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治験 NCT07425925（対象：HIV-related Stigma、心理的幸福、ケアの維持）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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ルンド大学Digital Peer-support-based Anti-HIV Stigma Intervention Among Adolescents Living With HIV in Ethiopia 282 思春期
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07425925 は 介入研究 臨床試験 で、HIV-related Stigma、心理的幸福、ケアの維持 に関するものです。現在は 募集中 で、2025年11月13日 から開始しています。282 名の参加者 の募集が計画されています。この試験は ルンド大学 によって主導され、2026年5月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月23日 です。
概要
Advances in HIV care and treatment turned a once deadly disease into a chronic condition where people living with HIV, including perinatally HIV acquired children, can now lead a healthy life and live longer with their highly effective antiretroviral therapy. Despite the advancements and successes in HIV care and treatment, HIV-related stigma remained a challenge to people living with HIV and for the provision of the...もっと見る
詳細説明
Introduction The advent of the antiretroviral therapy (ART) and its widespread use have turned HIV/AIDS, a condition once considered as a death sentence, into a chronic disease with perinatally HIV infected children are now living longer and transition into adulthood. Despite this clinical success story, psychological wellbeing of adolescents is overlooked, mainly due to HIV-related stigma, as interventions to reduce...もっと見る
公式タイトル
Feasibility and Effectiveness of Digital Peer-support-based Anti-HIV Stigma Intervention in Improving Clinical Outcomes Among Adolescents Living With HIV in Ethiopia
疾患名
HIV-related Stigma心理的幸福ケアの維持刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- Dnr 2023-04045-01
NCT番号
開始日
2025-11-13
最終更新日
2026-02-23
終了予定日
2026-05-01
目標参加者数
282
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
digital peer-support
HIV-related stigma
adolescents living with HIV
south Ethiopia
HIV-related stigma
adolescents living with HIV
south Ethiopia
主目的
医療サービス研究
割付方法
非無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Digital peer support In the digital peer support arm, adolescents and youth living with HIV will be networked digitally to share their experiences and receive a structured educational message designed based on literature review and also referring the national psychosocial support guidelines. Adolescents and youth who don't have smartphones will be offered with one to enable them connect digitally. Brief orientation about the Telegram mes...もっと見る | Peer support based digital anti-HIV stigma intervention Participants in the intervention arm will remotely attend educational sessions facilitated by peer leaders and supervised by healthcare providers and members of the research team. They will receive audiovisual content as part of modules (two modules in 12 sessions) designed to enhance both individual and social life skills. The intervention group will be organized into seven groups, each consisting at most 20 partici...もっと見る A standard in-clinic in-person psychosocial support In arm 2, the control arm, participants will receive the existing psychosocial support routinely provided in the hospitals where they receive care. As part of this in-clinic peer support, adolescents living with HIV meet monthly to sit together and discuss a topic under the supervision of an assigned healthcare provider. After the discussion, they spend time playing together, followed by sharing a meal before departi...もっと見る |
実薬対照薬In-person peer support In the in-clinic in-person peer support, adolescents and youth living with HIV meet in-person fortnightly and share experiences and receive peer led lessons based on the national psychosocial support module. They also had time to spend together playing and eating lunch. Furthermore, they receive a small amount of fee to cover transport. | A standard in-clinic in-person psychosocial support In arm 2, the control arm, participants will receive the existing psychosocial support routinely provided in the hospitals where they receive care. As part of this in-clinic peer support, adolescents living with HIV meet monthly to sit together and discuss a topic under the supervision of an assigned healthcare provider. After the discussion, they spend time playing together, followed by sharing a meal before departi...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
HIV-related stigma: internalised and anticipated | The Brief HIV Stigma Scale-12, translated into Amharic and validated for use in the Ethiopian context, will be employed to assess HIV-related stigma among adolescents living with HIV. The tool comprises 12 items measuring four constructs, each represented by three items. Responses are rated on a four-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). Total scores range from 12 to 48, with higher scores indicating greater levels of stigma (i.e., worse outcomes). | From enrollment at baseline to the end of intervention at 16 weeks. |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Psychological well-being | 1\. Psychological well-being will be assessed using measures of depression and anxiety. Depression will be measured with the Patient Health Questionnaire-9 (PHQ-9), a nine-item scale scored from 0 ("never at all") to 3 ("nearly everyday"), with total scores ranging from 0 to 27; higher scores indicate worse depressive symptoms. Anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), which uses the same response format (0 to 3) and yields scores from 0 to 21, with higher values indicating severe anxiety symptoms. Psychological well-being will be defined as "good" and "poor". Participants with PHQ-9 and GAD-7 scores\<10 will be classified as having good psychological well-being; others will be classified as poor. | From enrollment at baseline to the end of intervention at 16 weeks. |
Retention in care | 1\. Retention in HIV care will be measured as the proportion of kept clinic visits out of the total scheduled visits during the 12 months preceding the assessment period. | From enrollment at baseline to the end of intervention at 16 weeks. |
参加アシスタント
適格基準
対象年齢
小児, 成人
試験の最低年齢
14 Years
対象性別
全て
- Adolescents who have been disclosed of their HIV status
- adolescents and young people between the age of 15 and 22 years old
- receiving antiretroviral medications; and
- completed at least first cycle primary school education (i.e. grade 4).
- Participants with known diagnosed mental health condition
- Participants with hearing loss or loss of vision
ルンド大学試験中央連絡先
連絡先: Melkamu Merid Mengesha, Master of Public Health in Epi, +251912094941, [email protected]
連絡先: Cecilia Follin, PhD, +46709760463, [email protected]
5 1カ国の場所
South Ethiopia
Arba Minch General Hospital, Arba Minch, South Ethiopia, Ethiopia
完了
Dilla University Teaching Hospital, Dara, South Ethiopia, Ethiopia
Kassahun Alehegn, MD, 連絡先, +251912770715, [email protected]
募集中
Sawula General Hospital, Gofa, South Ethiopia, Ethiopia
Matusala Samuel, BSc, 連絡先, +251909203360, [email protected]
募集中
Jinka General Hospital, Jinka, South Ethiopia, Ethiopia
Tizita Chebud, BSc, 連絡先, +251913361175, [email protected]
募集中
Wolaita Sodo University Comprehensive Specialized Hospital, Sodo, South Ethiopia, Ethiopia
完了