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.

Integration of an Electronic Screening, Brief Intervention, and Referral to Treatment Program Into an HIV Testing Program to Reduce Substance Use and HIV Risk Behavior Among Men Who Have Sex With Men: Protocol for Intervention Development and a Pilot Randomized Controlled Trial.

BACKGROUND: Men who have sex with men (MSM) are disproportionally affected by HIV and drug and alcohol use; however, few effective HIV prevention interventions for MSM who use substances exist. Screening, Brief Intervention, and Referral to Treatment is an early intervention for non-treatment-seeking individuals with problematic substance use and for timely referral to treatment for those with substance use disorders. Electronic screening and brief interventions (e-SBIs) reduce implementation challenges. An e-SBI tailored for MSM at the time of HIV testing might be particularly opportune to strengthen their motivation to reduce substance use and HIV risk behavior. OBJECTIVE: This study aims to develop a tailored e-SBI program to reduce substance use and HIV risk behavior among MSM seeking HIV testing at Nexo Asociación Civil, our community partners in Argentina (primary); assess the feasibility and acceptability of integrating the e-SBI into the Nexo HIV testing program (primary); assess the feasibility and acceptability of implementing an adapted Men's Health Project (MHP) at Nexo (secondary); and finally, explore preliminary findings on substance use and sexual risk reduction outcomes (exploratory). METHODS: This mixed methods study has 2 stages. During stage 1 (development), we will use the User Centered Rapid App Design process consisting of focus groups (n=16), individual interviews (n=24), and a pilot deployment of the e-SBI (n=50) to iteratively develop the e-SBI. Quantitative and qualitative assessments at each step will inform the revision of the e-SBI. Furthermore, we will use the assessment, decision, administration, production, topic experts, integration, training, testing framework to adapt MHP. During stage 2 (pilot randomized controlled trial [RCT]), we will randomize 200 MSM coming to Nexo for HIV testing. They will complete a baseline assessment and then their assigned intervention (e-SBI vs screening only) and will be followed-up for 6 months. We will also conduct in-depth interviews with up to 45 participants: 15 participants from either study condition who entered or completed MHP or other substance abuse treatment and 15 from each arm who met the criteria for MHP but did not request it. RESULTS: The study began recruitment in October 2022, and the stage-1 pilot study is near completion. Preliminary findings from stage 1 show high e-SBI acceptability. Data analysis of the stage-1 pilot is now beginning. The stage-2 pilot RCT will be launched in March 2024, with all data collection completed by May 2025. CONCLUSIONS: This study will allow us to assess the acceptability and feasibility of e-SBI implementation during HIV testing encounters. We will also build the necessary research infrastructure for a subsequent RCT to assess the efficacy of e-SBIs in reducing substance use and HIV sexual risk behavior among MSM in this setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT05542914; https://tinyurl.com/yyjj64dm. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56683.

Depression Among Pregnant and Breastfeeding Persons Participating in Two Randomized Trials of the Dapivirine Vaginal Ring and Oral Pre-Exposure Prophylaxis (PrEP) in Malawi, South Africa, Uganda, and Zimbabwe.

Depression is associated with lower adherence to oral pre-exposure prophylaxis (PrEP) to prevent HIV, but data are not currently available on how depression may affect use of other HIV prevention methods including the dapivirine vaginal ring (DVR). We conducted a mixed methods study using data from the Microbicide Trials Network (MTN) 042/DELIVER (n = 558) and MTN-043/B-PROTECTED (n = 197) studies to describe the prevalence of depressive symptoms and explore how depressive symptoms may have influenced attitudes about use of the monthly DVR and once-daily oral PrEP tablet among pregnant and breastfeeding persons, respectively, in Malawi, South Africa, Uganda, and Zimbabwe. Eleven participants had high Edinburgh Postnatal Depression scores ≥ 10 in MTN-042/DELIVER (2%) and four participants (2%) in MTN-043/B-PROTECTED. In interviews with 9 participants who had high scores (6 DVR, 3 oral PrEP), those with depressive symptoms described overlapping stressors which were magnified by job loss and economic instability during the COVID-19 pandemic, and by experiences of pregnancy/postpartum. These participants experienced a lack of support from partners or family members, and conflict with partners related to trust, and infidelity. While we did not find evidence of a change in product adherence, there was a strong sense of commitment and motivation to use the study products for protection from HIV for participants themselves and their baby. Although lack of social support is usually an obstacle to adherence, in this study, the participants' lives and relationships seemed to have reinforced the need for HIV prevention and motivated women to protect themselves and their babies from HIV.

