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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Accuracy of beliefs about ART effectiveness (composite), post-intervention [Срок оценки: Immediately post-intervention]

Вторичные конечные точки (9)

• Accuracy of U=U transmission-risk belief [Срок оценки: Immediately post-intervention and 6 weeks follow-up]
• Accuracy of belief about personal harm under viral suppression [Срок оценки: Immediately post-intervention and 6 weeks follow-up]
• Accuracy of beliefs about ART effectiveness (composite), follow-up [Срок оценки: 6 weeks follow-up]
• Comprehension of "viral suppression" [Срок оценки: Immediately post-intervention and 6 weeks follow-up]
• Comprehension of "U=U" / "Undetectable=Untransmittable" [Срок оценки: Immediately post-intervention and 6 weeks follow-up]
• Attitude - residual transmission concern despite ART [Срок оценки: Immediately post-intervention and 6 weeks follow-up]
• Attitude - HIV fatalism [Срок оценки: Immediately post-intervention and 6 weeks follow-up]
• Intention - condom use under hypothetical viral suppression [Срок оценки: Immediately post-intervention and 6 weeks follow-up]
• Intention - motivation to initiate or continue ART [Срок оценки: Immediately post-intervention and 6 weeks follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07703891 · 26-6783

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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