History of Rectal Product Use and Country of Residence Influence Preference for Rectal Microbicide Dosage Forms Among Young Sexual and Gender Minorities: A Multi-country Trial Comparing Placebo Douche, Suppository, and Insert Products.

The DESIRE Study (MTN-035) explored product preference among three placebo rectal microbicide (RM) formulations, a rectal douche (RD), a suppository, and an insert, among 210 sexually active transgender people and men who have sex with men in five counties: the United States, Peru, Thailand, South Africa, and Malawi. Participants used each product prior to receptive anal sex (RAS) for 1 month, following a randomly assigned sequence, then selected their preferred product via computer assisted self-interview. In-depth interviews examined reasons for preference. We compared product preference and prior product use by country to explore whether geographic location and experience with the similar products impacted preference. A majority in the United States (56%) and Peru (58%) and nearly half in South Africa (48%) preferred the douche. Most in Malawi (59%) preferred the suppository, while half in Thailand (50%) and nearly half in South Africa (47%) preferred the insert. Participants who preferred the douche described it as quick and easy, already routinized, and serving a dual purpose of cleansing and protecting. Those who preferred the insert found it small, portable, discreet, with quick dissolution. Those who preferred the suppository found the size and shape acceptable and liked the added lubrication it provided. Experience with product use varied by country. Participants with RD experience were significantly more likely to prefer the douche (p = 0.03). Diversifying availability of multiple RM dosage forms can increase uptake and improve HIV prevention efforts globally.

RESUMEN: El estudio DESIRE (MTN-035) exploró la preferencia de producto entre tres formulaciones de microbicida rectal (MR) de placebo, una ducha rectal, un supositorio y un inserto, entre 210 personas transgénero y hombres que tienen sexo con hombres en cinco países: los Estados Unidos, Perú., Tailandia, Sudáfrica y Malawi. Los participantes utilizaron cada producto antes del sexo anal receptive (SAR) durante un mes, siguiendo una secuencia asignada al azar, luego seleccionaron su producto preferido mediante una autoentrevista asistida por computadora. Las entrevistas en profundidad examinaron los motivos de preferencia. Comparamos la preferencia de producto y el uso previo del producto por país para explorar si la ubicación geográfica y la experiencia con la forma farmacéutica impactaron la preferencia. Una mayoría en los Estados Unidos (56%) y Perú (58%) y casi la mitad en Sudáfrica (48%) prefirieron la ducha rectal. La mayoría en Malawi (59%) prefirió el supositorio, mientras que la mitad en Tailandia (50%) y casi la mitad en Sudáfrica (47%) prefirió el inserto. Los participantes que prefirieron la ducha rectal la describieron como rápida y fácil, ya parte de su rutina y que tenía el doble propósito de limpiar y proteger. Los que prefirieron el inserto lo consideraron pequeño, portátil, discreto y de rápida disolución. Los que prefirieron el supositorio encontraron que tenía un tamaño y forma aceptables y proveía lubricación adicional. La experiencia con el uso del producto varió según el país. Los participantes con experiencia con duchas rectales tenían significativamente más probabilidades de preferir la ducha rectal (p = 0,03). Diversificar la disponibilidad de múltiples formas farmacéuticas de MR puede aumentar la aceptación y mejorar los esfuerzos de prevención del VIH a nivel mundial.

A Systematic Review of Intervention Studies That Address HIV-Related Stigmas Among US Healthcare Workers and Health Systems: Applying a Theory-Based Ontology to Link Intervention Types, Techniques, and Mechanisms of Action to Potential Effectiveness.

BACKGROUND: To end the HIV epidemic, we need to better understand how to address HIV-related stigmas in healthcare settings, specifically the common theoretical bases across interventions so that we can generalize about their potential effectiveness. PURPOSE: We describe theory-based components of stigma interventions by identifying their functions/types, techniques, and purported mechanisms of change. METHODS: This systematic review examined studies published by April 2021. We applied a transtheoretical ontology developed by the Human Behaviour Change Project, consisting of 9 intervention types (ITs), 93 behavior change techniques (BCTs), and 26 mechanisms of action (MOAs). We coded the frequency and calculated the potential effectiveness of each IT, BCT, and MOA. We evaluated study quality with a 10-item adapted tool. RESULTS: Among the nine highest quality studies, indicated by the use of an experimental design, the highest potentially effective IT was "Persuasion" (i.e. using communication to induce emotions and/or stimulate action; 66.7%, 4/6 studies). The highest potentially effective BCTs were "Behavioral practice/rehearsal" (i.e. to increase habit and skill) and "Salience of consequences" (i.e. to make consequences of behavior more memorable; each 100%, 3/3 studies). The highest potentially effective MOAs were "Knowledge" (i.e. awareness) and "Beliefs about capabilities" (i.e. self-efficacy; each 67%, 2/3 studies). CONCLUSIONS: By applying a behavior change ontology across studies, we synthesized theory-based findings on stigma interventions. Interventions typically combined more than one IT, BCT, and MOA. Practitioners and researchers can use our findings to better understand and select theory-based components of interventions, including areas for further evaluation, to expedite ending the HIV epidemic.

