Disclosure to Family

NCT02111720 | Unknown DMC

• 2 other identifiers: MH097486R01MH097486
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

Brief Summary

The decision to disclose one's serostatus to family members creates considerable emotional strain for people living with HIV (PLWH), regardless of gender and sexual orientation. While disclosure to family members has been linked to positive outcomes including increased social support, improved health outcomes (i.e., sexual, physical, mental), reduced loneliness and stress, and improved HIV disease management, the decision not to disclose can also lead to positive outcomes. To date, most research about serostatus disclosure has focused on the act of disclosing - the who, what, where, and when of disclosing - rather than the decision process involved. The investigator's long-range goal is to further refine and evaluate an intervention designed to enhance HIV disclosure decision-making among PLWH. To reach this goal, the investigators are proposing a course of study with the following specific aims: Specific Aim 1. Assess the effectiveness of the intervention relative to an attention-control condition on a variety of primary outcomes related to disclosure and health. Specific Aim 2: Examine the effects of the intervention over time. Specific Aim 3: Explore the potential mediating effects of disclosure decision making on the primary outcomes. Specific Aim 4: Explore potential moderating effects of participant demographics (e.g., gender, age), relationship characteristics (i.e., relationship satisfaction, proximity, importance of disclosure), and contextual variables related to family (e.g., adaptability, problem-solving) on intervention effectiveness. Specific Aim 5: Evaluate the effects of treatment engagement, retention and expectations on outcomes.

Conditions

HIV Risk Reduction; Attention Control Case Management

Keywords

HIV; Disclosure; Family; Intervention

Outcome Measures

Primary Outcomes (1)

• Change from baseline to 52 weeks in HIV Transmission Risk

  Ordinal measure of HIV transmission risk. The ordinal measure is constructed from information provided by the participant on the last five sexual encounters during the prior 30 days, with the highest risk assigned to encounters involving discordant anal/vaginal intercourse, unprotected, with a discordant partner (XEF)

  Baseline, Week 7, Week 12, Week 24, Week 52

Secondary Outcomes (3)

• Change from baseline to 52 weeks in the number of family members to whom participants have disclosed their positive serostatus

  Baseline, Week 7, Week 12, Week 24, Week 52

• Change from baseline to 52 weeks in the odds of disclosure to sex partners

  Baseline, Week 7, Week 12, Week 24, Week 52

• Change from baseline to 52 weeks in the proportion of sex partners disclosed to

  Baseline, Week 7, Week 12, Week 24, Week 52

Other Outcomes (7)

• Change from baseline to 52 weeks in depression score (CES-D)

  Baseline, Week 7, Week 12, Week 24, Week 52

• Change from baseline to 52 weeks in anxiety score (CAS)

  Baseline, Week 7, Week 12, Week 24, Week 52

• Change from baseline to 52 weeks in self-esteem score (SERS)

  Baseline, Week 7, Week 12, Week 24, Week 52

Study Arms (2)

Maybe, Maybe Not

EXPERIMENTAL

The intervention is an individual-level 4-session + 3 month booster series designed to assist persons with HIV in making decisions regarding the disclosure of their HIV serostatus to family members.

Behavioral: Maybe, Maybe Not

Comprehensive Risk Counseling and Services

ACTIVE COMPARATOR

Comprehensive Risk Counseling and Services (CRCS) will be used to provide the attention-placebo control (CDC, 2006). CRCS combines traditional case management and HIV risk-reduction in an individualized, client-centered program which focuses on the reduction of risk behavior and addresses a client's psychosocial and medical needs.

Behavioral: Comprehensive Risk Counseling and Services

Interventions

Maybe, Maybe Not BEHAVIORAL

The goals of session one are to introduce participants to the intervention, to assess current decision context, to assist in the clarification of participant values, and to encourage the participant to set specific goals for disclosure decision-making. The goals for session two are to explore the participants' motivations to disclose or not to disclose and the potential costs and rewards of both disclosing and not disclosing. The goals for session three are to guide participants through disclosure decision making, and to support comfort/acceptance with decisions made. The goal of session four is to support the decision-making process. The booster session is used to reinforce the effects of the intervention through continued discussion of disclosure decisions in the preceding months, strategies used in disclosing, and rewards and costs of decision-making.

Maybe, Maybe Not

Comprehensive Risk Counseling and Services BEHAVIORAL

CRCS combines traditional case management and HIV risk-reduction in an individualized, client-centered program which focuses on the reduction of risk behavior and addresses a client's psychosocial and medical needs.CRCS focuses on seven core elements: recruitment and engagement; screening, enrolling, and assessing; prevention planning; risk reduction counseling; referrals and service coordination; monitoring; and discharge and maintenance. These core elements represent the framework of the intervention, and provide enough flexibility to allow implementation that most appropriately serves the needs of clients.

Also known as: CRCS

Comprehensive Risk Counseling and Services

Eligibility Criteria

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

You may qualify if:

• HIV-positive men and women
• over the age of 18
• indicate an interest in learning more about disclosure
• have at least one family member who does not know of diagnosis
• sexually active in past 90 days
• speak and understand English
• plan on living in Tampa area for at least one year

You may not qualify if:

• not HIV-positive
• children under the age of 18
• not able to speak and understand English
• do not plan on living in Tampa area for the year
• not sexually active in last 90 days

Sponsors & Collaborators

• University of South Florida: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

MeSH Terms

Interventions

Calcibiotic Root Canal Sealer

Study Officials

• Julianne M Serovich, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 11, 2014
• Study Start: July 1, 2013
• Primary Completion: August 17, 2020
• Study Completion: August 17, 2020
• Last Updated: April 1, 2020

Record last verified: 2020-03

Locations

US (1)