Clinical trial NCT04051177: Theory-based HIV Disclosure Intervention for Parents
Official title: Theory-based HIV Disclosure Intervention for Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Disclosure
Keywords: parental HIV disclosure
China
intervention
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
First posted: 2019-08-09
Enrollment: 791
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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.

Eligibility 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.

Primary outcomes:
measure: number of participants who have disclosed their HIV serostatus to their children assessed by one question in the survey
timeFrame: from baseline to 36 month follow-up
measure: participants' stage status regarding parental disclosure assessed by one question in the survey with 6 stages (see description)
timeFrame: from baseline to 36 month follow-up
Secondary outcomes:
measure: depression
timeFrame: from baseline to 36 month follow-up
measure: stress
timeFrame: from baseline to 36 month follow-up
measure: tobacco use
timeFrame: from baseline to 36 month follow-up
measure: alcohol use
timeFrame: from baseline to 36 month follow-up
measure: drug use
timeFrame: from baseline to 36 month follow-up
measure: condom use in sexual intercourse
timeFrame: from baseline to 36 month follow-up
measure: quality of life of people living with HIV
timeFrame: from baseline to 36 month follow-up
measure: most recent CD4 count
timeFrame: from baseline to 36 month follow-up
measure: most recent viral load
timeFrame: from baseline to 36 month follow-up
measure: disease progression
timeFrame: from baseline to 36 month follow-up
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
References: