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

NCT ID: NCT03248778

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-08
• Study Completion Date: 2017-12-31

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.

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

disclosure-support counseling

Group Type: EXPERIMENTAL

disclosure-support counseling intervention

Intervention Type: 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.

Treatment as Usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei-Ti Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale School of Nursing

Locations

Beijing Ditan Hospital

Beijing, , China

Countries

China

Other Identifiers

2000020567

Identifier Type: -

Identifier Source: org_study_id