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OBJECTIVES: DREAM-01 was an open label, dose-escalation and variable osmolarity study to identify a tenofovir HIV-prevention douche/enema that could achieve protective colon tissue cell concentrations and high acceptability. To assess impact on sexual enjoyment, iso-osmolar and hypo-osmolar placebo douches were provided for at-home use before receptive anal sex (RAS). METHODS: Eighteen HIV-uninfected men who have RAS were administered three tenofovir douches at the research clinic: Product A, an iso-osmolar dose; Product B, an iso-osmolar escalation dose; and Product C, a hypo-osmolar escalation dose. Following Products A and C, participants were given a saline douche of matching osmolarity to use at home before RAS. Participants reported acceptability via a computer-assisted self-interview and in-depth interview in this mixed-methods study. RESULTS: All three products were rated acceptable by 17 (95%) of the participants. A majority (94%) would be likely or very likely to use any of the three products before RAS. Of those who used the saline douches before RAS and then rated their sexual enjoyment, most reported that their sexual enjoyment was not affected. Interview data revealed that participants found the product easy to incorporate into their regular routine, but would prefer to use more liquid for cleansing. CONCLUSIONS: These findings indicate that the hypo-osmolar Product C, which also provides the most rapid delivery of tenofovir for HIV prevention, is acceptable for future safety trials and that our sample reports high likelihood of using a rectal microbicide douche for HIV prevention. Our findings support continued pursuit of a tenofovir rectal microbicide douche. TRIAL REGISTRATION NUMBER: NCT02750540.
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Peer-to-peer chain recruitment has been used for descriptive studies, but few intervention studies have employed it. We used this method to enroll sexually active women ages 18 to 25 into an online Pre-Exposure Prophylaxis (PrEP) information and motivation intervention pilot in eThekwini (Durban), South Africa. Seeds (N = 16) were recruited by study staff and randomized to Masibambane, Ladies Chat, a Gender-Enhanced group-based WhatsApp Workshop (GE), or Individual-Access (IA), a control condition that provided participants with online information/motivation materials only. Each seed could recruit up to three women to participate in the same study condition, with an incentive for each enrolled woman; participants in subsequent waves could choose to recruit or not. We evaluated if peer-to-peer recruitment was self-sustaining and resulted in enrolling women who, in subsequent waves, had less contact with the health care system and less knowledge about PrEP than the initial seeds. Over three recruitment waves beyond the seeds, 84 women were recruited. Almost 90% of women became recruiters, with each recruiting on average 1.90 women and 1.26 eligible enrolled women. The approach was successful at reaching women with less education but not women with less health system contact and PrEP knowledge across waves. IA participants had a slightly higher, though non-significantly different, percentage of individuals who became Peer Health Advocates (PHAs) than GE participants and, on average, they recruited slightly more women who enrolled. Our findings demonstrated that peer-to-peer recruitment is a feasible and self-sustaining way to recruit SA young women into a PrEP intervention study.
Assuntos
Infecções por HIV , Seleção de Pacientes , Grupo Associado , Profilaxia Pré-Exposição , Humanos , Feminino , Profilaxia Pré-Exposição/métodos , África do Sul , Infecções por HIV/prevenção & controle , Adulto , Adulto Jovem , Adolescente , Fármacos Anti-HIV/administração & dosagem , Fármacos Anti-HIV/uso terapêutico , Motivação , Conhecimentos, Atitudes e Prática em Saúde , Projetos PilotoRESUMO
We assessed pathways between sexual minority stigma and condomless anal intercourse (CAI) among two samples of Black South African men who have sex with other men (MSM). Two cross-sectional surveys were conducted in Tshwane, South Africa; one among 199 Black MSM and another among 480 Black MSM. Men reported on external and internalized experiences of sexual minority stigma, mental health, alcohol use, information-motivation-behavioral skills (IMB) model constructs, and CAI. Structural equation modeling was used to test whether external and internalized stigma were directly and indirectly associated with CAI. In both studies, external stigma and internalized stigma were associated with CAI through IMB model constructs. These results suggest a pathway through which stigma contributes to HIV risk. For HIV prevention efforts to be effective, strengthening safer sex motivation and thus decreasing sexual risk behavior likely requires reducing sexual minority stigma that MSM experience and internalize.
