Clinical trial NCT03248778: Readiness to Disclose Mother's HIV Diagnosis to Their Children in Beijing, China
Official title: Readiness to Disclose Mother's HIV Diagnosis to Their Children in Beijing, China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: disclosure
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: readiness to disclose
timeFrame: 16 weeks
Secondary outcomes:
measure: quality of life via Medical Outcomes Study HIV Health Survey
timeFrame: 16 weeks
measure: depression via the Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 16 weeks
measure: adherence
timeFrame: 16 weeks
measure: social support using the HIV Social Support tool
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital
Study officials:
affiliation: Yale School of Nursing
name: Wei-Ti Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: