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

24 de junho de 2026 atualizado por: Gloria Aidoo-Frimpong, State University of New York at Buffalo

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

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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

144

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Gloria A. Aidoo-Frimpong, PhD, MPH, MA
  • Número de telefone: 716-829-5721
  • E-mail: gloriaai@buffalo.edu

Locais de estudo

    • New York
      • Buffalo, New York, Estados Unidos, 14214
        • State University of New York at Buffalo
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

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

Exclusion Criteria:

  • 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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Proof of Concept Assessment
Participants matching the relationship typology prioritized through community deliberation in Aim 2 are assigned to receive a single co-developed behavioral intervention component. The intervention is delivered via Zoom in a standardized facilitation structure and focuses on relationship-based HIV prevention communication and decision-making within migration-shaped relationship contexts. Participants complete a baseline survey (T0) before the intervention and a post-intervention survey (T1) immediately after. A subset of participants completes an optional cognitive interview to assess feasibility, acceptability, perceived fit, and evidence of mechanism activation.
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-making. The intervention does not involve drugs, devices, or clinical procedures. Session duration: approximately 60-75 minutes.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Acceptability of Intervention - AIM Score and 75% Acceptability Threshold
Prazo: Immediately post-intervention (T1), within the same session as intervention exposure

Acceptability measured using the validated 4-item Acceptability of Intervention Measure (AIM), rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Scores range from 1 (completely disagree) to 5 (completely agree). Results will be reported as mean and standard deviation. Higher scores indicate greater acceptability (better outcome). In addition, the intervention will be considered acceptable if: (1) at least 75% of participants rate it as acceptable or very acceptable, and (2) at least 75% rate it as culturally relevant.

Unit of Measure: Mean AIM score (1-5 scale)

Immediately post-intervention (T1), within the same session as intervention exposure
Feasibility of Intervention - FIM Score
Prazo: Immediately post-intervention (T1), within the same session as intervention exposure

Feasibility of the intervention will be measured using the Feasibility of Intervention Measure (FIM), a validated 4-item scale with 5-point Likert responses. Scores range from 1 (completely disagree) to 5 (completely agree). Results will be reported as mean and standard deviation. Higher scores indicate greater feasibility (better outcome).

Unit of Measure: Mean FIM score (1-5 scale)

Immediately post-intervention (T1), within the same session as intervention exposure
Appropriateness of Intervention - IAM Score
Prazo: Immediately post-intervention (T1), within the same session as intervention exposure

Appropriateness of the intervention will be measured using the Intervention Appropriateness Measure (IAM), a validated 4-item scale with 5-point Likert responses. Scores range from 1 (completely disagree) to 5 (completely agree). Results will be reported as mean and standard deviation. Higher scores indicate greater perceived appropriateness (better outcome).

Unit of Measure: Mean IAM score (1-5 scale)

Immediately post-intervention (T1), within the same session as intervention exposure

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Mean Score of HIV Testing Intention
Prazo: Pre-intervention (T0) and immediately post-intervention (T1), within the same session

Intention to test for HIV will be measured on a 5-point Likert scale (1 = Very unlikely to 5 = Very likely). Change from baseline (T0) to post-intervention (T1) will be reported as mean change score. Higher scores indicate greater intention to test (better outcome).

Unit of Measure: Mean change in score (1-5 scale)

Pre-intervention (T0) and immediately post-intervention (T1), within the same session
Change in HIV Self-Testing Willingness
Prazo: Pre-intervention (T0) and immediately post-intervention (T1), within the same session

Willingness to use HIV self-testing will be measured on a 5-point Likert scale (1 = Very unlikely to 5 = Very likely) with a higher score indicating willingness to conduct HIV Self Testing. Change from T0 to T1 will be reported as mean change score.

Unit of Measure: Mean change in score (1-5 scale)

Pre-intervention (T0) and immediately post-intervention (T1), within the same session
Change in Communication Readiness
Prazo: Pre-intervention (T0) and immediately post-intervention (T1), within the same session

Readiness to discuss HIV prevention within intimate relationships will be measured using 3 items on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Change from T0 to T1 will be reported as mean change score. Higher scores indicate greater communication readiness (better outcome).

Unit of Measure: Mean change in score (1-5 scale)

Pre-intervention (T0) and immediately post-intervention (T1), within the same session
Change in PrEP Awareness and Interest
Prazo: Baseline (T0) and immediately post-intervention (T1), within the same session

Awareness and interest in PrEP will each be measured on a 5-point Likert scale (1 = not interested to 5 = extremely interested). The change from T0 to T1 will be reported as the mean change score. Higher scores indicate greater willingness and interest (better outcome).

Unit of Measure: Mean change in score (1-5 scale)

Baseline (T0) and immediately post-intervention (T1), within the same session

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Relationship Typologies
Prazo: During and after Aim 1 data collection, approximately Months 1-3

Categories of relationship structures among first-generation African immigrants derived from thematic analysis of Aim 1 qualitative interviews. Reported narratively as distinct typologies with descriptive characteristics.

Unit of Measure: Number of typologies identified

During and after Aim 1 data collection, approximately Months 1-3
HIV Prevention Awareness and Behaviors
Prazo: At Aim 1 survey completion, approximately Months 1-3

Self-reported HIV testing history, HIV self-testing awareness, and PrEP awareness from Aim 1 structured survey. Reported as frequencies and proportions.

Unit of Measure: Percentage of participants (%)

At Aim 1 survey completion, approximately Months 1-3

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Colaboradores

Investigadores

  • Investigador principal: Gloria A. Aidoo-Frimpong, PhD, MPH, MA, State University of New York at Buffalo

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

4 de agosto de 2026

Conclusão Primária (Estimado)

1 de agosto de 2027

Conclusão do estudo (Estimado)

1 de setembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

27 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de abril de 2026

Primeira postagem (Real)

4 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Due to the sensitive nature of data related to HIV status, HIV prevention intentions, immigration experiences, and relationship dynamics, and the use of a small, community-based sample in which re-identification is possible, individual participant data (IPD) will not be shared publicly to protect participant confidentiality and community trust.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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