HIVNCT03248778
Readiness to Disclose Mother's HIV Diagnosis to Their Children in Beijing, China
A study testing disclosure-support counseling intervention in people with HIV, run by Yale University at 1 site in China.
Trial summary
Specific aims of the 1-year project are to pilot test the disclosure support intervention by (a) evaluating acceptability and feasibility with a preliminary randomized trial among 10 HIV+ mothers (5 in the intervention group and 5 in the treatment as usual (TAU) group) and (b) assessing outcomes in mothers (quality of… 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?
- disclosure-support counseling intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2017to 31 Dec 2017
- 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
- HIV+ mother ≥18 years of age,
- not psychotic or demented;
- receiving clinical care at the Ditan hospital,
- a mother of an HIV-negative child of age 13-25 years who does not know about the mother's infection;
- well enough to attend study sessions as the clinic.
Who cannot join
- no psychotic or demented
Trial locations and contacts
1 site in 1 country.
About this study
Specific aims of the 1-year project are to pilot test the disclosure support intervention by (a) evaluating acceptability and feasibility with a preliminary randomized trial among 10 HIV+ mothers (5 in the intervention group and 5 in the treatment as usual (TAU) group) and (b) assessing outcomes in mothers (quality of life and mental health indicators, adherence, social support, and disclosure stress, efficacy, readiness, and completion). The intervention will be compared to treatment as usual, with baseline (0 weeks), immediate post-intervention (4 weeks), and 12-week follow-up (16 weeks) assessments.
Read the detailed description
HIV disclosure to children has been shown to strengthen family relations and increase assistance with medical care, reinforcing the parent's willingness to live. Some Chinese children aware of their parents HIV diagnosis do exhibit emotional and social dysfunction; however, adequate support from caregivers (e.g., grandparents or even their HIV+ parents) can improve the children's quality of life and academic performance. There is a clear need for practical interventions to address parental distress around HIV disclosure in China, where cultural norms often emphasize family identity and cohesion and underscore the need for family-based programs, which have been shown to be feasible and efficacious for HIV-affected families.
- Conditions
- HIV
- Being tested
- disclosure-support counseling intervention
- Keywords
- disclosure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disclosure-support counseling interventionBehavioural
The intervention will include three components: (a) assessment; (b) decision-making and support; and (c) disclosure, planning, and action. The individualized assessment comprehensively will consider the family's history, experiences with disclosure, communication skills, coping resources, and factors likely to affect disclosure (e.g., familial, psychological, social, cultural, and medical issues). The second component of decision-making and support focused on developing communication skills and strategies, with role-play and practice outside of the sessions as necessary. Costs and benefits of disclosure were considered along with the range of disclosure options. Materials, including a pros and cons chart of disclosure and a disclosure continuum worksheet, were used to stimulate discussions of possible plans and consequences. In the third component, parents were encouraged to formulate and practice a disclosure plan for later use.
| Study group | Role | What they receive |
|---|---|---|
| disclosure-support counseling | Experimental | Not described Receives: Behavioral: disclosure-support counseling intervention |
| Treatment as Usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
readiness to disclose
This data will be collected and evaluated with qualitative methods using the Disclosure Distress Questionnaire
Measured: 16 weeks
Secondary outcomes (4)
quality of life via Medical Outcomes Study HIV Health Survey
The Medical Outcomes Study HIV Health Survey (MOS-HIV) is a brief, comprehensive health status measure that has been used extensively in studies of human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS). MOS-HIV for quality of life is ranges from 0-60. The higher the score the better the quality of life.
Measured: 16 weeks
depression via the Center for Epidemiologic Studies Depression Scale (CES-D)
Depression is measured by CES-D, ranged from 0-40. A score higher than 16 is considered as depressed.
Measured: 16 weeks
adherence
Measured using a visual analog scale. Acceptable adherence is equal or higher than 95%.
