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

Study Overview
=================
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.

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

Conditions
-----------------
Hiv

Intervention / Treatment
-----------------
* Behavioral: self- and family-management intervention sessions


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: The same group of individuals will be measured pre and post intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All participants<br>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<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life