NCT Number: NCT07703891
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Divya Pandey, PhD
CONTACT
Teniola Egbe, MPH, MBE
CONTACT
University of Pennsylvania
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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