Scale-up of an Internet-Delivered Study for HIV+ Men (Positive View)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Public Health Solutions
Sponsor:
Collaborators:
Hunter College
Columbia University
CUNY Brooklyn College
Emory University
Medical College of Wisconsin
Information provided by (Responsible Party):
Sabina Hirshfield, Public Health Solutions
ClinicalTrials.gov Identifier:
NCT02023580
First received: December 17, 2013
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

Although HIV testing and highly effective antiretroviral therapy (ART) have improved survival with HIV, the relatively low level of ART adherence presents a significant public health challenge in terms of the potential to transmit HIV. Preventing transmission in virally unsuppressed HIV+ MSM who have unprotected anal intercourse (UAI) with serodiscordant partners can have a great public health impact. As new HIV infections in MSM have been attributed in part to increased access to sex partners online, it is critical to deliver behavioral interventions to HIV+ MSM online to reach many high-risk men at a relatively low cost.

The investigators' theoretically-grounded HIV prevention videos about UAI, HIV disclosure, and testing in MSM were rigorously evaluated among MSM recruited online. Findings indicated significant reductions in UAI and significant increases in HIV status disclosure at 3-month follow-up, compared to baseline. In a subsequent online, randomized controlled trial (RCT) for MSM, investigators found significant reductions in UAI among MSM in the video arm at 60-day follow-up, compared to baseline; HIV+ MSM in the video arm reduced UAI, including serodiscordant UAI (SDUAI) at 60-day follow-up, compared to baseline. Based on these findings, investigators worked with POZ.com (POZ), the largest website for HIV+ individuals, to test whether they could recruit ethnically diverse HIV+ MSM and were very successful. The investigators have identified a potentially highly effective and feasible risk reduction intervention approach for HIV+ MSM.

With the commitment of POZ and a strong team of experts, the investigators propose to refine our intervention by editing our 3 HIV prevention videos into short doses for 10 online sessions (including boosters); targeting HIV+ MSM who are virally unsuppressed; monitoring self-reported clinical indicators (i.e., viral load); targeting online recruitment by race/ethnicity to enroll equal numbers of HIV+ White, Black and Hispanic MSM for balanced representation; improving retention with incentives and a proven online platform; including educational information about ART adherence; and cost and cost-effectiveness analyses for potentially averted HIV infections to determine health-related cost savings. Online, the investigators will recruit and follow a national sample of 1,500 high-risk, virally unsuppressed HIV+ MSM for 12 months.


Condition Intervention Phase
HIV
Behavioral: Video treatments
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Scale-up of an Internet-Delivered Randomized Controlled Trial for HIV+ Men

Resource links provided by NLM:


Further study details as provided by Public Health Solutions:

Primary Outcome Measures:
  • SDUAI [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
    We will measure whether there is a reduction, increase, or no change in serodiscordant unprotected anal intercourse with HIV-negative or unknown status male sex partners across the two study arms.


Secondary Outcome Measures:
  • HIV disclosure [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
    We will measure whether there is an increase, decrease or no change in HIV disclosure to sex partners across the two study arms at the above mentioned time frames.


Estimated Enrollment: 1500
Study Start Date: June 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
The Video Treatment arm will complete baseline, 3-, 6-, 9-, and 12-month online survey assessments. Between baseline and 3-month follow-up, men will view 6 video vignettes (participants will receive a link to view a video vignette once a week for 6 weeks). Based on our team's experience of attenuated intervention effects at 6 months, men will receive 4 video boosters, spaced 1 week apart, after the 6-month assessment survey. Spacing the dose over time can improve critical thinking. The additional videos will be a continuation of the dramatic series plus additional video scenes on disclosure and serodiscordant partnerships.
Behavioral: Video treatments

The treatment video vignettes to be delivered between Baseline and 3 Months include: 1) Condom use/anal sex without HIV status disclosure (potentially SDUAI); 2) Condom use/anal sex without HIV status disclosure and perceived responsibility; 3) Discussion of nondisclosure of HIV status prior to sex and perceived responsibility, STIs; 4) Stigma associated with disclosing HIV status to sex partners; 5) HIV/STI testing; and 6) Diagnosis of an STI; STI disclosure to sex partners and perceived responsibility.

