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

Not Applicable

Completed

• Conditions: Hiv
• Interventions: Behavioral: self- and family-management intervention sessions

• Registration Number: NCT03049332
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-02
• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-07
• Last Update Submitted: 2017-02-07
• Study First Posted: 2017-02-10
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	self- and family-management intervention sessions	HIV+ Chinese women in China and a family member will be recruited for the pilot testing of the intervention.

Primary Outcome Measures

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

Trial Locations

Locations (2)

Beijing Ditan Hospital; 🇨🇳 Beijing, China

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, China