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Pre-Exposure Prophylaxis (PrEP) trials often implement counseling to support product adherence. Counseling fidelity can vary significantly across providers and time. Fidelity monitoring can ensure that counseling is delivered as designed. We describe the process, feasibility, and outcomes of monitoring Options counseling fidelity in an open-label study of the dapivirine vaginal ring MTN-025/HOPE. After initial training, 63 counselors from 14 sites in Sub-Sahara Africa audio-recorded counseling sessions with study participants. Sessions were rated by a New York-based team that included bilingual emigres from the study countries. Completed session rating forms were sent to counselors to provide feedback and counseling difficulties were discussed during monthly calls. Of 1456 study participants, 85.7% consented to at least one session, and 20% to all sessions, being audio-recorded. Among 9926 study visits in which Options was expected to occur, 5366 (54.1%) Options sessions were audio-recorded, of which 1238 (23.1%) were reviewed; 1039 (83.9%) were rated as "good" or "fair." Eleven counselors who failed to consistently deliver the intervention were reassigned to back-up status. This study demonstrates the feasibility and benefits of monitoring counseling fidelity using audio-recordings in a multi-site, multi-language, multi-country PrEP trial. Given the investment necessary to conduct such trials, providing counseling oversight is highly warranted. [ABSTRACT FROM AUTHOR]

The objective of the study was to explore HIV-testing practices among men who have sex with men (MSM) in Buenos Aires, Argentina, in light of current international health guidelines that recommend frequent HIV testing for MSM who engage in high-risk behavior. Participants, who were recruited using respondent-driven sampling (RDS), were 500 mostly young, nongay-identified MSM of low socioeconomic status, high levels of unemployment, living mainly in the less-affluent areas surrounding Buenos Aires, and lacking health insurance. They provided blood samples for HIV testing and responded to a Computer Assisted Self Interview. Fifty-two percent had never been tested for HIV, and 20% had been tested only once; 17% were found to be HIV infected, of whom almost half were unaware of their status. Main reasons for never having tested previously were: not feeling at risk, fear of finding out results, and not knowing where to get tested. Among those previously tested, men had been tested a median of 2 times with their most recent test having occurred a median of 2.7 years prior to study enrollment. Of those who had not tested positive before entering the study, only 41% returned for their results. HIV testing was infrequent and insufficient for early detection of infection, entry into treatment, and protection of sexual partners. This was particularly the case among nongay-identified MSM. Testing campaigns should aim to help MSM become aware of their risk behavior, decrease fear of testing by explaining available treatment resources and decreasing the stigma associated with HIV, and by publicizing information about free and confidential testing locations. Rapid HIV testing should be made available to eliminate the need for a return visit and make results immediately available to individuals who are tested. [ABSTRACT FROM AUTHOR]

Background: There is a high incidence of HIV among young sexual minority men in Florida. Many are unaware of their status due to low testing rates. Counseling, testing, and referral (CTR) services are essential for diagnosis and prevention of HIV and are integral to the Ending the HIV Epidemic (EHE) strategic plan. However, efforts to increase CTR among young sexual minority men have not been successful., Objective: The Young Adult Centered Healthforce Training (YACHT) program promotes developmentally sensitive, culturally appropriate, and evidence-based CTR services for young sexual minority men. This study tests whether the YACHT program increases HIV testing among young sexual minority men and fidelity to evidence-based CTR among testing providers., Methods: Agencies in Florida EHE counties that tested at least 24 young sexual minority men aged 18 to 29 years in 2021 will be invited to participate. The sites (N=42) will be randomized in blocks of 6 to participate in the YACHT program, following a stepped wedge design. Through YACHT, all sites will receive visits from mystery shoppers (MSs), who are trained to evaluate HIV testing services and complete postvisit quality monitoring assessments. Sites will be offered the opportunity to review their MS feedback and to receive tailored motivational interviewing training and evidence-based technical assistance to address areas of need identified through MS assessments. The study will evaluate whether YACHT leads to increased HIV testing by comparing numbers of young sexual minority men testing for HIV before versus after YACHT's implementation. The Exploration, Preparation, Implementation and Sustainment framework will help understand the barriers to and facilitators of the program's implementation and sustainment., Results: YACHT was funded in August 2022. Data collection began in June 2023. As of June 2024, 194 MS visits have taken place at 42 sites; 4 (67%) sites from the first block and 1 (33%) site from the second block have engaged with the study. At baseline, sites exhibited the lowest competencies in relationship context, counseling sessions, and safer sex education and the highest competency in privacy and confidentiality. Data collection will continue through May 2027, with results published by the end of 2027., Conclusions: To address the high incidence of HIV among young sexual minority men in Florida, YACHT aims to support testing sites with tailored motivational interviewing training and technical assistance to address needs identified by MS assessments. The program seeks to improve delivery of evidence-based CTR services, thereby increasing HIV testing, counseling, and pre-exposure prophylaxis referrals and reducing HIV incidence among this population., Trial Registration: ClinicalTrials.gov NCT06015581; https://classic.clinicaltrials.gov/ct2/show/NCT06015581., International Registered Report Identifier (irrid): DERR1-10.2196/63191., (©Rebecca Giguere, Maria Isabel Fernandez, Jose A Bauermeister, Iván C Balán, Subhash Aryal, Andrea Cheshure, Sara Green, Willey Lin, Jonathan Morgan, Sylvie Naar. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 20.11.2024.)

