Barriers and facilitators to HIV pre-exposure prophylaxis uptake among transgender women in Colombia: A qualitative analysis using the COM-B model.

Transgender women [TGW] in Colombia are disproportionately affected by HIV due to their low sociodemographic conditions, varied risk behaviours, difficulty accessing health services, and discrimination. Offering pre-exposure prophylaxis [PrEP] as part of a combination of prevention strategies is an appropriate option for this population to reduce their risk of HIV infection. However, little is known about how to implement a PrEP program for TGW in Colombia. Between June and October 2020, we conducted individual interviews with 16 TGW from four different cities in Colombia. The interviews assessed contextual influences, knowledge, skills, perceptions, and beliefs. We used qualitative thematic analysis to identify themes and the Capability, Opportunity, Motivation, and Behavior framework to further delineate barriers and possible interventions. After delineating the main themes across the three subdomains of the model, nine barriers were identified: one related to capability, knowledge, and perception of PrEP; six related to opportunity, which includes, family relations, sexual work environment, stable partner relations, interactions with healthcare workers, health service provision, and community interactions and opportunities; and two related to motivation, mental health, and concerns about medication side effects. Mapping barriers with interventions generated the following intervention functions: education, training, enablement, and environmental structure; and the following policy functions: communication/marketing, legislation, and changes in service provision. Examples of possible interventions are presented and discussed.

Scales to Assess Knowledge, Motivation, and Self-Efficacy for HIV PrEP in Colombian MSM: PrEP-COL Study.

OBJECTIVE: We evaluated the construct validity Spanish version of knowledge, stigma, norms, and self-efficacy scales regarding PrEP in MSM. METHODS: Sample of 287 MSM. Exploratory confirmatory factor analysis and item response theory were used to validate the constructs. Correlations and confidence interval-based estimation of relevance analyses were conducted to correlate the scales with willingness and intention to use PrEP. RESULTS: Attitude, stigma, and descriptive and subjective norms scales showed good construct validity and were related to intention and willingness to use PrEP. However, the knowledge scale and self-efficacy scales require further refinement. CONCLUSIONS: The study provides useful information for assessing information, motivation, and self-efficacy related to PrEP use. Our results could be used to test the scales and the theoretical model in other contexts to confirm their usefulness.

[Effectiveness and safety of generic version of lamivudine/tenofovir and efavirenz in treatment naïve HIV-infected patients: a nonrandomized, open-label, phase IV study in Cali-Colombia, 2012-2014]. / Efectividad y seguridad del esquema genérico lamivudina/tenofovir y efavirenz en pacientes con VIH/SIDA naïve: estudio fase IV no aleatorizado, Cali-Colombia 2012-2014.

BACKGROUND: Clinical studies aimed to evaluating the quality of generic drugs may be useful to strengthen policies of access to combined antiretroviral therapy (cART). AIM: To describe the effectiveness and safety of the generic schema lamivudine/tenofovir/efavirenz (3TC/TDF/EFV) in patients with HIV/AIDS naive, belonging to a comprehensive care program. METHODS: A nonrandomized, open-label, phase IV study, during 2012 to 2014 naive HIV-infected patients 18 years or older with indication to receive cART were recruited. Patients were treated with generic scheme 3TC/TDF/EFV and were followed-up during 12 months. Clinical, immunological and laboratory parameters were assessed at baseline, 3, 6 and 12 months of treatment. RESULTS: Of the 40 patients, 30 (75%) met the 12 months of treatment; of them, 80% achieved undetectable viral load (< 40 copies/mL) and 83.3% viral load < 50 copies/mL. Additionally, there was a significant increase (173 cells/mm3) in the median for CD4 T lymphocyte count. Moreover, the results of the whole blood count, creatinine and transaminases were preserved in normal ranges and did not generate changes in the cART. Potential side effects of antiretroviral drugs occurred in less than 10% of patients and had no serious implications. CONCLUSIONS: In this small group of patients, the generic scheme 3TC/TDF/EFV is effective and safe in the treatment of patients with HIV/AIDS naïve, and its effectiveness and safety profile is similar to show by innovator scheme 3TC/TDF/EFV in patients with similar clinical conditions. Registro Estudio: Registro Público Cubano de Ensayos Clínicos (RPCEC) ID: RPCEC00000134. Registered 20 July 2012.

Efectividad y seguridad del esquema genérico lamivudina/tenofovir y efavirenz en pacientes con VIH/SIDA naïve: estudio fase IV no aleatorizado, Cali-Colombia 2012-2014 / Effectiveness and safety of generic version of lamivudine/tenofovir and efavirenz in treatment naïve HIV-infected patients: a nonrandomized, open-label, phase IV study in Cali-Colombia, 2012-2014

Resumen Antecedentes: Los estudios clínicos orientados a evaluar la calidad de medicamentos genéricos pueden ser útiles para fortalecer políticas de acceso a terapia anti-retroviral combinada (TARc). Objetivo: Describir la efectividad y seguridad del esquema genérico lamivudina/tenofovir/efavirenz (3TC/TDF/EFV) en pacientes con infección por VIH/SIDA naïve, pertenecientes a un programa de atención integral. Materiales/Métodos: Estudio clínico prospectivo fase IV abierto y sin grupo control. Entre 2012-2014, se incluyeron y siguieron 40 pacientes con infección por VIH/SIDA naïve y con indicación para iniciar tratamiento. Los pacientes fueron tratados con el esquema genérico 3TC/TDF/EFV y fueron seguidos durante 12 meses. El seguimiento incluyó valoración clínica, parámetros inmunovirológicos y de laboratorio, al inicio del tratamiento y a los 3, 6 y 12 meses. Resultados: De los 40 pacientes, 30 (75%) cumplieron los doce meses de tratamiento; de ellos, 80% alcanzó CV indetectable (< 40 copias/mL) y 83,3% CV < 50 copias/mL. Adicionalmente, en el grupo hubo un incremento en la mediana de 173 linfocitos TCD4/mm3. Por su parte, los resultados del hemograma completo, creatininemia y transaminasas hepáticas se conservaron en rangos normales y no generaron cambios del TARc. Los efectos adversos reconocidos para estos medicamentos se presentaron en menos de 10% de los pacientes y no tuvieron implicaciones graves. Conclusiones: En este grupo pequeño de pacientes, el esquema genérico 3TC/TDF/EFV es efectivo y seguro en el tratamiento de pacientes con infección por VIH/SIDA naïve, y su perfil de efectividad y seguridad es similar al del esquema 3TC/TDF/EFV innovador en pacientes con condiciones clínicas similares.

Background: Clinical studies aimed to evaluating the quality of generic drugs may be useful to strengthen policies of access to combined antiretroviral therapy (cART). Aim: To describe the effectiveness and safety of the generic schema lamivudine/tenofovir/efavirenz (3TC/TDF/EFV) in patients with HIV/AIDS naive, belonging to a comprehensive care program. Methods: A nonrandomized, open-label, phase IV study, during 2012 to 2014 naive HIV-infected patients 18 years or older with indication to receive cART were recruited. Patients were treated with generic scheme 3TC/TDF/EFV and were followed-up during 12 months. Clinical, immunological and laboratory parameters were assessed at baseline, 3, 6 and 12 months of treatment. Results: Of the 40 patients, 30 (75%) met the 12 months of treatment; of them, 80% achieved undetectable viral load (< 40 copies/mL) and 83.3% viral load < 50 copies/mL. Additionally, there was a significant increase (173 cells/mm3) in the median for CD4 T lymphocyte count. Moreover, the results of the whole blood count, creatinine and transaminases were preserved in normal ranges and did not generate changes in the cART. Potential side effects of antiretroviral drugs occurred in less than 10% of patients and had no serious implications. Conclusions: In this small group of patients, the generic scheme 3TC/TDF/EFV is effective and safe in the treatment of patients with HIV/AIDS naïve, and its effectiveness and safety profile is similar to show by innovator scheme 3TC/TDF/EFV in patients with similar clinical conditions. Registro Estudio: Registro Público Cubano de Ensayos Clínicos (RPCEC) ID: RPCEC00000134. Registered 20 July 2012.

