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Not yet recruiting NCT07703891

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

No phase Interventional HIV HIV Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: B-OK Bead Bottles Intervention (delivered in person), B-OK Bottles Intervention (delivered by video), Control.
Who it may be relevant to
Registry conditions: HIV, HIV Treatment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral 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.
  • Behavioral 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.
  • Behavioral 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.

Primary outcome measures

  • Accuracy of beliefs about ART effectiveness (composite), post-intervention [Time frame: Immediately post-intervention]
Secondary outcome measures (9)
  • Accuracy of U=U transmission-risk belief [Time frame: Immediately post-intervention and 6 weeks follow-up]
  • Accuracy of belief about personal harm under viral suppression [Time frame: Immediately post-intervention and 6 weeks follow-up]
  • Accuracy of beliefs about ART effectiveness (composite), follow-up [Time frame: 6 weeks follow-up]
  • Comprehension of "viral suppression" [Time frame: Immediately post-intervention and 6 weeks follow-up]
  • Comprehension of "U=U" / "Undetectable=Untransmittable" [Time frame: Immediately post-intervention and 6 weeks follow-up]
  • Attitude - residual transmission concern despite ART [Time frame: Immediately post-intervention and 6 weeks follow-up]
  • Attitude - HIV fatalism [Time frame: Immediately post-intervention and 6 weeks follow-up]
  • Intention - condom use under hypothetical viral suppression [Time frame: Immediately post-intervention and 6 weeks follow-up]
  • Intention - motivation to initiate or continue ART [Time frame: Immediately post-intervention and 6 weeks follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07703891 · 26-6783

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