Objectives: DREAM-01 was an open label, dose-escalation and variable osmolarity study to identify a tenofovir HIV-prevention douche/enema that could achieve protective colon tissue cell concentrations and high acceptability. To assess impact on sexual enjoyment, iso-osmolar and hypo-osmolar placebo douches were provided for at-home use before receptive anal sex (RAS)., Methods: Eighteen HIV-uninfected men who have RAS were administered three tenofovir douches at the research clinic: Product A, an iso-osmolar dose; Product B, an iso-osmolar escalation dose; and Product C, a hypo-osmolar escalation dose. Following Products A and C, participants were given a saline douche of matching osmolarity to use at home before RAS. Participants reported acceptability via a computer-assisted self-interview and in-depth interview in this mixed-methods study., Results: All three products were rated acceptable by 17 (95%) of the participants. A majority (94%) would be likely or very likely to use any of the three products before RAS. Of those who used the saline douches before RAS and then rated their sexual enjoyment, most reported that their sexual enjoyment was not affected. Interview data revealed that participants found the product easy to incorporate into their regular routine, but would prefer to use more liquid for cleansing., Conclusions: These findings indicate that the hypo-osmolar Product C, which also provides the most rapid delivery of tenofovir for HIV prevention, is acceptable for future safety trials and that our sample reports high likelihood of using a rectal microbicide douche for HIV prevention. Our findings support continued pursuit of a tenofovir rectal microbicide douche., Trial Registration Number: NCT02750540., Competing Interests: Competing interests: CWH is contracted through Merck and Gilead for clinical study effort support through Johns Hopkins University. CWH and EJF are inventors at Johns Hopkins Technology Ventures and owners of two issued US patents and one pending patent related to rectal microbicides, through which they receive royalties. CWH and EJF are co-founders of Prionde Biopharma, LLC, a company focused on rectal microbicide development. CWH has also served on data safety monitoring board (DSMB) for MicrobicideTrial Network (MTN) clinical trials of vaginal PrEP products., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

This article summarizes published findings from Project LINKS. A total of 500 men who have sex with men were recruited through Respondent Driven Sampling into this study on factors associated with HIV infection. Among participants, 24.5 % identified as gay, 36.2 % as bisexual, 21.9 % as heterosexual, and 17.4 % as "other"; 33 % reported having sex with men, women, and transgender women during the prior two months. Prevalence of HIV, Hepatitis B, and syphilis was 17.3 %, 22.9 %, and 20.5 %, respectively; rates were significantly higher among participants who only had male sex partners. Over two-thirds of participants reported unprotected anal or vaginal intercourse during the prior two months, and 52 %had never been tested for HIV. Twenty-five percent reported heavy drinking, and 34 % reported poly-drug use during the past two months. Eighteen percent of participants reported a sexual experience prior to the age of thirteen with a partner who was at least four years older. Acceptability of microbicides and HIV home testing was high.

Estudios previos en Buenos Aires reportaron altas prevalencias de HIV entre HSH, con valores que oscilan entre 9 y 14% durante casi 10 años de continuo testeo. El objetivo principal de este estudio fue la evaluación de factores relacionados al comportamiento de alto riesgo para transmisión del HIV entre HSH entre los que se incluyen el conocimiento y factores emocionales, socioculturales y ambientales. Por otro lado se realizó la estimación de prevalencia e incidencia de HIV utilizando RDS (Respondent Driven Sampling), así como la presencia de otras infecciones de transmisión sexual. Por último se evaluaron los hábitos de testeo para HIV indagando que factores facilitan o impiden su realización. El estudio constó de dos fases, en primer lugar una fase cualitativa y posteriormente una fase cuantitativa con una duración total de 4 años y medio. Durante la fase cualitativa se realizaron 44 entrevistas individuales en profundidad, 8 grupos focales y 10 observaciones etnográficas (hoteles, baños públicos ("teteras"), cines pornográficos, fiestas privadas, dark rooms y discotecas). Durante la fase cuantitativa del estudio se realizó el reclutamiento de 500 participantes que provinieron de la Ciudad Autónoma de Buenos Aires, así como del Gran Buenos Aires. El reclutamiento se comenzó con 16 participantes llamados semillas. Se realizó el diagnóstico de infección por HIV, hepatitis B y C (HBV y HCV), Treponema pallidum, Virus Papiloma Humano (HPV) y Chlamidias. La colaboración establecida entre los grupos de trabajo enfocados en áreas diversas posibilitó el abordaje conjunto de nuevas estrategias de investigación antes no exploradas en nuestro país. Los resultados más relevantes de esta investigación serán progresivamente publicados en sucesivos números de Actualizaciones en SIDA.

El uso del diagnóstico rápido para HIV en Argentina, así como otros países de Latinoamérica, ha sido limitado hasta el momento. Este trabajo reporta los resultados provenientes de un estudio cualitativo realizado entre hombres gays y otros hombres que tienen sexo con hombres (G&HSH) de la Ciudad de Buenos Aires, Argentina. El objetivo principal del mismo fue conocer las ventajas y desventajas que los hombres G&HSH perciben en relación al diagnóstico rápido casero para HIV. Se realizaron ocho grupos focales con 73 participantes en los cuales se discutió acerca de las ventajas y desventajas del uso de los diagnósticos rápidos. Las respuestas fueron codificadas utilizando un programa para análisis de datos cualitativos (NVivo) y analizadas temáticamente. Los participantes describieron numerosas ventajas sobre el uso del diagnóstico rápido casero, aunque algunos reportaron importantes preocupaciones dentro de las cuales se destaca la posibilidad de impulsos suicidas si alguien recibe un resultado positivo estando solo. En términos generales se observó una gran aceptabilidad para el uso del diagnóstico rápido si el mismo es realizado por personal de salud en lugares acondicionados para este fin.