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Infecções por HIV , Minorias Sexuais e de Gênero , Masculino , Humanos , Homossexualidade Masculina/psicologia , África do Sul/epidemiologia , Motivação , Estudos Transversais , Infecções por HIV/prevenção & controle , Infecções por HIV/psicologia , Comportamento SexualRESUMO
Given poor adherence to treatment and prevention techniques, condomless sex jeopardizes adolescents and young adults (AYA) with perinatally-acquired HIV-infection (PHIV) or perinatal HIV-exposure who are uninfected (PHEU). We examined condomless sex and its association with PHIV-status, psychiatric disorder, and sociodemographics. Data come from a US-based study of primarily Black and Latinx AYAPHIV and AYAPHEU (N = 340). Linear regression models examined condomless sex longitudinally by PHIV-status, psychiatric trajectories, and sociodemographics. Rates of viremia (AYAPHIV) and PrEP use (AYAPHEU) were assessed. 56% of participants reported recent condomless sex, with higher prevalence among: AYAPHEU vs. AYAPHIV (24% vs. 19%, p = 0.017); Latinx vs. non-Latinx AYA (25% vs. 17%, p = 0.014); and AYA with increasing psychiatric comorbidity (44%) and consistent anxiety (23%) vs. low-level disorder (17%; p < 0.05). AYAPHIV had high rates of unsuppressed viral load and AYAPHEU limited PrEP use. Preventing condomless sex is challenging within AYAPHIV and AYAPHEU. Developing accessible combination HIV/mental health interventions is much-needed.
Assuntos
Fármacos Anti-HIV , Infecções por HIV , Profilaxia Pré-Exposição , Feminino , Gravidez , Adolescente , Adulto Jovem , Humanos , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , Infecções por HIV/tratamento farmacológico , Sexo sem Proteção , Transtornos de Ansiedade , Fármacos Anti-HIV/uso terapêuticoRESUMO
Tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS) predict viral breakthrough, but their use remains understudied in real-world clinic settings. This pilot study examined acceptability, feasibility, and initial adherence outcomes of providing adherence feedback using TFV-DP concentrations on patient- and provider-levels in Cape Town, South Africa. We enrolled 60 persons with HIV (PWH) receiving tenofovir-containing ART attending a primary health clinic. They were randomized 1:1 to an intervention receiving TFV-DP concentration feedback by research staff vs. no feedback at monthly visits for 4 months. Acceptability among medical providers and level of clinical follow-up of TFV-DP results was examined. Patient acceptability was assessed descriptively. Mean electronic adherence (EA), as measured by WisePill device, and TFV-DP in DBS were compared between the two arms. All participants in the intervention group (100%) reported finding TFV-DP feedback helpful and 86% reported changing adherence behaviors. Medical providers indicated high acceptability of incorporating TFV-DP concentration feedback into the clinic, yet among 29 results < 1000 fmol/punch, only 2 were reviewed with no follow-up actions performed. In the intervention arm, mean TFV-DP concentrations were significantly higher (t = 2.5, p < .01) during follow-up and EA in upper quartile (96-100%) was greater compared to controls (x2 = 7.8, p ≤ .05). This study found high acceptability among patients for receiving adherence feedback based on TFV-DP concentrations. TFV-DP and EA data demonstrated greater adherence in the intervention group. Providers indicated high acceptability of incorporating TFV-DP feedback into the clinic, but few providers reviewed results, which could impact clinic-level feasibility.
