Tenofovir Douche as HIV Preexposure Prophylaxis for Receptive Anal Intercourse: Safety, Acceptability, Pharmacokinetics, and Pharmacodynamics (DREAM 01).

BACKGROUND: Despite highly effective HIV preexposure prophylaxis (PrEP) options, no options provide on-demand, nonsystemic, behaviorally congruent PrEP that many desire. A tenofovir-medicated rectal douche before receptive anal intercourse may provide this option. METHODS: Three tenofovir rectal douches-220 mg iso-osmolar product A, 660 mg iso-osmolar product B, and 660 mg hypo-osmolar product C-were studied in 21 HIV-negative men who have sex with men. We sampled blood and colorectal tissue to assess safety, acceptability, pharmacokinetics, and pharmacodynamics. RESULTS: The douches had high acceptability without toxicity. Median plasma tenofovir peak concentrations for all products were several-fold below trough concentrations associated with oral tenofovir disoproxil fumarate (TDF). Median colon tissue mucosal mononuclear cell (MMC) tenofovir-diphosphate concentrations exceeded target concentrations from 1 hour through 3 to 7 days after dosing. For 6-7 days after a single product C dose, MMC tenofovir-diphosphate exceeded concentrations expected with steady-state oral TDF 300 mg on-demand 2-1-1 dosing. Compared to predrug baseline, HIV replication after ex vivo colon tissue HIV challenge demonstrated a concentration-response relationship with 1.9 log10 maximal effect. CONCLUSIONS: All 3 tenofovir douches achieved tissue tenofovir-diphosphate concentrations and colorectal antiviral effect exceeding oral TDF and with lower systemic tenofovir. Tenofovir douches may provide a single-dose, on-demand, behaviorally congruent PrEP option, and warrant continued development. Clinical Trials Registration . NCT02750540.

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.

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.

Understanding Women's Vaginal Douching Behaviors and Practices for Consideration in the Development of a Potential Future Vaginal Microbicide Douche for HIV Prevention: A Systematic Review of the Literature.

Despite clinicians consistently advising against vaginal douching, 29-92% of women worldwide report douching. This review documents women's douching practices, motivations for douching, and specific associations (or absence of associations) between vaginal douche use and vaginal outcomes thought to be associated with douching. Understanding women's existing douching behaviors and vaginal health outcomes is critical for developing a safe vaginal microbicide douche that can be used as HIV pre-exposure prophylaxis (PrEP). A vaginal douche as PrEP could help prevent new HIV infections, since emerging evidence shows some women discontinue oral PrEP. We performed a systematic review of the literature using the guidelines for Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA). Articles included in the analysis (N = 48) were published 2009-2019 in English and focused on women's experiences with douching. Two trained independent reviewers assessed these articles for content on vaginal douching, including racial/ethnic focus of studies, study design, sampling, women's reasons for douching, contents of douche solutions, and associations between vaginal douching and vaginal health outcomes. Several studies focused on Black women (N = 12 studies) or had no racial/ethnic focus (N = 12). Just over half of all studies (N = 24) were cross-sectional and involved a self-reported questionnaire and lab samples. Studies sampled women from health clinics where they were (N = 13) or were not (N = 14) presenting for vaginal health complaints. Women's primary motivation for douching was for "general cleanliness" (N = 13), and most douche solutions contained water (N = 12). There was little empirical agreement between vaginal douche use and most vaginal health outcomes. Future studies of PrEP vaginal douches should be well controlled and prioritize safety to ensure positive vaginal health outcomes.

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.

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.

The acceptability and feasibility of a pilot study examining the impact of a mobile technology-based intervention informed by behavioral economics to improve HIV knowledge and testing frequency among Latinx sexual minority men and transgender women.