Building an HIV Learning Health Care Community for Youth in Florida: Opportunities and Challenges.

In Florida, 33% of new HIV infections among men and 21% of new infections among women are among those younger than 29 years of age. We describe the development of a Learning Health Care Community for youth (Y-LHCC) in Orange County, FL. Its core implementation team (iTeam) was composed of representatives from community agencies and academics, whose work was informed by data from the Florida Department of Health (FDOH) and regional research, in-depth interviews (IDIs) with agency representatives, and a pilot implementation of Tailored Motivational Interviewing (TMI) to improve service provision. IDIs revealed limited programming specifically for youth, significant structural challenges providing them with PrEP, and differences in use of evidence-based behavioral interventions to improve HIV services. FDOH provided data on new HIV infections, linkage to care, viral suppression, and PrEP coverage, however, limitations such as minimal data on PrEP referrals and use, agency level data, and inability to generate data quarterly (which would facilitate program improvement) were encountered. Thirty staff members from five agencies serving youth in Orange County participated in TMI training. About half the agency staff (n = 16) completed at least three of the four online training sessions. MI skills improved from pre- (n = 28; M = 1.96) to post TMI training (n = 11; M = 2.48, SD = 0.57); (t(37) = - 3.14, p = 0.0033). The iTeam held seven remote meetings and two in-person half-day meetings at the end of the study, during which they reassessed areas of focus for improving youth services. They also reiterated their commitment to continuing to meet beyond the study period and to engage other agencies in the newly established coalition. Findings highlight the potential of creating a Y-LHCC in Florida as well as some of the challenges that will need to be overcome to achieve ending the HIV Epidemic goals for young people in the region.

RESUMEN: En Florida, el 33% y 21% de las nuevas infecciones del VIH entre hombres y mujeres, respectivamente, fueron entre personas menores de 29 años de edad. Describimos el desarrollo de una Comunidad de Aprendizaje de Atención Médica para jóvenes (Y-LHCC) en el Condado de Orange, FL. Su equipo central de implementación (iTeam) estuvo compuesto de representantes de agencias comunitarias y académicos, cuyo trabajo se basó en datos del Departamento de Salud de Florida (FDOH) e investigaciones regionales, entrevistas en profundidad con representantes de agencias y un programa piloto de implementación de la Entrevista Motivacional a la Medida (TMI) para mejorar la prestación de servicios. Las entrevistas revelaron poca programación específica para los jóvenes, desafíos estructurales significativos para proporcionarles PrEP, y diferencias en el uso de intervenciones conductuales basadas en evidencia para mejorar los servicios de VIH. El FDOH proporcionó datos sobre nuevas infecciones por el VIH, vinculación con la atención médica, supresión viral y cobertura de PrEP. Sin embargo, se encontraron limitaciones en la data, tales como datos limitados sobre derivaciones u uso de PrEP, falta de datos a nivel de agencia, e incapacidad para generar datos trimestrales (lo que facilitaría la mejora de programas en la agencia). Treinta miembros del personal de cinco agencias que atienden a jóvenes en el Condado de Orange participaron en la capacitación de TMI. Aproximadamente la mitad del personal de la agencia (n = 16) completó al menos tres de las cuatro sesiones de capacitación remota. Las habilidades de MI mejoraron desde antes (n = 28; M = 1.96, SD = .042) hasta después del entrenamiento de TMI (n = 11; M = 2.48, SD = 0.57); (t(37) = − 3.14, p = 0.0033). El iTeam realizó siete reuniones remotas y dos reuniones en persona de medio día al final del estudio, durante las cuales reevaluaron las áreas de enfoque para mejorar los servicios para jóvenes. También reiteraron su compromiso de continuar reuniéndose más allá del período de estudio y de involucrar a otras agencias en la coalición recién establecida. Los hallazgos destacan el potencial de crear un Y-LHCC en Florida, así como algunos de los desafíos que deberán superarse para lograr los objetivos de terminar con la epidemia de VIH para los jóvenes de la región.

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.

HTPN 078: an enhanced case management study to achieve viral suppression among viremic HIV-positive men who have sex with men in the United States.