Transgender Women's Experiences Using SMARTtest, a Smartphone Application to Facilitate Self- and Partner-HIV/Syphilis Testing Using the INSTI Multiplex.

We present experiences of transgender women (TW) who have sex with men with SMARTtest, a smartphone app to accompany the INSTI Multiplex®, a one-minute, dual blood-based HIV/syphilis rapid test. TW participants (N = 11) received 10 INSTI Multiplex® tests to take home for self- and/or partner-testing and installed the SMARTtest app on their phones. The SMARTtest app aimed to support INSTI Multiplex users in correctly performing the test, interpreting the results, and connecting with care following a positive HIV or syphilis screening. After 3 months, users completed in-depth interviews on their experiences. A total of 9 TW used SMARTtest with partners. App feedback was positive, but refining is necessary. Specifically, TW reported that SMARTtest is easy to use and convenient; instructions on how to use the INSTI Multiplex presented on the app were helpful to complete procedures correctly; the most frequently used feature on SMARTtest was the information on clinics that offered confirmatory testing; and participants and their partners were not concerned about app privacy but reported that this could change if INSTI Multiplex detected an HIV-positive result. Further, participants provided recommendations on how to improve SMARTtest, and changes were mostly related to features, content, functionality, navigation, and overall "look" of the app. SMARTtest is promising to facilitate INSTI Multiplex® use in TW. User feedback should be integrated in future versions.

The Long-Acting Cabotegravir Tail as an Implementation Challenge: Planning for Safe Discontinuation.

The long-acting feature of cabotegravir, an integrase-inhibitor highly effective in preventing acquisition of HIV in adolescents and adults, is both its greatest strength and a challenge to its implementation. Cab-LA is administered at 8-week intervals (after an initial loading dose) but has a long, variable drug "tail" that may leave users vulnerable to future drug resistance if they contract HIV during this critical period. The potential for cab-LA to meaningfully contribute to ending the HIV Epidemic is hindered by, among other factors, limited resources to guide patients and providers on how to safely discontinue injections. We suggest three key strategies to overcome this specific challenge: (1) Comprehensive patient education and counseling about the drug tail; (2) Training and coaching PrEP care teams, including clinical and non-clinical staff, on communication around the tail; (3) Adherence support strategies, including monitoring of cabotegravir drug levels after discontinuation, for a personalized medicine approach to safe discontinuation.

Negotiating Use of a Blood-Based, Dual HIV and Syphilis Test with Potential Sexual Partners Among a Sample of Cisgender Men and Transgender Women Who Have Sex with Men in New York City.

Cisgender men who have sex with men (cMSM) and transgender women (TGW) are disproportionally burdened by HIV. Among these populations, HIV partner-testing is a highly acceptable harm reduction tool. Particularly, cMSM and TGW report a stronger preference for blood-based tests that include assays for multiple STIs. However, no existing research has explored how these populations negotiate blood-based testing with sexual partners. In the SMARTtest study, 48 sexually active cMSM and TGW took home dual, blood-based HIV/Syphilis kits for self- and partner-testing. After 3 months, they completed a follow-up assessment and in-depth interviews about their experiences initiating testing. Of the 42 responding participants, 27 (64%) reported that it had been "fairly" or "very easy" to raise the idea of testing with partners. Participants predominantly employed partner-conscious communication strategies, including framing the testing proposal as a mandatory, non-personal component of their participation in a research study, gradually incorporating testing mentions into discussions about sexual health, and using the kits to facilitate joint testing. Yet, 21 (44%) participants reported having sex with at least one partner they did not ask to test. Concern regarding partner reactions emerged as a significant barrier to discussing test use; similarly, many partners were averse to taking a blood-based test in the context of a casual sexual encounter. Nonetheless, these findings suggest that dual, blood-based HIV/STI rapid tests may represent acceptable harm reduction tools among similar populations of cMSM and TGW, particularly if future partner-testing research is broadened to consider key couples' dynamics that may impact test usage.

