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Набор скоро начнётся NCT07565584

Examining Migration, Social Bonds, Transnationalism, and HIV Prevention Pathways Among African Immigrants.

Без фазы С лечением HIV Prevention HIV Testing Sexual and Reproductive Health

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Relationship-Centered HIV Prevention Intervention Component (Proof-of-Concept).
Кому может быть актуально
Состояния в реестре: HIV Prevention, HIV Testing, Sexual and Reproductive Health. Базовые параметры: 18 лет — 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Migration, Social Bonds, Transnationalism, and HIV Prevention Pathways Among African Immigrants (MiST-Pathways)

Обзор

The goal of this mixed-methods pilot study is to learn whether migration experiences, social bonds, and transnational ties shape HIV prevention decision-making, including HIV testing, HIV self-testing (HIVST), and pre-exposure prophylaxis (PrEP) uptake, among first-generation African immigrants aged 18 to 50 residing in New York and Massachusetts. The main questions it aims to answer are: * What relationship typologies and migration-related relational mechanisms influence HIV testing, HIVST, and PrEP decision-making among African immigrants? * Can a relationship-tailored HIV prevention intervention component, co-developed with the community, demonstrate feasibility and acceptability among African immigrants? * Does exposure to the prioritized intervention component show directional increases in HIV testing intention, willingness to use HIVST, interest in PrEP, and readiness for relationship-based prevention communication? There is no comparison group. All Aim 3 participants receive the same co-developed intervention component. Participants will: * Complete a qualitative interview (60-90 minutes) and/or a structured electronic survey (15-20 minutes) about their relationship experiences, migration history, and HIV prevention behaviors. * Take part in a 3-4 hour structured group deliberation session called a Palava Hut Conversation to co-develop and prioritize HIV prevention intervention ideas. * Complete a baseline survey, receive the prioritized intervention component in a structured Zoom session, and complete a follow-up survey with an optional 60-90 minute cognitive interview for a subset of participants.

Подробное описание

African immigrants in the United States account for a disproportionate share of new HIV diagnoses relative to their population size, yet this community remains underrepresented in HIV prevention research. Existing prevention strategies rarely address the relational and structural contexts that shape prevention engagement in this population. Relationships, including intimate partnerships, family systems, and co-ethnic social networks, function as key mechanisms through which HIV risk perception, disclosure, and prevention decisions are negotiated. Migration reorganizes these relational structures by altering trust dynamics, communication norms, household decision-making authority, and transnational obligations in ways that are not well understood. The proposed study addresses this gap by generating foundational, mechanism-focused evidence on how migration-shaped relational contexts influence engagement with HIV testing, HIV self-testing, and PrEP among African immigrants in the United States.

The study is guided by a relational-socioecological framework that positions relationships as central mechanisms linking individual, interpersonal, and structural determinants of HIV prevention behavior. Within this framework, migration is not treated as a direct risk factor but as a structural force that reshapes the relational contexts through which prevention decisions occur. Processes such as separation, reunification, and transnational living alter intimacy, trust, and communication, while cross-border financial obligations and dense co-ethnic networks reinforce norms of discretion and respectability that may suppress prevention engagement. This framework builds on prior qualitative and community-engaged research by the principal investigator, including PCORI-supported African immigrant-led agenda-setting work that identified relationships, trust, and communication as central yet under-addressed drivers of HIV prevention in this community.

The study uses a three-phase sequential design in which each phase builds directly on the findings of the prior one. AIM 1, where relationship typologies and relational mechanisms must first be empirically identified before intervention components can be meaningfully co-developed, and community deliberation must occur in AIM 2. The final step in AIM 3 will be a proof-of-concept assessment that can be conducted with a typology-matched sample.

This sequencing ensures that the intervention component tested in Aim 3 is grounded in both empirical evidence and community priorities rather than researcher-imposed assumptions.