Video boosters to be delivered weekly for 4 weeks between 6 and 9 Months include: 7) HIV status disclosure, condom use, STIs; 8) STI disclosure to sex partners, disclosure to friends, serodiscordant partnerships; 9 & 10) Support of HIV disclosure and perceived responsibility.

Active Comparator: Control
The video control arm will complete baseline, 3-, 6-, 9-, and 12-month online survey assessments. The control arm will receive the same number (and timing of) video clips as the intervention arm, but from a non-theoretically driven gay-oriented show with videos that are similar in length in order to preserve dosing equality across both arms. As the video treatment arm will be provided efficacious theory-driven videos, investigators expect to find a significant decrease in sexual risk behaviors in the intervention arm, compared to the control arm. Should this occur by month 6, with agreement from the data safety monitoring board (DSMB), investigators will provide the control arm with the video treatments.
Behavioral: Video treatments

The treatment video vignettes to be delivered between Baseline and 3 Months include: 1) Condom use/anal sex without HIV status disclosure (potentially SDUAI); 2) Condom use/anal sex without HIV status disclosure and perceived responsibility; 3) Discussion of nondisclosure of HIV status prior to sex and perceived responsibility, STIs; 4) Stigma associated with disclosing HIV status to sex partners; 5) HIV/STI testing; and 6) Diagnosis of an STI; STI disclosure to sex partners and perceived responsibility.

Video boosters to be delivered weekly for 4 weeks between 6 and 9 Months include: 7) HIV status disclosure, condom use, STIs; 8) STI disclosure to sex partners, disclosure to friends, serodiscordant partnerships; 9 & 10) Support of HIV disclosure and perceived responsibility.


  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • biologically male
  • age 18 or over
  • able to read and respond in English or Spanish
  • reside within the U.S.
  • report UAI (including dipping, i.e., brief acts of UAI) with any HIV-negative or unknown status male partners in the past 6 months
  • identify as HIV-positive
  • in the past year, report a detectable viral load or report not being on ART and not knowing their viral load
  • report their race and ethnicity as White, Black or Hispanic
  • be willing to participate in an online intervention study for 12 months
  • have a working email address and cell phone number for intervention follow-up

Exclusion Criteria:

  • HIV-positive MSM with a self-reported undetectable viral load (or a viral load < 400 copies/ml, as this may be the most sensitive test some men have had)
  • HIV-negative or untested MSM
  • women
  • transgendered persons
  • anyone under age 18
  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: NCT02023580

Locations
United States, New York
Public Health Solutions Not yet recruiting
New York, New York, United States, 10013
Contact: Sabina Hirshfield, PhD    646-619-6676    shirshfield@healthsolutions.org   
Contact: Mary Ann Chiasson, DrPH    646-619-6411    machiasson@healthsolutions.org   
Principal Investigator: Sabina Hirshfield, PhD         
Sponsors and Collaborators
Public Health Solutions
Hunter College
Columbia University
CUNY Brooklyn College
Emory University
Medical College of Wisconsin
Investigators
Principal Investigator: Sabina Hirshfield, PhD Public Health Solutions
  More Information

Additional Information:
Publications:
Responsible Party: Sabina Hirshfield, Senior Research Scientist, Public Health Solutions
ClinicalTrials.gov Identifier: NCT02023580     History of Changes
Other Study ID Numbers: R01MH100973-01A1
Study First Received: December 17, 2013
Last Updated: December 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Public Health Solutions:
Viral suppression
Sexual risk

ClinicalTrials.gov processed this record on July 10, 2014