Características de personas que retornan voluntariamente a repetirse la prueba de VIH, 2012-2015 / Characteristics of people who voluntarily repeat the HIV test, 2012-2015

RESUMEN Objetivo Comparar características de personas con prácticas sexuales de riesgo que acudieron a campañas voluntarias de toma de una primera prueba de Virus de la Inmunodeficiencia Humana (VIH) y el retorno voluntario a repetirse la prueba en meses posteriores. Método Entre 2012 y 2015 en Cali, participaron voluntariamente 82 personas mayores de 18 años. Se implementó un cuestionario estructurado para evaluar características sociodemográficas, conocimientos y comportamientos relacionados con VIH. Se hicieron análisis descriptivos y de comparación de muestras relacionadas. Resultados Edad promedio de participantes 26,9±8,6 años. El 100% eran hombres con orientación sexual homosexual. La mayoría con baja escolaridad e ingresos. Cerca de la mitad reportó consumo riesgoso de alcohol y sustancias psicoactivas. La mayoría tenía bajo conocimiento sobre la transmisión del VIH y bajo uso de condón con pareja estable. La comparación entre el momento de la primera prueba de VIH y la repetición posterior no evidenció cambios significativos en conocimientos y comportamientos, únicamente se observó menor reporte del consumo de sustancias (p=0,0209) y aumento de realización de tatuajes/piercing (p=0,0455). Resultado reactivo en la repetición de la prueba fue 4,9% (I.C95% 0,1%-9,6%). Conclusión Los resultados sugieren que el retorno voluntario a repetirse la prueba del VIH en este grupo de personas que comparten prácticas de riesgo para la infección por VIH no evidencia cambios en los conocimientos o comportamientos.(AU)

ABSTRACT Objective To compare the characteristics of people with risky sexual behavior who participated in campaigns directed to take the first HIV test and voluntarily returned to retake the test afterwards. Materials and Methods In Cali Colombia, between 2012 and 2015, 82 people over the age of 18 participated voluntarily in this campaign. A structured questionnaire was applied to assess sociodemographic characteristics, knowledge and behaviors related to HIV. Descriptive and comparative analyses of related samples were performed. Results The average age of the participants was 26.9±8.6 years. 100% were homosexual men, mostly with low educational attainment and income. Nearly half of the sample reported risky use of alcohol and psychoactive substances. Most of them had little knowledge about HIV transmission and a low rate of condom use with a stable partner. The comparison between the moment when the first HIV test was taken and the repetition did not show significant changes regarding knowledge and behaviors, only a lower report of substance use (p=0.0209) and an increase in the practice of tattoos/piercings (p=0.0455). The reactive result of the second test was 4.9% (95%CI: 0.1%-9.6%). Conclusion The results suggest that the voluntary return to retake the HIV test in this group of people who share risk practices for HIV infection does not show changes in knowledge or behavior.(AU)

[Characteristics of people who voluntarily repeat the HIV test, 2012-2015]. / Características de personas que retornan voluntariamente a repetirse la prueba de VIH, 2012-2015.

OBJECTIVE: To compare the characteristics of people with risky sexual behavior who participated in campaigns directed to take the first HIV test and voluntarily returned to retake the test afterwards. MATERIALS AND METHODS: In Cali Colombia, between 2012 and 2015, 82 people over the age of 18 participated voluntarily in this campaign. A structured questionnaire was applied to assess sociodemographic characteristics, knowledge and behaviors related to HIV. Descriptive and comparative analyses of related samples were performed. RESULTS: The average age of the participants was 26.9±8.6 years. 100% were homosexual men, mostly with low educational attainment and income. Nearly half of the sample reported risky use of alcohol and psychoactive substances. Most of them had little knowledge about HIV transmission and a low rate of condom use with a stable partner. The comparison between the moment when the first HIV test was taken and the repetition did not show significant changes regarding knowledge and behaviors, only a lower report of substance use (p=0.0209) and an increase in the practice of tattoos/piercings (p=0.0455). The reactive result of the second test was 4.9% (95%CI: 0.1%-9.6%). CONCLUSION: The results suggest that the voluntary return to retake the HIV test in this group of people who share risk practices for HIV infection does not show changes in knowledge or behavior.

