Disclosure to Family (D2F)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of South Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT02111720
First received: March 28, 2014
Last updated: April 8, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
HIV Risk Reduction
Attention Control Case Management
Behavioral: Maybe, Maybe Not
Behavioral: Comprehensive Risk Counseling and Services

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Maybe, Maybe Not: Deciding to Disclose HIV Status to Family

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Change from baseline to 52 weeks in HIV Transmission Risk [ Time Frame: Baseline, Week 7, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Change from baseline to 52 weeks in the number of family members to whom participants have disclosed their positive serostatus [ Time Frame: Baseline, Week 7, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    At baseline, the ASSIS interview tool is used to identify participants' family members who do not know the participants' serostatus. During the study period, they will report any of these family members to whom they disclosure their serostatus (i.e., the status of disclosure has changed from "not disclosed to" to "disclosed to")

  • Change from baseline to 52 weeks in the odds of disclosure to sex partners [ Time Frame: Baseline, Week 7, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Participants will indicate, for each of their last 5 encounters, whether or not they disclosed their serostatus to sex partners (DPA)

  • Change from baseline to 52 weeks in the proportion of sex partners disclosed to [ Time Frame: Baseline, Week 7, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Participants will indicate the number of sex partners disclosed to during the prior 30 days (DBC)


Other Outcome Measures:
  • Change from baseline to 52 weeks in depression score (CES-D) [ Time Frame: Baseline, Week 7, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Participants provide depression scores on the 20-item Center for Epidemeologic Studies Depression Scale

  • Change from baseline to 52 weeks in anxiety score (CAS) [ Time Frame: Baseline, Week 7, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Anxiety assessed with the 9-item Costello-Comrey Anxiety Scale.

  • Change from baseline to 52 weeks in self-esteem score (SERS) [ Time Frame: Baseline, Week 7, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Self-esteem assessed with the 40-item Self-Esteem Rating Scale.

  • Change from baseline to 52 weeks in coping score (WCI) [ Time Frame: Baseline, Week 7, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Coping assessed with the 50-item Ways of Coping Inventory

  • Change from baseline to 52 weeks in HIV Stigma score (STG) [ Time Frame: Baseline, Week 7, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    HIV Stigma assessed with the 40-item HIV Stigma scale

  • Change from baseline to 52 weeks in health (MDH) [ Time Frame: Baseline, Week 7, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    General health and physical functioning assessed with the 21-item Multidimensional Health Scale

  • Change from baseline to 52 weeks in unprotected anal intercourse [ Time Frame: Baseline, Week 7, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Participants are asked to provide the number of sexual encounters involving unprotected anal intercourse during the prior 30 day period (XBC)


Estimated Enrollment: 450
Study Start Date: July 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maybe, Maybe Not
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
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.
Active Comparator: Comprehensive Risk Counseling and Services
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
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.
Other Name: CRCS

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02111720

Contacts
Contact: Julianne M Serovich, PhD 813-974-1990 jserovich@usf.edu
Contact: Judy A Kimberly, PhD 813-974-4198 jkimberly@usf.edu

Locations
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Judy A Kimberly, PhD    813-974-4198    jkimberly@usf.edu   
Principal Investigator: Julianne M Serovich, PhD         
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Julianne M Serovich, PhD University of South Florida
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02111720     History of Changes
Other Study ID Numbers: MH097486, R01MH097486
Study First Received: March 28, 2014
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
HIV
Disclosure
Family
Intervention

ClinicalTrials.gov processed this record on July 24, 2014