BACKGROUND: We developed a novel intervention that uses behavioral economics incentives and mobile-health text messages to increase HIV knowledge and testing frequency among Latinx sexual minority men and Latinx transgender women. Here we provide a theoretically-grounded assessment regarding the intervention's acceptability and feasibility. METHODS: We conducted 30-min exit interviews with a stratified sample of participants (n = 26 Latinx sexual minority men, 15 Latinx transgender women), supplemented with insights from study staff (n = 6). All interviews were recorded, transcribed, and translated for a content analysis using Dedoose. Cohen's Kappa was 89.4% across coded excerpts. We evaluated acceptability based on how participants cognitively and emotionally reacted to the intervention and whether they considered it to be appropriate. We measured feasibility based on resource, scientific and process assessments (e.g., functionality of text messaging service, feedback on study recruitment procedures and surveys). RESULTS: Regarding acceptability, most participants clearly understood the intervention as a program to receive information about HIV prevention methods through text messages. Participants who did not complete the intervention shared they did not fully understand what it entailed at their initial enrollment, and thought it was a one-time engagement and not an ongoing program. Though some participants with a higher level of education felt the information was simplistic, most appreciated moving beyond a narrow focus on HIV to include general information on sexually transmitted infections; drug use and impaired sexual decision-making; and differential risks associated with sexual positions and practices. Latinx transgender women in particular appreciated receiving information about Pre-Exposure Prophylaxis. While participants didn't fully understand the exact chances of winning a prize in the quiz component, most enjoyed the quizzes and chance of winning a prize. Participants appreciated that the intervention required a minimal time investment. Participants shared that the intervention was generally culturally appropriate. Regarding feasibility, most participants reported the text message platform worked well though inactive participants consistently said technical difficulties led to their disengagement. Staff shared that clients had varying reactions to being approached while being tested for HIV, with some unwilling to enroll and others being very open and curious about the program. Both staff and participants relayed concerns regarding the length of the recruitment process and study surveys. CONCLUSIONS: Our theoretically-grounded assessment shows the intervention is both acceptable and feasible. TRIAL REGISTRATION: The trial was registered on May 5, 2017 with the ClinicalTrials.gov registry [ NCT03144336 ].

Then We Looked at His Results: Men Who Have Sex With Men from New York City and Puerto Rico Report Their Sexual Partner's Reactions to Receiving Reactive HIV Self-Test Results.

Secondary distribution of HIV self-tests to sexual partners is acceptable but concerns remain about reactions if a partner tests HIV-positive. We report on 14 participants whose sexual partners tested HIV-positive during the "I'll Show You Mine" Study, a randomized controlled trial (N = 272) of HIV self- and partner-testing among men who have sex with men (MSM) and transgender women (TGW). All 14 were MSM and racial/ethnic minorities, mean age was 36.6 years; 86% were gay-identified. Twenty-four partners tested positive; about half were new partners. Six participants had multiple partners test positive. During in-depth interviews with 10 of these participants, they reported their partners' reactions ranged from tearful and worried among those whose result was unexpected, to resignation among those who suspected a positive result, to nonchalance among partners who participants concluded knew of their HIV infection. After testing, some HIV-positive partners disclosed prior knowledge of their status. No partner reacted violently. Participants typically comforted their partners and encouraged confirmatory testing. Four participants had anal intercourse with partners who tested positive. Participants and partners were able to effectively handle situations in which the partner tested HIV-positive.

Substance Use and Testing Sexual Partners Using HIV Self-tests.

HIV self-tests (HIVST) provide the possibility of testing partners prior to sexual activity. This study examines the role of substance use among men who have sex with men (n = 123) and transgender women (n = 13) who were provided HIVST to use with potential sex partners. Several reported avoiding/delaying alcohol (44%) or drug use (27%) because they intended to use HIVST. Those who used HIVST with alcohol (37%) or drugs (24%) did not differ from those who did not on number of partners asked, proportion who agreed, or intentions to use HIVST. A minority reported problems caused by substances. Ten did not ask someone to test because they were too drunk/high. Fourteen said it was fairly or very hard to use HIVST when under the influence. Eleven reported substances caused problems when discussing or administering HIVST, but only two of those felt the problems were major.

Using an HIV Self-test Kit to Test a Partner: Attitudes and Preferences Among High-Risk Populations.

For those most at risk of contracting HIV, new strategies for preventing transmission and increasing testing are needed. As part of a multi-site, randomized, controlled trial, we explored attitudes and preferences among 272 HIV-negative men who have sex with men and HIV-negative transgender women using an HIV self-testing (HIVST) kit to test partners. Less than one quarter had previously self-tested with HIVST kits (21.7%) and few had partner-tested (4.8%). Most preferred gum swab (96%) over fingerprick tests (69%), but would prefer a blood test if it gave results for other sexually transmitted infections (STIs) (86%). Five percent reported difficulties performing the test, four percent with storage, and 26% with portability. Ninety-three percent reported likelihood of using HIVST to test partners in future, but only 3% were willing to pay the current price. Efforts to improve HIVST uptake should focus on incorporating testing for other STIs, reducing test kit size, and reducing cost.

RESUMEN: Se necesitan nuevas estrategias para prevenir la transmisión del VIH e incrementar el testeo para aquellos con mayor riesgo al contagio. Como parte de un ensayo controlado aleatorio (ECA) multicentrico, exploramos las actitudes y preferencias entre 272 hombres VIH-negativos que tienen sexo con hombres y mujeres transgenero VIH-negativos que utilizaron kits del auto-test para el VIH (HIVST) para testear a sus parejas. Menos de una cuarta parte de los participantes había utilizado HIVST para auto-testearse (21.7%), y solo pocos para testear a sus parejas (4.8%) antes del comienzo del estudio. El hisopo bucal fue preferido (96%) sobre una prueba con un pinchazo de sangre (69%) por la mayoría de los participantes pero estos preferirían la prueba de sangre si puedieran obtener resultados para otras enfermedades de transmisión sexual (ETS) (86%). Cinco por ciento reportó problemas con el uso de la prueba, 4% con el almacenamiento, y el 26% con la portabilidad. Noventa y tres por ciento reportó que utilizarían HIVST para testear a sus parejas en el futuro, pero solo 3% estaba dispuesto a pagar el precio actual. Los futuros esfuerzos para mejorar la adopción del HIVST deberían enfocarse en incorporar otras pruebas de ETS, en reducir el tamaño del kit y en reducir los costos.

Transgender Women's Experiences Using a Home HIV-Testing Kit for Partner-Testing.

HIV partner-testing (PT) may represent a unique and empowering HIV prevention strategy for groups that face structural and institutional barriers to HIV testing and care, including transgender women. We report on in-depth interviews (IDIs) with N = 10 transgender women who used HIV self-test kits for three months to screen potential sexual partners in a randomized controlled trial (iSUM; "I'll Show You Mine") that took place in New York City and San Juan, Puerto Rico. Participants were assigned to intervention (supplied with 10 self-test kits immediately) or control groups (received 6 test kits after 3 months). We conducted IDIs with the first N = 10 transgender women to enroll in the intervention group after three months in the study (after participants used kits with partners) to understand their experiences. Themes discussed in IDIs included: partners' reaction to HIV testing, participants' reactions to partners' test results or refusal to test, partners' own reaction to their test results, and decision-making around test use. Data were independently analyzed by two coders. Overwhelmingly, participants' experiences with PT was positive. Participants reported kits were convenient and acceptable to most partners. Transgender women felt that PT could pose additional risk for them; one woman experienced violence related to kit use. Furthermore, the availability of kits appeared to encourage participants and their partners to think about their HIV status and, in some cases, modify sexual behavior. Work suggests that HIV PT could be a viable risk-reduction strategy for transgender women.

Broaching the Topic of HIV Self-testing with Potential Sexual Partners Among Men and Transgender Women Who Have Sex with Men in New York and Puerto Rico.

