Clinical trial NCT03049332: Self- and Family-management Intervention in HIV+ Chinese Women
Official title: Self- and Family-management Intervention in HIV+ Chinese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Keywords: Quality of Life
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Beijing Ditan Hospital
name: Shanghai Public Health Clinical Center
name: National Institute of Nursing Research (NINR)
First posted: 2017-02-10
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The same group of individuals will be measured pre and post intervention.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project is to develop a culturally sensitive and feasible self- and family-management intervention that will assist HIV+ Chinese women and their families to manage the illness and improve quality of life and clinical outcomes.

Detailed description: The study will be conducted in 3 phases.

Phase 1: The PI conducted a secondary qualitative analysis of in-depth interviews to further illuminate the sociocultural and family context of HIV+ Chinese women. The data were obtained from three previous projects conducted in China from 2005 to 2011.

Phase 2: The PI developed and adapted a theory-driven, culturally sensitive and feasible intervention to improve the quality of life and clinical outcomes of HIV+ Chinese women and their families.

Phase 3: The PI conducted a feasibility, compliance, and acceptability study for a self- and family-management intervention with HIV+ women and of their family members.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria for HIV+ women.

* be at least 18 years of age,
* be able to give informed consent for the study and to cognitively participate,
* be receiving clinical care at Ditan Hospital and SPHCC,
* have been diagnosed with HIV within the past 12 months,
* have disclosed their status to at least one family member and willing to invite that family member to the intervention,
* be well enough to attend counseling sessions at the hospital, and
* be able to attend follow-up visits at the hospital.

Inclusion criteria for family members.

* be 18 years of age,
* be able to give informed consent for the study and to cognitively participate,
* have a female family member who is HIV+, and is currently receiving clinical care at Ditan Hospital and SPHCC,
* be a family member who are taking care of the female HIV+ family member,
* be well enough to attend counseling sessions at the hospital, and
* be able to attend follow-up visits at the hospital.

Exclusion Criteria:

Exclusion criteria for HIV+ women

* history of an affective illness such as depression or bipolar disease,
* are under age 18, or
* are unwilling or unable to bring a family member to participate in the study.

Exclusion criteria for family members.

* have a history of an affective illness such as depression or bipolar disease,
* are under age 18,
* or are unwilling or unable to come with their HIV+ family member to participate the study.

Primary outcomes:
measure: retention rates
timeFrame: 6 months
measure: compliance with data collection procedures
timeFrame: 6 months
measure: acceptability
timeFrame: 6 months
measure: feelings of safety
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
Study officials:
affiliation: Yale University School of Nursing
name: Weiti Chen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen WT, Shiu C, Zhang L, Zhao H. Care engagement with healthcare providers and symptom management self-efficacy in women living with HIV in China: secondary analysis of an intervention study. BMC Public Health. 2022 Jun 15;22(1):1195. doi: 10.1186/s12889-022-13573-3.