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

Yale University

Status: Completed

Conditions: Hiv

Treatments: Behavioral: self- and family-management intervention sessions

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03049332

K23NR014107-02 (U.S. NIH Grant/Contract)

1207010522

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

All participants

Experimental group

Description:

HIV+ Chinese women in China and a family member will be recruited for the pilot testing of the intervention.

Treatment:

Behavioral: self- and family-management intervention sessions