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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03049332
Enrollment
82
Registered
2017-02-10
Start date
2014-07-31
Completion date
2016-03-31
Last updated
2017-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv

Keywords

Quality of Life

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.

Interventions

BEHAVIORALself- 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.

Sponsors

Beijing Ditan Hospital
CollaboratorOTHER
Shanghai Public Health Clinical Center
CollaboratorOTHER_GOV
National Institute of Nursing Research (NINR)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

The same group of individuals will be measured pre and post intervention.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
retention rates6 monthsthe percentage of self- and family-management intervention sessions attended by both HIV+ women and one family member
compliance with data collection procedures6 monthsincludes attending counseling sessions and completing questionnaires
acceptability6 monthsincluding reports of burden related to the study and/or intervention procedures measured by intervention session logs and exit interview
feelings of safety6 monthsfamily members and study participants feelings of safety related to participating in this project measured by intervention session logs and exit interview

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026