Measured: 16 weeks
social support using the HIV Social Support tool
social support will ranged from 0-20. The higher the score, shown more support in life.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start8 Aug 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will assess feasibility and acceptability and get a broad sense of the initial efficacy of the intervention with a two-arm RCT implemented with 10 HIV+ mothers: 5 will be randomly assigned to the disclosure-support counseling intervention and 5 to a treatment-as-usual (TAU) condition.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Ti Chen, PhD, Principal investigator, Yale School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248778
- Sponsor's protocol ID
- 2000020567
- Status last verified
- Jul 2019
- First submitted
- 10 Aug 2017
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Readiness to Disclose Mother's HIV Diagnosis to Their Children in Beijing, China
- ClinicalTrials.gov ID
- NCT03248778
- Acronym / sponsor ID
- 2000020567
- Conditions
- HIV
- Keywords
- disclosure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 14 Aug 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.
Specific aims of the 1-year project are to pilot test the disclosure support intervention by (a) evaluating acceptability and feasibility with a preliminary randomized trial among 10 HIV+ mothers (5 in the intervention group and 5 in the treatment as usual (TAU) group) and (b) assessing outcomes in mothers (quality of life and mental health indicators, adherence, social support, and disclosure stress, efficacy, readiness, and completion). The intervention will be compared to treatment as usual, with baseline (0 weeks), immediate post-intervention (4 weeks), and 12-week follow-up (16 weeks) assessments.
Detailed description
HIV disclosure to children has been shown to strengthen family relations and increase assistance with medical care, reinforcing the parent's willingness to live. Some Chinese children aware of their parents HIV diagnosis do exhibit emotional and social dysfunction; however, adequate support from caregivers (e.g., grandparents or even their HIV+ parents) can improve the children's quality of life and academic performance. There is a clear need for practical interventions to address parental distress around HIV disclosure in China, where cultural norms often emphasize family identity and cohesion and underscore the need for family-based programs, which have been shown to be feasible and efficacious for HIV-affected families.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will assess feasibility and acceptability and get a broad sense of the initial efficacy of the intervention with a two-arm RCT implemented with 10 HIV+ mothers: 5 will be randomly assigned to the disclosure-support counseling intervention and 5 to a treatment-as-usual (TAU) condition.
| Arm | Type | Receives |
|---|---|---|
| disclosure-support counseling | Experimental | Behavioral: disclosure-support counseling intervention |
| Treatment as Usual | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV+ mother ≥18 years of age,
- not psychotic or demented;
- receiving clinical care at the Ditan hospital,
- a mother of an HIV-negative child of age 13-25 years who does not know about the mother's infection;
- well enough to attend study sessions as the clinic.
Key exclusion criteria (1 listed)
- no psychotic or demented
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 |
|---|---|---|
| disclosure-support counseling interventionThe intervention will include three components: (a) assessment; (b) decision-making and support; and (c) disclosure, planning, and action. The individualized assessment comprehensively will consider the family's history, experiences with disclosure, communication skills, coping resources, and factors likely to affect disclosure (e.g., familial, psychological, social, cultural, and medical issues). The second component of decision-making and support focused on developing communication skills and strategies, with role-play and practice outside of the sessions as necessary. Costs and benefits of disclosure were considered along with the range of disclosure options. Materials, including a pros and cons chart of disclosure and a disclosure continuum worksheet, were used to stimulate discussions of possible plans and consequences. In the third component, parents were encouraged to formulate and practice a disclosure plan for later use. | Behavioural | disclosure-support counseling |
Primary outcome
readiness to disclose
Time frame: 16 weeks
This data will be collected and evaluated with qualitative methods using the Disclosure Distress Questionnaire
4 secondary outcomes
quality of life via Medical Outcomes Study HIV Health Survey
Time frame: 16 weeks
depression via the Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 16 weeks
adherence
Time frame: 16 weeks
social support using the HIV Social Support tool
Time frame: 16 weeks
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 8 Jul 2019.
- 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.
Wei-Ti Chen, PhD principal investigator
Yale School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing disclosure-support counseling intervention in people with HIV, run by Yale University at 1 site 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 5 inclusion and 1 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 8 Jul 2019. 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 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?
readiness to disclose (time frame: 16 weeks). 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 8 Jul 2019.