Readiness to Disclose Mother's HIV Diagnosis to Their Children in Beijing, China
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03248778|
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: disclosure-support counseling intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Primary Purpose:||Supportive Care|
|Official Title:||Readiness to Disclose Mother's HIV Diagnosis to Their Children in Beijing, China|
|Actual Study Start Date :||August 8, 2017|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
|Experimental: disclosure-support counseling||
Behavioral: disclosure-support counseling intervention
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.
|No Intervention: Treatment as Usual|
- readiness to disclose [ Time Frame: 16 weeks ]This data will be collected and evaluated with qualitative methods using the Disclosure Distress Questionnaire
- quality of life via Medical Outcomes Study HIV Health Survey [ Time Frame: 16 weeks ]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.
- depression via the Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 16 weeks ]Depression is measured by CES-D, ranged from 0-40. A score higher than 16 is considered as depressed.
- adherence [ Time Frame: 16 weeks ]Measured using a visual analog scale. Acceptable adherence is equal or higher than 95%.
- social support using the HIV Social Support tool [ Time Frame: 16 weeks ]social support will ranged from 0-20. The higher the score, shown more support in life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248778
|Contact: Weiti Chen, PhD||+1 (203) email@example.com|
|Beijing Ditan Hospital||Recruiting|
|Contact: Zhao Hongxin, MD +86 10 8432 2000|
|Principal Investigator:||Wei-Ti Chen, PhD||Yale School of Nursing|