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.

The Global Impact of Diversifying PrEP Options: Results of an International Discrete Choice Experiment of Existing and Potential PrEP Strategies with Gay and Bisexual Men and Physicians.

To improve current and future use of existing (oral, injectable) and potential future (implants, douches) pre-exposure prophylaxis (PrEP) products, we must understand product preferences relative to one another, among gay and bisexual men (GBM), and physicians who prescribe PrEP. We completed an online discrete choice experiment (DCE) with separate groups of GBM and/or physicians from the United States, South Africa, Spain, and Thailand. Participants were presented information on PrEP products, including daily pills, event-driven pills (2-1-1 regimen), injections, subdermal implants (dissolvable, removable), and rectal douches. Next, they completed a choice exercise in which they were shown 10 screens, each presenting 3 of the aforementioned products at a time with 11 attributes for physicians and 10 attributes for GBM. For the attributes that were not constant, one level was shown per screen for each product. Participants selected the product they preferred most and rated their likelihood to select (GBM) or recommend (physicians) that product. Data were modeled using hierarchical Bayes estimation; resulting model coefficients were used to develop attribute importance measures and product preferences. For GBM across all countries, if all aforementioned PrEP products were on the market at the same time, over 90% of GBM would use some form of PrEP; 100% of physicians would recommend at least one of the PrEP products. There were variations in product preference by country. GBM in the United States and Thailand preferred the injection (21.7%, 22.9%, respectively), while the dissolvable implant was preferred in South Africa and Spain (19.9%, 19.8%, respectively). In the United States, South Africa, and Spain (where physician data were available), physicians were most likely to recommend the dissolvable implant (37.2%, 40.6%, 38.3%, respectively).

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.

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.

A randomized trial of safety, acceptability and adherence of three rectal microbicide placebo formulations among young sexual and gender minorities who engage in receptive anal intercourse (MTN-035).

Efforts to develop a range of HIV prevention products that can serve as behaviorally congruent viable alternatives to consistent condom use and oral pre-exposure prophylaxis (PrEP) remain crucial. MTN-035 was a randomized crossover trial seeking to evaluate the safety, acceptability, and adherence to three placebo modalities (insert, suppository, enema) prior to receptive anal intercourse (RAI). If participants had no RAI in a week, they were asked to use their assigned product without sex. We hypothesized that the modalities would be acceptable and safe for use prior to RAI, and that participants would report high adherence given their behavioral congruence with cleansing practices (e.g., douches and/or enemas) and their existing use to deliver medications (e.g., suppositories; fast-dissolving inserts) via the rectum. Participants (N = 217) were sexual and gender minorities enrolled in five different countries (Malawi, Peru, South Africa, Thailand, and the United States of America). Mean age was 24.9 years (range 18-35 years). 204 adverse events were reported by 98 participants (45.2%); 37 (18.1%) were deemed related to the study products. The proportion of participants reporting "high acceptability" was 72% (95%CI: 65% - 78%) for inserts, 66% (95%CI: 59% - 73%) for suppositories, and 73% (95%CI: 66% - 79%) for enemas. The proportion of participants reporting fully adherent per protocol (i.e., at least one use per week) was 75% (95%CI: 69% - 81%) for inserts, 74% (95%CI: 68% - 80%) for suppositories, and 83% (95%CI: 77% - 88%) for enemas. Participants fully adherent per RAI-act was similar among the three products: insert (n = 99; 58.9%), suppository (n = 101; 58.0%) and enema (n = 107; 58.8%). The efficacy and effectiveness of emerging HIV prevention drug depends on safe and acceptable delivery modalities that are easy to use consistently. Our findings demonstrate the safety and acceptability of, and adherence to, enemas, inserts, and suppositories as potential modalities through which to deliver a rectal microbicide.

Preferences Among Physicians and Men Who Have Sex with Men (MSM) for a Long-Acting, Removable Implant for HIV Prevention: A Discrete Choice Study.

