Self-managementNCT04353739
Testing a Self-management Intervention in HIV+ Asian Pacific Americans
A study testing Social justice Oriented, Family-Informed self-management intervention for APAWH (SOFIAA) in people with Self-management, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
HIV infection rates are on a rapid rise within Asian Pacific Americans (APA) communities, with 80% of new infects being men. The purpose of this study is to adapt and evaluate the feasibility of a 4-session, 4-week family-informed self-management intervention protocol to promote health among APA people living with HIV… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Self-management
- What is being tested?
- Social justice Oriented, Family-Informed self-management intervention for APAWH (SOFIAA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must:
- be at least 18 years of age,
- be self-identifying as APA,
- be self-identifying as men,
- be able to give informed consent to the study,
- are currently taking ART and
- be physically well enough to attend counseling sessions and follow-up visits.
Who cannot join
- Participants who:
- have a significant condition such as neurological or cardiovascular diseases that prevents them from fully participating the study, or
- are unable to communicate in English or a major Asian language.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
APAIT
Los Angeles, California, 90095
Chinese-American Planning Council., Inc.
New York, New York, 90012
About this study
HIV infection rates are on a rapid rise within Asian Pacific Americans (APA) communities, with 80% of new infects being men. The purpose of this study is to adapt and evaluate the feasibility of a 4-session, 4-week family-informed self-management intervention protocol to promote health among APA people living with HIV (APAWH). Family-informed self-management is a promising intervention to assist APAWH in securing family support and promoting health, and hence help address HIV epidemics in this understudied population.
Read the detailed description
HIV infection rates are on a rapid rise within Asian Pacific Americans (APA) communities, 17% annually, with men comprising 80% of new infections in the United States. Optimal self-management is a key to HIV treatment success, because it may alleviate physical and mental symptoms, promote health behaviors, and therefore enhance quality of life and suppress virus replication. Studies suggested that securing assistance from family members in self-management may be effective in addressing these challenges in APA communities.
The purpose of this study is to adapt and evaluate the feasibility of a 4-session, 4-week family-informed self-management intervention protocol to promote health among APA living with HIV (APAWH). The scientific premise is, regardless of Asian ethnicity, APA communities often share a more collectivist orientation, such that APA prioritizing their responsibilities to their families over their own individual needs. To preserve the harmony in family, HIV disclosure is often indirect. In previous projects, investigators interviewed an ethnically diverse sample of 40 APAWH and 20 family members to explore self- and family- management strategies. The hypothesis is that APAWH will receive greater levels of family support and health following the family-informed self-management intervention. This study addresses the critical need to optimize self-management skills among APAWH that simultaneously address the needs of APAWH with support from their families. The long-term goal is to implement a comprehensive, family-informed self-management intervention for APAWH.
In this project, researchers will conduct a mixed-methods study with two study phases. In Phase 1, researchers will analyze the available qualitative data from the prior projects to revise the conceptualization of family-informed self-management. Based on the revised conceptualization, researchers will adapt an evidence-based self-management intervention (Social justice Oriented, Family Informed, also known as SOFI) using a modified ADAPT-ITT model. In Phase 2, researchers will conduct an implementation study to test the appropriateness, acceptability, feasibility, and preliminary efficacy of the Social justice Oriented, Family Informed self-management intervention among APAWH (SOFIAA) without explicitly involving their family members. Researchers will use study findings to revise this family-informed self-management intervention protocol for a future fully powered randomized controlled trial to test its efficacy. Aims are to: 1. Follow the ADAPT-ITT model to culturally adapt an evidence-based family-informed self-management intervention 2. Evaluate the feasibility, acceptability, appropriateness and preliminary efficacy of the SOFIAA. And, 3. Finalize the study protocols for future project operations by documenting emerging difficulties and solutions throughout this project's implementation.
- Conditions
- Self-management
- Being tested
- Social justice Oriented, Family-Informed self-management intervention for APAWH (SOFIAA)
- Keywords
- family-informed self-management, Asian Pacific Americans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social justice Oriented, Family-Informed self-management intervention for APAWH (SOFIAA)Behavioural
The study intervention (SOFIAA) is delivered during a series of 4-sessions over a 4-week period via one-on-one format. The sessions are held either via Zoom or in-person. Intervention Core Modules: Developed on the basis of the results of the investigators' prior studies involving familial relations among APA HIV+ populations, the family-informed self-management intervention has eight modules: (1) psycho-education, (2) cognitive-behavioral management skills training, (3) preparation for disclosure, (4) family relations and support management, (5) anxiety and depressive symptom management, (6) brief mindfulness training, (7) symptom reduction, and (8) the Life-Steps program. Each module will take about 30 minutes for delivery and each session will deliver two modules in sequence for a total time of about 60 minutes per week over a span of four weeks.
| Study group | Role | What they receive |
|---|---|---|
| SOFIAA | Experimental | This single arm implementation study will evaluate the appropriateness, acceptability, and feasibility of the SOFIAA intervention protocol among Asian Americans living with HIV. Receives: Behavioral: Social justice Oriented, Family-Informed self-management intervention for APAWH (SOFIAA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention
The Acceptability of Intervention Measure (AIM) is a 4-item implementation outcome measure of acceptability used to monitor and evaluate the success of implementation efforts. AIM uses a Response Scale that includes: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Higher scores indicate greater acceptability.
Measured: Week 10
Appropriateness of Intervention
The Intervention Appropriateness Measure (IAM) is designed to assess the suitability and relevance of an intervention. It aims to provide a generalizable assessment of the appropriateness of interventions by capturing individual perspectives on the alignment of the intervention with professional values and perceived efficacy in meeting patient needs. IAM is a 4-item instrument that uses a Response Scale that includes: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Higher scores indicate greater appropriateness.
Measured: Week 10
Feasibility of Intervention
The Feasibility of Intervention Measure (FIM) measures the feasibility or extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. FIM is a 4-item instrument uses a Response Scale that includes: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Higher scores indicate greater feasibility.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 Jul 2023
- Primary completion30 Jun 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-managementStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention, called the Social justice Oriented, Family-Informed self-management intervention for APAWH (SOFIAA), is delivered via four one-on-one counseling sessions to participants over 4 weeks. Implementation Assessment Outcomes including Exit Interview, Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) will be used to assess the appropriateness, feasibility and acceptability of the intervention among APAWH.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Apait Health Center, Chinese-American Planning Council., Inc.
- Responsible party
- Principal investigator, Weiti Chen, RN, CNM, PhD, FAAN, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353739
- Sponsor's protocol ID
- IRB#20-000580
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2020
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators will make sure CPC and study participants are willing to share their personal data with researchers. Then, the investigators can release the data.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Self-management Intervention in HIV+ Asian Pacific Americans
- ClinicalTrials.gov ID
- NCT04353739
- Acronym / sponsor ID
- IRB#20-000580
- Conditions
- Self-management
- Keywords
- family-informed self-management, Asian Pacific Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Apait Health Center, Chinese-American Planning Council., Inc.
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 20 Apr 2020 (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.
HIV infection rates are on a rapid rise within Asian Pacific Americans (APA) communities, with 80% of new infects being men. The purpose of this study is to adapt and evaluate the feasibility of a 4-session, 4-week family-informed self-management intervention protocol to promote health among APA people living with HIV (APAWH). Family-informed self-management is a promising intervention to assist APAWH in securing family support and promoting health, and hence help address HIV epidemics in this understudied population.
Detailed description
HIV infection rates are on a rapid rise within Asian Pacific Americans (APA) communities, 17% annually, with men comprising 80% of new infections in the United States. Optimal self-management is a key to HIV treatment success, because it may alleviate physical and mental symptoms, promote health behaviors, and therefore enhance quality of life and suppress virus replication. Studies suggested that securing assistance from family members in self-management may be effective in addressing these challenges in APA communities.
The purpose of this study is to adapt and evaluate the feasibility of a 4-session, 4-week family-informed self-management intervention protocol to promote health among APA living with HIV (APAWH). The scientific premise is, regardless of Asian ethnicity, APA communities often share a more collectivist orientation, such that APA prioritizing their responsibilities to their families over their own individual needs. To preserve the harmony in family, HIV disclosure is often indirect. In previous projects, investigators interviewed an ethnically diverse sample of 40 APAWH and 20 family members to explore self- and family- management strategies. The hypothesis is that APAWH will receive greater levels of family support and health following the family-informed self-management intervention. This study addresses the critical need to optimize self-management skills among APAWH that simultaneously address the needs of APAWH with support from their families. The long-term goal is to implement a comprehensive, family-informed self-management intervention for APAWH.
