Readiness to Disclose Mother's HIV Diagnosis to Their Children in Beijing, China

HIV Clinical Trial

Official title:

Readiness to Disclose Mother's HIV Diagnosis to Their Children in Beijing, China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248778
• Other study ID #: 2000020567
• Status: Completed
• Phase: N/A
• Start date: August 8, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2019
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• no psychotic or demented

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Ditan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	readiness to disclose	This data will be collected and evaluated with qualitative methods using the Disclosure Distress Questionnaire	16 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks
Secondary	adherence	Measured using a visual analog scale. Acceptable adherence is equal or higher than 95%.	16 weeks
Secondary	social support using the HIV Social Support tool	social support will ranged from 0-20. The higher the score, shown more support in life.	16 weeks