Theory-based HIV Disclosure Intervention for Parents

NCT04051177 | Completed

• 1 other identifier: 10006371
• Study Type: interventional
• Target: 791
• Locations: 1 country
• Sites: 1

Brief 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

HIV/AIDS; Disclosure

Keywords

parental HIV disclosure; China; intervention

Outcome Measures

Primary Outcomes (2)

• number of participants who have disclosed their HIV serostatus to their children assessed by one question in the survey

  question in questionnaire "have you disclosed your HIV serostatus to your children"?

  from baseline to 36 month follow-up

• participants' stage status regarding parental disclosure assessed by one question in the survey with 6 stages (see description)

  question in questionnaire "what stage status are you in now regarding disclosing your status to your children" 1 = "having not started disclosure in the past 6 months and no intention to start", 2 = "having not started disclosure in the past 6 months but is intending to start", 3 = "having not started disclosure in the past 6 months but already made a plan", 4 = "started disclosing but not mentioning HIV", 5 = "started disclosing with the word HIV", and 6 = "started disclosing with the word HIV and how I got infected".

  from baseline to 36 month follow-up

Secondary Outcomes (10)

• depression

  from baseline to 36 month follow-up

• stress

  from baseline to 36 month follow-up

• tobacco use

  from baseline to 36 month follow-up

• alcohol use

  from baseline to 36 month follow-up

• drug use

  from baseline to 36 month follow-up

Study Arms (2)

parents living with HIV intervention group

EXPERIMENTAL

Parents living with HIV in this group received five two-hour parent HIV disclosure intervention, delivered one session per week for five weeks in the clinics where the parents are recruited. The intervention curriculum is modeled after the TRACK program with supplemental materials from TALC.

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

Parents living with HIV control group

OTHER

Parents living with HIV in this group received five two-hour nutrition education curriculum in same delivery way. The nutrition curriculum is modeled after the "Simply Good Eating: curriculum developed at University of Minnesota.

Behavioral: Nutrition Curriculum

Interventions

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

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.

parents living with HIV intervention group

Nutrition Curriculum BEHAVIORAL

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")

Parents living with HIV control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years of age;
• a confirmed diagnosis of HIV or AIDS;
• living with at least one child 6 to 15 years of age;
• having not disclosed their HIV status to their children;
• willing to consent one child to participate in the study.

You may not qualify if:

• linguistic, mental or physical inability to respond to assessment questions or to participate in intervention;
• currently incarcerated or institutionalized for drug use or commercial sex;
• plan to permanently relocate outside of the province within a year.

Sponsors & Collaborators

• University of South Carolina: lead
• Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control: collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: August 9, 2019
• Study Start: August 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2018
• Last Updated: December 9, 2019

Record last verified: 2019-08

Locations

US (1)