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

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: disclosure-support counseling intervention

• Registration Number: NCT03248778
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-08-08
• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-14
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-05
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5

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.

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Exclusion Criteria

• no psychotic or demented

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
disclosure-support counseling	disclosure-support counseling intervention	-

Primary Outcome Measures

Name	Time	Method
readiness to disclose	16 weeks	This data will be collected and evaluated with qualitative methods using the Disclosure Distress Questionnaire

Secondary Outcome Measures

Name	Time	Method
quality of life via Medical Outcomes Study HIV Health Survey	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.
depression via the Center for Epidemiologic Studies Depression Scale (CES-D)	16 weeks	Depression is measured by CES-D, ranged from 0-40. A score higher than 16 is considered as depressed.
adherence	16 weeks	Measured using a visual analog scale. Acceptable adherence is equal or higher than 95%.
social support using the HIV Social Support tool	16 weeks	social support will ranged from 0-20. The higher the score, shown more support in life.

Trial Locations

Locations (1)

Beijing Ditan Hospital; 🇨🇳 Beijing, China