Men who have sex with men (MSM) and transgender women (TGW) are highly affected by HIV and need novel prevention strategies. Using HIV self-testing (HIVST) kits to screen sexual partners may represent a viable risk-reduction alternative; however, more research is needed on effective strategies for broaching HIVST with partners. In the ISUM study, 136 MSM and TGW were given ten HIVST kits for self- and partner-testing. After 3 months, they returned for a follow-up assessment; thirty participants were also selected for in-depth interviews about their experiences initiating HIVST with partners. Most found proposing HIVST to a diverse array of partners relatively easy. They employed strategies such as joint testing and integrating HIVST into larger discussions about protection and sexual health, with moderate success. Nonetheless, real or anticipated negative partner reactions were a significant barrier. Future research can inform best practices for safely and successfully broaching HIVST with sexual partners.

RESUMEN: Los hombres que tienen sexo con hombres (HSH) y las mujeres tránsgenero (MTG) están muy afectados por el VIH y necesitan estrategias innovadoras de prevención. El uso del autotest de VIH (HIVST) para testear a parejas sexuales podría ser una alternativa viable de reducir el riesgo; sin embargo, se necesitan más investigaciones sobre estrategias eficaces para abordar el tema de usar el HIVST con parejas. En el estudio ISUM, 136 HSH y MTG fueron provistos de diez HIVST para testear a sí mismo y a parejas. Después de tres meses, volvieron para una evaluación de seguimiento; treinta participantes también fueron seleccionados para una entrevista en profundidad sobres sus experiencias abordando el tema del uso del HIVST con parejas. La mayoría encontró que proponer HIVST a una gran variedad de parejas fue relativamente fácil. Emplearon estrategias como hacerse la prueba juntos y integrar HIVST en una conversación más amplia sobre la protección y la salud sexual, con leve éxito. No obstante, las reacciones negativas de parejas, ya sean reales o anticipadas, representaron una barrera importante. Las investigaciones futuras pueden informar las mejores prácticas para abordar el tema de HIVST con parejas sexuales de manera segura y exitosa.

Few Aggressive or Violent Incidents are Associated with the Use of HIV Self-tests to Screen Sexual Partners Among Key Populations.

Men who have sex with men and transgender women who had multiple sexual partners in the prior 3 months participated in ISUM, a randomized, controlled trial of self- and partner-testing in New York City and San Juan, PR. Only 2% of screened participants were ineligible to enroll due to anticipating they would find it very hard to avoid or handle violence. The intervention group received free rapid HIV self-test kits. During the trial, 114 (88%) of intervention participants who were assessed at follow-up used self-tests with at least one potential partner. Only 6% of participants who asked a partner in person to test reported that at least one of their partners got physically violent, some in the context of sex work. In total, 16 (2%) partners reacted violently. Post-trial, only one participant reported finding it very hard to handle violence, and none found it very hard to avoid potential violence.

A Mixed-Methods Study Examining Adherence to and Acceptability of Intravaginal Rings for HIV Prevention: Behavioral Results of MTN-027.

Intravaginal rings (IVR) containing antiretroviral drugs are a promising method for HIV prevention. We triangulated quantitative and qualitative assessments to evaluate the acceptability of four IVRs used continuously for 28 days as part of a Phase I trial (N = 48 HIV-negative women; ages 18-45). Adherence was high throughout the trial, yet 30% of participants reported involuntary IVR expulsions followed by re-insertion. Most participants (93.6%) felt comfortable with the IVR being inside their body. Participants reported liking the IVR more (36.2%) or the same amount (55.3%) since starting the study. When given the option of choosing between the IVR and/or a male condom for HIV-prevention, most reported preferring the IVR (n = 29, 63.0%), and over a quarter of the sample reported liking them equally (n = 12, 26.1%). We observed no differences in IVR acceptability across the study arms. High adherence and acceptability underscores the promise of an IVR as a female-controlled, sustained mechanism for HIV prevention.

Use of Rapid HIV Self-Test to Screen Potential Sexual Partners: Results of the ISUM Study.

