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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03049332
• Other study ID #: 1207010522
• Secondary ID: K23NR014107-02
• Status: Completed
• Phase: N/A
• First received: February 7, 2017
• Last updated: February 7, 2017
• Start date: July 2014
• Est. completion date: March 2016

Study information

• Verified date: February 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hiv

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.

Locations

Country	Name	City	State
China	Beijing Ditan Hospital	Beijing
China	Shanghai Public Health Clinical Center	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Yale University	Beijing Ditan Hospital, National Institute of Nursing Research (NINR), Shanghai Public Health Clinical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	retention rates	the percentage of self- and family-management intervention sessions attended by both HIV+ women and one family member	6 months
Primary	compliance with data collection procedures	includes attending counseling sessions and completing questionnaires	6 months
Primary	acceptability	including reports of burden related to the study and/or intervention procedures measured by intervention session logs and exit interview	6 months
Primary	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