OBJECTIVES: After identifying and recruiting men who have sex with men living with HIV and virally unsuppressed, this study attempted to enhance treatment and care via case management to increase the proportion who achieved viral suppression. DESIGN: Participants were randomized into one of two study arms: standard of care (SOC) or enhanced case management (CM) intervention. Participants were followed for 12 months with quarterly study assessments, with blood collected for CD4+ cell count testing, HIV viral load testing (primary prespecified outcome), and plasma storage. METHODS: Participants identified via respondent-driven sampling and direct recruitment and were invited to participate in the randomized controlled trial. The CM intervention provided a wide range of support services including, health education, clinical care coordination, medication adherence support, and social service assistance. The month-12 assessment included questions about healthcare utilization, stigma, substance use, and mental health. RESULTS: Among the 144 participants virally unsuppressed at baseline, most had had a previous positive HIV test result; were Black, non-Hispanic, gay and bisexual men, aged 22-50. Among the 128 participants at the last study visit, 68 were virally suppressed, with no statistically significant difference between the CM and SOC arms (viral suppression 42% and 53%, respectively; adjusted odds ratio = 0.62 [P = 0.15; 95% confidence interval: 0.32, 1.2]). CONCLUSIONS: Reaching targets of at least 90% sustained viral suppression among all people with HIV will likely require more than an individual-level CM approach that addresses barriers to optimal care and treatment at multiple levels.

Engagement in Care Among Newly Diagnosed HIV-Positive Gay, Bisexual, and Other Men Who Have Sex With Men in the United States: Results From the Together 5,000 Study.

One-quarter of gay, bisexual, and other men who have sex with men (GBMSM) with diagnosed HIV are not engaged in HIV care. Between 2018 and 2019, 50 GBMSM completed qualitative interviews 3 months after receiving an HIV-positive result. Interviews explored barriers to and facilitators of engagement and retention in HIV testing and care. Thematic analysis revealed five major themes: (1) reason for HIV testing (e.g., self-testing), (2) linkage to care (e.g., appointment/logistic issues and social support as encouragement), (3) barriers to engagement in care (e.g., financial burden, competing priorities, and fear/stigma), (4) facilitators of engagement (e.g., financial assistance, patient-provider relationships, auxiliary support services, and health agency), and (5) PrEP as a missed prevention opportunity. Addressing individual-, social-, and policy-level barriers could improve GBMSM's engagement in HIV care. Further, capitalizing on GBMSM's health agency through partnerships with local agencies and fostering better patient-provider relationships could optimize HIV care continuity.

Women's experience receiving drug feedback and adherence counseling in MTN-025/HOPE - an HIV Prevention open-label trial of the Dapivirine Vaginal Ring.

In the Phase IIIB MTN-025/HOPE open label extension trial, participants were offered the dapivirine vaginal ring as HIV prophylaxis, and those who accepted the ring received semi real-time individual adherence feedback, based on residual drug level (RDL) from returned rings, during Motivational Interviewing-based counseling. Counseling messages, based on the best knowledge at the time, framed RDL results in terms of ring use and HIV protection, from no use /no protection (0 RDL) to high use /high protection (3 RDL). At six HOPE sites, in-depth-Interviews (IDIs) about RDL were conducted with 64 participants who had received at least one RDL result. We found mixed interpretations of what the RDL meant and strong emotional reactions with a focus on the external validation of the level itself. Counseling was critical to help participants process their reactions to the RDL and make decisions accordingly (i.e., persistence, adherence improvement, and/or switching to another HIV prevention method). Providing drug adherence feedback was complex to implement yet proved useful as a component of a multi-pronged adherence support strategy.

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.

"The role of case management in HIV treatment adherence: HPTN 078".

Adherence to care and antiretroviral therapy is challenging, especially for people living with HIV (PLWH) with additional co-occurring risk factors. Case management interventions, including motivational interviewing (MI), show promise to improve HIV treatment adherence, but few studies have examined how such interventions are delivered to or experienced by PLWH who have been reengaged in care. We conducted qualitative interviews with six case managers and 110 PLWH exiting from a randomized study (HPTN 078) who received a MI-based case management intervention in addition to standard patient-navigation services, or standard services only. Our study provided greater insight into the main findings from HPTN 078, including an in-depth description of the multiple barriers to adherence faced by this largely "out-of-care" population, as well as a more nuanced understanding of the benefits and challenges of implementing MI. A blend of MI plus more intensive interventions may be needed for PLWH facing multiple structural barriers.

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.

Acceptability and Use of a Dual HIV/Syphilis Rapid Test and Accompanying Smartphone App to Facilitate Self- and Partner-Testing Among Cisgender Men and Transgender Women Who Have Sex with Men.