Assuntos
Fármacos Anti-HIV , Infecções por HIV , Humanos , Fármacos Anti-HIV/uso terapêutico , Estudos de Viabilidade , Infecções por HIV/tratamento farmacológico , Projetos Piloto , África do Sul/epidemiologiaRESUMO
Hope for the future has been found protective against suicidal ideation (SI) in adolescents and young adults (AYA) yet has not been examined in AYA with perinatal HIV-infection (PHIV) or AYA who were perinatally HIV-exposed but uninfected (PHEU), who are at higher risk for SI than general populations. Using data from a New York City-based longitudinal study of AYAPHIV and AYAPHEU enrolled when 9-16 years old, we examined associations between hope for the future, psychiatric disorders, and SI over time using validated measures. Generalized estimating equations were used to estimate differences in mean hope for the future scores by PHIV-status and to estimate adjusted odds ratios for associations between hope for the future and SI. AYA reported high hope for the future scores and low SI across visits, irrespective of PHIV-status. Higher hope for the future scores were associated with lower odds of SI (AOR = 0.48, 95% CI: 0.23, 0.996). Mood disorder was associated with increased odds of SI (AOR = 13.57, 95% CI: 5.11, 36.05) in a model including age, sex, follow-up, PHIV-status, mood disorder, and hope for the future. Understanding how hope can be cultivated and how it protects against SI can help to inform preventive interventions for HIV-affected AYA.
Assuntos
Infecções por HIV , Gravidez , Feminino , Humanos , Adolescente , Adulto Jovem , Criança , Infecções por HIV/psicologia , Ideação Suicida , Estudos Longitudinais , Transtornos do Humor , Teste de HIV , Transmissão Vertical de Doenças Infecciosas/prevenção & controleRESUMO
We present experiences of transgender women (TW) who have sex with men with SMARTtest, a smartphone app to accompany the INSTI Multiplex®, a one-minute, dual blood-based HIV/syphilis rapid test. TW participants (N = 11) received 10 INSTI Multiplex® tests to take home for self- and/or partner-testing and installed the SMARTtest app on their phones. The SMARTtest app aimed to support INSTI Multiplex users in correctly performing the test, interpreting the results, and connecting with care following a positive HIV or syphilis screening. After 3 months, users completed in-depth interviews on their experiences. A total of 9 TW used SMARTtest with partners. App feedback was positive, but refining is necessary. Specifically, TW reported that SMARTtest is easy to use and convenient; instructions on how to use the INSTI Multiplex presented on the app were helpful to complete procedures correctly; the most frequently used feature on SMARTtest was the information on clinics that offered confirmatory testing; and participants and their partners were not concerned about app privacy but reported that this could change if INSTI Multiplex detected an HIV-positive result. Further, participants provided recommendations on how to improve SMARTtest, and changes were mostly related to features, content, functionality, navigation, and overall "look" of the app. SMARTtest is promising to facilitate INSTI Multiplex® use in TW. User feedback should be integrated in future versions.
Assuntos
Infecções por HIV , Aplicativos Móveis , Sífilis , Pessoas Transgênero , Masculino , Humanos , Feminino , Sífilis/diagnóstico , Smartphone , Infecções por HIV/diagnóstico , Infecções por HIV/prevenção & controle , Homossexualidade MasculinaRESUMO
HIV/syphilis self- and partner-testing may be especially appropriate for transgender women, since they shoulder a disproportionate burden of HIV, other STIs (e.g., syphilis), and report high levels of medical mistrust. The SMARTest study enrolled N = 50 sexual and gender minority individuals. The present analysis aims to understand the experiences (via in-depth interviews) of a subset of n = 11 transgender women who used INSTI Multiplex®, a combination HIV/syphilis rapid self-test, on themselves and potential sex partners. Participants reported that many partners were willing to test, and reported no testing-related violence. Most participants completed tests successfully, though gaining comfort with blood collection took time. There were no HIV-positive tests in this study; one participant and two partners reported a positive syphilis screening. All sought care. Our sample was small and results should be interpreted with caution, but indicate potential future directions for conducting research on self- and partner-testing among transgender women.
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Infecções por HIV , Sífilis , Pessoas Transgênero , Feminino , Infecções por HIV/diagnóstico , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , Humanos , Autoteste , Parceiros Sexuais , Sífilis/diagnóstico , Sífilis/epidemiologia , ConfiançaRESUMO
Testing for sexually transmitted infections (STIs) remains low among sexual and gender minority populations. We assessed STI testing history using a retrospective survey among 129 HIV-negative cisgender men who have sex with men (cMSM) and transgender women who have sex with men (tWSM) who were at high risk for STI acquisition. All participants were enrolled in a parent study on self- and partner-testing for HIV and syphilis, and reported condomless anal intercourse with multiple partners during the prior 3 months. We additionally used bivariate tests to evaluate participants' STI testing by their history of using pre-exposure prophylaxis (PrEP). One-in-seven respondents (n = 18) reported having never tested for an STI, one-quarter (n = 33) had not tested in the past year, and two-thirds (n = 83) had never used PrEP. PrEP-naïve respondents were less likely to report recent STI testing (47% vs. 85%). "Routine doctor's visit" was the most prevalent reason for testing, but was less common among PrEP-naïve respondents (83% vs. 100%). Testing was remarkably low given the sample's high risk of HIV and STI infection. Findings suggest that STI testing is more frequent among those who have ever used PrEP, but the risk of selection bias warrants evaluation in a larger probability sample.
