Integrating iSYV Within HIV Clinical Care for Youth Living With HIV in Tanzania
2026年5月27日 更新者:Duke University
Youth living with HIV (YLWH) experience mental health (MH) challenges that compromise their HIV care.
Though the MH gap is well described, MH service delivery to YLWH is rare, especially in low resource settings.
MH professionals are few and interventions tailored to the needs of this population are scarce.
This project proposes a way to bridge the gap by streamlining the Sauti ya Vijana (SYV, The Voice of Youth) intervention redesigned to integrate into the differentiated HIV clinical care model in Tanzania.
SYV is a peer-led, group-based treatment designed with and for YLWH to address their self-reported MH challenges and stressors living with HIV.
調査の概要
状態
まだ募集していません
詳細な説明
SYV incorporates components of existing evidence-based models: Trauma Focused-Cognitive Behavioral Therapy, Interpersonal Psychotherapy, and Motivational Interviewing to address the needs youth described in formative interviews.
Preliminary data indicates implementation success with estimated effects towards improved MH, antiretroviral therapy adherence, and a 10% greater increase in viral suppression in the intervention arm compared to standard of care.
The central hypothesis here is that the new integrated "i" SYV will be acceptable, feasible, and effective to improve virologic suppression and improve retention in care.
The mechanism of change is that improved MH leads to better medication adherence, viral suppression, and care engagement.
The rationale is twofold: 1) Tanzania is planning to initiate MH screening in HIV clinical visits, but the MH treatment gap persists; 2) the iSYV stepped-care package could be an effective approach to support integrated MH care for YLWH.
The central hypothesis will be tested in a hybrid type-2 effectiveness-implementation trial.
The first aim will leverage the Fit to Context Framework, using an iterative Designing for Dissemination and Sustainability approach.
Current SYV peer-group leaders with extensive experience delivering SYV will co-design the new iSYV package.
The iSYV in-person sessions will be delivered by trained peer youth leaders and be aligned to the Tanzanian differentiated care model: stable youth (those fully suppressed) attend clinic every 6 months; and unstable youth (those with HIV RNA > 50 copies/mL) attend enhanced adherence counseling monthly.
Youth with symptoms of MH difficulties on screening (PHQ9-depression, GAD7-anxiety, Trauma-related stress) will join the unstable group.
To support engagement between visits, iSYV will explore use of a mHealth gamification strategy.
The second aim includes a pilot and a four-arm cluster randomized trial.
Two large implementing partners of PEPFAR clinics will support testing of the iSYV care package.
The primary outcome is powered to show an increase in viral suppression (HIV RNA <50 copies/mL) in the unstable group and improved retention in care among the stable group.
Change in MH is measured as a secondary outcome.
The third aim will evaluate implementation determinants and outcomes, including acceptability, feasibility, fidelity, and cost informed by the Consolidated Framework for Implementation Research.
The proposal is significant because it is expected to help address the MH gap for YLWH with implications for HIV care in Tanzania and other low income areas.
研究の種類
介入
入学 (推定)
5000
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
- 名前:Stuart T Carr, BA
- 電話番号:(919) 668-4849
- メール:stuart.carr@duke.edu
研究連絡先のバックアップ
- 名前:Sandy Askew, MPh
- メール:sandy.askew@duke.edu
研究場所
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-
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Moshi、タンザニア
- Elizabeth Glaser Pediatric AIDS Foundation implementing partner sites in Tanzania
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主任研究者:
- Akwila Temu, MD, MMED
-
-
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
- 子
- 大人
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- youth living with HIV (YLWH) 15-24 years;
- have understanding of their HIV status;
- able to attend iSYV sessions if site is randomized to the intervention.
Exclusion Criteria:
- inability to provide informed consent/assent or participate meaningfully in the intervention due to cognitive impairment, psychosis, or other disability;
- enrollment in any other MH, stigma-related, or adherence intervention research study.
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:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:eSOC (enhanced Standard of Care)
Currently mental health screening is not part of routine care.
Youth at all trial clinics who report moderate to severe symptoms will be referred for care within the local standard.
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mental health screening and referral within the standard of care for moderate to severe symptoms
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実験的:eSOC (enhanced Standard of Care) + iSYV (integrated Sauti ya Vijana or The voice of youth)
iSYV is an intervention that will be peer-led and group based in six monthly sessions.
|
mental health screening and referral within the standard of care for moderate to severe symptoms
Integrated "i"SYV is a streamlined version of the original intervention SYV that is adapted for integration into routine clinical care.
The original SYV intervention included 10 group weekly sessions (2 incorporating caregivers) and 2 individual sessions with adaptation to fit without routine adolescent HIV care based on Tanzanian National HIV Guidelines for HIV care follow up visits.
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実験的:eSOC (enhanced Standard of Care) + iSYV + mHealth (mobile Health)
mHealth will be an additional experimental intervention exploring the boosting effect of gamification of intervention content to boost participant knowledge and understanding of iSYV content
|
mental health screening and referral within the standard of care for moderate to severe symptoms
Integrated "i"SYV is a streamlined version of the original intervention SYV that is adapted for integration into routine clinical care.
