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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorState University of New York at Buffalo

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

144 Participants
are divided into 1 treatment group
Group A: Proof of Concept AssessmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Immediately post-intervention (T1), within the same session as intervention exposure
2

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)

Time frame
Immediately post-intervention (T1), within the same session as intervention exposure
3

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)

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

Secondary outcomes

1

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)

Time frame
Pre-intervention (T0) and immediately post-intervention (T1), within the same session
2

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)

Time frame
Pre-intervention (T0) and immediately post-intervention (T1), within the same session
3

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)

Time frame
Pre-intervention (T0) and immediately post-intervention (T1), within the same session
4

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)

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

Other outcomes

1

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

Time frame
During and after Aim 1 data collection, approximately Months 1-3
2

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 (%)

Time frame
At Aim 1 survey completion, approximately Months 1-3

Sponsors and contacts

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