Assuntos
Infecções por HIV , Profilaxia Pré-Exposição , Minorias Sexuais e de Gênero , Infecções Sexualmente Transmissíveis , Feminino , Infecções por HIV/diagnóstico , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , Homossexualidade Masculina , Humanos , Masculino , Cidade de Nova Iorque/epidemiologia , Estudos Retrospectivos , Comportamento Sexual , Infecções Sexualmente Transmissíveis/diagnóstico , Infecções Sexualmente Transmissíveis/epidemiologia , Infecções Sexualmente Transmissíveis/prevenção & controleRESUMO
At home self- and partner-testing may reduce HIV and syphilis transmission by detecting undiagnosed infections. Forty-eight cisgender men and transgender women who men who have sex with men were given ten INSTI Multiplex kits and downloaded the SMARTtest app to facilitate self- and partner testing over the next three months. Thirty-seven (77%) participants self-tested using the INSTI (mean = 3.7 times, SD = 3.9); 26 (54%) tested partners (mean = 1.6 times, SD = 2.2). Participants liked the test for its ease of use, quick results, and dual HIV/syphilis testing but its blood-based nature hindered use with partners. Participants with reactive syphilis results always attributed them to a past infection and these results presented a challenge to testing with partners and the ability to accurately assess risk of infection. Most participants stated they would use the INSTI for self-testing (100%) and for partner-testing (89%). Acceptability of the SMARTtest app was high for functionality (M = 4.16 of max 5, SD = 0.85) and helpfulness (M = 6.12 of max 7, SD = 1.09). Participants often used the app as needed, eschewing its use if they felt comfortable conducting the test and interpreting its results. Seventy-eight percent would recommend the app to a friend. Availability of the INSTI Multiplex as a self-test with the accompanying SMARTtest app might increase frequency of HIV and syphilis testing, allowing for earlier detection of infection and reduced transmission.
RESUMEN: El uso de pruebas rápidas caseras con parejas y como auto-pruebas puede reducir la transmisión del VIH y la sifilis al detectar infecciones no diagnosticadas. Cuarenta y ocho hombres cisgénero y mujeres transgénero que tienen sexo con hombres recibieron diez kits del INSTI Multiplex y descargaron la aplicación SMARTtest para facilitar su uso con parejas y para auto-pruebas durante los próximos tres meses. Treinta y siete (77%) participantes se auto-testearon utilizando el INSTI (media = 3.7 veces, DE = 3.9); 26 (54%) testearon a sus parejas (media = 1.6 veces, DE = 2.2). A los participantes les gustó la prueba por su facilidad de uso, rapidez de los resultados y por ser una prueba dual de VIH/sífilis, pero al ser una prueba basada en sangre dificultó su uso con parejas. Los participantes con resultados de sífilis reactivos siempre atribuyeron éstos a una infección pasada y sus resultados presentaron un desafío para el uso de pruebas con parejas. La mayoría de los participantes afirmaron que utilizarían el INSTI como auto-pruebas (100%) y para testear a sus parejas (89%). La aceptabilidad de la aplicación SMARTtest fue alta para la funcionalidad (M = 4.16 de un máximo de 5, SD = 0.85) y utilidad (M = 6.13 de un máximo de 7, SD = 1.09). Los participantes solían utilizar la aplicación según fuera necesario, evitando su uso si se sentían cómodos realizando la prueba e interpretando sus resultados. El 78% recomendaría la aplicación a un amigo. La disponibilidad del INSTI Multiplex como auto-prueba con la aplicación SMARTtest podría aumentar la frecuencia de las pruebas de VIH y sífilis, lo que permite una detección más temprana de la infección y reduce la transmisión.
