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

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: disclosure-support counseling intervention

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Ditan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as Usual
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
readiness to disclose	This data will be collected and evaluated with qualitative methods using the Disclosure Distress Questionnaire	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
adherence	Measured using a visual analog scale. Acceptable adherence is equal or higher than 95%.	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.	16 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Wei-Ti Chen, PhD, Yale School of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 14, 2017

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 5, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: disclosure
• Other Study ID Numbers: 2000020567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No