---
title: Self- and Family-management Intervention in HIV+ Chinese Women
nct_id: NCT03049332
overall_status: COMPLETED
phase: NA
sponsor: Yale University
study_type: INTERVENTIONAL
primary_condition: Hiv
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03049332.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03049332"
ct_last_update_post_date: 2017-02-10
last_seen_at: "2026-05-12T07:25:03.713Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Self- and Family-management Intervention in HIV+ Chinese Women

**NCT ID:** [NCT03049332](https://clinicaltrials.gov/study/NCT03049332)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 82
- **Lead Sponsor:** Yale University
- **Collaborators:** Beijing Ditan Hospital, Shanghai Public Health Clinical Center, National Institute of Nursing Research (NINR)
- **Conditions:** Hiv
- **Start Date:** 2014-07
- **Completion Date:** 2016-03
- **CT.gov Last Update:** 2017-02-10

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** FEMALE
- **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.

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.
```

## Arms

- **All participants** (EXPERIMENTAL) — HIV+ Chinese women in China and a family member will be recruited for the pilot testing of the intervention.

## Interventions

- **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

- **retention rates** _(time frame: 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** _(time frame: 6 months)_ — includes attending counseling sessions and completing questionnaires
- **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
- **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

## Locations (2)

- Beijing Ditan Hospital, Beijing, China
- Shanghai Public Health Clinical Center, Shanghai, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.beijing ditan hospital|beijing||china` — added _(2026-05-12)_
- `locations.shanghai public health clinical center|shanghai||china` — added _(2026-05-12)_

---

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