The original SYV intervention included 10 group weekly sessions (2 incorporating caregivers) and 2 individual sessions with adaptation to fit without routine adolescent HIV care based on Tanzanian National HIV Guidelines for HIV care follow up visits.
A gamified version of iSYV that can be played via SMS or Whatsapp messaging.
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実験的:eSOC (enhanced Standard of Care) + mHealth (mobile Health)
mHealth is evaluated as a stand alone experimental intervention in this arm to evaluate if mHealth alone (without in person iSYV content) can improve mental health and/or HIV RNA outcomes.
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mental health screening and referral within the standard of care for moderate to severe symptoms
A gamified version of iSYV that can be played via SMS or Whatsapp messaging.
|
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 |
|---|---|---|
|
viral load
時間枠:at 6-months
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HIV RNA <50 copies/mL considered suppression (per National guidelines)
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at 6-months
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retention in care
時間枠:at 6-months
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clinical follow up as prescribed within 30 days of scheduled 6-month appointment
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at 6-months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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changes in self-reported antiretroviral therapy (ART) regarding adherence
時間枠:6-months, 12-months, 18-months
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Self-reported adherence on a 3 question survey (Wilson) 0-100 range, higher scores indicate greater adherence
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6-months, 12-months, 18-months
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change in self-reported mental health difficulties related to depression
時間枠:6-months, 12-months, 18-months
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self-report of the Patient Health Questionnaire-9 (PHQ-9 ) range is 0-27, higher scores indicate greater depression
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6-months, 12-months, 18-months
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change in self-reported mental health difficulties related to anxiety
時間枠:6-months, 12-months, 18-months
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self-report on the Generalized Anxiety Disorder-7 (GAD-7) range 0-21 with higher scores indicating greater anxiety
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6-months, 12-months, 18-months
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change in HIV knowledge in the SOC+iSYV intervention arm compared to SOC arm at 6 month follow-up and at all timepoints in the intervention arm compared to SOC arm
時間枠:6-months, 12-months, 18-months
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self reported knowledge on the HIV-KQ18 (HIV Knowledge questionnaire 18) range 0-18.
higher score indicates more HIV knowledge
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6-months, 12-months, 18-months
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viral load
時間枠:12-months, 18-months as drawn per standard of care
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HIV RNA
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12-months, 18-months as drawn per standard of care
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retention in care
時間枠:12-months and 18-months
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follow up in routine HIV care within 30 days of scheduled 12-month and 18-month appointments
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12-months and 18-months
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change in coping and self efficacy on the Coping and Self-Efficacy Scale (CSES)
時間枠:6-months, 12-months, 18-months
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self-reported, 13 questions with scale of 0 to 2 (range 0 to 26), where a higher number is a better outcome, more coping and self-efficacy
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6-months, 12-months, 18-months
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change in resilience on People Living with HIV (PLHIV) Resilience Scale
時間枠:6-months, 12-months, 18-months
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10 items, scale 0 to 2 (range 0 to 20), higher number means more resilience and a better outcome
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6-months, 12-months, 18-months
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SYV risk behaviors scale
時間枠:6-months, 12-months, 18-months
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5 items assessing sexual activity, number of sexual partners, condom use, consumption of alcohol, cocaine, heroin, or other substances.
These are yes/no response with clarification of rate/amount.
Higher numbers is higher risk.
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6-months, 12-months, 18-months
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interpersonal violence on the World Health Organization intimate partner violence (WHO IPV) scale
時間枠:6-months, 12-months, 18-months
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self report, 15 items with 0=no and 1-yes.
More yes (higher scale) means more experience with IPV.
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6-months, 12-months, 18-months
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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
捜査官
- 主任研究者:Dorothy Dow, MD, MSc、Duke Universtiy
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 (推定)
2027年1月10日
一次修了 (推定)
2029年3月31日
研究の完了 (推定)
2030年9月30日
試験登録日
最初に提出
2026年5月13日
QC基準を満たした最初の提出物
2026年5月27日
最初の投稿 (実際)
2026年6月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月2日
QC基準を満たした最後の更新が送信されました
2026年5月27日
最終確認日
2026年3月1日
詳しくは
本研究に関する用語
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?
はい
IPD プランの説明
de-identified data
IPD 共有時間枠
at the conclusion of trial analysis
IPD 共有アクセス基準
Data sharing is critical to confirm findings, discover important new associations, and to test new ideas that impact health.
Our core quantitative dataset will be archived in the National Institute of Mental Health (NIMH) Data Archive (NDA).
To achieve this we will harmonize our data to NDA common data elements (CDE) as much as possible prior to data collection.
We will follow the standard practices of the NDA for data uploads, submitting data biannually beginning in the second submission cycle following the Notice of Award.
Data will be made publicly available in the data archive at the time of publication.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
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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