Community-engaged implementation strategies to increase doxycycline post-exposure prophylaxis uptake among men who have sex with men in China (DoxyForward): a three-group, open-label, randomised controlled trial.

BACKGROUND

Implementation strategies to support equitable uptake of doxycycline post-exposure prophylaxis (doxy-PEP) for sexually transmitted infections have not been examined. We compared three layered community-engaged implementation strategies to increase doxy-PEP use among men who have sex with men (MSM) in China.

METHODS

DoxyForward (ChiCTR2300074903) was a three-group, open-label, randomised controlled trial conducted at community-based organisations in seven provinces in China. MSM receiving sexual health services at community-based organisations were randomly allocated in a 1:1:1 ratio using permuted blocks to either co-creation alone (co-creation group), which provided educational materials introducing doxy-PEP co-created with local MSM community members; co-creation plus pay-it-forward (CC + PIF group), which additionally offered free doxy-PEP supported by peer donations with an optional invitation to donate; or co-creation plus pay-it-forward with social network distribution (CC + PIF + SND group), which provided additional doxy-PEP to distribute to peers. To be eligible, participants needed to be 16 years or older, identify as a cisgender man or transgender woman, and report one or more sexually transmitted infection (STI) risk behaviour in the past 12 months. Randomly allocated participants (ie, index participants) from the co-creation and CC + PIF + SND groups recruited MSM peers (ie, alter participants). The primary outcome was doxy-PEP use within 72 h of condomless anal or oral sex with a male partner on one or more occasions at 6 months. All index participants were included in the primary analysis, with missing data addressed using multiple imputation. Proportions of alter participants who achieved the primary outcome were compared between the co-creation and CC + PIF + SND groups.

FINDINGS: Between July 9 and Dec 27, 2024, 483 community-based organisation attendees were screened, and 399 (83%) were enrolled as index participants. All participants were cisgender men, and median age was 30 years (IQR 25-39). Before joining this study, 140 (35%) had heard of doxy-PEP, and 27 (7%) had used doxy-PEP. 6-month follow-up was completed by 343 (86%) of the 399 index participants. Doxy-PEP use after condomless sex at six months was reported by 48 (41%) of 117 of index participants in the co-creation group, 89 (76%) of 117 in the CC + PIF group (risk difference [RD] 31·3 vs co-creation group [95% CI 19·1-43·6]; p<0·0001), and 80 (73%) of 109 in the CC + PIF + SND group (RD 34·3 vs co-creation group [22·5-46·2]; p<0·0001). Doxy-PEP use was also higher among alter participants who received doxy-PEP through social network distribution than referral to community-based organisations (32 [68%] of 47 vs 39 [40%] of 98; RD 28·3 [95% CI 11·8-44·8]; p<0·0001).

INTERPRETATION: Community-engaged implementation strategies significantly increased doxy-PEP uptake in a setting with low baseline use. Co-creation and pay-it-forward worked synergistically to increase doxy-PEP use.

FUNDING: Dermatology Hospital of Southern Medical University, United States National Institutes of Health (R01AI158826).

TRANSLATION: For the Chinese translation of the abstract see Supplementary Materials section.