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Completed

NCT Number: NCT03049332

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Ditan Hospital, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

self- and family-management intervention sessions

Behavioral

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.

Primary outcomes

  1. retention rates

    Time frame: 6 months

    the percentage of self- and family-management intervention sessions attended by both HIV+ women and one family member

  2. compliance with data collection procedures

    Time frame: 6 months

    includes attending counseling sessions and completing questionnaires

  3. acceptability

    Time frame: 6 months

    including reports of burden related to the study and/or intervention procedures measured by intervention session logs and exit interview

  4. feelings of safety

    Time frame: 6 months

    family members and study participants feelings of safety related to participating in this project measured by intervention session logs and exit interview

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Beijing Ditan Hospital
  • National Institute of Nursing Research (NINR)
  • Shanghai Public Health Clinical Center

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 10, 2017
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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