About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Unwilling or unable to provide written informed consent for study participation

Trial design

Design model

Parallel

Treatments tested in this trial

B-OK Bead Bottles Intervention (delivered in person)
Behavioral
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.
B-OK Bottles Intervention (delivered by video)
Behavioral
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.
Control
Behavioral
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.

Treatment groups

600 Participants

are divided into 3 treatment groups

Group A: ControlActive comparator 1 intervention

Group B: B-OK Bottles Intervention (delivered in person)Experimental treatment 1 intervention

Group C: B-OK Bottles Intervention (delivered by video)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Accuracy of beliefs about ART effectiveness (composite), 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

Secondary outcomes

1

Accuracy of U=U transmission-risk belief

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

2

Accuracy of belief about personal harm under viral suppression

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

Immediately post-intervention and 6 weeks follow-up

3

Accuracy of beliefs about ART effectiveness (composite), 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

6 weeks follow-up

4

Comprehension of "viral suppression"

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

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts