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Clinical Trials/NCT04018573
NCT04018573
Completed
Not Applicable

Developing an HIV Prevention Intervention for Young MSM Through Improved Parent-child Communication

George Washington University1 site in 1 country61 target enrollmentJune 14, 2019
ConditionsHIV Infections

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
George Washington University
Enrollment
61
Locations
1
Primary Endpoint
Change in Sexual Health Communication Checklist score -- Parents
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Young men who have sex with men (MSM) are at high risk for HIV infection in the United States, representing 80% of all infections among youth ages 14-24, and 92% of infections among boys ages 14-19. Despite these risks, the field has not even one HIV prevention intervention shown to be effective in decreasing sexual risks or increasing HIV testing among adolescent MSM (AMSM). Historically, reaching AMSM for HIV prevention has been challenging, given their relative geographic isolation and lack of access to traditional gay congregating spaces (e.g., bars and many gay-related social networking websites). However, the investigators have developed a novel online platform for delivering interventions to parents of LGB youth that currently sees thousands of visitors each year. HIV prevention advocates have identified parents of AMSM as an untapped resource for reducing HIV risk in this population. Parent-child communication about sex has well-demonstrated associations with adolescent risk behaviors, and interventions with parents of heterosexual youth have been shown to be effective in increasing parent-adolescent communication, and thereby, reducing adolescent health risks. Thus, the aim of the proposed study is to pilot test the efficacy of an online intervention to increase and improve parent communication with AMSM about sexuality and HIV, with the ultimate goal of decreasing adolescent sexual risk and increasing HIV testing. This will be achieved by randomizing parents who come to seek resources on the investigators' existing website to receive either (a) a film designed to support parents of LGB youth, or (b) that film + the online communication intervention materials, and then gathering longitudinal, online data from parents in both study arms and their AMSM sons over a 2-4 month period. It is hypothesized that parents in the intervention group will increase their communication with their sons about HIV and condoms.

Registry
clinicaltrials.gov
Start Date
June 14, 2019
End Date
June 1, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Huebner

Associate Professor

George Washington University

Eligibility Criteria

Inclusion Criteria

  • Parent or legal guardian of a child with all of the following characteristics:
  • cisgender male
  • self-identify as gay or bisexual
  • lives in the same house with parent at least 2 days per week.

Exclusion Criteria

  • Child with known HIV infection

Outcomes

Primary Outcomes

Change in Sexual Health Communication Checklist score -- Parents

Time Frame: Parents are queried about whether they engaged in these behaviors at three time points: baseline, 4-6 week follow-up, and 8-12 week follow-up. We will assess change from baseline to each of the two followup points.

This is a new measure developed for this pilot study. Thus, we will first examine the measure's reliability and validity. Assuming acceptable psychometric properties, this will be the primary outcome measure. The checklist queries parents and children whether they have engaged in four different activities specifically recommended by our intervention: providing information about HIV, providing information about correct condom usage, providing information about condom acquisition, and supporting HIV testing. For each of those four activities, families have multiple ways to do the activity (e.g., for providing information about correct condom use, parents can: send a video, explain the process, or demonstrate the process). Thus, the checklist queries 11 specific behaviors. Families are coded as having completed the activity if they have engaged in any one of the multiple behaviors congruent with the corresponding activity. Thus, scores on the measure range from 0-4.

Change in Sexual Health Communication Checklist score -- Child

Time Frame: Sons are queried about whether their parents engaged in these behaviors at baseline and at 12 week followup. We will assess change from baseline to followup.

This is a new measure developed for this pilot study. Thus, we will first examine the measure's reliability and validity. Assuming acceptable psychometric properties, this will be the primary outcome measure. The checklist queries parents and children whether they have engaged in four different activities specifically recommended by our intervention: providing information about HIV, providing information about correct condom usage, providing information about condom acquisition, and supporting HIV testing. For each of those four activities, families have multiple ways to do the activity (e.g., for providing information about correct condom use, parents can: send a video, explain the process, or demonstrate the process). Thus, the checklist queries 11 specific behaviors. Families are coded as having completed the activity if they have engaged in any one of the multiple behaviors congruent with the corresponding activity. Thus, scores on the measure range from 0-4.

Secondary Outcomes

  • Change in Parent-Adolescent Sexual Health Communication Assessment(Parents are queried at baseline, 8-week followup, and 12-week followup. Sons are queried at baseline and 12-week followup.)
  • Change in condom-use self efficacy(For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up)
  • Change in parent intentions for sexual health communication(Parents are given this measure at baseline, immediately post-intervention, and at 4-6 week follow-up after engaging with booster material. We will assess change from baseline to post intervention and from baseline to 4-6 week followup.)

Study Sites (1)

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