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

NCT07565584 | Not Yet Recruiting

• 1 other identifier: STUDY00010347
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Prevention; HIV Testing; Sexual and Reproductive Health

Keywords

HIV selt-testing (HIVST); Pre-exposure prophylaxis (PrEP); African immigrants; Transnationalism; Relationship Typologies; HIV Prevention; Palava Hut Conversations

Outcome Measures

Primary Outcomes (3)

• Acceptability of Intervention - AIM Score and 75% Acceptability Threshold

  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

  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

  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 Outcomes (4)

• Change in Mean Score of HIV Testing Intention

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

• Change in HIV Self-Testing Willingness

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

• Change in Communication Readiness

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

• Change in PrEP Awareness and Interest

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

Other Outcomes (2)

• Relationship Typologies

  During and after Aim 1 data collection, approximately Months 1-3

• HIV Prevention Awareness and Behaviors

  At Aim 1 survey completion, approximately Months 1-3

Study Arms (1)

Proof of Concept Assessment

EXPERIMENTAL

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.

Behavioral: Relationship-Centered HIV Prevention Intervention Component (Proof-of-Concept)

Interventions

Relationship-Centered HIV Prevention Intervention Component (Proof-of-Concept) BEHAVIORAL

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.

Proof of Concept Assessment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Yale University Center for Interdisciplinary Research on AIDS: collaborator

Study Sites (1)

State University of New York at Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Gloria A. Aidoo-Frimpong, PhD, MPH, MA

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gloria A. Aidoo-Frimpong, PhD, MPH, MA

CONTACT

716-829-5721; gloriaai@buffalo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A sequential, mixed-methods pilot study. Participants in Aim 1 complete interviews and/or surveys to identify relationship typologies. Aim 2 participants engage in structured community deliberation (Palava Hut Conversations) to co-develop and prioritize intervention components. Aim 3 participants complete a proof-of-concept assessment of the prioritized component using pre- and post-exposure surveys and optional cognitive interviews.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)