Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 10, 2023
Open Peer Review Period: Mar 10, 2023 - Apr 24, 2023
Date Accepted: May 5, 2023
(closed for review but you can still tweet)
Voluntary medical male circumcision and incident HIV infection among men who have sex with men in China (the CoM Study): protocol for a randomized controlled trial
ABSTRACT
Background:
Systematic reviews and meta-analyses based on observational studies have shown voluntary medical male circumcision (VMMC) may reduce HIV risk among men who have sex with men (MSM). There is a lack of randomized controlled trial (RCT) data assessing the efficacy of VMMC.
Objective:
The primary objective of this study is to assess the efficacy of VMMC for preventing HIV acquisition among MSM who primarily engage in insertive anal sex.
Methods:
A multi-center RCT will be conducted among MSM in eight cities in China. Eligible participants are men aged 18-49 years who self-report ≥2 male sex partners in the past 6 months, predominantly practice insertive anal sex, and are willing to undergo circumcision. Interested men who satisfy inclusion criteria will be tested for HIV one month before enrollment and at enrollment, and only those who are HIV negative will be enrolled. At baseline all enrolled participants will be asked to report sociodemographic characteristics and sexual behaviors, provide a blood sample for HIV, syphilis and HSV-2 testing, and provide a penile swab for HPV testing. Participants will be randomly assigned to the intervention or control group. Those in the intervention group will receive VMMC and undergo an online weekly follow-up assessment of post-surgery healing for six consecutive weeks. All participants will be tested for HIV at 3-, 6-, 9-, and 12-month follow-up. All participants will also be asked to report sexual behaviors and undergo repeat HSV-2 and HPV testing at 6- and 12-month follow-up. The primary endpoint is HIV seroconversion. Secondary endpoints are the safety and satisfaction with VMMC, and the changes in sexual behaviors after VMMC. The grouped censored data will be analyzed in intention-to-treat.
Results:
Recruitment for the RCT began in August 2020 and continued through July 2022. Data collection is expected to be completed by July 2023, with full data analysis completed by September 2023.
Conclusions:
This study will be the first RCT to assess the efficacy of VMMC in preventing HIV infection among MSM. Results from this trial will provide preliminary evidence for the potential efficacy of VMMC to reduce incident HIV infection among MSM. Clinical Trial: ChiCTR2000039436.
Citation
Per the author's request the PDF is not available.
Copyright
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