Gay and Bisexual Men Who Report Anal Sex Stigma Alongside Discomfort Discussing Anal Sex with Health Workers Are Less Likely to Have Ever Received an Anal Examination or Anal Swab.

Purpose: We sought to determine whether stigma toward anal sexuality was associated with having ever received an anal examination or anal swab among gay and bisexual men (GBM). Methods: In 2017, we conducted a cross-sectional online survey with 1513 adult cisgender GBM living in the United States. We used structural equation modeling to test whether the Anal Sex Stigma Scales (a validated measure comprising provider stigma, self-stigma, and silence) was negatively associated with lifetime receipt of anorectal examination or anal swabbing by a medical provider. The model assessed mediation by respondents' comfort discussing anal sex practices with health workers and adjusted for possible confounders. Results: As hypothesized, anal sex stigma was associated with less comfort discussing anal sex (ß = -0.44, 95% confidence interval [CI]: -0.50 to -0.38, p < 0.001), and greater comfort was associated with greater likelihood of screening (ß = 0.28, 95% CI: 0.19 to 0.37, p < 0.001). The model demonstrated good fit (root mean square error of approximation = 0.045, comparative fit index, and Tucker-Lewis index each = 0.99) and adjusted for everyday discrimination, social support specific to anal sex, age, income, education, medical coverage, outness, and ethnic/racial identification. Collectively, model variables accounted for 48% of the variance in screening (p < 0.001). Conclusion: GBM who endorsed less anal sex stigma reported greater comfort discussing anal sex with health workers and were more likely to have ever received anal health screening by a medical provider. To improve anal health and cancer prevention among GBM, anal sex stigma and related discomfort discussing anal sex with health workers are targets for intervention.

The Inventory of Anal Sex Knowledge (iASK): A New Measure of Sexual Health Knowledge Among Adolescent Sexual Minority Males.

INTRODUCTION: Knowledge about sexual health is a key determinant of sexual behavior among adolescent sexual minority males (ASMM). No measures exist to assess anal sex knowledge, even though anal sex is the primary route by which ASMM acquire sexually transmitted infections (STIs), including a disproportionate burden of human immunodeficiency virus (HIV). AIM: We developed a new measure as a first step toward assessing the prevalence and correlates of anal sex knowledge and potential effects of interventions to improve knowledge. METHODS: Two coders independently outlined domains of knowledge within 2 sex education videos designed to address anal sex knowledge among ASMM. An initial set of 56 items, some duplicative, encompassed all domains. A larger team, including a psychometrician, then iteratively revised and reduced the set of items, and assessed construct validity via cognitive testing among ASMM (N = 4, aged 16-17 years old, 75% identifying as racial/ethnic minorities). For the final set of 10 items, factor structure and convergent and divergent validity were assessed using baseline responses to an online survey within a randomized controlled pilot trial among 154 ASMM. Open-ended questions assessed their comprehension and the acceptability of items. OUTCOMES: We examined correlates that we anticipated would be theoretically related (ie, the HIV Knowledge Questionnaire [HIV-KQ-18] and the STD-Knowledge Questionnaire [STD-KQ]) and theoretically distinct (ie, the Patient Health Questionnaire [PHQ-2], Generalized Anxiety Disorder scale [GAD-2], and employment status). RESULTS: The one-factor model explained 42% of the items' common variance and demonstrated acceptable internal reliability (Cronbach's alpha = 0.72). The measure withstood tests of convergent and divergent validity when compared to current measures (HIV knowledge, r = 0.35 and STI knowledge, r = 0.24, both P < .05; internalizing mental health symptoms, r = -0.07 and employment status, r = 0.13, both P > .05). Few respondents found words unfamiliar or uncomfortable. CLINICAL IMPLICATIONS: A method for assessing anal sex knowledge may offer opportunities to intervene to lessen harmful sequelae of a lack of knowledge. STRENGTH & LIMITATIONS: We developed a brief, psychometrically valid measure of anal sex knowledge. The measure may neither generalize to all anal health knowledge nor to more sexually experienced, older SMM. CONCLUSION: The resulting 10-item, single-factor measure, the Inventory of Anal Sex Knowledge (iASK), is psychometrically sound and addresses the lack of anal sex knowledge measures among ASMM. The iASK can function to assess the prevalence and sequelae of anal sex knowledge among ASMM as well as the impact of interventions targeting anal sex knowledge. Kutner BA, Perry N, Stout C, et al. The Inventory of Anal Sex Knowledge (iASK): A New Measure of Sexual Health Knowledge Among Adolescent Sexual Minority Males. J Sex Med 2022;19:521-528.