At home self- and partner-testing may reduce HIV and syphilis transmission by detecting undiagnosed infections. Forty-eight cisgender men and transgender women who men who have sex with men were given ten INSTI Multiplex kits and downloaded the SMARTtest app to facilitate self- and partner testing over the next three months. Thirty-seven (77%) participants self-tested using the INSTI (mean = 3.7 times, SD = 3.9); 26 (54%) tested partners (mean = 1.6 times, SD = 2.2). Participants liked the test for its ease of use, quick results, and dual HIV/syphilis testing but its blood-based nature hindered use with partners. Participants with reactive syphilis results always attributed them to a past infection and these results presented a challenge to testing with partners and the ability to accurately assess risk of infection. Most participants stated they would use the INSTI for self-testing (100%) and for partner-testing (89%). Acceptability of the SMARTtest app was high for functionality (M = 4.16 of max 5, SD = 0.85) and helpfulness (M = 6.12 of max 7, SD = 1.09). Participants often used the app as needed, eschewing its use if they felt comfortable conducting the test and interpreting its results. Seventy-eight percent would recommend the app to a friend. Availability of the INSTI Multiplex as a self-test with the accompanying SMARTtest app might increase frequency of HIV and syphilis testing, allowing for earlier detection of infection and reduced transmission.

RESUMEN: El uso de pruebas rápidas caseras con parejas y como auto-pruebas puede reducir la transmisión del VIH y la sifilis al detectar infecciones no diagnosticadas. Cuarenta y ocho hombres cisgénero y mujeres transgénero que tienen sexo con hombres recibieron diez kits del INSTI Multiplex y descargaron la aplicación SMARTtest para facilitar su uso con parejas y para auto-pruebas durante los próximos tres meses. Treinta y siete (77%) participantes se auto-testearon utilizando el INSTI (media = 3.7 veces, DE = 3.9); 26 (54%) testearon a sus parejas (media = 1.6 veces, DE = 2.2). A los participantes les gustó la prueba por su facilidad de uso, rapidez de los resultados y por ser una prueba dual de VIH/sífilis, pero al ser una prueba basada en sangre dificultó su uso con parejas. Los participantes con resultados de sífilis reactivos siempre atribuyeron éstos a una infección pasada y sus resultados presentaron un desafío para el uso de pruebas con parejas. La mayoría de los participantes afirmaron que utilizarían el INSTI como auto-pruebas (100%) y para testear a sus parejas (89%). La aceptabilidad de la aplicación SMARTtest fue alta para la funcionalidad (M = 4.16 de un máximo de 5, SD = 0.85) y utilidad (M = 6.13 de un máximo de 7, SD = 1.09). Los participantes solían utilizar la aplicación según fuera necesario, evitando su uso si se sentían cómodos realizando la prueba e interpretando sus resultados. El 78% recomendaría la aplicación a un amigo. La disponibilidad del INSTI Multiplex como auto-prueba con la aplicación SMARTtest podría aumentar la frecuencia de las pruebas de VIH y sífilis, lo que permite una detección más temprana de la infección y reduce la transmisión.

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.

Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study.

BACKGROUND: Two phase 3 clinical trials showed that use of a monthly vaginal ring containing 25 mg dapivirine was well tolerated and reduced HIV-1 incidence in women by approximately 30% compared with placebo. We aimed to evaluate use and safety of the dapivirine vaginal ring (DVR) in open-label settings with high background rates of HIV-1 infection, an important step for future implementation. METHODS: We did a phase 3B open-label extension trial of the DVR (MTN-025/HIV Open-label Prevention Extension [HOPE]). Women who were HIV-1-negative and had participated in the MTN-020/ASPIRE phase 3 trial were offered 12 months of access to the DVR at 14 clinical research centres in Malawi, South Africa, Uganda, and Zimbabwe. At each visit (monthly for 3 months, then once every 3 months), women chose whether or not to accept the offer of the ring. Used, returned rings were tested for residual amounts of dapivirine as a surrogate marker for adherence. HIV-1 serological testing was done at each visit. Dapivirine amounts in returned rings and HIV-1 incidence were compared with data from the ASPIRE trial, and safety was assessed. This study is registered with ClinicalTrials.gov, NCT02858037. FINDINGS: Between July 16, 2016, and Oct 10, 2018, of 1756 women assessed for eligibility, 1456 were enrolled and participated in the study. Median age was 31 years (IQR 27-37). At baseline, 1342 (92·2%) women chose to take the DVR; ring acceptance was more than 79% at each visit up until 12 months and 936 (73·2%) of 1279 chose to take the ring at all visits. 12 530 (89·3%) of 14 034 returned rings had residual dapivirine amounts consistent with some use during the previous month (>0·9 mg released) and the mean dapivirine amount released was greater than in the ASPIRE trial (by 0·21 mg; p<0·0001). HIV-1 incidence was 2·7 per 100 person-years (95% CI 1·9-3·8, 35 infections), compared with an expected incidence of 4·4 per 100 person-years (3·2-5·8) among a population matched on age, site, and presence of a sexually transmitted infection from the placebo group of ASPIRE. No serious adverse events or grade 3 or higher adverse events observed were assessed as related to the DVR. INTERPRETATION: High uptake and persistent use in this open-label extension study support the DVR as an HIV-1 prevention option for women. With an increasing number of HIV-1 prophylaxis choices on the horizon, these results suggest that the DVR will be an acceptable and practical option for women in Africa. FUNDING: The Microbicide Trials Network and the National Institute of Allergy and Infectious Diseases, The Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health, all components of the US National Institutes of Health.