A longer acting, removable implant for HIV prevention has the potential to improve uptake of HIV pre-exposure prophylaxis (PrEP) by removing the need for daily adherence to an oral tablet, reducing potential side effects, and eliminating concerns about residual drug following injections. To end the HIV epidemic, we must understand the needs and preferences of groups most affected by HIV (e.g., men who have sex with men; MSM), and the physicians who prescribe PrEP to them. This article describes a discrete choice experiment to estimate the preference share for the implant within a competitive context of other PrEP products (including the oral tablet, dissolvable implant, and injection) and evaluate the impact of potential implant attributes. Physicians who had prescribed oral PrEP (n = 75) and MSM at risk for HIV (n = 175) completed a web-based survey that prompted decision-making about PrEP product preferences. The findings from both physicians and MSM demonstrated that the removable implant could capture a meaningful portion of the preference share, making it feasible to advance in the development pipeline as an important addition to the biomedical HIV prevention toolkit. Among MSM, specifically, the cost of treatment was the most important attribute impacting product preference. Our findings inform implant developers and future payers (e.g., commercial manufacturers, insurance companies) about specific device attributes that will likely affect MSM's willingness to use and physicians' willingness to prescribe this HIV prevention strategy.

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.

Conjoint Analysis of User Acceptability of Sustained Long-Acting Pre-Exposure Prophylaxis for HIV.

Long-acting delivery modalities of HIV pre-exposure prophylaxis (PrEP), such as subdermal implants, are in development. To facilitate end-user uptake and sustained use, it is critical to understand potential consumers' and physician prescribers' preferences about, interest in, and relative importance of different implant features. The ordered identification of these key attributes allows implant developers to incorporate this feedback into product design, which theoretically improves acceptability, feasibility, and user experience with the device. In this study, n = 75 PrEP-prescribing physicians and n = 143 men having sex with men (MSM) at risk for HIV completed web-based surveys that directly compared the importance of eight to nine different implant features, respectively. Conjoint analysis determined the importance of these features, relative to each other. Implants presented in the study were well received, with a majority of physicians and MSM indicating that they were likely to recommend or use them. The implant was perceived as unique, reliable, and convenient, as well as able to deliver better compliance. The attributes most critical to the adoption of the implant among physicians and MSM were (1) the chance of becoming infected with HIV while on implant treatment, (2) the length of protection and size of the implant, and (3) the side effect advantages over current PrEP oral pill treatment. Some concerns about the implant included side effects and the product's safety (among MSM) and the cost or insurance coverage level for the implant (both physicians and MSM). There was also some resistance to the implantation procedure itself.

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.

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 ].

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.

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.

Brief Report: Using Behavioral Economics to Increase HIV Knowledge and Testing Among Latinx Sexual Minority Men and Transgender Women: A Quasi-Experimental Pilot Study.

OBJECTIVE: To determine how weekly text messages and small incentives impact HIV knowledge and frequency of HIV testing among Latinx sexual minority men (LSMM) and transgender women (LTGW). DESIGN: Prospectively randomized participants into 2 intervention arms compared with a nonrandomized comparison group. SETTING: Bienestar, a primarily Latinx focused HIV service provider located across Los Angeles County. SUBJECTS, PARTICIPANTS: Two hundred eighteen participants self-identifying as LSMM or LTGW, HIV negative, having regular mobile phone access, ≥18 years, and fluent in English or Spanish. INTERVENTION: The "information only" (IO) group received text messages with HIV prevention information. The "information plus" (IP) group additionally could win incentives by answering weekly quiz questions correctly and testing for HIV once every 3 months. We followed participants for 12 months. MAIN OUTCOME MEASURE(S): HIV knowledge and frequency of HIV testing. RESULTS: We found no effect on HIV knowledge in the IO group but a statistically significant improvement in the IP group (79.2%-88.1%; P = 0.007). The frequency of HIV testing was higher in both intervention groups relative to the comparison group: On average, 22.0% of IO participants and 24.9% of IP participants tested at a Bienestar site within a given 3-month period, compared with 13.0% in the comparison group. This represents unadjusted relative risk ratios of 1.69 for the IO group (95% CI: 1.25 to 2.1; P < 0.01) and 1.91 for the IP group (95% CI: 1.51 to 2.31; P < 0.01), respectively. CONCLUSIONS: This study demonstrates that a simple, low-cost intervention may help increase HIV testing frequency among LSMM and LTGW, 2 groups at high HIV risk.

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.

Understanding the Acceptability of Subdermal Implants as a Possible New HIV Prevention Method: Multi-Stage Mixed Methods Study.