Assessing the Information-Motivation-Behavioral Skills Model to Predict Pre-exposure Prophylaxis Adherence Among Black Men Who have Sex with Men and Transgender Women in a Community Setting in New York City.

The Information-Motivation-Behavioral Skills (IMB) Model has been used to understand adherence to medications and intentions to uptake pre-exposure prophylaxis (PrEP) to prevent HIV infection. In the current study, the IMB Model was used to understand factors that predict adherence to PrEP among a community-based cohort of 204 Black men who have sex with men (MSM) and transgender women (TGW) using structural equation modeling. PrEP motivation was directly associated with PrEP behavioral skills (ß = 0.320, p = 0.009), and PrEP behavioral skills were directly associated with PrEP adherence (ß = 0.416, p = 0.001). PrEP knowledge and PrEP motivation were not associated with PrEP adherence, directly or indirectly. The analysis identified intervenable factors that predicted PrEP adherence. Screening for motivation and behavioral skills could be used to identify where additional support to improve PrEP adherence is needed, or whether to offer alternative PrEP modalities or delivery strategies.

RESUMEN: El Modelo de Información-Motivación-Habilidades Conductuales (IMB) ha sido utilizado para comprender la adherencia a los medicamentos y la intención de tomar la profilaxis pre-exposición (PrEP) para prevenir la infección por el VIH. En el estudio actual, se usó el modelo IMB para comprender los factores que predicen la adherencia a la PrEP entre una cohorte reclutada en la comunidad de 204 hombres que tienen sexo con hombres (HSH) y mujeres transgénero (TGW) de raza negra, usando modelos de ecuaciones estructurales. La motivación de adherir a la PrEP se asoció directamente con las habilidades conductuales de la PrEP adherencia (ß = 0.320, p = 0.009), y las habilidades conductuales de la PrEP adherencia se asociaron directamente con la adherencia a la PrEP (ß = 0.416, p = 0.001). El conocimiento de PrEP y la motivación de adherir a la PrEPno se asociaron con la adherencia a la PrEP, ni directa o indirectamente. El análisis identificó factores intervenibles que predijeron la adherencia a la PrEP. La evaluación de la motivación de adherir a la PrEP y las habilidades conductuales de la PrEP adherencia podría ser usado para identificar situaciones en que se necesita apoyo adicional para mejorar la adherencia a la PrEP, o si se deben ofrecer modalidades alternativas de recibir PrEP o estrategias alternativas para entregar PrEP.

Infrequent STI Testing in New York City Among High Risk Sexual and Gender Minority Individuals Interested In Self- and Partner-Testing.

Testing for sexually transmitted infections (STIs) remains low among sexual and gender minority populations. We assessed STI testing history using a retrospective survey among 129 HIV-negative cisgender men who have sex with men (cMSM) and transgender women who have sex with men (tWSM) who were at high risk for STI acquisition. All participants were enrolled in a parent study on self- and partner-testing for HIV and syphilis, and reported condomless anal intercourse with multiple partners during the prior 3 months. We additionally used bivariate tests to evaluate participants' STI testing by their history of using pre-exposure prophylaxis (PrEP). One-in-seven respondents (n = 18) reported having never tested for an STI, one-quarter (n = 33) had not tested in the past year, and two-thirds (n = 83) had never used PrEP. PrEP-naïve respondents were less likely to report recent STI testing (47% vs. 85%). "Routine doctor's visit" was the most prevalent reason for testing, but was less common among PrEP-naïve respondents (83% vs. 100%). Testing was remarkably low given the sample's high risk of HIV and STI infection. Findings suggest that STI testing is more frequent among those who have ever used PrEP, but the risk of selection bias warrants evaluation in a larger probability sample.

