HivNCT03049332
Self- and Family-management Intervention in HIV+ Chinese Women
A study testing self- and family-management intervention sessions in people with Hiv, run by Yale University at 2 sites in China.
Trial summary
This project is to develop a culturally sensitive and feasible self- and family-management intervention that will assist HIV+ Chinese women and their families to manage the illness and improve quality of life and clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hiv
- What is being tested?
- self- and family-management intervention sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2014to Mar 2016
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be at least 18 years of age,
- be able to give informed consent for the study and to cognitively participate,
- be receiving clinical care at Ditan Hospital and SPHCC,
- have been diagnosed with HIV within the past 12 months,
- have disclosed their status to at least one family member and willing to invite that family member to the intervention,
- be well enough to attend counseling sessions at the hospital, and
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- be able to attend follow-up visits at the hospital.
- be 18 years of age,
- be able to give informed consent for the study and to cognitively participate,
- have a female family member who is HIV+, and is currently receiving clinical care at Ditan Hospital and SPHCC,
- be a family member who are taking care of the female HIV+ family member,
- be well enough to attend counseling sessions at the hospital, and
- be able to attend follow-up visits at the hospital.
Who cannot join
- history of an affective illness such as depression or bipolar disease,
- are under age 18, or
- are unwilling or unable to bring a family member to participate in the study.
- have a history of an affective illness such as depression or bipolar disease,
- are under age 18,
- or are unwilling or unable to come with their HIV+ family member to participate the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Ditan Hospital
Beijing
Shanghai Public Health Clinical Center
Shanghai
About this study
This project is to develop a culturally sensitive and feasible self- and family-management intervention that will assist HIV+ Chinese women and their families to manage the illness and improve quality of life and clinical outcomes.
Read the detailed description
The study will be conducted in 3 phases.
Phase 1: The PI conducted a secondary qualitative analysis of in-depth interviews to further illuminate the sociocultural and family context of HIV+ Chinese women. The data were obtained from three previous projects conducted in China from 2005 to 2011.
Phase 2: The PI developed and adapted a theory-driven, culturally sensitive and feasible intervention to improve the quality of life and clinical outcomes of HIV+ Chinese women and their families.
Phase 3: The PI conducted a feasibility, compliance, and acceptability study for a self- and family-management intervention with HIV+ women and of their family members.
- Conditions
- Hiv
- Being tested
- self- and family-management intervention sessions
- Keywords
- Quality of Life
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self- and family-management intervention sessionsBehavioural
The self- and family management intervention will have six elements: (a) biofeedback for relaxation; (b) family support; (c) coping skills; (d) anxiety, stress, and depression management; (e) cognitive-behavioral management skills; and (f) psycho-educational classes.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | HIV+ Chinese women in China and a family member will be recruited for the pilot testing of the intervention. Receives: Behavioral: self- and family-management intervention sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention rates
the percentage of self- and family-management intervention sessions attended by both HIV+ women and one family member
Measured: 6 months
compliance with data collection procedures
includes attending counseling sessions and completing questionnaires
Measured: 6 months
acceptability
including reports of burden related to the study and/or intervention procedures measured by intervention session logs and exit interview
Measured: 6 months
feelings of safety
family members and study participants feelings of safety related to participating in this project measured by intervention session logs and exit interview
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study startJul 2014
- Primary completionMar 2016
- Study completionMar 2016
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 HivStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 same group of individuals will be measured pre and post intervention.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Ditan Hospital, Shanghai Public Health Clinical Center, National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Weiti Chen, Principal investigator, Yale University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049332
- Sponsor's protocol ID
- 1207010522
- Other IDs
- K23NR014107-02
- Status last verified
- Feb 2017
- First submitted
- 7 Feb 2017
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen WT, Shiu C, Zhang L, Zhao H. Care engagement with healthcare providers and symptom management self-efficacy in women living with HIV in China: secondary analysis of an intervention study. BMC Public Health. 2022 Jun 15;22(1):1195. doi: 10.1186/s12889-022-13573-3.
PubMed 35705934
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self- and Family-management Intervention in HIV+ Chinese Women
- ClinicalTrials.gov ID
- NCT03049332
- Acronym / sponsor ID
- 1207010522
- Conditions
- Hiv
- Keywords
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Beijing Ditan Hospital, Shanghai Public Health Clinical Center, National Institute of Nursing Research (NINR)
- Study start
- Jul 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Feb 2017 (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.
This project is to develop a culturally sensitive and feasible self- and family-management intervention that will assist HIV+ Chinese women and their families to manage the illness and improve quality of life and clinical outcomes.
Detailed description
The study will be conducted in 3 phases.
Phase 1: The PI conducted a secondary qualitative analysis of in-depth interviews to further illuminate the sociocultural and family context of HIV+ Chinese women. The data were obtained from three previous projects conducted in China from 2005 to 2011.
Phase 2: The PI developed and adapted a theory-driven, culturally sensitive and feasible intervention to improve the quality of life and clinical outcomes of HIV+ Chinese women and their families.
Phase 3: The PI conducted a feasibility, compliance, and acceptability study for a self- and family-management intervention with HIV+ women and of their family members.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The same group of individuals will be measured pre and post intervention.
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Behavioral: self- and family-management intervention sessionsHIV+ Chinese women in China and a family member will be recruited for the pilot testing of the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- be at least 18 years of age,
- be able to give informed consent for the study and to cognitively participate,
- be receiving clinical care at Ditan Hospital and SPHCC,
- have been diagnosed with HIV within the past 12 months,
- have disclosed their status to at least one family member and willing to invite that family member to the intervention,
Key exclusion criteria (6 listed)
- history of an affective illness such as depression or bipolar disease,
- are under age 18, or
- are unwilling or unable to bring a family member to participate in the study.
- have a history of an affective illness such as depression or bipolar disease,
- are under age 18,
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 |
|---|---|---|
| self- and family-management intervention sessionsThe self- and family management intervention will have six elements: (a) biofeedback for relaxation; (b) family support; (c) coping skills; (d) anxiety, stress, and depression management; (e) cognitive-behavioral management skills; and (f) psycho-educational classes. | Behavioural | All participants |
Primary outcome
retention rates
Time frame: 6 months
the percentage of self- and family-management intervention sessions attended by both HIV+ women and one family member
compliance with data collection procedures
Time frame: 6 months
includes attending counseling sessions and completing questionnaires
acceptability
Time frame: 6 months
including reports of burden related to the study and/or intervention procedures measured by intervention session logs and exit interview
feelings of safety
Time frame: 6 months
family members and study participants feelings of safety related to participating in this project measured by intervention session logs and exit interview
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 10 Feb 2017.
- Derived from this study: PubMed 35705934Chen WT, Shiu C, Zhang L, Zhao H. Care engagement with healthcare providers and symptom management self-efficacy in women living with HIV in China: secondary analysis of an intervention study. BMC Public Health. 2022 Jun 15;22(1):1195. doi: 10.1186/s12889-022-13573-3.
- Individual participant dataSharing planned: No
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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.
Weiti Chen principal investigator
Yale University School of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self- and family-management intervention sessions in people with Hiv, run by Yale University at 2 sites in China.
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 13 inclusion and 6 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 10 Feb 2017. 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 China. 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?
retention rates (time frame: 6 months). The study lists 4 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 NCT03049332, 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 10 Feb 2017.