Assuntos
Infecções por HIV , Aplicativos Móveis , Minorias Sexuais e de Gênero , Sífilis , Pessoas Transgênero , Feminino , Infecções por HIV/diagnóstico , Infecções por HIV/prevenção & controle , Homossexualidade Masculina , Humanos , Masculino , Sífilis/diagnósticoRESUMO
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.
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Conselheiros , Infecções por HIV , África Subsaariana , Aconselhamento , Infecções por HIV/prevenção & controle , HumanosRESUMO
Cisgender men who have sex with men (cMSM) and transgender women (TGW) are disproportionally burdened by HIV. Among these populations, HIV partner-testing is a highly acceptable harm reduction tool. Particularly, cMSM and TGW report a stronger preference for blood-based tests that include assays for multiple STIs. However, no existing research has explored how these populations negotiate blood-based testing with sexual partners. In the SMARTtest study, 48 sexually active cMSM and TGW took home dual, blood-based HIV/Syphilis kits for self- and partner-testing. After 3 months, they completed a follow-up assessment and in-depth interviews about their experiences initiating testing. Of the 42 responding participants, 27 (64%) reported that it had been "fairly" or "very easy" to raise the idea of testing with partners. Participants predominantly employed partner-conscious communication strategies, including framing the testing proposal as a mandatory, non-personal component of their participation in a research study, gradually incorporating testing mentions into discussions about sexual health, and using the kits to facilitate joint testing. Yet, 21 (44%) participants reported having sex with at least one partner they did not ask to test. Concern regarding partner reactions emerged as a significant barrier to discussing test use; similarly, many partners were averse to taking a blood-based test in the context of a casual sexual encounter. Nonetheless, these findings suggest that dual, blood-based HIV/STI rapid tests may represent acceptable harm reduction tools among similar populations of cMSM and TGW, particularly if future partner-testing research is broadened to consider key couples' dynamics that may impact test usage.
Assuntos
Infecções por HIV , Minorias Sexuais e de Gênero , Infecções Sexualmente Transmissíveis , Sífilis , Pessoas Transgênero , Feminino , Infecções por HIV/diagnóstico , Homossexualidade Masculina , Humanos , Masculino , Negociação , Cidade de Nova Iorque , Comportamento Sexual , Parceiros Sexuais , Sífilis/diagnósticoRESUMO
PURPOSE: Gender-based stigma is a fundamental cause of mental health disparities among transgender and non-binary (TGNB) individuals, while resilience factors may be protective. We examined prospective relationships between gender-based enacted stigma, psychological distress, and resilience factors among TGNB individuals. METHODS: Between 2016 and 2017, we enrolled 330 TGNB individuals in three metropolitan areas in the U.S. in a prospective cohort study focused on gender identity development, risk, and resilience across the lifespan. Using multilevel regression, we examined prospective associations between enacted gender-based stigma and psychological distress (measured by the Global Severity Index/BSI-18), and examined transgender pride and social support as moderators, adjusting for age, sex assigned at birth, race/ethnicity, education, and income. RESULTS: Our sample was diverse in age (M = 34.4, range 16-87) and race/ethnicity (56.4% non-White). Over 2 years of follow-up, there was a decrease in reported gender-based stigma (b = - 0.61, p < 0.001) and transgender pride (b = - 0.14, p = 0.003), increase in social support (b = 0.21, p < 0.001), and no change in psychological distress. In adjusted analyses, gender-based stigma was positively associated with psychological distress (b = 1.10, p < 0.001) and social support was negatively associated with psychological distress (b = - 2.60, p < 0.001). Transgender pride moderated the relationship between stigma and psychological distress (p < 0.01), such that the association was stronger for lower levels of transgender pride. CONCLUSIONS: Our study provides longitudinal evidence for the deleterious role of gender-based stigma among TGNB individuals. Future interventions should consider fostering transgender pride and social support to promote mental health and mitigate negative effects of gender-based stigma.