Inconsistent Counselor Fidelity in Delivering an Evidence-Based Adherence Intervention During a PrEP Trial.

Evidence-based adherence counseling interventions must be delivered with fidelity to ensure that their effectiveness is retained, but little is known regarding how counselors in biomedical HIV trials deliver these interventions. Forty-two counselors from the MTN-025/HOPE Study, which was conducted in 14 sites in sub-Saharan Africa, participated. They completed a quantitative assessment and consented for their HOPE counseling session ratings to be analyzed. Twenty-two (52%) self-identified as research nurses and 20 (48%) as counselors. Of 928 session ratings, 609 (66%) were classified as Good, 188 (20%) as Fair, and 131 (14%) as Poor, based on pre-established criteria. Overall mean ratings for session tasks and global components (each rated from 1 to 5) were 4.12 (SD = 0.45; range 2.46-4.73) and 4.02 (SD = 0.64; range 1.75-4.79), respectively. Twenty-six (62%) counselors attained Good or Fair ratings on at least 85% of their sessions, but 33% of counselors had more than 25% of their sessions rated as Poor; three counselors (7%) never met criteria for a Good session. Even after extensive training, counselors' fidelity to the intervention varied. Our findings highlight the value of fidelity monitoring using session audio-recordings, the importance of ongoing coaching and support, and the need to plan for counselors with consistently poor fidelity.

RESUMEN: Las intervenciones de consejería de adherencia basadas en la evidencia deben ser realizadas con fidelidad para asegurar que retengan su efectividad, pero se sabe poco sobre cómo los consejeros en ensayos biomédicos de VIH realizan estas intervenciones. Cuarenta y dos consejeros participaron del Estudio MTN-025/HOPE, el cual se llevó a cabo en 14 sitios en África subsahariana. Completaron un cuestionario cuantitativo y dieron su consentimiento para el análisis de las calificaciones de sus sesiones de consejería para HOPE. Veintidós (52%) se identificaron como enfermeras investigadoras y 20 (48%) como consejeros. De 928 sesiones calificadas, 609 (66%) fueron clasificadas como Buenas, 188 (20%) como Suficientes, y 131 (14%) como Mediocres, basado en criterios preestablecidos. Las calificaciones promedias de las tareas de las sesiones y de los componentes globales (calificados de 1 a 5) fueron de 4.12 (SD = 0.45; rango 2.46­4.73) y de 4.02 (SD = 0.64; rango 1.75­4.79), respectivamente. Veintiséis (62%) consejeros lograron calificaciones Buenas o Suficientes en al menos el 85% de sus sesiones, pero para el 33% de los consejeros, más del 25% de sus sesiones fueron calificadas como Mediocres; tres consejeros (7%) nunca cumplieron con los criterios de una Buena sesión. Aún después de una capacitación intensiva, la fidelidad a la intervención variaba. Nuestros hallazgos destacan el valor de monitorear para la fidelidad usando audio-grabaciones de las sesiones, la importancia de la instrucción y el apoyo continuo, y la necesidad de planear qué medidas tomar cuando hay consejeros que no son fieles a la intervención.

Experiences of Transgender Women Who Used a Dual HIV/Syphilis Rapid Self-test to Screen Themselves and Potential Sexual Partners (the SMARTtest Study).

HIV/syphilis self- and partner-testing may be especially appropriate for transgender women, since they shoulder a disproportionate burden of HIV, other STIs (e.g., syphilis), and report high levels of medical mistrust. The SMARTest study enrolled N = 50 sexual and gender minority individuals. The present analysis aims to understand the experiences (via in-depth interviews) of a subset of n = 11 transgender women who used INSTI Multiplex®, a combination HIV/syphilis rapid self-test, on themselves and potential sex partners. Participants reported that many partners were willing to test, and reported no testing-related violence. Most participants completed tests successfully, though gaining comfort with blood collection took time. There were no HIV-positive tests in this study; one participant and two partners reported a positive syphilis screening. All sought care. Our sample was small and results should be interpreted with caution, but indicate potential future directions for conducting research on self- and partner-testing among transgender women.

Attitudes and Perceptions About Disclosing HIV and Syphilis Results Using Smarttest, a Smartphone App Dedicated to Self- and Partner Testing.