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.

Sharing Objective Measures of Adherence to a Vaginal Microbicide Promotes Candor About Actual Use and Bolsters Motivation to Prevent HIV.

Discrepancies between self-reported and actual adherence to biomedical HIV interventions is common and in clinical trials can compromise the integrity of findings. One solution is to monitor adherence biomarkers, but it is not well understood how to navigate biomarker feedback with participants. We surveyed 42 counselors and interviewed a subset of 22 to characterize their perspectives about communicating with participants about residual drug levels, an objective marker of adherence, within MTN-025/HOPE, a Phase 3b clinical trial of a vaginal ring to prevent HIV. When biomarkers indicated low drug levels that mismatched high adherence by self-report, counselors encountered barriers to acceptance and comprehension among participants. However, discrepancies between low self-report and higher drug levels generally stimulated candor. Women recollected times they had not used the product and disclosed problems that counselors thought might otherwise have remained forgotten or concealed. Navigating conversations toward HIV prevention was easier at mid-range drug levels and when women indicated motivation to prevent HIV. Ratings of residual drug level offered a somewhat objective measure of adherence and protection that counselors perceived as meaningful to participants and as a valuable catalyst for broaching conversation about HIV prevention. However, communication about drug levels required that counselors navigate emotional barriers, respond skillfully to questions about accuracy, and pivot conversations non-judgmentally away from numerical results and toward the priority of HIV prevention. Findings suggest a role for biomarker feedback in future clinical trials as well as other clinical contexts where biomarkers may be monitored, to motivate disclosure of actual adherence and movement toward HIV prevention.Clinical Trial Number NCT02858037.

RESUMEN: Discrepancias entre la adherencia auto-reportada y la verdadera a intervenciones biomédicas de VIH pueden comprometer los ensayos clínicos. Una solución es monitorear la adherencia por medio de ensayos biológicos, pero no se entiende bien cómo comunicar estas medidas a los participantes. En MTN-025/HOPE, un ensayo fase 3b de un anillo vaginal para prevenir VIH, encuestamos a 42 consejeros de adherencia y entrevistamos a un subconjunto de 22 para caracterizar sus perspectivas sobre comunicar una medida objetiva de adherencia al anillo, el nivel residual de droga (RDL por sus siglas en inglés). Los consejeros reportaron que los participantes apreciaron la retroalimentación del RDL como una indicación de su protección de VIH. Niveles más altos de droga estimularon euforia y alivio mientras niveles mas bajos resultaron en desilusión. Una postura no crítica y el apoyo a la autonomía de elegir otras alternativas al anillo promovieron divulgación de las razones por la falta de adherencia. Hablar del monitoreo de RDL como "protección" en vez de "adherencia" ayudó a cambiar el enfoque desde resultados numéricos hasta la meta mayor del ensayo de prevenir el VIH. Personalizar la retroalimentación de medidas objetivas de adherencia requiere una conversación cuidadosa para minimizar las actitudes defensivas. La retroalimentación personalizada también se puede implementar de forma que motive la divulgación de la falta de adherencia y evoque un compromiso a prácticas de prevención. Enfatizar las motivaciones de las mujeres a prevenir el VIH, en vez de los resultados numéricos, puede incentivar a los usuarios consistentes a continuar y a los usuarios inconsistentes a usar métodos alternativos de prevención.

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.