Theory-based HIV Disclosure Intervention for Parents

NCT04051177 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 791

Last updated 2019-12-09

No results posted yet for this study

Summary

The investigators propose to develop, implement, and evaluate a theory-driven parental disclosure intervention to assist parents living with HIV (PLH) to make a planned, developmentally appropriate disclosure of their HIV status to their uninfected children or, for PLH with younger children, to articulate a clear plan for disclosure to their children when developmentally appropriate. The majority of the 33.4 million individuals living with HIV worldwide reside in low-resource settings and are also of reproductive and child-rearing age. It is therefore important to the field of public health to develop an evidence-based parental disclosure intervention that can be effectively delivered to parents by a broad range of paraprofessionals. The investigators hypothesize that the proposed intervention will demonstrate efficacy in helping PLH to make developmentally appropriate disclosure to children or make a developmentally appropriate plan of disclosure and will demonstrate short, medium, and long-term efficacy in improving the well-being of parents, children, and families. The proposed scientifically rigorous evaluation includes mixed methods of data collection, a cluster randomized controlled trial, multiple data sources, and a 36-month longitudinal follow-up involving a large sample of parents, children, and providers. The intervention program to be developed and the evaluation data to be collected in the current study will inform the practice and clinic guidelines aimed at improving both parental HIV disclosure and the well-being of PLH, children and families in China and other low-and middle-income countries (LMICs).

Conditions

Interventions

BEHAVIORAL

Interactive Communication with Openness, Passion, and Empowerment "ICOPE"

The parent curriculum consists of five interactive training sessions (120 minutes each session for 10 hours total) with three specific focuses: understanding the stages of childhood cognitive development in the context of parental illness (Session #1 "Child's readiness for disclosure"); improving the parents' cognitive and behavioral skills related to parental HIV disclosure (Session #2 "Benefits and risks of disclosure", Session #3 "How to tell and what to tell", and Session #4 "Disclosure is an ongoing process"); and improving parental psychosocial well-being in adapting to living with HIV/AIDS (Session #5 "Cope with my infection/illness"). The curriculum addresses the issues of child and family strengths and community support across sessions.

BEHAVIORAL

Nutrition Curriculum

The modified curriculum consists of five 2-hour interactive training sessions with aims to increase parents' knowledge of nutrition (Session #1: Food variety; Session #2: Food for growing child), healthy diets and cooking practice (Session 3: Fat, salt and sugar; Session 4: Fruits, vegetables and minerals), and food safety (Session #5 "Food safety")

Sponsors & Collaborators

  • Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

    collaborator OTHER_GOV
  • University of South Carolina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2017-08-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04051177 on ClinicalTrials.gov