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Completed

NCT Number: NCT03248778

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Ditan Hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

disclosure-support counseling intervention

Behavioral

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.

Primary outcomes

  1. readiness to disclose

    Time frame: 16 weeks

    This data will be collected and evaluated with qualitative methods using the Disclosure Distress Questionnaire

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 14, 2017
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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