BACKGROUND: A long-acting implant for HIV pre-exposure prophylaxis (PrEP) is in development in the Sustained Long-Action Prevention Against HIV (SLAP-HIV) trial. This could provide an alternative to oral PrEP. OBJECTIVE: Our mixed methods study aimed to understand (1) users' experiences with a similar subdermal implant for contraception and (2) factors influencing the likelihood that gay and bisexual men (GBM) would use a proposed PrEP implant. METHODS: Work was completed in 4 stages. In stage 1, we conducted a scientific literature review on existing subdermal implants, focusing on users' experiences with implant devices. In stage 2, we reviewed videos on YouTube, focusing on the experiences of current or former contraceptive implant users (as these implants are similar to those in development in SLAP-HIV). In stage 3, individuals who indicated use of a subdermal implant for contraception in the last 5 years were recruited via a web-based questionnaire. Eligible participants (n=12 individuals who liked implants a lot and n=12 individuals who disliked implants a lot) completed in-depth phone interviews (IDIs) about their experiences. In stage 4, results from IDIs were used to develop a web-based survey for HIV-negative GBM to rate their likelihood of using a PrEP implant on a scale (1=very unlikely and 5=very likely) based on likely device characteristics and implant concerns identified in the IDIs. RESULTS: In the scientific literature review (stage 1), concerns about contraceptive implants that could apply to the PrEP implants in development included potential side effects (eg, headache), anticipated high cost of the device, misconceptions about PrEP implants (eg, specific contraindications), and difficulty accessing PrEP implants. In the stage 2 YouTube review, individuals who had used contraceptive implants reported mild side effects related to their device. In stage 3, implant users reported that devices were comfortable, unintrusive, and presented only minor discomfort (eg, bruising) before or after insertion and removal. They mainly reported removing or disliking the device due to contraceptive-related side effects (eg, prolonged menstruation). Participants in the stage 4 quantitative survey (N=304) were mainly gay (204/238, 85.7%), white (125/238, 52.5%), cisgender men (231/238, 97.1%), and 42.0% (73/174) of them were on oral PrEP. Not having to take a daily pill increased the likelihood of using PrEP implants (mean 4.13). Requiring >1 device to achieve 1 year of protection (mean range 1.79-2.94) mildly discouraged PrEP implant use. Participants did not mind moderate bruising, a small scar, tenderness, or bleeding after insertion or removal, and an implant with a size slightly larger than a matchstick (mean ratings 3.18-3.69). CONCLUSIONS: PrEP implants are promising among GBM. Implant features and insertion or removal-related concerns do not seem to discourage potential users. To ensure acceptability, PrEP implants should require the fewest possible implants for the greatest protection duration.

Text Messaging and Disaster Preparedness Aids Engagement, Re-Engagement, Retention, and Communication Among Puerto Rican Participants in a Human Immunodeficiency Virus (HIV) Self-Testing Study After Hurricanes Irma and Maria.

OBJECTIVE: Hurricanes can interrupt communication, exacerbate attrition, and disrupt participant engagement in research. We used text messaging and disaster preparedness protocols to re-establish communication, re-engage participants, and ensure retention in a human immunodeficiency virus (HIV) self-test study. METHODS: Participants were given HIV home test kits to test themselves and/or their non-monogamous sexual partners before intercourse. A daily text message-based short message service computer-assisted self-interview (SMS-CASI) tool reminded them to report 3 variables: (1) anal sex without a condom, (2) knowledge of partners' testing history, and (3) proof of partners' testing history. A disaster preparedness protocol was put in place for hurricanes in Puerto Rico. We analyzed 6315 messages from participants (N = 12) active at the time of Hurricanes Irma and Maria. Disaster preparedness narratives were assessed. RESULTS: All participants were able to communicate sexual behavior and HIV testing via SMS-CASI within 30 days following María. Some participants (n = 5, 42%) also communicated questions. Re-engagement within 30 days after the hurricane was 100% (second week/89%, third week/100%). Participant re-engagement ranged from 0-16 days (average = 6.4 days). Retention was 100%. CONCLUSIONS: Daily SMS-CASI and disaster preparedness protocols helped participant engagement and communication after 2 hurricanes. SMS-CASI responses indicated high participant re-engagement, retention, and well-being.

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.

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.

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.