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Theory-based HIV Disclosure Intervention for Parents (ICOPE)

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ClinicalTrials.gov Identifier: NCT04051177
Recruitment Status : Completed
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
Information provided by (Responsible Party):
Xiaoming Li, University of South Carolina

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).

Condition or disease Intervention/treatment Phase
HIV/AIDS Disclosure Behavioral: Interactive Communication with Openness, Passion, and Empowerment "ICOPE" Behavioral: Nutrition Curriculum Not Applicable

Detailed Description:
Because programs preventing prenatal HIV transmission are reaching a greater number of pregnant women worldwide and are successfully reducing vertical transmission, an ever increasing majority of children born to HIV-positive mothers are uninfected. In addition, new medical innovations and increasing availability of antiretroviral therapy (ART) have improved the health and longevity of HIV-positive parents, which means they are more likely to raise their children for many years after the initial diagnosis. For parents living with HIV ("PLH"), disclosing their HIV infection to their seronegative children ("parental HIV disclosure") becomes an increasingly important issue in terms of well-being of parents, children and families. The global literature in parental HIV disclosure suggests that developmentally appropriate, well-planned disclosure can greatly benefit the well-being of PLH, their children and families. However, for multiple reasons including fear of stigma and the psychological burden such knowledge might place on their children, PLH often struggle about whether, when, what, and how to talk to their children about their HIV infection. Many of them do not disclose their HIV infection to children primarily because they lack the confidence and behavioral skills to appropriately and effectively accomplish this task. To date, the issues surrounding parental HIV disclosure have been understudied, particularly in low- and middle-income countries (LMICs) including China where the HIV epidemic has been steadily expanding. In this application, the investigators propose to adapt relevant components from two evidence-based programs developed in the US to produce a theory-driven developmentally appropriate parental HIV disclosure intervention in Guangxi, China, where the investigators have built a strong research infrastructure and community collaboration through NIH-funded research since 2004. The proposed project consists of three main operational phases. Phase I includes formative research to examine current practices, barriers and facilitators, cultural influences, and effects of disclosure on PLH and their children. The data to be collected in this phase will complement the data the investigators have collected and will inform the adaption of intervention content and delivery modality. Phase II includes the development and pilot-testing of a theory-guided parental HIV disclosure intervention program with two components (a primary parent component and a secondary care provider component) by culturally adapting and integrating aspects of two US-based programs that were efficacious in either helping parents to make appropriate HIV disclosure or improving mental health status of PLH and their children. Phase III will rigorously evaluate the efficacy of the proposed intervention on well-being of PLH, children and families over 36 months through a cluster randomized controlled trial involving 800 PLH (either fathers or mothers) and their children (6 to 15 years of age). The research will also identify contextual and individual factors that potentially mediate or moderate the effect of the proposed intervention on parent, child, and family outcomes. The proposed research will address the dearth of targeted interventions supporting parental efforts in disclosing their HIV status to their children by examining whether a theory-based intervention can improve parental HIV disclosure in a low-resource setting. The proposed study will also provide cross-cultural evidence to support the role of parental disclosure in the well-being of parents, children, and families.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 791 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Theory-based HIV Disclosure Intervention for Parents
Actual Study Start Date : August 2012
Actual Primary Completion Date : August 2017
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: parents living with HIV intervention group
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"
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 control group
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
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")




Primary Outcome Measures :
  1. number of participants who have disclosed their HIV serostatus to their children assessed by one question in the survey [ Time Frame: from baseline to 36 month follow-up ]
    question in questionnaire "have you disclosed your HIV serostatus to your children"?

  2. participants' stage status regarding parental disclosure assessed by one question in the survey with 6 stages (see description) [ Time Frame: from baseline to 36 month follow-up ]
    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".


Secondary Outcome Measures :
  1. depression [ Time Frame: from baseline to 36 month follow-up ]
    The Center for Epidemiologic Studies Depression Scale. Depression is measured using the Center for Epidemiologic Studies Short Depression Scale (CES‐D 10) with a 4-point ordinal response: 0 = rarely or none of the time (less than 1 day); 1 = some or a little of the time (1-2 days); 2 = occasionally or a moderate amount of the time (3-4 days); 3 = most or all of the time (5-7 days). A summary score of all 10 items is calculated with higher scores indicating higher levels of depression. The summary score ranges between 0 to 30, and a score of 10 or greater is considered depressed.

  2. stress [ Time Frame: from baseline to 36 month follow-up ]
    Perceived Stress Scale. Perceived stress is assessed using 14 items from the perceived stress scales (PSS) with a 5-point responses option (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). A composite score was calculated by summing all 14 item responses. The composite score ranges between 0 to 56, and Higher scores indicating a higher level of perceived stress.

  3. tobacco use [ Time Frame: from baseline to 36 month follow-up ]
    tobacco use

  4. alcohol use [ Time Frame: from baseline to 36 month follow-up ]
    alcohol use

  5. drug use [ Time Frame: from baseline to 36 month follow-up ]
    drug use

  6. condom use in sexual intercourse [ Time Frame: from baseline to 36 month follow-up ]
    condom use

  7. quality of life of people living with HIV [ Time Frame: from baseline to 36 month follow-up ]
    The Medical Outcomes Study HIV Health Survey is composed of 35 items with 3, 5, and 6-point likert-type scale and dichotomous yes/no. 11 of the 35 items in the survey require recoding. Item scores are linearly transformed to a 0-100 scale with higher score indicating a higher level of quality of life.

  8. most recent CD4 count [ Time Frame: from baseline to 36 month follow-up ]
    most recent CD4 count

  9. most recent viral load [ Time Frame: from baseline to 36 month follow-up ]
    most recent viral load

  10. disease progression [ Time Frame: from baseline to 36 month follow-up ]
    disease progression using the HIV staging system by WHO



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051177


Locations
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United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

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Responsible Party: Xiaoming Li, Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT04051177     History of Changes
Other Study ID Numbers: 10006371
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaoming Li, University of South Carolina:
parental HIV disclosure
China
intervention