Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa

25 de agosto de 2026 actualizado por: University of Pennsylvania
Consistent use of antiretroviral therapy (ART) is essential for achieving suppression among people with HIV (PWH). Yet despite improvements in access to ART and improving viral suppression rates, an estimated one-third of PWH globally do not take ART as prescribed, thus allowing the virus to remain detectable and transmissible. This study tests whether a low-cost visual education tool, B-OK bottles, improves understanding of HIV, antiretroviral therapy (ART), and the concept of Undetectable = Untransmittable (U=U) among adults in Gauteng, South Africa using a randomized trial. Participants will be randomly assigned to one of three groups: (1) standard-of-care verbal information based on Department of Health guidelines, (2) information delivered in person using B-OK bottles, or (3) information delivered via a video demonstrating the B-OK bottles. The study will compare the two intervention formats to standard care, and to each other, to assess whether the tool improves knowledge, attitudes, and intentions related to HIV treatment and prevention, and whether the intervention results depend on delivery mode (in-person vs. video). Outcomes will be measured at baseline, immediately after the intervention, and at six-week follow-up.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

600

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Sudáfrica
    • Gauteng
      • Johannesburg, Gauteng, Sudáfrica
        • Reclutamiento
        • Health Economics and Epidemiology Research Office (HE2RO), University of the Witwatersrand
        • Contacto:
          • Caroline Govathson, PhD
          • Número de teléfono: +27 (0)10 001 7930
          • Correo electrónico: cgovathson@heroza.org
        • Investigador principal:
          • Caroline Govathson, PhD
        • Investigador principal:
          • Candice Chetty-Makkan, PhD

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • Aged 18 years or older
  • Residing in Gauteng
  • Able to understand and communicate in English or another study-supported language
  • Willing to attend an in-person study visit at the HE2RO offices
  • Willing to provide contact details for follow-up at six weeks

Exclusion Criteria:

  • Unwilling or unable to provide written informed consent for study participation

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Control
Participants enrolled in the control group will receive standard-of-care verbal information about HIV and ART based on South African Department of Health guidelines, delivered via standardized script.
Conductual: Control
Participants enrolled in this group will receive standard-of-care verbal information about HIV and ART based on South African Department of Health guidelines, delivered via standardized script.
Experimental: B-OK Bottles Intervention (delivered in person)
Participants enrolled in this group will receive information about HIV and ART that is communicated using B-OK bottles as visual aids to make the information more salient. The bottles explain how HIV affects a person's health and how ART reduces viral load and eliminates HIV transmission risk.
Conductual: B-OK Bead Bottles Intervention (delivered in person)
Participants in this group will receive information about HIV and ART that is communicated using B-OK bottles as visual aids to make the information more salient. The bottles explain how HIV affects a person's health and how ART reduces viral load and eliminates HIV transmission risk.
Experimental: B-OK Bottles Intervention (delivered by video)
Participants enrolled in this group will receive information about HIV and ART in the form of a video that illustrates B-OK. The video will use the bottles to explain how HIV affects a person's health and how ART reduces viral load and eliminates HIV transmission risk.
Conductual: B-OK Bottles Intervention (delivered by video)
Participants in this group will receive information about HIV and ART in the form of a video that illustrates the B-OK bead bottles and how they work. The video will demonstrate use of the B-OK bead bottles to explain how HIV affects a person's health and how ART reduces viral load and eliminates HIV transmission risk.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Accuracy of beliefs about ART effectiveness (composite), post-intervention
Periodo de tiempo: Immediately post-intervention

A composite score will be derived from two items assessing beliefs about the effectiveness of HIV treatment, each scored 0-10: (1) prevention benefit - "Imagine a person living with HIV who is taking HIV treatment and has an undetectable viral load. How likely is it that this person would pass HIV to a regular sexual partner?"; (2) clinical benefit - "Imagine a person living with HIV who is taking HIV treatment and has an undetectable viral load. How likely is it that this person would be harmed by HIV?"