OBJETIVO: Comparar características de personas con prácticas sexuales de riesgo que acudieron a campañas voluntarias de toma de una primera prueba de Virus de la Inmunodeficiencia Humana (VIH) y el retorno voluntario a repetirse la prueba en meses posteriores. MÉTODO: Entre 2012 y 2015 en Cali, participaron voluntariamente 82 personas mayores de 18 años. Se implementó un cuestionario estructurado para evaluar características sociodemográficas, conocimientos y comportamientos relacionados con VIH. Se hicieron análisis descriptivos y de comparación de muestras relacionadas. RESULTADOS: Edad promedio de participantes 26,9±8,6 años. El 100% eran hombres con orientación sexual homosexual. La mayoría con baja escolaridad e ingresos. Cerca de la mitad reportó consumo riesgoso de alcohol y sustancias psicoactivas. La mayoría tenía bajo conocimiento sobre la transmisión del VIH y bajo uso de condón con pareja estable. La comparación entre el momento de la primera prueba de VIH y la repetición posterior no evidenció cambios significativos en conocimientos y comportamientos, únicamente se observó menor reporte del consumo de sustancias (p=0,0209) y aumento de realización de tatuajes/piercing (p=0,0455). Resultado reactivo en la repetición de la prueba fue 4,9% (I.C95% 0,1%-9,6%). CONCLUSIÓN: Los resultados sugieren que el retorno voluntario a repetirse la prueba del VIH en este grupo de personas que comparten prácticas de riesgo para la infección por VIH no evidencia cambios en los conocimientos o comportamientos.

Effectiveness and safety of generic version of abacavir/lamivudine and efavirenz in treatment naïve HIV-infected patients: a nonrandomized, open-label, phase IV study in Cali-Colombia, 2011-2012.

BACKGROUND: Generic drug policies are often associated with concerns about the quality and effectiveness of these products. Phase IV clinical trials may be a suitable design to assess the effectiveness and safety of generic drugs. The objective of this study was to describe the effectiveness and the safety of the generic abacavir/lamivudine and efavirenz in treatment-naïve HIV-infected patients. METHODS: A monocentric, nonrandomized, open-label, phase IV study in treatment naïve HIV-infected patients 18 years or older with indication to receive abacavir/lamivudine and efavirenz were recruited from a program that provides comprehensive outpatient consultation and continuing care. The primary end-point was to achieve viral load <40 copies/mL at 12 months after baseline to assess effectiveness. Secondary end-point of the study were 1) to asses increasing in T-CD4 lymphocytes levels as accompaniment to asses effectiveness, and 2) to assess both gastrointestinal, skin, and central nervous system symptoms, and lipid profile, cardiovascular risk, renal, and hepatic function as safety profile. Data were determined at baseline, 3, 6, and 12 months. Close clinical monitoring and pharmaceutical care were used for data collection. Wilcoxon matched-pairs signed-rank test was used to compare proportions or medians. RESULTS: Sixty patients were invited to participate in the study; 42 were enrolled and 33 completed the follow-up. Of the nine patients excluded from the study, only one was withdrawn due to adverse events. At 12 months, 31 of 42 patients (73.8 % in intention-to-treat analysis) achieved a viral load of HIV1 RNA <40 copies/mL. There was a significant increase (172 cells/mm3) in the median for CD4 T lymphocyte count. The adverse events were mild and met the safety profile for this antiretroviral regimen, mainly of central nervous system symptoms, skin rash, lipid abnormalities, and an increase of 2 % in the median of the percentage of cardiovascular risk. CONCLUSIONS: The clinical outcomes of generic version of abacavir/lamivudine and efavirenz in HIV treatment naïve patients showed the expected safety and effectiveness profile of proprietary ARV drugs. TRIAL REGISTRATION: Registro Público Cubano de Ensayos Clínicos (RPCEC) ID: RPCEC00000202 . Registered 19 November 2015.

