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

NCT07703891 | Not Yet Recruiting

• 1 other identifier: 26-6783
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV; HIV Treatment

Keywords

South Africa; HIV; Treatment adherence; Visual tools

Outcome Measures

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.

  Immediately post-intervention

Secondary Outcomes (9)

• Accuracy of U=U transmission-risk belief

  Immediately post-intervention and 6 weeks follow-up

• Accuracy of belief about personal harm under viral suppression

  Immediately post-intervention and 6 weeks follow-up

• Accuracy of beliefs about ART effectiveness (composite), follow-up

  6 weeks follow-up

• Comprehension of "viral suppression"

  Immediately post-intervention and 6 weeks follow-up

• Comprehension of "U=U" / "Undetectable=Untransmittable"

  Immediately post-intervention and 6 weeks follow-up

Study Arms (3)

Control

ACTIVE COMPARATOR

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

B-OK Bottles Intervention (delivered in person)

EXPERIMENTAL

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)

B-OK Bottles Intervention (delivered by video)

EXPERIMENTAL

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)

Interventions

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 in person)

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.

B-OK Bottles Intervention (delivered by video)

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Health Economics and Epidemiology Research Office, University of the Witwatersrand: collaborator

MeSH Terms

Conditions

Treatment Adherence and Compliance

Interventions

Parturition

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Aaron Richterman, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Divya Pandey, PhD

CONTACT

6123230324; Divya.Pandey@PennMedicine.upenn.edu

Teniola Egbe, MPH, MBE

CONTACT

215-898-2939; tegbe@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 15, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07