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

NCT03248778 | Completed

• 1 other identifier: 2000020567
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

disclosure

Outcome Measures

Primary Outcomes (1)

• readiness to disclose

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

  16 weeks

Secondary Outcomes (4)

• quality of life via Medical Outcomes Study HIV Health Survey

  16 weeks

• depression via the Center for Epidemiologic Studies Depression Scale (CES-D)

  16 weeks

• adherence

  16 weeks

• social support using the HIV Social Support tool

  16 weeks

Study Arms (2)

disclosure-support counseling

EXPERIMENTAL

Behavioral: disclosure-support counseling intervention

Treatment as Usual

NO INTERVENTION

Interventions

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.

disclosure-support counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• no psychotic or demented

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Beijing Ditan Hospital

Beijing, China

Location

Study Officials

• Wei-Ti Chen, PhD

  Yale School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 14, 2017
• Study Start: August 8, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)