HIVNCT07703891
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
A study testing B-OK Bead Bottles Intervention (delivered in person) and B-OK Bottles Intervention (delivered by video) in people with HIV and HIV Treatment, run by University of Pennsylvania at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, HIV Treatment
- What is being tested?
- B-OK Bead Bottles Intervention (delivered in person) and B-OK Bottles Intervention (delivered by video)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSouth Africa
- Study dates
- 27 Jul 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unwilling or unable to provide written informed consent for study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
Health Economics and Epidemiology Research Office (HE2RO), University of the Witwatersrand
Johannesburg, Gauteng
Caroline Govathson, PhD, +27 (0)10 001 7930, cgovathson@heroza.org
Caroline Govathson, PhD
About this study
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
- Being tested
- B-OK Bead Bottles Intervention (delivered in person), B-OK Bottles Intervention (delivered by video), Control
- Keywords
- South Africa, HIV, Treatment adherence, Visual tools
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-OK Bead Bottles Intervention (delivered in person)Behavioural
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)Behavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: B-OK Bottles Intervention (delivered by video) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately post-intervention
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately post-intervention and 6 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start27 Jul 2026
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Health Economics and Epidemiology Research Office, University of the Witwatersrand
- Responsible party
- Sponsor
- Investigators
- Aaron Richterman, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703891
- Sponsor's protocol ID
- 26-6783
- Status last verified
- Nov 2026
- First submitted
- 8 Jul 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators are still determining the data sharing plan and if we will be sharing IPD yet.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
- ClinicalTrials.gov ID
- NCT07703891
- Acronym / sponsor ID
- 26-6783
- Conditions
- HIV, HIV Treatment
- Keywords
- South Africa, HIV, Treatment adherence, Visual tools
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Health Economics and Epidemiology Research Office, University of the Witwatersrand
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlParticipants 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. |
| B-OK Bottles Intervention (delivered in person) | Experimental | Behavioral: B-OK Bead 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. |
| B-OK Bottles Intervention (delivered by video) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Unwilling or unable to provide written informed consent for study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | B-OK Bottles Intervention (delivered in person) |
| 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. | Behavioural | B-OK Bottles Intervention (delivered by video) |
| ControlParticipants 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. | Behavioural | Control |
Primary outcome
Accuracy of beliefs about ART effectiveness (composite), post-intervention
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided. The investigators are still determining the data sharing plan and if we will be sharing IPD yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron Richterman, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-OK Bead Bottles Intervention (delivered in person) and B-OK Bottles Intervention (delivered by video) in people with HIV and HIV Treatment, run by University of Pennsylvania at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Divya Pandey, PhD (6123230324, Divya.Pandey@PennMedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of beliefs about ART effectiveness (composite), post-intervention (time frame: Immediately post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.