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.

More than just oral PrEP: exploring interest in rectal douche, dissolvable implant, removable implant and injection HIV prevention approaches among racially diverse men who have sex with men in the Northeast Corridor.

OBJECTIVES: HIV scholars and practitioners have worked to expand strategies for prevention among marginalised populations who are disproportionately impacted by the epidemic, such as racial minority men who have sex with men (MSM). Given this urgency, the objective of this study was to assess interest in biomedical prevention strategies. METHODS: This exploratory and cross-sectional study investigated interest in four biomedical prevention tools-rectal douche, dissolvable implant, removable implant and injection-among a racially diverse sample of MSM from the Northeast Corridor region between Philadelphia and Trenton. Data were collected as part of screening for Connecting Latinos en Pareja, a couples-based HIV prevention intervention for Latino MSM and their partners. RESULTS: A total of 381 individuals participated in the screener and provided information about their interest in bio tools. Approximately 26% of participants identified as black, 28% as white and 42% as 'other' or multiracial; 49% identified as Latino. Majority (54%) reported some form of child sexual abuse. Of the participants who reported being in a primary relationship (n=217), two-thirds reported unprotected anal sex within that relationship over the past 90 days (n=138, 64%) and approximately half (n=117, 54%) reported unprotected anal sex outside of the relationship in this period. Majority of participants reported interest in all bio tools assessed, including dissolvable implants (60%), removable implants (64%), rectal douching (79%) and injection (79%). Although interest in bio tools was broadly unassociated with demographics and sexual risk behaviours, analyses revealed significant associations between reports of child sexual abuse and interest in implant and injection methods. CONCLUSIONS: The authors recommend investing in these prevention methods, particularly rectal douching and injection, as a means of preventing HIV among racial minority MSM. Given the interest in biomedical prevention tools, future studies should explore potential strategies for adherence.

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.

Transgender Women's Barriers, Facilitators, and Preferences on Tailored Injection Delivery Strategies to Administer Long-Acting Injectable Cabotegravir (CAB-LA) for HIV Pre-exposure Prophylaxis (PrEP).

Long-acting injectable cabotegravir (CAB-LA) is in advanced stages of clinical trials. Under the standard protocol, CAB-LA is injected into the gluteal muscle by a healthcare provider every eight weeks. To explore transgender women's barriers and facilitators to tailored delivery strategies-including self-injection and injection in "drop-in" centers-we completed in-depth interviews with N = 15 transgender women in New York City. Participants endorsed the alternative delivery methods and the corresponding features we proposed, and expressed likes and dislikes about each. These fell into the following categories: competence (e.g., the person delivering CAB-LA must have skills to do so), convenience (e.g., CAB-LA must be easy to obtain), and privacy or fear of judgement (e.g., participants did not want to feel judged for using CAB-LA by providers or other service consumers). Findings suggest the need to offer CAB-LA to transgender women through multiple delivery protocols.

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.

Likely clinical depression and HIV-related decline in antiretroviral therapy untreated women who seroconverted during participation in microbicide trials in sub-Saharan Africa.

Depression worsens HIV outcomes in populations treated with antiretroviral therapy (ART) medications. Data are limited on the relationship between depression and HIV in untreated populations in sub-Saharan Africa. We aimed to identify associations between likely clinical depression, alcohol use, social support by partners, and HIV viral load (VL) among ART untreated women who recently became HIV positive and enrolled in the Microbicide Trials Network (MTN)-015 study. Analyses used cross-sectional data collected at baseline in MTN-015. Participants in this analysis (N = 190) enrolled from other MTN trials were not receiving ART and provided data on their HIV disclosure status to their husband or male partner and alcohol use behavior. The dependent variable, VL, was categorized as: low (≤400 RNA copies/mL; 9.1% of participants), medium (401-20,000 RNA copies/mL; 48.8%), and high (>20,000 RNA copies/mL; 42.0%). Depression was assessed using eight items from Hopkins Symptom Checklist; a cutoff of ≥1.75 indicated likely clinical depression. Independent variables with a significance of p ≤ 0.05 in unadjusted regressions were included in a regression adjusted for age, education, and time since seroconversion. Depressive symptoms were positively associated with high VL, in the adjusted regression (OR = 1.80; 95% CI = 1.07-3.01). Results suggest that likely having clinical depression may have a biological relationship with HIV disease progression.

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 ].

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.

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.

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.

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.

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.

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.

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.

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.

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.