Clinical trial NCT04018573: Testing an Online Intervention to Improve Parents' Communication With Gay and Bisexual Sons About Sex and HIV
Official title: Developing an HIV Prevention Intervention for Young MSM Through Improved Parent-child Communication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-07-12
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Parent or legal guardian of a child with all of the following characteristics:

  1. cisgender male
  2. age 14-22
  3. self-identify as gay or bisexual
  4. lives in the same house with parent at least 2 days per week.

     Exclusion Criteria:
* Child with known HIV infection

Primary outcomes:
measure: Change in Sexual Health Communication Checklist score -- Parents
timeFrame: 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.
measure: Change in Sexual Health Communication Checklist score -- Child
timeFrame: 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.
Secondary outcomes:
measure: Change in parent intentions for sexual health communication
timeFrame: 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.
measure: Change in Parent-Adolescent Sexual Health Communication Assessment
timeFrame: Parents are queried at baseline, 8-week followup, and 12-week followup. Sons are queried at baseline and 12-week followup.
measure: Change in condom-use self efficacy
timeFrame: For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up
Other outcomes:
measure: Change in HIV knowledge
timeFrame: For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up.
measure: Change in condom knowledge
timeFrame: For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up
measure: Change in self-efficacy for communicating with a child about condoms
timeFrame: Change from baseline to (a) immediate post-intervention, (b) 8 week followup, and (c) 12 week followup.
measure: Change in outcome expectancy for condom communication
timeFrame: Change from baseline to (a) immediate post-intervention, (b) 8 week followup, and (c) 12 week followup.
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
Study officials:
affiliation: George Washington University
name: David M Huebner, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huebner DM, Barnett AP, Baucom BRW, Guilamo-Ramos V. Effects of a Parent-Focused HIV Prevention Intervention for Young Men Who have Sex with Men: A Pilot Randomized Clinical Trial. AIDS Behav. 2023 May;27(5):1502-1513. doi: 10.1007/s10461-022-03885-1. Epub 2022 Nov 10.