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Formación de Profesionales de la Salud 2: Objetivo 1 (THP-2)

9 de octubre de 2026 actualizado por: University of Minnesota

Evaluación de los efectos de la capacitación en salud reproductiva en el comportamiento de los proveedores

The goal of this randomized, controlled, single blinded trial is to evaluate the medium to long-term effects of an Afrocentric sexual health curriculum on health professional students' knowledge, attitudes, and clinical skills in providing sexual health in Tanzania.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

All enrollees will be health students at MUHAS recruited through announcements in class, flyers on student noticeboards, and email. Students who are interested in learning more about the study can do so by asking questions of the recruiting faculty member, by going to, telephoning, or emailing the study office (at MUHAS). Students can also visit the study website. In addition, all students who contact the office will be given a copy of a flyer advertising the study and a copy of the consent documents to preview prior to participation. Students contacting the office by email will be sent electronic versions of the same documents.

Participants in Aim 1 are informed to schedule an appointment (in the month prior to the seminar) to complete a pre-evaluation. At the study site, participants complete pen and paper surveys, and are videotaped interviewing two standardized patients. Next, participants are randomized to either the intervention or waitlist control condition. Participants in the intervention will attend the 4-day sexual health seminar and complete a short post-test. In addition, at 6- and 12-month follow-up after the pre-test, participants in both arms complete surveys and two videotaped interviews (at each follow-up) and a final survey at 24-month follow-up. At the end of the study, participants assigned to the control condition can attend the seminar.

Tipo de estudio

Intervencionista

Inscripción (Actual)

312

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Dar es Salaam, Tanzania
        • Muhimbili University of Health and Allied Sciences

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • A health student studying at MUHAS and verified by being registered as a pre-final year midwifery, nursing or medical student (or its equivalent).
  • "Pre-final" year is defined as a student who is just about to enter year 3 of nursing, or year 4 of midwifery or medicine.
  • Living or studying in Tanzania
  • Experienced, operationalized as having worked at least 100 hours as a health worker in a clinic, hospital or community setting so students can discuss what happens in the clinical setting
  • Able to speak English and Kiswahili.

Exclusion Criteria:

  • Students who will not be able to attend all days of the seminar at their health institution or be on their campus for the follow-up.
  • Students who express any reservations about attending (e.g., due to religious objections)
  • Students who express a fear of violence due to attending (e.g., from a spouse or relative).
  • Students who attended the sexual health seminar (e.g., during THP-1 or at another site). This is to prevent a student participating more than once.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Comprehensive Sexual Health Curriculum

Participants received a four-day comprehensive sexual health curriculum tailored for Africa.

This is a randomized, controlled, single blinded, trial, stratified by health profession, of the intervention versus waitlist control assessing the effects on sexual health knowledge, attitudes, and sexual history and counseling skills at medium (6-) and long-term (12 and 24 months) follow-up. At the end of the intervention as compared with waitlist controls.

The intervention was a 4-day, Afrocentric, comprehensive sexual health curriculum. Tanzanian faculty wrote the curriculum in English and Kiswahili to address the most common sexual health challenges clinicians experience in Tanzania. The 4-day curriculum covers sexual health across the lifespan, lesbian, gay, bisexual, and transgender (LGBT) and sexual violence, clinical skills training, ethics, and community resources and cultural considerations.

Sin intervención: Waitlist Control

Participants in this arm completed a follow-up survey and scheduled to receive the intervention after the end of the trial.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Sexual Health Knowledge Score
Periodo de tiempo: Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.

Sexual health knowledge was assessed using 16 multichoice items created by the research team. The items covered female sexual health concerns (2 items), sexual development and masturbation (3 items), sexual orientation (3 items), sexual violence (3 items), sexuality in middle age (3 items), sexual history taking and sexual counseling (2 items). Total scores were used for analysis (maximum total score of 16). Participants get one point for every item answer correctly. Because there are 16 items in this section, participants can have a minimum total score of 0 and a maximum total score of 16. A higher score signifies better sexual health knowledge.

Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.
Change in Sexual Health Attitudes: Confidence in Ability to Discuss
Periodo de tiempo: Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.

Confidence in their ability to discuss the sexual health of patients, and confidence in their ability to discuss their patients' sexual health concerns were assessed using the Sexual Health Education for Professionals Scale (SHEPS). This section consists of 37 items where participants rate their confidence from (1) very unconfident to (5) confident. Because there are 37 items in this section, participants can have a minimum total score of 37 and a maximum total score of 185. A higher value signifies better confidence in the ability to discuss sexual health topics.

Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.
Change in Sexual Health Attitudes: Confidence in Having Knowledge
Periodo de tiempo: Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.

Confidence in their knowledge to assess the sexual health of patients, and confidence in their ability to discuss their patient's sexual health concerns were assessed using the Sexual Health Education for Professionals Scale (SHEPS). This section consists of 37 items where participants rate their confidence from (1) very unconfident to (5) confident. Because there are 37 items in this section, participants can have a minimum total score of 37 and a maximum total score of 185. A higher value signifies better confidence in having knowledge of sexual health topics.

Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.
Change in Sexual Counseling Skills: Interpersonal Communications
Periodo de tiempo: Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.

Skills were assessed by faculty raters assessing two videos (per each time point) of student counseling blind to whether the participant was in the intervention or control group and whether the assessment was at baseline or follow-up. Each participant was rated on 10 items assessing their interpersonal communication (IC) abilities. Each item was on a 3-point scale (0=not done; 1=partially done; 2=done). The scale has a minimum score of 0 and a maximum score of 20 per video. The investigators aggregated scores for each time point by summing the two videos at each time point. Therefore, the minimum total score is 0 and the maximum total score is 40. A higher score value signifies better interpersonal communication skills.

Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.
Change in Sexual Counseling Skills: Medical History Taking
Periodo de tiempo: Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.

Skills were assessed by faculty raters assessing the two videos (per time point) of student counseling blind to whether the participant was in the intervention or control group and whether the assessment was at baseline or follow-up. Medical history taking (MHT) was rated by six key pieces of information on a 2-point scale, where 0=not obtained information and 1=obtained information. The scale has a minimum score of 0 and a maximum score or 6 per video. The investigators aggregated scores for each time point by summing the two videos at each time point. Therefore, the minimum total score is 0 and the maximum total score is 12.

Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.
Change in Sexual Health Beliefs
Periodo de tiempo: Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.

The SHEPS Attitudes section comprises 27 items. Participants rate their level of agreement (1=strongly agree; 5=strongly disagree), with 13 items being reverse coded. Because there are 27 items in this section, participants can have a minimum total score of 27 and a maximum total score of 135. Low scores correspond to "liberal" views and high scores correspond to "conservative" views.

Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: B.R. Simon Rosser, PhD, University of Minnesota

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

28 de junio de 2024

Finalización primaria (Actual)

1 de octubre de 2026

Finalización del estudio (Estimado)

31 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

20 de mayo de 2024

Primero enviado que cumplió con los criterios de control de calidad

20 de mayo de 2024

Publicado por primera vez (Actual)

24 de mayo de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • R01HD092655 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Only group data will be analyzed.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .