- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07565584
Examining Migration, Social Bonds, Transnationalism, and HIV Prevention Pathways Among African Immigrants. (MiST-Pathways)
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
Status
Intervenção / Tratamento
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
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
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
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New York
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Buffalo, New York, Estados Unidos, 14214
- State University of New York at Buffalo
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Contato:
- Gloria A. Frimpong, PhD, MPH, MA
- Número de telefone: 716-829-5721
- E-mail: gloriaai@buffalo.edu
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
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
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
|
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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
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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
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HIV Prevention Awareness and Behaviors
Prazo: At Aim 1 survey completion, approximately Months 1-3
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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
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Gloria A. Aidoo-Frimpong, PhD, MPH, MA, State University of New York at Buffalo
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
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Outros números de identificação do estudo
- STUDY00010347
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