We explored interest in disclosing test results through a smartphone app dedicated to self- and partner testing for HIV/syphilis. Fifty-nine cisgender men and transgender women each participated in an in-person survey and interview. We examined their interests in sharing test results by audience (e.g., partners, physicians) and by positive versus negative test result. Participants wanted the ability to share results, with notable interest in disclosing negative results to sexual partners and on social media and forwarding positive results to physicians. Participants envisioned smartphone sharing as a means to normalize testing, to notify partners of results, and to expedite linkage to care. Some questioned the authenticity of results shared by smartphone, while others voiced optimism that a personalized, authenticated app could ensure the security and veracity of results. Smartphone testing apps for HIV/syphilis may facilitate disclosure, partner notification, and linkage to care, but need to address concerns about the security and veracity of results.

How Stigma Toward Anal Sexuality Promotes Concealment and Impedes Health-Seeking Behavior in the U.S. Among Cisgender Men Who Have Sex with Men.

Gay, bisexual, and other men who have sex with men (MSM) experience alarming HIV disparities alongside sub-optimal engagement in HIV interventions. Among MSM, stigma toward anal sexuality could interfere with engagement in HIV prevention, yet few studies have examined MSM perspectives on anal sex stigma or its health-related sequelae. Guided by theory, we aimed to characterize anal sex stigma, related sexual concerns, and barriers to health seeking, like concealment. We elicited community input by purposively interviewing 10 experts in MSM health and then 25 racially, ethnically, and geographically diverse cisgender MSM. Participants reported experienced, internalized, and anticipated forms of anal sex stigma that inhibited health seeking. Experienced stigma, including direct and observed experiences as well as the absence of sex education and information, contributed to internalized stigma and anticipation of future devaluation. This process produced psychological discomfort and concealment of health-related aspects of anal sexuality, even from potentially supportive sexual partners, social contacts, and health workers. Participants characterized stigma and discomfort with disclosure as normative, pervasive, and detrimental influences on health-seeking behavior both during sex and within healthcare interactions. Omission of information appears to be a particularly salient determinant of sexual behavior, inhibiting prevention of harm, like pain, and leading to adverse health outcomes. The development of measures of anal sex stigma and related sexual concerns, and testing their impact on comfort with disclosure, sexual practices, and engagement in health services could identify modifiable social pathways that contribute to health disparities among MSM, like those seen in the HIV epidemic.

Client-Centered Adherence Counseling with Adherence Measurement Feedback to Support Use of the Dapivirine Ring in MTN-025 (The HOPE Study).

Fostering adherence and open communication about adherence challenges is key to harnessing the potential of biomedical HIV prevention products. We describe the counseling intervention and objective adherence measure feedback process implemented to support adherence to the dapivirine vaginal ring among participants in four sub-Saharan countries and present findings on the counselors' likeability and acceptability of the intervention. Most counselors (N = 42; 86%) liked Options counseling "very much" and during in-depth interviews (N = 22), reported that the intervention reshaped their adherence counselling approach by emphasizing understanding participants' experiences using the ring, which facilitated open discussion of adherence challenges. Counselors found that reframing residual drug level (RDL) discussions from the "adherence" to "protection" perspective encouraged adherence among consistent users and facilitated decisions to switch to a different HIV prevention approach among infrequent users. Among counselors, 24% said participants "liked it very much" while 26% said that participants "liked it a little" possibly due to two main complaints: perceived repetitiousness of sessions and variability in the RDL assay, which at times resulted in unexpected low RDLs.

RESUMEN: Fomentar la adherencia y la comunicación abierta sobre los desafíos con la adherencia es clave para aprovechar el potencial de los productos biomédicos de prevención del VIH. Describimos la intervención de consejería y el proceso de compartir los resultados de medidas objetivas de adherencia con participantes en cuatro países subsaharianos para apoyar la adherencia al anillo vaginal de dapivirine y presentamos los resultados sobre la agradabilidad y la aceptabilidad de la intervención a los consejeros. A la mayoría de los consejeros (N=42; 86%) "les gustó mucho" la consejería quienes, durante entrevistas en profundidad (N=22) y reportaron que la intervención cambió su aproximación a la consejería sobre la adherencia. Se enfocaban más en comprender la experiencia de uso del anillo entre las participantes, lo cual facilitaba una conversación abierta sobre posibles desafíos a la adherencia. Los consejeros encontraron que cambiar el enfoque de "adherencia" a "protección" en las conversaciones sobre los niveles residuos de drogas fomentaba la adherencia entre las mujeres que usaban el anillo consistentemente y facilitaba la decisión de cambiar a otro método de prevención del VIH entre las mujeres que lo usaban con poca frecuencia. Entre los consejeros, 24% dijeron que a las participantes "les gustó mucho" la consejería y 26% que a las participantes "les gustó un poco". Es posible que esto se deba a dos quejas principales: la percepción de que las sesiones sean repetitivas y la variabilidad en el ensayo de los niveles residuos de drogas, lo cual a veces resultaba en niveles bajos inesperados.

