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

2026年8月25日 更新者：University of Pennsylvania
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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

600

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • 南アフリカ
    • Gauteng
      • Johannesburg、Gauteng、南アフリカ
        • 募集
        • Health Economics and Epidemiology Research Office (HE2RO), University of the Witwatersrand
        • コンタクト：
        • 主任研究者：
          • Caroline Govathson, PhD
        • 主任研究者：
          • Candice Chetty-Makkan, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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.
行動：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.
実験的：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.
行動：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.
実験的：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.
行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Accuracy of beliefs about ART effectiveness (composite), post-intervention
時間枠：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.
Immediately post-intervention

二次結果の測定

結果測定
メジャーの説明
時間枠
Accuracy of U=U transmission-risk belief
時間枠：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.
Immediately post-intervention and 6 weeks follow-up
Accuracy of belief about personal harm under viral suppression
時間枠：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.
Immediately post-intervention and 6 weeks follow-up
Accuracy of beliefs about ART effectiveness (composite), follow-up
時間枠：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.
6 weeks follow-up
Comprehension of "viral suppression"
時間枠：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.
Immediately post-intervention and 6 weeks follow-up
Comprehension of "U=U" / "Undetectable=Untransmittable"
時間枠：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.
Immediately post-intervention and 6 weeks follow-up
Attitude - residual transmission concern despite ART
時間枠：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.
Immediately post-intervention and 6 weeks follow-up
Attitude - HIV fatalism
時間枠：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.
Immediately post-intervention and 6 weeks follow-up
Intention - condom use under hypothetical viral suppression
時間枠：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.
Immediately post-intervention and 6 weeks follow-up
Intention - motivation to initiate or continue ART
時間枠：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.
Immediately post-intervention and 6 weeks follow-up

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Pennsylvania

協力者

Health Economics and Epidemiology Research Office, University of the Witwatersrand

捜査官

  • 主任研究者：Aaron Richterman, PhD、University of Pennsylvania

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年7月27日

一次修了 (推定)

2026年9月1日

研究の完了 (推定)

2026年11月1日

試験登録日

最初に提出

2026年7月8日

QC基準を満たした最初の提出物

2026年7月8日

最初の投稿 (実際)

2026年7月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月27日

QC基準を満たした最後の更新が送信されました

2026年8月25日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 26-6783

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

The investigators are still determining the data sharing plan and if we will be sharing IPD yet.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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