HIV PreventionMiST-PathwaysNCT07565584
Examining Migration, Social Bonds, Transnationalism, and HIV Prevention Pathways Among African Immigrants.
A study testing Relationship-Centered HIV Prevention Intervention Component (Proof-of-Concept) in people with HIV Prevention and HIV Testing, run by State University of New York at Buffalo at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, HIV Testing, Sexual and Reproductive Health
- What is being tested?
- Relationship-Centered HIV Prevention Intervention Component (Proof-of-Concept)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
State University of New York at Buffalo
Buffalo, New York, 14214
Gloria A. Frimpong, PhD, MPH, MA, 716-829-5721, gloriaai@buffalo.edu
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- HIV Prevention, HIV Testing, Sexual and Reproductive Health
- Being tested
- Relationship-Centered HIV Prevention Intervention Component (Proof-of-Concept)
- Keywords
- HIV selt-testing (HIVST), Pre-exposure prophylaxis (PrEP), African immigrants, Transnationalism, Relationship Typologies, HIV Prevention, Palava Hut Conversations
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relationship-Centered HIV Prevention Intervention Component (Proof-of-Concept)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Relationship-Centered HIV Prevention Intervention Component (Proof-of-Concept) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: Immediately post-intervention (T1), within the same session as intervention exposure
Secondary outcomes (4)
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)
Measured: Pre-intervention (T0) and immediately post-intervention (T1), within the same session
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)
Measured: Pre-intervention (T0) and immediately post-intervention (T1), within the same session
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)
Measured: Pre-intervention (T0) and immediately post-intervention (T1), within the same session
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)
Measured: Baseline (T0) and immediately post-intervention (T1), within the same session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start4 Dec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Principal investigator, Gloria Aidoo-Frimpong, State University of New York at Buffalo
- Investigators
- Gloria A. Aidoo-Frimpong, PhD, MPH, MA, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565584
- Sponsor's protocol ID
- STUDY00010347
- Acronym
- MiST-Pathways
- Status last verified
- Jun 2026
- First submitted
- 27 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the sensitive nature of data related to HIV status, HIV prevention intentions, immigration experiences, and relationship dynamics, and the use of a small, community-based sample in which re-identification is possible, individual participant data (IPD) will not be shared publicly to protect participant confidentiality and community trust.
Publications
Aidoo-Frimpong G, Oduro MA, Kamara P, Smith D. Examining Migration, Social Bonds, Transnationalism, and HIV Prevention Pathways Among African Immigrants (MiST-Pathways): A Study Protocol. medRxiv [Preprint]. 2026 May 28:2026.05.27.26354266. doi: 10.64898/2026.05.27.26354266.
PubMed 42245060
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migration, Social Bonds, Transnationalism, and HIV Prevention Pathways Among African Immigrants (MiST-Pathways)
- ClinicalTrials.gov ID
- NCT07565584
- Acronym / sponsor ID
- MiST-Pathways / STUDY00010347
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 4 Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Proof of Concept Assessment | Experimental | Behavioral: Relationship-Centered HIV Prevention Intervention Component (Proof-of-Concept)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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relationship-Centered HIV Prevention Intervention Component (Proof-of-Concept)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. | Behavioural | Proof of Concept Assessment |
Primary outcome
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)
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)
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)
4 secondary outcomes
Change in Mean Score of HIV Testing Intention
Time frame: 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
Change in Communication Readiness
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 42245060Aidoo-Frimpong G, Oduro MA, Kamara P, Smith D. Examining Migration, Social Bonds, Transnationalism, and HIV Prevention Pathways Among African Immigrants (MiST-Pathways): A Study Protocol. medRxiv [Preprint]. 2026 May 28:2026.05.27.26354266. doi: 10.64898/2026.05.27.26354266.
- Individual participant dataSharing planned: No. Due to the sensitive nature of data related to HIV status, HIV prevention intentions, immigration experiences, and relationship dynamics, and the use of a small, community-based sample in which re-identification is possible, individual participant data (IPD) will not be shared publicly to protect participant confidentiality and community trust.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gloria A. Aidoo-Frimpong, PhD, MPH, MA principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relationship-Centered HIV Prevention Intervention Component (Proof-of-Concept) in people with HIV Prevention and HIV Testing, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gloria A. Aidoo-Frimpong, PhD, MPH, MA (716-829-5721, gloriaai@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention - AIM Score and 75% Acceptability Threshold (time frame: Immediately post-intervention (T1), within the same session as intervention exposure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07565584, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.