NCT03049332

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

February 7, 2017

Last Update Submit

February 7, 2017

Conditions

Hiv

Keywords

Quality of Life

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

All participants

EXPERIMENTAL

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

Interventions

self- and family-management intervention sessionsBEHAVIORAL

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.

All participants

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Ditan Hospital

Beijing, China

Location

Shanghai Public Health Clinical Center

Shanghai, China

Location

Related Publications (1)

  • Chen WT, Shiu C, Zhang L, Zhao H. Care engagement with healthcare providers and symptom management self-efficacy in women living with HIV in China: secondary analysis of an intervention study. BMC Public Health. 2022 Jun 15;22(1):1195. doi: 10.1186/s12889-022-13573-3.

    PMID: 35705934DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Weiti Chen

    Yale University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: The same group of individuals will be measured pre and post intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 10, 2017

Study Start

July 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

February 10, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)