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Pessoas Transgênero , Estudos de Coortes , Feminino , Identidade de Gênero , Humanos , Recém-Nascido , Masculino , Saúde Mental , Estudos Prospectivos , Estigma Social , Pessoas Transgênero/psicologia , Estados Unidos/epidemiologiaRESUMO
Perceived HIV stigma and mental health are fluid across the lifespan for people living with perinatally-acquired HIV (PHIV). The process of navigating discredited identities over time in the context of other life demands potentially exerts a toll on the mental health of adolescents and young adults living with PHIV (AYAPHIV). Based on data from a longitudinal study in New York City examining mental health and health risk behaviors among 182 AYAPHIV, we examined if increased perceived HIV stigma predicted mental health, future orientation, HIV-disclosure, and healthcare transition over time (2003-2018). Findings from linear mixed-effects modeling indicated that older age predicted poorer mental health, less future orientation, more HIV-serostatus disclosure, and adult medical services utilization. Perceived stigma was the only significant predictor of mental health and mediated the association between age and mental health-highlighting the importance of addressing stigma across development for AYAPHIV while addressing systems that perpetuate them.
Assuntos
Infecções por HIV , Transição para Assistência do Adulto , Adolescente , Idoso , Feminino , Infecções por HIV/epidemiologia , Humanos , Estudos Longitudinais , Saúde Mental , Cidade de Nova Iorque/epidemiologia , Gravidez , Estigma Social , Adulto JovemRESUMO
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.
Assuntos
Fármacos Anti-HIV , Infecções por HIV , Profilaxia Pré-Exposição , Pessoas Transgênero , Fármacos Anti-HIV/uso terapêutico , Feminino , Infecções por HIV/tratamento farmacológico , Infecções por HIV/prevenção & controle , Humanos , PiridonasRESUMO
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.
Assuntos
Anti-Infecciosos/administração & dosagem , Infecções por HIV/prevenção & controle , Administração Intravaginal , Adulto , Anti-Infecciosos/uso terapêutico , Ensaios Clínicos como Assunto , Feminino , Humanos , Adesão à Medicação/psicologia , Motivação , Aceitação pelo Paciente de Cuidados de Saúde , Preparações Farmacêuticas , Cremes, Espumas e Géis Vaginais/uso terapêuticoRESUMO
Acceptability of rapid HIV self-testing is high but potential users remain concerned about correct use, interpretation of test results, and linkage to care. This article describes user preferences for a smartphone app to mitigate these challenges and how these were integrated into the SMARTtest app to support self- and partner-testing using the INSTI Multiplex®. Sixty men and transgender women who have sex with men self-tested for HIV and syphilis while guided by a prototype app that provided a video, pictorial step-by-step instructions, and sample test results presented textually ("positive," "negative"). Subsequently, participants provided feedback on revisions and additional app content. Participants recommended offering different user modes (self, partner, both), and retaining the video, step-by-step instructions, and textual test results. They strongly favored the ability to save and send test results to sexual partners or providers. These features were integrated into the SMARTtest app to facilitate HIV/syphilis self- and partner-testing, HIV/syphilis status awareness and disclosure, and linkage to care.
Assuntos
Infecções por HIV , Smartphone , Sífilis , Adulto , Idoso , Feminino , Identidade de Gênero , Infecções por HIV/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Parceiros Sexuais , Sífilis/diagnóstico , Adulto JovemRESUMO
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.
Assuntos
Infecções por HIV/prevenção & controle , Homossexualidade Masculina/psicologia , Programas de Rastreamento/métodos , Parceiros Sexuais , Transtornos Relacionados ao Uso de Substâncias/psicologia , Pessoas Transgênero/psicologia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Comportamento de Redução do RiscoRESUMO
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.
Assuntos
Infecções por HIV/diagnóstico , Soropositividade para HIV/diagnóstico , Homossexualidade Masculina/psicologia , Programas de Rastreamento/métodos , Kit de Reagentes para Diagnóstico , Autocuidado/psicologia , Comportamento Sexual , Parceiros Sexuais , Adulto , Feminino , Infecções por HIV/epidemiologia , Infecções por HIV/psicologia , Homossexualidade Masculina/etnologia , Humanos , Entrevistas como Assunto , Masculino , Cidade de Nova Iorque/epidemiologia , Porto Rico , Pesquisa Qualitativa , RiscoRESUMO
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.