The two items will be combined into a composite, to be pre-specified in the statistical analysis plan; lower scores indicate more accurate beliefs about the prevention and clinical benefits of HIV treatment with viral suppression.
Immediately post-intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Accuracy of U=U transmission-risk belief
Periodo de tiempo: Immediately post-intervention and 6 weeks follow-up
The outcome will be measured on a 0-10 scale, based on this question: "Imagine a person living with HIV who is taking HIV treatment and has an undetectable viral load. How likely is it that this person would pass HIV to a regular sexual partner?" Minimum 0, maximum 10; lower scores indicate more accurate beliefs consistent with U=U.
Immediately post-intervention and 6 weeks follow-up
Accuracy of belief about personal harm under viral suppression
Periodo de tiempo: Immediately post-intervention and 6 weeks follow-up
The outcome will be measured on a 0-10 scale, based on this question: "Imagine a person living with HIV who is taking HIV treatment and has an undetectable viral load. How likely is it that this person would be harmed by HIV?" Minimum 0, maximum 10; lower scores indicate more accurate belief.
Immediately post-intervention and 6 weeks follow-up
Accuracy of beliefs about ART effectiveness (composite), follow-up
Periodo de tiempo: 6 weeks follow-up

A composite score will be derived from two items assessing beliefs about the effectiveness of HIV treatment, each scored 0-10: (1) prevention benefit - "Imagine a person living with HIV who is taking HIV treatment and has an undetectable viral load. How likely is it that this person would pass HIV to a regular sexual partner?"; (2) clinical benefit - "Imagine a person living with HIV who is taking HIV treatment and has an undetectable viral load. How likely is it that this person would be harmed by HIV?"

The two items will be combined into a composite, to be pre-specified in the statistical analysis plan; lower scores indicate more accurate beliefs about the prevention and clinical benefits of HIV treatment with viral suppression.
6 weeks follow-up
Comprehension of "viral suppression"
Periodo de tiempo: Immediately post-intervention and 6 weeks follow-up
This outcome measures self-rated understanding of the term "viral suppression," based on the question: "How well do you understand the term 'viral suppression'?" Measured on a 0-10 scale. Minimum 0, maximum 10; higher scores indicate greater comprehension.
Immediately post-intervention and 6 weeks follow-up
Comprehension of "U=U" / "Undetectable=Untransmittable"
Periodo de tiempo: Immediately post-intervention and 6 weeks follow-up
This outcome measures self-rated understanding of the term "U=U" or "Undetectable=Untransmittable," based on the question: "How well do you understand the term 'U=U' or 'Undetectable=Untransmittable'?" Measured on a 0-10 scale. Minimum 0, maximum 10; higher scores indicate greater comprehension.
Immediately post-intervention and 6 weeks follow-up
Attitude - residual transmission concern despite ART
Periodo de tiempo: Immediately post-intervention and 6 weeks follow-up
The outcome measures agreement that HIV medication does not completely eliminate the risk of getting HIV through sex. Measured on a 0-10 scale. Minimum 0, maximum 10; higher scores indicate greater concern.
Immediately post-intervention and 6 weeks follow-up
Attitude - HIV fatalism
Periodo de tiempo: Immediately post-intervention and 6 weeks follow-up

This outcome measures agreement with "Having HIV means I will eventually die from it".

Measured on a 0-10 scale. Minimum 0, maximum 10; higher scores indicate higher fatalistic beliefs about HIV.
Immediately post-intervention and 6 weeks follow-up
Intention - condom use under hypothetical viral suppression
Periodo de tiempo: Immediately post-intervention and 6 weeks follow-up

This outcome measures self-rated likelihood of using a condom to prevent transmission to an HIV-negative partner, in a hypothetical scenario where the participant is virally suppressed on treatment.

Measured on a 0-10 scale. Minimum 0, maximum 10; higher scores indicate greater likelihood of condom use.
Immediately post-intervention and 6 weeks follow-up
Intention - motivation to initiate or continue ART
Periodo de tiempo: Immediately post-intervention and 6 weeks follow-up

This outcome measures the self-rated motivation to stay on or restart HIV treatment.

Measured on a 0-10 scale. Minimum 0, maximum 10; higher scores indicate greater motivation.

For participants living with HIV, the question refers to their own treatment; for participants who are HIV-negative or of unknown status, it is framed as a hypothetical scenario.
Immediately post-intervention and 6 weeks follow-up

Colaboradores e Investigadores

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

Patrocinador

University of Pennsylvania

Colaboradores

Health Economics and Epidemiology Research Office, University of the Witwatersrand

Investigadores

  • Investigador principal: Aaron Richterman, PhD, University of Pennsylvania

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)

27 de julio de 2026

Finalización primaria (Estimado)

1 de septiembre de 2026

Finalización del estudio (Estimado)

1 de noviembre de 2026

Fechas de registro del estudio

Enviado por primera vez

8 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de julio de 2026

Publicado por primera vez (Actual)

15 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de agosto de 2026

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

25 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 26-6783

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

The investigators are still determining the data sharing plan and if we will be sharing IPD yet.

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. .

Suscribir