Resistencia a fármacos en pacientes en tratamiento antirretroviral, Cali, Colombia, 2008-2010 / HIV drug resistance in ART-experienced patients in Cali, Colombia, 2008-2010

Introducción. En Colombia se ha publicado poco sobre farmacorresistencia del VIH en pacientes que reciben tratamiento antirretroviral. Las guías de VIH de Colombia de 2006, no recomiendan el uso de los estudios de genotipo de resistencia en pacientes nunca expuestos a medicamentos antirretrovirales ni después del primer fracaso terapéutico. Objetivo. Determinar la frecuencia de mutaciones de resistencia y el grado de sensibilidad/resistencia del VIH a los antirretrovirales en pacientes que han recibido tratamiento antirretroviral. Materiales y métodos. Se reclutó una muestra no probabilística de 170 pacientes con infección por VIH que recibían tratamiento antirretroviral, experimentaban fracaso virológico y que tenían estudios de genotipo de resistencia. Se estudió la farmacorresistencia del VIH en dos grupos: estudios de genotipo de resistencia tempranos Vs . tardíos. Resultados. El tipo de resistencia más frecuente en pacientes bajo tratamiento antirretroviral, afectó a los inhibidores no nucleosídicos (76 %). El grupo de estudio tardío tuvo mayor riesgo de resistencia a inhibidores nucleosídicos y a los inhibidores de proteasa, mayor número de mutaciones de resistencia y mayor complejidad de las resistencias, que el grupo de estudio temprano. También, se encontró un alto grado (30 %) de resistencia cruzada a los inhibidores nucleosídicos en el grupo de estudio tardío. Los medicamentos menos afectados fueron tenofovir y darunavir. Conclusiones. Los resultados de este estudio sugieren que practicar estudios de genotipo de resistencia tardíos se asocia con altos niveles de resistencia, lo cual puede restringir el uso de un gran número de antirretrovirales esenciales en esquemas subsiguientes. Es necesario revisar las actuales recomendaciones sobre el uso de dichos exámenes en las guías colombianas de manejo de VIH.

Introduction: Little has been published in Colombia on HIV drug resistance in patients taking antiretroviral treatment (ART). Currently, the Colombian guidelines do not recommend the use of genotypic antiretroviral resistance tests (GART) for treatment-naive patients or for those experiencing a first therapeutic failure. Objective: To determine the frequency of relevant resistance mutations and the degree of susceptibility/ resistance of HIV to antiretroviral drugs (ARVs) in ART-experienced patients. Materials and methods: A non-random sample of 170 ART-experienced HIV patients with virologic failure and who underwent GART was recruited. A study of HIV drug resistance was carried out in two groups of patients: one group that underwent early GART and the other group that received late GART testing. Results: The most frequent type of resistance affected the non-nucleoside class (76%). The late-GART group had higher risk of nucleoside analog and protease inhibitor drug resistance, a higher number of resistance mutations and more complex mutational profiles than the early-GART group. A high cross resistance level (30%) was found in the nucleoside analog class. The least affected medications were tenofovir and darunavir. Conclusions: Our results suggest that performing GART late is associated with levels of ARV resistance that could restrict the use of an important number of essential ARV in subsequent regimens. There is a need to revise the current recommendations to include GART prior to start of treatment and after the first virologic failure.

Resistencia transmitida del virus de la inmunodeficiencia humana en pacientes sin exposición previa a tratamiento antirretroviral, Cali, Colombia, 2010 / Transmitted HIV Resistance in ART-Naïve Patients in Cali, Colombia, 2010