Palava Hut Conversations (PHC) is an African-centered deliberative method adapted from traditional West African communal dialogue practices. It structures collective reasoning through facilitated discussion, negotiated agreement, and consensus-building. PHC was selected for Aim 2 because it centers community knowledge and cultural authority in the co-development process, moves beyond nominal input to genuine co-creation, and generates actionable, community-validated outputs through structured prioritization. This approach ensures that intervention components reflect the lived experiences, cultural values, and practical constraints of the target population.

Aim 1 qualitative data will undergo thematic analysis to identify relationship typologies and relational mechanisms. Survey data will be analyzed descriptively to contextualize typology distribution and prevention awareness across the sample.

Aim 2 deliberation outputs, including facilitator notes, decision logs, and prioritization matrices, will be synthesized using rapid qualitative methods to produce a ranked list of intervention components.

Aim 3 pre- and post-exposure survey data will be summarized using descriptive statistics to assess the direction and consistency of change across prevention intention outcomes. Cognitive interview data will undergo rapid thematic analysis focused on implementation-relevant constructs including acceptability, feasibility, perceived fit, usability, and evidence of mechanism activation.

Вмешательства

  • Поведенческое Relationship-Centered HIV Prevention Intervention Component (Proof-of-Concept)
    A structured, culturally grounded, relationship-tailored behavioral intervention component co-developed and prioritized through Palava Hut Conversations in Aim 2. The intervention is delivered via Zoom in a standardized facilitation structure and may include guided reflection prompts, scenario-based discussions, structured relational messaging, or communication skill-building exercises designed to address migration-shaped relational dynamics influencing HIV testing, HIVST, and PrEP decision-maki

Первичные конечные точки

  • Acceptability of Intervention - AIM Score and 75% Acceptability Threshold [Срок оценки: Immediately post-intervention (T1), within the same session as intervention exposure]
  • Feasibility of Intervention - FIM Score [Срок оценки: Immediately post-intervention (T1), within the same session as intervention exposure]
  • Appropriateness of Intervention - IAM Score [Срок оценки: Immediately post-intervention (T1), within the same session as intervention exposure]
Вторичные конечные точки (4)
  • Change in Mean Score of HIV Testing Intention [Срок оценки: Pre-intervention (T0) and immediately post-intervention (T1), within the same session]
  • Change in HIV Self-Testing Willingness [Срок оценки: Pre-intervention (T0) and immediately post-intervention (T1), within the same session]
  • Change in Communication Readiness [Срок оценки: Pre-intervention (T0) and immediately post-intervention (T1), within the same session]
  • Change in PrEP Awareness and Interest [Срок оценки: Baseline (T0) and immediately post-intervention (T1), within the same session]

Критерии участия

Inclusion Criteria: Individuals must meet ALL of the following criteria:

  • Age 18 to 50 years at the time of enrollment
  • Self-identify as a first-generation African immigrant (born in an African country and currently residing in the United States)
  • Currently reside in New York or Massachusetts
  • Able to communicate in English at approximately a 3rd-grade reading level
  • Have access to a smartphone or computer with internet capability sufficient to participate in Zoom and/or WhatsApp-based study activities
  • Willing and able to provide informed consent

Критерии исключения

  • Are under 18 years of age
  • Do not self-identify as a first-generation African immigrant
  • Do not reside in New York or Massachusetts
  • Are unable to provide informed consent
  • Do not have access to the technology required for virtual participation (Zoom and/or WhatsApp)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • State University of New York at Buffalo — Buffalo

Публикации

  • Aidoo-Frimpong G, Oduro MA, Kamara P, Smith D. Examining Migration, Social Bonds, Transnationalism, and HIV Prevention Pathways Among African Immigrants (MiST-Pathways): A Study Protocol. medRxiv [Preprint]. 2026 May 28:2026.05.27.26354266. doi: 10.64898/2026.05.27.26354266. PMID 42245060

Идентификаторы

NCT: NCT07565584 · STUDY00010347

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