In this project, researchers will conduct a mixed-methods study with two study phases. In Phase 1, researchers will analyze the available qualitative data from the prior projects to revise the conceptualization of family-informed self-management. Based on the revised conceptualization, researchers will adapt an evidence-based self-management intervention (Social justice Oriented, Family Informed, also known as SOFI) using a modified ADAPT-ITT model. In Phase 2, researchers will conduct an implementation study to test the appropriateness, acceptability, feasibility, and preliminary efficacy of the Social justice Oriented, Family Informed self-management intervention among APAWH (SOFIAA) without explicitly involving their family members. Researchers will use study findings to revise this family-informed self-management intervention protocol for a future fully powered randomized controlled trial to test its efficacy. Aims are to: 1. Follow the ADAPT-ITT model to culturally adapt an evidence-based family-informed self-management intervention 2. Evaluate the feasibility, acceptability, appropriateness and preliminary efficacy of the SOFIAA. And, 3. Finalize the study protocols for future project operations by documenting emerging difficulties and solutions throughout this project's implementation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention, called the Social justice Oriented, Family-Informed self-management intervention for APAWH (SOFIAA), is delivered via four one-on-one counseling sessions to participants over 4 weeks. Implementation Assessment Outcomes including Exit Interview, Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) will be used to assess the appropriateness, feasibility and acceptability of the intervention among APAWH.
| Arm | Type | Receives |
|---|---|---|
| SOFIAA | Experimental | Behavioral: Social justice Oriented, Family-Informed self-management intervention for APAWH (SOFIAA)This single arm implementation study will evaluate the appropriateness, acceptability, and feasibility of the SOFIAA intervention protocol among Asian Americans living with HIV. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- be at least 18 years of age,
- be self-identifying as APA,
- be self-identifying as men,
- be able to give informed consent to the study,
- are currently taking ART and
Key exclusion criteria (3 listed)
- have a significant condition such as neurological or cardiovascular diseases that prevents them from fully participating the study, or
- are unable to communicate in English or a major Asian language.
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 |
|---|---|---|
| Social justice Oriented, Family-Informed self-management intervention for APAWH (SOFIAA)The study intervention (SOFIAA) is delivered during a series of 4-sessions over a 4-week period via one-on-one format. The sessions are held either via Zoom or in-person. Intervention Core Modules: Developed on the basis of the results of the investigators' prior studies involving familial relations among APA HIV+ populations, the family-informed self-management intervention has eight modules: (1) psycho-education, (2) cognitive-behavioral management skills training, (3) preparation for disclosure, (4) family relations and support management, (5) anxiety and depressive symptom management, (6) brief mindfulness training, (7) symptom reduction, and (8) the Life-Steps program. Each module will take about 30 minutes for delivery and each session will deliver two modules in sequence for a total time of about 60 minutes per week over a span of four weeks. | Behavioural | SOFIAA |
Primary outcome
Acceptability of Intervention
Time frame: Week 10
The Acceptability of Intervention Measure (AIM) is a 4-item implementation outcome measure of acceptability used to monitor and evaluate the success of implementation efforts. AIM uses a Response Scale that includes: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Higher scores indicate greater acceptability.
Appropriateness of Intervention
Time frame: Week 10
The Intervention Appropriateness Measure (IAM) is designed to assess the suitability and relevance of an intervention. It aims to provide a generalizable assessment of the appropriateness of interventions by capturing individual perspectives on the alignment of the intervention with professional values and perceived efficacy in meeting patient needs. IAM is a 4-item instrument that uses a Response Scale that includes: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Higher scores indicate greater appropriateness.
Feasibility of Intervention
Time frame: Week 10
The Feasibility of Intervention Measure (FIM) measures the feasibility or extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. FIM is a 4-item instrument uses a Response Scale that includes: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Higher scores indicate greater feasibility.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Undecided. The investigators will make sure CPC and study participants are willing to share their personal data with researchers. Then, the investigators can release the data.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social justice Oriented, Family-Informed self-management intervention for APAWH (SOFIAA) in people with Self-management, run by University of California, Los Angeles at 2 sites 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention (time frame: Week 10). 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?
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 4 May 2026.