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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV; HIV Treatment
• Intervention / Treatment: Behavioral: Control; Behavioral: B-OK Bead Bottles Intervention (delivered in person); Behavioral: B-OK Bottles Intervention (delivered by video)

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Teniola Egbe, MPH, MBE; Phone Number: 215-898-2939; Email: tegbe@pennmedicine.upenn.edu
• Study Contact Backup: Name: Divya Pandey, PhD; Phone Number: 6123230324; Email: Divya.Pandey@PennMedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately post-intervention and 6 weeks follow-up
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.	Immediately post-intervention and 6 weeks follow-up
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.	6 weeks follow-up
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.	Immediately post-intervention and 6 weeks follow-up
Comprehension of "U=U" / "Undetectable=Untransmittable"	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	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	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	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	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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Health Economics and Epidemiology Research Office, University of the Witwatersrand
• Investigators: Principal Investigator: Aaron Richterman, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: HIV; South Africa; Treatment adherence; Visual tools
• Additional Relevant MeSH Terms: Behavior; Health Behavior; Treatment Adherence and Compliance; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Parturition
• Other Study ID Numbers: 26-6783

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators are still determining the data sharing plan and if we will be sharing IPD yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No