Evaluation of self-directed specimen collection for chlamydia and gonorrhea testing among people who use drugs.

Background: People who use drugs (PWUD) often have elevated sexually transmitted infection (STI) risk and unmet healthcare needs. Self-directed STI specimen collection (i.e., individuals collect the specimen and mail to the laboratory) may be valuable in addressing STI testing barriers among PWUD. Methods: Within a cohort study among PWUD in New York City, we conducted a cross-sectional substudy from November 2021-August 2022 assessing sexual health with a one-time online survey (n = 120); participants could opt-in to receive a self-collection kit. Participants who opted-in were mailed a kit containing collection materials (males: urine cup, females: vaginal swab), pre-paid return label, instructions, and educational information. Specimens were sent to the laboratory and tested for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). We measured the number of kits requested, delivered, mailed to the lab, and CT/GC positive; and examined differences in requesting a kit by sociodemographic and behavioral characteristics. Results: Sixty-three total kits were requested by 44 unique participants. Of the 63 requested, 41 were delivered; one kit was undeliverable at the provided address and the rest were not sent due to no address provided or being duplicate requests. Of the 41 kits delivered, three participants returned the kit to the lab; of those, one was positive for CT and GC. The greatest differences in those who did and did not request a kit were observed by age, sexual orientation, past-year sex trade and casual partnerships, and experiences of relationship violence. Conclusions: Self-directed specimen collection may be desirable for PWUD, but research is needed to understand barriers to this testing approach for this population.

Post-randomization Differences in Condomless Vaginal Sex Among Women Randomized to Intramuscular Depot Medroxyprogesterone Acetate Injections, a Copper Intrauterine Device or a Levonorgestrel Implant in the ECHO Trial.

The Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial found no substantial difference in HIV acquisition risk between women randomised to injectable intramuscular depot medroxyprogesterone acetate (DMPA-IM), copper intrauterine device (Cu-IUD) or the levonorgestrel (LNG) implant. We evaluated post-randomization sexual behavior using an objective marker of condomless vaginal sex in a subset of participants. We conducted a sub-study among 458 ECHO participants at three sites (Cape Town, Johannesburg, Kisumu) to evaluate the frequency of condomless vaginal sex, measured by prostate specific antigen (PSA) detection in vaginal swabs, collected at the month 6 and final visit and the concordance of self-reported condomless vaginal sex with PSA detection, by randomized arm. We compared PSA detection frequency and concordance of PSA and self-reported condomless vaginal sex, by randomized group using Cochran-Mantel-Haenszel tests and adjusted generalized logistic growth curve models. PSA was detected less frequently in the DMPA-IM (16%), compared to the Cu-IUD (21%) and LNG implant (24%) groups, although results were not statistically significant in the unadjusted model when accounting for pre-specified multiple-testing criteria. There were significant differences in PSA detection between the DMPA-IM and LNG-implant groups (odds ratio 0.61 (95% CI 0.40, 0.94) in the adjusted model. There was moderate discordance between self-reported condomless vaginal sex and detection of PSA that was similar across randomized groups. These data suggest that women randomized to Cu-IUD and LNG implant may have had condomless sex more frequently than women randomized to DMPA-IM. The discordance between detectable PSA and self-reported sexual behaviour has important implications for design of future HIV prevention studies.

What's Sex Got to Do With It? Understanding Potential Confounding and Exposure Misclassification in Mechanistic Sexually Transmitted Infection Research.

We conducted a prospective study of 13 heterosexual couples to understand the impact of recent condomless vaginal sex on vaginal immune marker measurement and potential exposure misclassification due to the presence of semen. All immune markers were detectable in semen and concentrations of vaginal immune markers varied by sex recency.

Methods for detection of Trichomonas vaginalis in the male partners of infected women: implications for control of trichomoniasis.

Trichomonas vaginalis infection in men is an important cause of nongonococcal urethritis. Effective detection of the parasite in men using culture requires examination of multiple specimens. We compared culture and PCR-enzyme-linked immunosorbent assay in urethral swabs, urine, and semen for T. vaginalis detection in male sexual partners of women with trichomoniasis identified by wet mount and culture. Trichomonads were detected by at least one positive test in 205/280 men (73.2%) who submitted at least one specimen for culture and PCR. Whereas InPouch TV culture detected only 46/205 cases (22.5%), PCR detected 201/205 (98.0%). Urethral swab cultures from men with urethritis were more likely to be positive with shorter incubation than specimens from men without urethritis. T. vaginalis was detected more often in men with wet-mount-positive partners. Even with a sensitive PCR assay, reliable detection of T. vaginalis in male partners required multiple specimens. The majority of male sexual partners in this study were infected, emphasizing the importance of partner evaluation and treatment.

Increased immunogenicity of HIV envelope subunit complexed with alpha2-macroglobulin when combined with monophosphoryl lipid A and GM-CSF.

Critical to the success of HIV-1 subunit vaccines is the development of strategies to augment vaccine immunogenicity. Successful adjuvants must not only improve immunogenicity above current adjuvant levels, but must also decrease the dose of immunogen required for optimal immunogenicity. We have evaluated activated alpha2-macroglobulin (alpha2M*) and a squalene-based stable emulsion containing monophosphoryl lipid A (MPL-SE) with granulocyte-macrophage colony stimulating factor (GM-CSF) as adjuvants to enhance the immunogencity of candidate HIV immunogens. Balb/c mice were subcutaneously immunized on days 0, 14 and 28 with 100-0.1 microg of HIV-1 envelope gp120 C4-V3 immunogens from either HIV IIIB (C4-V3(IIIB)) or SHIV 89.6P (C4-V3(89.6P)). Immunogens were tested covalently coupled to alpha2M*, formulated with MPL-SE/GM-CSF, or as a combination of both. Using CFA/IFA, only 50 and 100 microg, but not lower doses of C4-V3(IIIB) peptides, induced antibody responses. In contrast, peak antibody responses were detected in mice immunized with 10 microg of C4-V3 peptide coupled to alpha2M* (alpha2M*-peptide). Similar to CFA/IFA, MPL-SE/GM-CSF induced optimal antibody responses at 50 and 100 microg of C4-V3 immunogen. However, the combination of MPL-SE/GM-CSF with alpha2M*-C4-V3 peptide decreased the dose of C4-V3 required for optimal response to 5 microg for C4-V3(IIIB), and to 0.1 microg for C4-V3(89.6P). Taken together, HIV envelope gp120 C4-V3 peptides covalently complexed with alpha2M* and formulated with MPL-SE/GM-CSF resulted in a subunit HIV immunogen capable of inducing anti-HIV envelope antibody responses at doses up to 100-fold less than those needed with CFA/IFA or MPL-SE/GM-CSF alone.