Introducción: En Colombia, existe poca información publicada sobre farmacorresistencia transmitida en el virus de inmunodeficiencia humana (VIH), y actualmente, las pruebas genotípicas de resistencia no son recomendadas por las guías colombianas para pacientes nunca expuestos ( naïve ) a terapia antirretroviral (TAR). Se condujo un estudio para determinar la frecuencia de resistencias transmitidas en pacientes naïve a TAR, quienes fueron atendidos en una clínica especializada en VIH/síndrome de inmunodeficiencia adquirida en Cali, Colombia. Metodología: Se realizó un estudio transversal en 152 pacientes adultos elegibles, con infección confirmada por VIH, naïve a TAR, con pruebas genotípicas de resistencia disponibles, y que accedieron a participar. El período de reclutamiento fue de 2008 a 2010. Las mutaciones de resistencias incluidas en el análisis fueron las definidas por la Organización Mundial de la Salud 2009 e International AIDS Society-USA 2010. Adicionalmente, se recolectó información sociodemográfica y condiciones relacionadas con el VIH. Resultados: La edad promedio fue 32 ± 10,2 años, 76% fueron hombres. La frecuencia de resistencia primaria fue de 6,6% (según la lista de Bennett-Organización Mundial de la Salud 2009), pero se encontró algún nivel de resistencia hasta en un 11,8% de los casos (al considerar mutaciones de la lista International AIDS Society-USA 2010). Las mutaciones más comunes fueron K103N/S (2%), F77L (2%) y M46L (2%). Mutaciones a los inhibidores no nucleosídicos de transcriptasa reversa fueron encontradas en 5,3%, mutaciones a los inhibidores no nucleosídicos de transcriptasa reversa en 3,9% y mutaciones a inhibidor de proteasa en 2% de las secuencias. El único factor relacionado con la resistencia primaria fue la duración de la infección por VIH. Conclusiones: La frecuencia de resistencia transmitida es similar a la encontrada en estudios previos en Colombia y en otros países con amplio uso de antirretrovirales, y está por encima del umbral sobre el cual sería costo-efectivo incluir el estudio genotípico de resistencias como test de rutina antes de la iniciación de la TAR, especialmente en pacientes con infección por VIH de menos de un año de duración.

Introduction: In Colombia, little has been published on HIV-transmitted drug resistance, and genotype resistance testing (GART) is not recommended for antiretroviral therapy (ART)-Naïve patients, according to Colombian HIV guidelines. We conducted a study to determine the frequency of HIV-transmitted drug resistance from a sample of ART-Naïve patients attending an HIV clinic in Cali, Colombia. Methodology: A cross-sectional study was carried out on 152 eligible adult patients with confirmed HIV infection who were ART-Naïve, had HIV GART results, and who agreed to participate. The recruitment period was from 2008 to 2010. Resistance mutations included in the analysis are those defined by the WHO- 2009 and IAS-USA, 2010. Additional data was collected, including socio-demographic characteristics and HIV-related conditions. Results: The mean age was 32 ±10.2 years; 76% were men. Frequency of transmitted drug resistance was 6.6%, but some level of resistance was found in up to 11.8% of total cases (if IAS-USA 2010 mutations were also included). The most common mutations were K103N/S (2%), F77L (2%) and M46L (2%). NNRTI mutations were found in 5.3%, NRTI mutations in 3.9% and PI mutations in 2% of the sequences. The only factor associated with primary resistance was the duration of HIV infection.

[HIV drug resistance in ART-experienced patients in Cali, Colombia, 2008-2010]. / Resistencia a fármacos en pacientes en tratamiento antirretroviral, Cali, Colombia, 2008-2010.

INTRODUCTION: Little has been published in Colombia on HIV drug resistance in patients taking antiretroviral treatment (ART). Currently, the Colombian guidelines do not recommend the use of genotypic antiretroviral resistance tests (GART) for treatment-naive patients or for those experiencing a first therapeutic failure. OBJECTIVE: To determine the frequency of relevant resistance mutations and the degree of susceptibility/ resistance of HIV to antiretroviral drugs (ARVs) in ART-experienced patients. MATERIALS AND METHODS: A non-random sample of 170 ART-experienced HIV patients with virologic failure and who underwent GART was recruited. A study of HIV drug resistance was carried out in two groups of patients: one group that underwent early GART and the other group that received late GART testing. RESULTS: The most frequent type of resistance affected the non-nucleoside class (76%). The late-GART group had higher risk of nucleoside analog and protease inhibitor drug resistance, a higher number of resistance mutations and more complex mutational profiles than the early-GART group. A high cross resistance level (30%) was found in the nucleoside analog class. The least affected medications were tenofovir and darunavir. CONCLUSIONS: Our results suggest that performing GART late is associated with levels of ARV resistance that could restrict the use of an important number of essential ARV in subsequent regimens. There is a need to revise the current recommendations to include GART prior to start of treatment and after the first virologic failure.