study.

Setting
Transgender community clinic in Metro Manila, Philippines from March 2017 to December 2019.

Participants
Gender-affirming care-seeking individuals of at least 18 years old, who self-identified as transgender or non-binary, and who self-reported current or previous use of GAHT at baseline consult.

Primary outcome measures
Reported drugs and/or administration routes not congruent with the World Professional Association for Transgender Health Standard of Care eighth edition were classified as hormone use outside the reference regimen.

Results
253 transgender people reported current or previous intake of GAHT. Many trans women and transfeminine people (TWTFP; 58.9%, 86/146) reported using oral contraceptive pills (OCPs), whereas most trans men (TM; 73.8%, 79/107) reported injecting testosterone esters. Furthermore, 59.7% (151/253) used hormones outside the reference regimen, widely using OCP and anabolic steroids among TWTFP and TM, respectively. TWTFP (crude prevalence ratio, PR, 3.52; 95% CI 2.35 to 5.49) and those who take unprescribed GAHT (crude PR 2.37; 95% CI 1.08 to 6.68) were more likely to use hormones outside the reference regimen than TM and taking healthcare provider-prescribed GAHT, respectively. On adjusting for covariates, the prevalence of using hormones outside the reference regimen was approximately three times higher (adjusted PR 3.22; 95% CI 2.09 to 5.12) among TWTFP than TM.

Conclusion
Trans people act on their high unmet gender-affirming care needs by taking unprescribed GAHT, many outside the reference regimen. Structural changes in the health system are warranted, including strengthened community-based self-administration practices.

Leggi
Settembre 2023