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

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ClinicalTrials.gov Identifier: NCT02023580
Recruitment Status : Completed
First Posted : December 30, 2013
Last Update Posted : December 29, 2017
Sponsor:
Collaborators:
Hunter College of City University of New York
Columbia University
City University of New York, School of Public Health
Emory University
Information provided by (Responsible Party):
Sabina Hirshfield, Public Health Solutions

Brief Summary:

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 condomless anal sex (CAS) 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 CAS, HIV disclosure, and testing in MSM were rigorously evaluated among MSM recruited online. Findings indicated significant reductions in CAS 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 CAS among MSM in the video arm at 60-day follow-up, compared to baseline; HIV+ MSM in the video arm reduced UAI, including serodiscordant CAS (SDCAS) 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 reshoot the videos to show the perspective of an HIV-positive man's experience with relationships and struggle ART adherence. The intervention videos will provide short doses for 10 online sessions (including boosters). We will target HIV+ MSM who are virally unsuppressed and monitor self-reported clinical indicators (i.e., viral load). Further, we will target 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 or disease Intervention/treatment Phase
HIV Behavioral: Video treatments Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Scale-up of an Internet-Delivered Randomized Controlled Trial for HIV+ Men
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
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 SDCAS); 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 SDCAS); 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.




Primary Outcome Measures :
  1. SDCAS [ Time Frame: 3 months, 6 months, 9 months, 12 months ]
    We will measure whether there is a reduction, increase, or no change in serodiscordant condomless anal sex with HIV-negative or unknown status male sex partners across the two study arms.


Secondary Outcome Measures :
  1. HIV disclosure [ Time Frame: 3 months, 6 months, 9 months, 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • biologically male
  • age 18 or over
  • able to read and respond in English
  • reside within the U.S.
  • report CAS 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 OR report past month suboptimal ART adherence
  • 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-negative or untested MSM
  • women
  • transgender persons
  • anyone under age 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023580


Locations
United States, New York
Public Health Solutions
New York, New York, United States, 10013
Sponsors and Collaborators
Public Health Solutions
Hunter College of City University of New York
Columbia University
City University of New York, School of Public Health
Emory University
Investigators
Principal Investigator: Sabina Hirshfield, PhD Public Health Solutions