ISUM ("I'll show you mine") was a randomized controlled trial in which 272 transgender women and men who have sex with men in New York, NY (NYC) and San Juan, Puerto Rico (SJU) were assigned to an intervention group (n = 136), in which they had access to free HIV self-testing (ST) kits, or to a control group (n = 136). The trial aimed to determine whether the intervention group would use ST to screen sexual partners and have fewer condomless anal intercourse (CAI) occasions with serodiscordant or unknown status partners than the control group. The intervention group had on average 10 (32%) fewer CAI occasions; though clinically relevant, this difference fell short of statistical significance (p = .08). In NYC (n = 166) intervention participants had significantly fewer CAI occasions, whereas in SJU (n = 106) they reported non-significantly more CAI occasions. Two devastating hurricanes hit SJU during the study and may have impacted results in unmeasured ways.

Use of HIV Self-Testing Kits to Screen Clients Among Transgender Female Sex Workers in New York and Puerto Rico.

Transgender female sex workers (TFSW) are highly affected by HIV, with a global prevalence of 27%. HIV self-testing (HIVST) to screen sexual partners has helped men who have sex with men and female sex workers make informed sexual decisions and avoid HIV exposure. This is the first report on TFSW's experiences screening clients using HIVST. Ten TFSW were each given ten HIVST kits and returned after 3 months to complete an online questionnaire and undergo an interview. Eight of them reported using HIVST with potential partners. Among fifty potential partners who were asked in person to test, 42 (84%) were clients. Thirty-four out of fifty (68%) accepted and 16 (32%) refused. Very few violent incidents occurred, and participants felt empowered by offering HIVST to others. Nevertheless, HIVST market cost was prohibitive for future use. HIVST use with clients could be feasible for TFSW if the cost were lowered or subsidized.

Transgender Women's Concerns and Preferences on Potential Future Long-Acting Biomedical HIV Prevention Strategies: The Case of Injections and Implanted Medication Delivery Devices (IMDDs).

There are several long-acting biomedical HIV prevention products in the development pipeline, including injections and implanted medication delivery devices (IMDDs). It is critical to understand concerns and preferences on the use of these products in populations that shoulder a disproportionate burden of the HIV epidemic, such as transgender women. This will allow researchers and public health professionals to construct interventions tailored to the needs of these women to promote optimal use of these tools. In studies of other biomedical HIV prevention products (e.g., oral PrEP) it is clear that transgender women have unique concerns related to the use of these strategies. This may have an impact on this group's uptake and sustained use of longacting HIV prevention products. This study conducted four focus groups with N = 18 transgender women in New York City to understand their concerns and preferences on long-acting PrEP injections and IMDDs. Findings showed that participants were overwhelmingly positive about long-acting HIV prevention strategies, though they had some apprehensions. Overall, participants felt that injections and IMDDs could help address adherence challenges, and that transgender-specific needs should be addressed during clinical trials. Also, there were concerns related to injection or IMDD logistics, concerns about injections' or IMDDs' presence in the body, and familiarity with these products affected participants' opinions on them. Findings from this work can be used to inform protocols, measures, materials, and adherence interventions in future initiatives for transgender women using PrEP injections or IMDDs.

Information and Motivation Predict HIV-Serostatus Among a Population of High-Risk Men and Transgender Women Who Have Sex with Men.

Two constructs from the information-motivation-behavioral skills model were used to predict HIV-serostatus among a sample of men and transgender women who have sex with men. Hypotheses were that lower levels of HIV knowledge and lower levels of motivation to remain HIV-negative would be associated with an increased likelihood of receiving a positive HIV test result at a study eligibility-screening session. Results of a backwards stepwise logistic regression analysis demonstrated that lower levels of HIV knowledge, lower levels of motivation to remain HIV-negative, lower levels of education, and identifying as Hispanic/Latinx were associated with greater odds of receiving a positive HIV test result. These findings are consistent with the broader HIV-prevention literature that demonstrates that information and motivation are fundamental determinants of HIV preventive behavior. This work has implications for informing the development and improvement of HIV-prevention interventions.

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.