About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Relationship-Centered HIV Prevention Intervention Component (Proof-of-Concept)
BehavioralA 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.
Treatment groups
Trial outcomes
Primary outcomes
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)
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)
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)
Secondary outcomes
Change in Mean Score of HIV Testing Intention
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)
Change in HIV Self-Testing Willingness
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)
Change in Communication Readiness
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)
Change in PrEP Awareness and Interest
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)
Other outcomes
Relationship Typologies
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
HIV Prevention Awareness and Behaviors
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 (%)
Sponsors and contacts
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State University of New York at Buffalo
Lead sponsor
Yale University
Collaborator
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