- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gloria A. Aidoo-Frimpong, PhD, MPH, MA
- Phone Number: 716-829-5721
- Email: gloriaai@buffalo.edu
Study Locations
-
-
New York
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Buffalo, New York, United States, 14214
- State University of New York at Buffalo
-
Contact:
- Gloria A. Frimpong, PhD, MPH, MA
- Phone Number: 716-829-5721
- Email: gloriaai@buffalo.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of Intervention - AIM Score and 75% Acceptability Threshold
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mean Score of HIV Testing Intention
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relationship Typologies
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gloria A. Aidoo-Frimpong, PhD, MPH, MA, State University of New York at Buffalo
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00010347
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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