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Clinical Trials/NCT03248778
NCT03248778
Completed
Not Applicable

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

Yale University1 site in 1 country5 target enrollmentAugust 8, 2017
ConditionsHIV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
Yale University
Enrollment
5
Locations
1
Primary Endpoint
readiness to disclose
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 8, 2017
End Date
December 31, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

readiness to disclose

Time Frame: 16 weeks

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

Secondary Outcomes

  • 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 Sites (1)

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