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. Identifier: NCT03248778
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Information provided by (Responsible Party):
Yale University

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: disclosure-support counseling intervention Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. readiness to disclose [ Time Frame: 16 weeks ]
    This data will be collected and evaluated with qualitative methods using the Disclosure Distress Questionnaire

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. adherence [ Time Frame: 16 weeks ]
    Measured using a visual analog scale. Acceptable adherence is equal or higher than 95%.

  4. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03248778

Contact: Weiti Chen, PhD +1 (203) 737-2416

Beijing Ditan Hospital Recruiting
Beijing, China
Contact: Zhao Hongxin, MD    +86 10 8432 2000      
Sponsors and Collaborators
Yale University
Principal Investigator: Wei-Ti Chen, PhD Yale School of Nursing

Responsible Party: Yale University Identifier: NCT03248778     History of Changes
Other Study ID Numbers: 2000020567
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University: