A Pilot, Randomized Controlled Trial of Dual Daily HIV and Sexually Transmitted Infection Pre-exposure Prophylaxis Using Tenofovir Disoproxil Fumarate/Emtricitabine and Doxycycline in Gay, Bisexual, and Other Men Who Have Sex With Men and Transgender Women: The DuDHS Study
Bibliographic record
Abstract
BACKGROUND: Men who have sex with men (MSM) and transgender women experience high sexually transmitted infection (STI) rates. This study evaluated the feasibility of doxycycline pre-exposure prophylaxis (doxyPrEP) for STI prevention in these key populations. METHODS: Sexually-active MSM and transgender women without human immunodeficiency virus (HIV) with prior syphilis were recruited. Participants initiated HIV PrEP with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) daily for 48 weeks and were randomized 1:1 to daily doxyPrEP for 48 weeks (immediate arm), or doxyPrEP initiated at 24 weeks (deferred arm). Primary outcomes included adherence, measured using questionnaires, along with tolerability; STI incidence (chlamydia, gonorrhea, syphilis) was a secondary outcome. Nasal carriage of Staphylococccus aureus was assessed serially for doxycycline resistance. RESULTS: Fifty-two participants were enrolled into the immediate (n = 26) and deferred (n = 26) arms. At 48 weeks, self-reported adherence (≥95%) was 75.0% versus 66.7% (P = .538) for TDF/FTC, and 70.8% versus 61.9% (P = .526) for doxycycline in the immediate versus deferred arms, respectively. No doxyPrEP-related serious adverse events occurred. Incidence of any STI at 24 weeks was reduced in the immediate versus deferred arms, and over 48 weeks, being on doxycycline (vs being off; ie, first 24 weeks of deferred arm) was associated with STI reduction (adjusted odds ratio [aOR] 0.36; 95% confidence interval [CI]: .15-.89). Emergent doxycycline-resistant S. aureus was identified in six individuals, with five in the immediate arm (P = .077). CONCLUSIONS: Dual HIV/doxyPrEP is feasible and associated with a significant reduction in incident STI. Further evaluation of dosing strategies, efficacy and impact on antimicrobial resistance is warranted.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".