Self- and Family-management Intervention in HIV+ Chinese Women

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.

Study Overview

• Status: Completed
• Conditions: Hiv
• Intervention / Treatment: Behavioral: self- and family-management intervention sessions

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Ditan Hospital
  • Shanghai, China
    • Shanghai Public Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All participants; HIV+ Chinese women in China and a family member will be recruited for the pilot testing of the intervention.	Behavioral: self- and family-management intervention sessions; The self- and family management intervention will have six elements: (a) biofeedback for relaxation; (b) family support; (c) coping skills; (d) anxiety, stress, and depression management; (e) cognitive-behavioral management skills; and (f) psycho-educational classes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
retention rates	the percentage of self- and family-management intervention sessions attended by both HIV+ women and one family member	6 months
compliance with data collection procedures	includes attending counseling sessions and completing questionnaires	6 months
acceptability	including reports of burden related to the study and/or intervention procedures measured by intervention session logs and exit interview	6 months
feelings of safety	family members and study participants feelings of safety related to participating in this project measured by intervention session logs and exit interview	6 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Nursing Research (NINR); Beijing Ditan Hospital; Shanghai Public Health Clinical Center
• Investigators: Principal Investigator: Weiti Chen, Yale University School of Nursing

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Actual): February 10, 2017

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Quality of Life
• Other Study ID Numbers: 1207010522; K23NR014107-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No