Counselors' acceptability of adherence counseling session recording, fidelity monitoring, and feedback in a multi-site HIV prevention study in four African countries.

Biomedical HIV prevention trials increasingly include evidence-based adherence counseling to encourage product use. To retain effectiveness, interventions must contain key components. Monitoring counseling fidelity ensures inclusion of components but is challenging in multinational contexts with different languages and scarce local supervision. The MTN-025/HOPE Study, a Phase 3b open-label trial to assess continued safety of and adherence to the dapivirine vaginal ring for HIV prevention, was the largest such trial to integrate fidelity monitoring using audio recordings of counseling sessions. We describe the monitoring process, along with counselor and participants' perceptions of it, which were collected via quantitative online survey (counselors only N = 42) and in-depth interviews with a subset of counselors (N = 22) and participants (N = 10). Sessions were conducted in five languages across 14 study sites in four countries. In total, 1238 sessions (23% of submitted sessions) were randomly selected and rated. Assessment of interrater reliability was essential to address drift in ratings. Counselors were apprehensive about being monitored, but appreciated clear guidance and found ratings very helpful (mean = 6.64 out of 7). Some participants perceived sessions as time-consuming; others found monitoring improved counseling quality. Fidelity monitoring of counseling sessions in mult-isite biomedical HIV studies is feasible and supportive for counselors.

The Anal Sex Stigma Scales: A New Measure of Sexual Stigma Among Cisgender Men Who have Sex with Men.

We conducted a series of studies to validate a new scale of stigma toward anal sex, culturally tailored to cisgender men who have sex with men (MSM). In Study 1 we conducted in-depth interviews (N = 35) to generate items. In Study 2, we reduced the item pool through an online survey (N = 268), testing scale performance, dimensionality, and convergent and discriminant validity. For Study 3, we recruited another online sample (N = 1605), randomized to exploratory or confirmatory factor analyses to finalize item reduction, then assessed validity among sexually active MSM (n = 1263). Final subscales encompassed self-stigma (6 items, Cronbach's α = .72), provider stigma (5 items, Cronbach's α = .79), and omission of information (6 items, Cronbach's α = .73; full 3-factor scale = .80). We developed a 17-item measure, grounded in the lived experience of cisgender MSM. Future work should examine associations with health-seeking behavior.

Does Stigma Toward Anal Sexuality Impede HIV Prevention Among Men Who Have Sex With Men in the United States? A Structural Equation Modeling Assessment.

INTRODUCTION: Men who have sex with men (MSM) are suboptimally engaged in efficacious HIV interventions, due in part to stigma. AIM: We sought to validate the Anal Health Stigma Model, developed based on theory and prior qualitative data, by testing the magnitude of associations between measures of anal sex stigma and engagement in HIV prevention practices, while adjusting for covariates. METHODS: We conducted a cross-sectional online survey of 1,263 cisgender MSM living in the United States and analyzed data with structural equation modeling. We tested a direct path from Anal Sex Stigma to Engagement in HIV Prevention alongside 2 indirect paths, 1 through Anal Sex Concerns and another through Comfort Discussing Anal Sexuality with Health Workers. The model adjusted for Social Support, Everyday Discrimination, and Sociodemographics. MAIN OUTCOME MEASURE: Engagement in HIV Prevention comprised an ad hoc measure of (i) lifetime exposure to a behavioral intervention, (ii) current adherence to biomedical intervention, and (iii) consistent use of a prevention strategy during recent penile-anal intercourse. RESULTS: In the final model, anal sex stigma was associated with less engagement (ß = -0.22, P < .001), mediated by participants' comfort talking about anal sex practices with health workers (ß = -0.52; ß = 0.44; both P < .001), adjusting for covariates (R2 = 67%; χ2/df = 2.98, root mean square error of approximation = 0.040, comparative fit index = 0.99 and Tucker-Lewis index = 0.99). Sex-related concerns partially mediated the association between stigma and comfort (ß = 0.55; ß = 0.14, both P < .001). Modification indices also supported total effects of social support on increased comfort discussing anal sex (ß = 0.35, P < .001) and, to a lesser degree, on decreased sex-related concerns (ß = -0.10; P < .001). CLINICAL IMPLICATIONS: Higher stigma toward anal sexuality is associated with less engagement in HIV prevention, largely due to discomfort discussing anal sex practices with health workers. STRENGTH & LIMITATIONS: Adjustment for mediation in a cross-sectional design cannot establish temporal causality. Self-report is vulnerable to social desirability and recall bias. Online samples may not represent cisgender MSM in general. However, findings place HIV- and health-related behaviors within a social and relational context and may suggest points for intervention in health-care settings. CONCLUSION: Providers' willingness to engage in discussion about anal sexuality, for example, by responding to questions related to sexual well-being, may function as social support and thereby bolster comfort and improve engagement in HIV prevention. Kutner BA, Simoni JM, King KM, et al. Does Stigma Toward Anal Sexuality Impede HIV Prevention Among Men Who Have Sex With Men in the United States? A Structural Equation Modeling Assessment. J Sex Med 2020;17:477-490.

Do gay and bisexual men who conceal their same-sex behavior prefer different kinds of health services? Findings across four cities to inform client-centered HIV prevention in China.

BACKGROUND: In China, addressing disparities in the HIV epidemic among men who have sex with men (MSM) requires targeted efforts to increase their engagement and retention in prevention. In an effort to advance MSM-friendly HIV services within China, and informed by community-based partnerships, we tested whether MSM who have ever versus never disclosed their same-sex behavior to healthcare providers (HCP) differ in sociodemographic and behavioral characteristics as well as the qualities of sexual health services each group would prefer to access. METHODS: We conducted a cross-sectional survey among HIV-negative MSM who went to MSM-focused voluntary counseling and testing clinics in four cities in China. The survey was anonymous and collected information on sociodemographic characteristics, testing behaviors, sexual-health related behavior, and sexual health service model preferences. RESULTS: Of 357 respondents, 68.1% participants had ever disclosed same-sex behavior to HCPs when seeking advice for sexual health. Younger age (aOR = 1.04; 95% CI: 1.01-1.08), and worry of HIV acquisition (aOR = 1.39; 95% CI: 1.05-1.84) were associated with higher odds of past disclosure. The availability of comprehensive sexual health services was one of the most valued characteristics of the ideal sexual health clinic. Those who ever disclosed and never disclosed differed significantly in their ranking of the importance of three out of ten dimensions: sexual health counseling services available (M = 3.99 vs. M = 3.65, p = .002), gay identity support available (M = 3.91 vs. M = 3.62, p = .016) and clinic collaborates with a gay CBO (M = 3.81 vs. M = 3.56, p = .036). CONCLUSIONS: Our hypothesis that MSM who had disclosed versus never disclosed same-sex behavior would differ in the value they placed on different dimensions of sexual health service was partially borne out. As health authorities in China decide on implementation models for pre-exposure prophylaxis (PrEP) delivery and specifically within which institutions to integrate PrEP services, the preferences of target populations should be considered to develop comprehensive, patient-centric and LGBT-friendly services.

Culturally-Based Challenges to and Recommendations for Delivering Adherence Counseling in a Multicultural Biomedical HIV Prevention Trial in Four African Countries.

Research is needed to identify how to effectively tailor evidence-based interventions across cultures with limited resources, particularly for behavioral components in large HIV prevention trials. Through surveys and interviews with counselors of sub-Saharan African women during an open-label microbicide trial (MTN-025), we examined language, education, and cultural barriers in delivering a motivational interviewing-based adherence counseling intervention (i.e., Options Counseling). Counselors encountered an array of barriers, most prominently that participants struggled to comprehend culturally incongruent pictorial guides, such as traffic light images, and to uphold product use when primary partners disapproved. Overwhelmingly, counselors cited the intervention's inherent flexibility as an asset; it encouraged them to tailor language and examples to be more culturally relevant to participants. Future resource-conscious researchers may preemptively offset similar barriers by consulting with communities during intervention development. Similarly, affording counselors flexibility while delivering the chosen intervention may enable them to troubleshoot barriers that arise on the ground.